\nOur mission is to develop therapies that empower the immune system to combat neurodegeneration and our team is focused on developing treatments for some of the most challenging diseases facing our society. We are supported in this mission by experienced and accomplished scientists and clinicians, a novel portfolio of programs, leading healthcare investors, and pharma company partners, who share in our commitment to bettering the lives of patients and realizing a world where we make brain disorders history \n\n\nAs the Biostatistics Director, you will provide statistical leadership and expertise in support of the clinical development activities for multiple therapeutic areas. You will be responsible to provide statistic contribute strategically to project decisions with a focus on pre-study planning, protocol development, sample size/power calculations, Statistical Analysis Plan preparation/review, data quality reviews, development of tables/listings/figures, preparation/mapping of clinical study data for regulatory submission, and integrated safety and efficacy reporting. You are expected to apply innovative statistical approaches to the work; support and defend analyses and their interpretations in meetings and teleconferences with regulatory agencies and prepare written responses to agency questions. The Director will possess the ability to influence key decision-makers within the project team and within senior management to ensure a high degree of rigor to the statistical and scientific decision-making process and outcomes.\n\n\nDo you want to apply your existing technical skills, join a high-performing team and learn and implement new capabilities? Can you see yourself playing a key role in clinical development and trial design for our antibody therapeutics? If so, we want to hear from you. \n\n\n\nDuring your first year, your goals will include:\n* Define how you will contribute to Alector's overall 3-5 year vision to continually improve our clinical development strategy\n* Collaborate with internal and external partners in the optimized clinical study design, end point selection and sample size calculations, analysis, interpretation, and publication of clinical trial data\n* Execute protocols, statistical analysis plans, study reports, ensure statistical integrity of presentations and publications of clinical studies\n* Support project team and clinical study team including but not limited to derivation of go/no-go criteria, generation of data visualizations and summary reports, and interpretation of results to support internal decision-making\n* Participate in regulatory interactions and responsible for biostatistics input into study protocols and clinical study reports\n* Review study randomization specifications, oversee outsourced development of analysis data and results; and reviewing case report forms while managing workflow to ensure quality, prioritization, and timeliness across multiple programs\n* Provide statistical oversight in the development of key study documents\n* Manage external vendors and serve as a key Biostats liaison with external organizations\n* Participate in establishing and maintaining policies, standards, and guidance for Biostatistical operations\n* Ensure up to date knowledge of industry and academic developments in the Neuroscience and Orphan disease fields and apply to clinical study design and analysis \n\n\n\nWe'd love to hear for you if you have:\n* PhD with 8-10 years, or MS with 10-12 years of proven experience in academia or industry. Pharmaceutical/biotech industry experience preferred\n* Solid understanding of theoretical and applied statistics\n* Experience with multiple imputation, multivariate statistics and statistical methods to quantify uncertainty in multi-dimensional data; experience running simulations and mixed models\n* Hands-on ability to drive and lead statistical strategies for clinical development of drug candidates from first-in-human testing to all later phases of clinical investigation, including pivotal Phase 2/3 studies and NDA/BLA submissions\n* Experience with rare disease and real world data\n* Demonstrated success in leading the statistical strategy, analysis, and design of a clinical development program\n* Knowledge of applicable regulatory rules and guidelines, e.g., ICH, GCP, HIPAA\n* Advanced programming skills in in SAS and/or R and other relevant statistical software solutions.\n* Ability to code programs to analyze and report complex clinical trial data, as well as for electronic review, exchange, transformation, and submission of data in CDlSC, SDTM and ADaM formats\n* Strong application of innovative study designs and developing landmark criteria (e.g. Go/No Go criteria).\n* Detailed knowledge of adaptive designs, Bayesian methodology, trial simulation, and data modeling strongly preferred\n\n\n\n\n$250,000 - $265,000 a yearBase salary ranges will be determined by the candidateโs level, qualifications, skill set, and experience\n\n#LI-BL1\n#LI-Remote\n\n\nAt Alector, our vision is bold, people are our priority, and our values are at the core of everything we do. Our dynamic and flexible environment encourages our teams to experiment, take ownership of decisions, and question convention to solve complex problems. We value shared wins, perseverance, and a growth mindset, which drives us forward, together. \n\n\nAmong the things you'll discover at Alector from your very first day are our committed and driven colleagues, a bold company vision, and new, modern offices designed to inspire innovation and collaboration in South San Francisco, right at the heart of Biotech Bay. Our benefits are thoughtfully designed around Alectorians and their loved ones and include flexible hybrid work options, competitive compensation, and comprehensive and unique benefits that enhance your health and well-being. Come join us! \n \nWe believe that hard-working teams include people from a wide variety of backgrounds and experiences who can challenge each otherโs assumptions with fresh perspectives and bring creative ideas to the table. We are committed to building an open, diverse, and inclusive environment for all employees. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, sexual orientation, age, marital status, veteran status, or disability status, or any other characteristics protected under applicable federal, state, or local laws. \n\n\nWe will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, perform essential job functions, and receive other benefits and privileges of employment. Please contact us to request accommodation. \n\n\nReview our Privacy Policy \n\n#Salary and compensation\n
No salary data published by company so we estimated salary based on similar jobs related to Design and Senior jobs that are similar:\n\n
$77,500 — $117,500/year\n
\n\n#Benefits\n
๐ฐ 401(k)\n\n๐ Distributed team\n\nโฐ Async\n\n๐ค Vision insurance\n\n๐ฆท Dental insurance\n\n๐ Medical insurance\n\n๐ Unlimited vacation\n\n๐ Paid time off\n\n๐ 4 day workweek\n\n๐ฐ 401k matching\n\n๐ Company retreats\n\n๐ฌ Coworking budget\n\n๐ Learning budget\n\n๐ช Free gym membership\n\n๐ง Mental wellness budget\n\n๐ฅ Home office budget\n\n๐ฅง Pay in crypto\n\n๐ฅธ Pseudonymous\n\n๐ฐ Profit sharing\n\n๐ฐ Equity compensation\n\nโฌ๏ธ No whiteboard interview\n\n๐ No monitoring system\n\n๐ซ No politics at work\n\n๐ We hire old (and young)\n\n
\n\n#Location\nUnited States
๐ Please reference you found the job on Remote OK, this helps us get more companies to post here, thanks!
When applying for jobs, you should NEVER have to pay to apply. You should also NEVER have to pay to buy equipment which they then pay you back for later. Also never pay for trainings you have to do. Those are scams! NEVER PAY FOR ANYTHING! Posts that link to pages with "how to work online" are also scams. Don't use them or pay for them. Also always verify you're actually talking to the company in the job post and not an imposter. A good idea is to check the domain name for the site/email and see if it's the actual company's main domain name. Scams in remote work are rampant, be careful! Read more to avoid scams. When clicking on the button to apply above, you will leave Remote OK and go to the job application page for that company outside this site. Remote OK accepts no liability or responsibility as a consequence of any reliance upon information on there (external sites) or here.
IMVT Corporation is hiring a Remote Senior Director Program Management
\n \n\nOrganizational Overview:\n\nImmunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As a trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases. \n\n \n\nThe Role: \n\nImmunovant is seeking a highly skilled Project Manager to play a key role on a highly dynamic cross-functional team. In this role, you will be responsible for collaborating across many company workstreams, including strategic planning and for managing one of Immunovantโs development pipeline programs heading into Ph 2 and Ph 3 development. The individual in this position will have the unique opportunity to participate in the rapid growth of a biotech startup.\n\n \n\nKey Responsibilities: \n\n\n* Provide program level support to a therapeutic teamโs Ph 2 and/or Ph3 program.\n\n* Maintain visibility across indications to identify synergies/impact across functional areas.\n\n* Align with the cross-functional leadership team to develop strategic plans for the program and detailed, integrated timelines.\n\n* Develop and maintain relationships across the cross functional areas that support the program.\n\n* Lead discussions, gain cross-functional alignment towards goals, and set priorities towards expediting the development and commercialization of key programs.\n\n* Propose and explore multiple scenarios and challenge the team to consider innovative approaches to achieve faster execution while maintaining high quality.\n\n* Lead cross-functional risk discussions, Develop and maintain risk registry, and develop/monitor actionable mitigation and contingency plans across all functions (ie: clinical, non-clinical, CMC, regulatory).\n\n* Monitor and track progress against set goals for program delivery.\n\n* Lead decision making discussions, capture and document key decisions and escalate appropriately to bring resolution to open / pending decisions effectively and in a timely manner.\n\n* Develop and support strategic initiatives to meet overall corporate goals.\n\n* Maintain dashboard and provide status updates for regular portfolio meetings.\n\n\n\n\n \n\nRequirements:\n\n\n* 15+ years of experience at a life sciences, biotech, or pharmaceutical company in a project management role in a fast-paced, demanding environment\n\n* BA/BS in math, science or engineering; MBA or advanced degree preferred\n\n* Demonstrated experience with full drug development lifecycle at a program level leading teams to deliver across late phases of development from (Ph 2 - BLA - to commercialization). Recent experience with Ph 3 leading to submissions and launch highly desirable.\n\n* Demonstrated ability to manage cross functional teams and diverse sets of stakeholders\n\n* Multitasking ability to oversee a large Program with multiple projects and reach milestones on time and with quality\n\n* Strong project management skills with a proven track record of success, expertise with PPM tools (eg: MS project). PMP certification desirable\n\n* Strong written and oral communication skills with incredible attention to detail\n\n* Willingness to roll up your sleeves and get in the details of the program\n\n* Demonstrate strategic thinking with ability to develop solid executable tactical plans\n\n* Ability to think outside of the box and challenge the status quo\n\n* Natural entrepreneurial spirit with unrelenting dedication to delivering results\n\n* Desire to work in a fast-paced, innovative environment\n\n* Facilitate risk discussions and develop actionable mitigation and contingency plans.\n\n* Natural collaborator who enjoys working on a cross-functional team\n\n\n\n\n \n\nWork Environment:\n\n\n* The position is flexible for remote work.\n\n* Dynamic, interactive, fast-paced, and entrepreneurial environment\n\n* Domestic or international travel are required (10-20%)\n\n\n\n\n \n\nCompensation is based on a number of factors including market location and may vary depending on job-related knowledge, skills, and experience. Equity, sign-on bonuses, and other forms of compensation may be provided as part of a total compensation package, in addition to a full range of medical, dental, vision, 401k and other benefits, including unlimited paid time off and parental leave. The annual base salary for this position ranges from $265,000.00 - $280.000.00.\n\n \n\n \n\n#Salary and compensation\n
No salary data published by company so we estimated salary based on similar jobs related to Travel and Senior jobs that are similar:\n\n
$100,000 — $155,000/year\n
\n\n#Benefits\n
๐ฐ 401(k)\n\n๐ Distributed team\n\nโฐ Async\n\n๐ค Vision insurance\n\n๐ฆท Dental insurance\n\n๐ Medical insurance\n\n๐ Unlimited vacation\n\n๐ Paid time off\n\n๐ 4 day workweek\n\n๐ฐ 401k matching\n\n๐ Company retreats\n\n๐ฌ Coworking budget\n\n๐ Learning budget\n\n๐ช Free gym membership\n\n๐ง Mental wellness budget\n\n๐ฅ Home office budget\n\n๐ฅง Pay in crypto\n\n๐ฅธ Pseudonymous\n\n๐ฐ Profit sharing\n\n๐ฐ Equity compensation\n\nโฌ๏ธ No whiteboard interview\n\n๐ No monitoring system\n\n๐ซ No politics at work\n\n๐ We hire old (and young)\n\n
๐ Please reference you found the job on Remote OK, this helps us get more companies to post here, thanks!
When applying for jobs, you should NEVER have to pay to apply. You should also NEVER have to pay to buy equipment which they then pay you back for later. Also never pay for trainings you have to do. Those are scams! NEVER PAY FOR ANYTHING! Posts that link to pages with "how to work online" are also scams. Don't use them or pay for them. Also always verify you're actually talking to the company in the job post and not an imposter. A good idea is to check the domain name for the site/email and see if it's the actual company's main domain name. Scams in remote work are rampant, be careful! Read more to avoid scams. When clicking on the button to apply above, you will leave Remote OK and go to the job application page for that company outside this site. Remote OK accepts no liability or responsibility as a consequence of any reliance upon information on there (external sites) or here.
Alpine Immune Sciences is hiring a Remote Senior Director Regulatory Affairs
\nAlpine Immune Sciences is a leading clinical-stage biopharmaceutical company dedicated to discovering and developing innovative, protein-based immunotherapies for autoimmune and inflammatory diseases. Exciting challenges lie aheadโguided by our core values, weโll meet these challenges. Join us!\n\n\n\n\nThe Senior Director, Regulatory Affairs is a leader, who provides vision and direction in a fast-paced, dynamic, and competitive drug development environment. They report to the Executive Director of Regulatory Affairs and are responsible for contributing to the global company regulatory strategy and working closely with cross functional leaders in all regulatory interactions and activities for the development of Alpineโs therapeutic candidates. \n \nDuties and responsibilities:\n \nโขLead strategic regulatory activities to support cross functional product development teams in alignment with corporate and program goals.\nโขServe as the global regulatory lead for select development programs.\nโขDevelop and implement regulatory strategy for INDs, CTAs, BLAs; MAAs, NDAs; identify opportunities globally for expedited development. \nโขProvide strategic regulatory input on clinical, including therapeutic indication(s), study designs, patient populations, pediatric development; CMC; and nonclinical development. \nโขPrepare and coordinate authoring, review, and submission of high-quality regulatory documents, including Information Requests, IND/CTA submissions, BLAs/MAAs/NDA, Annual Reports/DSURs, briefing books for health authority interactions, clinical documents to ensure they are complete, well-written, and meet all relevant regulatory requirements. This may involve writing relevant sections of documents.\nโขLead regulatory aspects of clinical study executing including management of correspondence with health authorities and coordination with partner companies and vendors.\nโขEnsure compliance of all Alpine activities with applicable global regulations, standards, and clinical practice guidelines. \nโขMonitor regulatory developments within the industry globally, evaluate impact to Alpineโs programs, and provide actionable guidance to internal and external partners to adapt to and address the developments. \nโขIdentify and communicate with senior management and cross-functional teams regarding potential regulatory issues; propose risk mitigation strategies and resolutions. \nโขLeads continuous improvement efforts on existing department processes and strategies, providing recommendations in areas of expertise.\nโขSupervise, mentor, and help develop the strategic and technical expertise of regulatory colleagues within the Alpine organization.\n \nQualifications:\n \nโขBS/BA degree (or equivalent) in a relevant scientific field required, with an advanced degree preferred.\nโข10+ years of experience in biotechnology or pharmaceutical industry with hands on experience and knowledge of the drug development process and regulatory submission and approval process required.\nโขExperience working in a regulatory affairs leadership role with sole responsibility for a clinical-stage development program and marketing authorization applications, with experience as a manager/supervisor. \nโขLate-stage clinical development experience and experience submitting BLAs, NDAs, and/or MAA is required.\nโขCMC experience, including biologics, is desired.\nโขIn depth knowledge of FDA, EMA, and ICH regulatory requirements and guidelines specific to the areas of clinical research, nonclinical testing, product development, and labeling is required. \nโขMust be capable of developing and implementing regulatory strategy and of managing complex negotiations with Regulatory Authorities.\nโขDemonstrated ability to develop/maintain strong working relationships with cross-functional internal and external teams, participate on and/or lead multifunctional teams, manage, and prioritize multiple projects and work independently.\nโขPrior global regulatory experience required; experience in Asia Pacific and Latin America is desired.\nโขStrong vendor management experience is desired. \nโขTherapeutic area experience in autoimmune disease is desired.\nโขMust be detail-oriented while also retaining the ability to see the big picture.\nโขMust have effective technical/analytical skills to identify and solve problems independently.\nโขMust be able to work in a fast-paced, timeline-driven environment.\nโขShould have experience writing and developing SOPs.\n\n\n\n\n\nAt Alpine we engage equitable workplace strategies to ensure fair compensation. Actual compensation is dependent upon current market data, experience, and pay parity within our organization. This is a Director level position with a compensation range of $230,000 to $270,000. Note that there is a strong preference for candidates to be located in one of the following five states: CA, MA, NC, OR, or WA. We take care of our employees with a competitive benefits package that includes stock options, annual bonus, premium medical, dental, and vision coverage for employees and their dependents, as well as life and disability benefits, FSA, and 401(k) plans. We believe quality time outside the office is vital to our employeesโ satisfaction at work, so our flexible PTO plan of 160 hours, generous holiday time (generally 12 days), and parental benefits encourages team members to take time off so they can come back refreshed. Alpine team members enjoy competitive salaries and equity participation (stock options).\n\n\nAlpinists share a passion for meaningful work and are committed to solving the most complex problems in immunology to create new therapies for patients. We believe in innovative thinking, collaboration, flexibility, bias for action, and healthy debate. To foster our team of outstanding scientists and business professionals, we provide a premier work environment with a state-of-the-art lab and office spaces with truly inspiring views, and an open design to facilitate teamwork.\n\n\nOur treasured culture has been shaped by our diverse team who truly enjoys working and playing together. We nurture Alpineโs culture in many ways, including all-company social events and happy hours, lunch-and-learn and education opportunities, interest groups like book club and movie nights, peer-to-peer recognition programs, a robust wellness program to help support physical, mental, and emotional health, and more.\n\n\nAlpine is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. Alpine is also committed to compliance with all fair employment practices regarding citizenship and immigration status.\n\n\nOur office and lab are located in the blossoming biotech neighborhood of Eastlake in Seattle. Alpinists enjoy the flexibility to work onsite, remotely, or a hybrid schedule, with evolving options as we prioritize keeping Alpinists safe and healthy. Onsite employees enjoy an open-office layout with comfortable huddle rooms and Zoom Room-enabled conference rooms, a spacious breakroom and kitchen with a coffee bar and snacks, and rooftop access to enjoy gorgeous views of Lake Union and Gas Works Park.\n\n\nExciting challenges lie aheadโguided by our core values, weโll meet these challenges. Join us!\n \n\n#Salary and compensation\n
No salary data published by company so we estimated salary based on similar jobs related to Design, Education, Senior and Marketing jobs that are similar:\n\n
$70,000 — $105,000/year\n
\n\n#Benefits\n
๐ฐ 401(k)\n\n๐ Distributed team\n\nโฐ Async\n\n๐ค Vision insurance\n\n๐ฆท Dental insurance\n\n๐ Medical insurance\n\n๐ Unlimited vacation\n\n๐ Paid time off\n\n๐ 4 day workweek\n\n๐ฐ 401k matching\n\n๐ Company retreats\n\n๐ฌ Coworking budget\n\n๐ Learning budget\n\n๐ช Free gym membership\n\n๐ง Mental wellness budget\n\n๐ฅ Home office budget\n\n๐ฅง Pay in crypto\n\n๐ฅธ Pseudonymous\n\n๐ฐ Profit sharing\n\n๐ฐ Equity compensation\n\nโฌ๏ธ No whiteboard interview\n\n๐ No monitoring system\n\n๐ซ No politics at work\n\n๐ We hire old (and young)\n\n
\n\n#Location\nRemote
๐ Please reference you found the job on Remote OK, this helps us get more companies to post here, thanks!
When applying for jobs, you should NEVER have to pay to apply. You should also NEVER have to pay to buy equipment which they then pay you back for later. Also never pay for trainings you have to do. Those are scams! NEVER PAY FOR ANYTHING! Posts that link to pages with "how to work online" are also scams. Don't use them or pay for them. Also always verify you're actually talking to the company in the job post and not an imposter. A good idea is to check the domain name for the site/email and see if it's the actual company's main domain name. Scams in remote work are rampant, be careful! Read more to avoid scams. When clicking on the button to apply above, you will leave Remote OK and go to the job application page for that company outside this site. Remote OK accepts no liability or responsibility as a consequence of any reliance upon information on there (external sites) or here.
IMVT Corporation is hiring a Remote Senior Director Associate General Counsel
\n \nCompany Description:\n\nImmunovant, Inc. is a clinical-stage biopharmaceutical company dedicated to enabling normal lives for people with autoimmune diseases. As a leader in FcRn inhibitor technology, we are boldly developing innovative therapies for a range of debilitating autoimmune diseases with significant unmet patient needs. Our investigational compounds, batoclimab and IMVT-1402, are novel, fully human, monoclonal antibodies targeting the neonatal Fc receptor (FcRn). Both are optimized as a subcutaneous injection with potential flexibility in dosing and approach and are designed to reduce immunoglobin G (IgG) antibodies that cause inflammation and disease.\n\n \n\nDue to our growth, we are seeking an Associate General Counsel to join the Immunovant legal department, occupying a position of significant responsibility and reporting directly to Immunovantโs Chief Legal Officer. This individual will work cross-functionally and throughout the organization to provide a broad array of legal and compliance support. The attorney will support Immunovantโs development programs and its multiple clinical trials, SEC filings, and provide counsel and guidance on privacy, business development/alliance management and strategic transactions. High-quality performance in this role will contribute meaningfully to Immunovantโs overall success.\n\n \nKey Responsibilities:\n\n\n* Provide high quality legal advice and serve as a trusted strategic partner to a variety of internal teams\n\n* Coordinate transactional workflows to ensure consistent and efficient delivery of legal support\n\n* Draft and negotiate a broad range of agreements with a particular emphasis on clinical development agreements and related matters\n\n* Serve as a generalist on complex legal and compliance matters for Immunovant, adding legal and business value across all functional areas\n\n* Maintain frequent contact with all functions within the company while managing requests and prioritizing projects\n\n* Develop and present materials on relevant legal and business issues\n\n* Support business development, securities offerings, and other transactions\n\n\n\n\n \nRequirements:\n\n\n* Juris Doctor degree from an ABA-accredited law school and admission to at least one state bar\n\n* 10+ years of relevant experience including biotech/biopharma/pharma experience in an in-house setting and 15+ years of overall legal experience\n\n* Significant transactional experience and exemplary drafting and negotiating skills on a wide range of agreements\n\n* Excellent judgement and ability to asses risks and benefits and convey them in a clear and concise manner\n\n* Strong work ethic and ability to work independently, yet collaboratively, at all levels of the organization with minimal supervision\n\n* Self-motivated, self-starter, and independent\n\n* Excellent productivity, organizational, and time management abilities\n\n* Demonstrated ability to quickly grasp scientific and technical concepts\n\n* Agility and flexibility to handle multiple tasks in a fast-paced, dynamic, biotech environment\n\n* Effectively handle all job office equipment and software (including computer, Microsoft Office, SharePoint, and Slack)\n\n* Outstanding attention to detail and ability to react and respond quickly and effectively\n\n* Ability to exercise initiative and sound judgment and identify opportunities for improvement\n\n* Excellent written and verbal communication skills\n\n* Strong interpersonal skills\n\n* Creative problem solver and ability to think โout of the boxโ\n\n\n\n\n \nWork Environment:\n\n\n* The position is remote (work from home)\n\n* Dynamic, interactive, fast-paced, and entrepreneurial environment\n\n* Travel as required (<5%)\n\n\n\n\n \n\nCompensation is based on a number of factors including market location and may vary depending on job-related knowledge, skills, and experience. Equity, sign-on bonuses, and other forms of compensation may be provided as part of a total compensation package, in addition to a full range of medical, dental, vision, 401k and other benefits, including unlimited paid time off and parental leave. The annual base salary for this position ranges from $280,000.00 - $300,000.00.\n\n \n\n \n\n#Salary and compensation\n
No salary data published by company so we estimated salary based on similar jobs related to React, Microsoft, Senior and Legal jobs that are similar:\n\n
$60,000 — $110,000/year\n
\n\n#Benefits\n
๐ฐ 401(k)\n\n๐ Distributed team\n\nโฐ Async\n\n๐ค Vision insurance\n\n๐ฆท Dental insurance\n\n๐ Medical insurance\n\n๐ Unlimited vacation\n\n๐ Paid time off\n\n๐ 4 day workweek\n\n๐ฐ 401k matching\n\n๐ Company retreats\n\n๐ฌ Coworking budget\n\n๐ Learning budget\n\n๐ช Free gym membership\n\n๐ง Mental wellness budget\n\n๐ฅ Home office budget\n\n๐ฅง Pay in crypto\n\n๐ฅธ Pseudonymous\n\n๐ฐ Profit sharing\n\n๐ฐ Equity compensation\n\nโฌ๏ธ No whiteboard interview\n\n๐ No monitoring system\n\n๐ซ No politics at work\n\n๐ We hire old (and young)\n\n
๐ Please reference you found the job on Remote OK, this helps us get more companies to post here, thanks!
When applying for jobs, you should NEVER have to pay to apply. You should also NEVER have to pay to buy equipment which they then pay you back for later. Also never pay for trainings you have to do. Those are scams! NEVER PAY FOR ANYTHING! Posts that link to pages with "how to work online" are also scams. Don't use them or pay for them. Also always verify you're actually talking to the company in the job post and not an imposter. A good idea is to check the domain name for the site/email and see if it's the actual company's main domain name. Scams in remote work are rampant, be careful! Read more to avoid scams. When clicking on the button to apply above, you will leave Remote OK and go to the job application page for that company outside this site. Remote OK accepts no liability or responsibility as a consequence of any reliance upon information on there (external sites) or here.
Cerevel Therapeutics is hiring a Remote Director Clinical Trials Transparency and Disclosure
\nCompany Overview\n\n\nCerevel Therapeutics is dedicated to unraveling the mysteries of the brain to treat neuroscience diseases. We are tackling neuroscience diseases with a differentiated approach that combines expertise in neurocircuitry with a focus on receptor selectivity. Our portfolio of pre-commercial neuroscience assets targets a broad range of central nervous system (CNS) disorders, including schizophrenia, epilepsy, Parkinsonโs disease and substance use disorder. \n \nHeadquartered in the Greater Boston area, we are bold thinkers, deep experts, resilient pathfinders, and transparent partners who push the boundaries of scientific understanding to unlock breakthrough CNS therapies that have real impact on peopleโs lives.\n \nCerevel aspires to develop and nurture a culture characterized by trust, respect, courage, curiosity, and compassion, with a relentless focus on mission and results. Our patient-centricity guides our purpose, how we treat each other and what we work on every day. The successful candidate will bring their own unique thinking and approach to Cerevel while sharing our core values and convictions.\n\n\nRole Summary:\nThe Director of Clinical Trials Transparency and Disclosure is responsible for leading and managing Global Clinical Trial Disclosure and Data Transparency activities per applicable laws, regulations, and policies. This role will serve as a subject matter expert and primary point of contact for Cerevelโs transparency and disclosure activities (eg, clinical trial results postings, document redactions, and layperson results summaries). The Director will partner with and lead interactions with senior management and team members in relevant functional areas and manage staff and/or vendors who are directly involved in activities related to disclosure and transparency. The successful candidate must be flexible, detailed oriented, self-directed and manage workload to meet submission timelines across all company programs.\n\n\n\nKey Responsibilities\n* Lead Global Clinical Trials Transparency Workstream and provide vendor oversight; potentially build and manage a Clinical Trial Transparency and Disclosure team\n* Establish strategic plans and objectives for Cerevelโs global clinical trials transparency and disclosure capabilities\n* Lead the development of Cerevelโs overall global clinical trials transparency and disclosures policy with key stakeholders, updating the policy as necessary\n* Manage the preparation of plain language (layperson) summaries and redaction of clinical documents in accordance with EMA Policy 0070, EU Clinical Trial Regulation, Health Canada Public Release of Clinical Information (PRCI), and other global regulations\n* Educate and provide company-wide awareness of transparency/disclosure regulations and industry trends\n* Coordinate efforts of cross-functional teams to produce high-quality, scientifically accurate documents & postings (eg, plain language [layperson] summaries, interim and/or final results postings, and redaction documents); acting as liaison between the vendor and Cerevel teams\n* Work on multiple projects/across programs, coordinating work plans that align with corporate timelines and strategic plans\n* Lead teams in the preparation and maintenance of CCI and PPD rules across programs, ensuring consistency of publicly disclosed information across countries, websites, databases, and documents\n* Lead initiatives (including trainings and workshops) and develop/update SOPs, work instructions, and user guides, as needed\n* Ensure lean writing practices for regulatory documents such as clinical trial protocols, Investigatorโs Brochures, and Clinical Study Reports to minimize CCI and PPD\n* Act as a subject matter expert during regulatory inspections\n\n\n\nRequired Qualifications\n* Minimum of 8 years experience in the biotech or pharma industry; including a minimum of 5 years in transparency and disclosure. Advanced degree/academic research or other transferrable skills may be considered in lieu of industry experience.\n* Experience writing plain language (layperson) summaries, results postings, and redactions and understanding of Good Lay Summary Practice (CTEG working Group)\n* Expertise with postings on clinicaltrials.gov and with EU CTR 536/2014 regulations\n* Deep understanding of US and EU requirements for global transparency and clinical trial disclosure as well as other related policies (ICMJE, PhRMA/EFPIA principles for responsible data sharing, etc.)\n* Experience working with CTIS preferred\n* Understands the clinical drug development process, including clinical trial design, operations and results analysis\n* Strong leadership, planning, and project management skills, along with initiative and ability to be productive independently and with minimal administrative support\n* Ability to evaluate and recommend process improvement and suggest/implement best practices\n* Outstanding oral and written communication skills\n* Strong analytical and problem-solving skills; ability to organize/track complex information & prioritize\n* Flexible; adapts work style to meet organization needs\n* Proficient with Microsoft Office products such as (Outlook, Word, Excel, PowerPoint, SharePoint, and Teams), Smart Sheet, Please Review, Veeva Vault, and Adobe Suite\n\n\n\nDesired Qualifications\n* Recent neuroscience experience (within 2 years)\n* Experience contributing to outsourcing strategies and vendor selection, including resourcing/budgeting forecasts for assigned projects\n* Prior experience working in Clinical Development, Clinical Operations, or Medical Writing\n* 2+ yearsโ managing direct reports\n\n\n\nEducation\n* Academic degree (BA/BS at minimum) in a relevant scientific or healthcare discipline, advanced degree (eg PhD) in scientific or healthcare field preferred\n\n\n\n\n\nCerevel is an Equal Opportunity Employer and does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other characteristic protected by applicable law. \n\n#Salary and compensation\n
No salary data published by company so we estimated salary based on similar jobs related to Microsoft and Senior jobs that are similar:\n\n
$50,000 — $85,000/year\n
\n\n#Benefits\n
๐ฐ 401(k)\n\n๐ Distributed team\n\nโฐ Async\n\n๐ค Vision insurance\n\n๐ฆท Dental insurance\n\n๐ Medical insurance\n\n๐ Unlimited vacation\n\n๐ Paid time off\n\n๐ 4 day workweek\n\n๐ฐ 401k matching\n\n๐ Company retreats\n\n๐ฌ Coworking budget\n\n๐ Learning budget\n\n๐ช Free gym membership\n\n๐ง Mental wellness budget\n\n๐ฅ Home office budget\n\n๐ฅง Pay in crypto\n\n๐ฅธ Pseudonymous\n\n๐ฐ Profit sharing\n\n๐ฐ Equity compensation\n\nโฌ๏ธ No whiteboard interview\n\n๐ No monitoring system\n\n๐ซ No politics at work\n\n๐ We hire old (and young)\n\n
\n\n#Location\nBoston, MA (Remote)
๐ Please reference you found the job on Remote OK, this helps us get more companies to post here, thanks!
When applying for jobs, you should NEVER have to pay to apply. You should also NEVER have to pay to buy equipment which they then pay you back for later. Also never pay for trainings you have to do. Those are scams! NEVER PAY FOR ANYTHING! Posts that link to pages with "how to work online" are also scams. Don't use them or pay for them. Also always verify you're actually talking to the company in the job post and not an imposter. A good idea is to check the domain name for the site/email and see if it's the actual company's main domain name. Scams in remote work are rampant, be careful! Read more to avoid scams. When clicking on the button to apply above, you will leave Remote OK and go to the job application page for that company outside this site. Remote OK accepts no liability or responsibility as a consequence of any reliance upon information on there (external sites) or here.
Alpine Immune Sciences is hiring a Remote Director Clinical Trial Liaisons
\nAlpine Immune Sciences is a leading clinical-stage biopharmaceutical company dedicated to discovering and developing innovative, protein-based immunotherapies for autoimmune and inflammatory diseases. Exciting challenges lie aheadโguided by our core values, weโll meet these challenges. Join us!\n\n\n\n\nThe Director, Clinical Trial Liaisons (CTL) is a critical position within Alpine Immune Sciences (ALPN) Clinical Operations team and will be responsible for developing and providing non-promotional clinical information and study support across ALPNโs clinical development portfolio. Poised and articulate, the CTL Director is a listener and educator, problem solver, and a gifted cultivator of new and existing relationships. This position reports to the Head of Clinical Operations.\n \nDuties and responsibilities\n \nโข Will direct field-based staff to forge, cultivate, and maintain relationships with a range of key clinical site/study personnel (Investigators, Study Coordinators, Pharmacists, and Clinical Research Associates, etc.) to build a well-informed and motivated clinical site base for ALPNโs clinical development programs. \nโข Develop a strong understanding of clinical site practices to curate and deliver clinical site engagement strategies \n โข Gathers and shares โBest Practicesโ and tactics for rapid patient enrollment among trial sites. \n โข Gathers data and information on leading indicators of site challenges/successes and feeds back to the study management team and other functional stakeholders to develop pragmatic solutions to address challenges to enable successful execution of studies.\nโข Partners with sites to understand barriers to clinical trial participation and develops and implements effective local and regional subject recruitment strategies, suggest local outreach options, facilitate escalation of site questions/concerns, and develop recruitment/retention initiatives. \nโข Establish process to ensure site staff requests are managed efficiently and effectively, positioning ALPNโs clinical studies as a high priority within investigational site operations.\nโข Collaborates with ALPN Clinical Operations, Clinical Development, and external stakeholders to support study performance and progress.\nโข Frequent and varied site and study leadership engagement through presentations at site initiation, office visits, investigator meetings, and/or advisory boards to enhance current and future clinical trial awareness.\nโข Facilitates identification of clinical trial site and community educational needs for ALPN clinical trials.\nโข Participates in ALPN community outreach and engagement activities for ALPN clinical trials.\nโข Maintains business and clinical knowledge of the treatment landscape including current treatment strategies, current and pending competitors, and new therapeutic developments.\n \nQualifications\n \nTo perform this job successfully, an individual must be able to perform each essential duty. The requirements listed below are representative of the knowledge, skill, abilities, and prior experience required.\n \nโข At least 5 years clinical trials leadership experience\nโข Previous experience in a CTL, MSL, or similar site-facing role preferred\nโข Strong communication, interpersonal, and relationship management skills\nโข Ability to travel domestically and internationally up to 70%; including travel to ALPN at least 6 times/year\nโข Working knowledge of protocol and clinical drug development processes, clinical study design, study planning and management, and monitoring\nโข High attention to detail\nโข Ability to set priorities and juggle multiple demands\nโข Ability to think critically and be a proactive problem-solver\nโข Ability to work independently while exercising initiative, flexibility, and sound judgment\nโข Comfortable working with various levels of the company including senior level management\nโข Demonstrated proficiency in Microsoft Word, PowerPoint, and Excel\nโข Ability to operate in alignment with ALPNโs values\n\n\n#LI-Remote\n \n\n\n\n\n\nAt Alpine we engage equitable workplace strategies to ensure fair compensation. Actual compensation is dependent upon current market data, experience, and pay parity within our organization. This position is a Director level position, with a compensation range of $200,000 - $230,000. Note that there is a strong preference for candidates to be located in one of the following five states: CA, MA, NC, OR, or WA. We take care of our employees with a competitive benefits package that includes stock options, annual bonus, premium medical, dental, and vision coverage for employees and their dependents, as well as life and disability benefits, FSA, and 401(k) plans. We believe quality time outside the office is vital to our employeesโ satisfaction at work, so our flexible PTO plan of 160 hours, generous holiday time (generally 12 days), and parental benefits encourages team members to take time off so they can come back refreshed. Alpine team members enjoy competitive salaries and equity participation (stock options).\n\n\nAlpinists share a passion for meaningful work and are committed to solving the most complex problems in immunology to create new therapies for patients. We believe in innovative thinking, collaboration, flexibility, bias for action, and healthy debate. To foster our team of outstanding scientists and business professionals, we provide a premier work environment with a state-of-the-art lab and office spaces with truly inspiring views, and an open design to facilitate teamwork.\n\n\nOur treasured culture has been shaped by our diverse team who truly enjoys working and playing together. We nurture Alpineโs culture in many ways, including all-company social events and happy hours, lunch-and-learn and education opportunities, interest groups like book club and movie nights, peer-to-peer recognition programs, a robust wellness program to help support physical, mental, and emotional health, and more.\n\n\nAlpine is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. Alpine is also committed to compliance with all fair employment practices regarding citizenship and immigration status.\n\n\nOur office and lab are located in the blossoming biotech neighborhood of Eastlake in Seattle. Alpinists enjoy the flexibility to work onsite, remotely, or a hybrid schedule, with evolving options as we prioritize keeping Alpinists safe and healthy. Onsite employees enjoy an open-office layout with comfortable huddle rooms and Zoom Room-enabled conference rooms, a spacious breakroom and kitchen with a coffee bar and snacks, and rooftop access to enjoy gorgeous views of Lake Union and Gas Works Park.\n\n\nExciting challenges lie aheadโguided by our core values, weโll meet these challenges. Join us!\n \n\n#Salary and compensation\n
No salary data published by company so we estimated salary based on similar jobs related to Design, Education, Microsoft and Senior jobs that are similar:\n\n
$45,000 — $85,000/year\n
\n\n#Benefits\n
๐ฐ 401(k)\n\n๐ Distributed team\n\nโฐ Async\n\n๐ค Vision insurance\n\n๐ฆท Dental insurance\n\n๐ Medical insurance\n\n๐ Unlimited vacation\n\n๐ Paid time off\n\n๐ 4 day workweek\n\n๐ฐ 401k matching\n\n๐ Company retreats\n\n๐ฌ Coworking budget\n\n๐ Learning budget\n\n๐ช Free gym membership\n\n๐ง Mental wellness budget\n\n๐ฅ Home office budget\n\n๐ฅง Pay in crypto\n\n๐ฅธ Pseudonymous\n\n๐ฐ Profit sharing\n\n๐ฐ Equity compensation\n\nโฌ๏ธ No whiteboard interview\n\n๐ No monitoring system\n\n๐ซ No politics at work\n\n๐ We hire old (and young)\n\n
\n\n#Location\nSeattle, WA or Remote
๐ Please reference you found the job on Remote OK, this helps us get more companies to post here, thanks!
When applying for jobs, you should NEVER have to pay to apply. You should also NEVER have to pay to buy equipment which they then pay you back for later. Also never pay for trainings you have to do. Those are scams! NEVER PAY FOR ANYTHING! Posts that link to pages with "how to work online" are also scams. Don't use them or pay for them. Also always verify you're actually talking to the company in the job post and not an imposter. A good idea is to check the domain name for the site/email and see if it's the actual company's main domain name. Scams in remote work are rampant, be careful! Read more to avoid scams. When clicking on the button to apply above, you will leave Remote OK and go to the job application page for that company outside this site. Remote OK accepts no liability or responsibility as a consequence of any reliance upon information on there (external sites) or here.
Prilenia is hiring a Remote Senior Director Commercial Supply Chain and Manufacturing
\nAbout Prilenia \nPrilenia Therapeutics, a clinical-stage biotech company focused on the urgent mission of developing novel therapeutics to slow the progression of neurodegenerative diseases and neurodevelopmental disorders, is looking for a Senior Director, Commercial Supply Chain and Manufacturing to join its team in the East Coast of the United States or Europe.\nWe are a flexible, fast-moving team that is quickly advancing a potential therapy poised to have major impact on the lives of patients and their families. Our lead product candidate, pridopidine, is a first-in-class small molecule, holding Orphan Drug Designation in both Huntingtonโs disease (HD) and Amyotrophic lateral Sclerosis Amyotrophic (ALS) in the U.S. and EU, as well as Fast Track designation from the FDA for the treatment of HD. Prilenia is working on preparing for a potential regulatory filing for HD and for starting a global phase 3 in ALS with pridopidine.\nPridopidine has the potential to be the first treatment to address HD disease clinical progression. Prilenia also believes pridopidineโs novel mechanism of action as a Sigma-1 receptor agonist gives it potential in numerous other neurological diseases. \n \nAbout the role\nWe seek a forward-thinking supply chain hands-on leader to join our team as Senior Director, Commercial Supply Chain and Manufacturing. This position will establish end-to-end global commercial supply chain strategy and serve as an internal SME for matters related to commercial manufacturing, demand planning and global logistics including packaging, shipping, and serialization validation. The ideal candidate will bring in-depth expertise in clinical and commercial supply chain management, launch readiness, DP manufacturing, packaging and labeling, serialization, supply planning, supplier (CDMO) relationship management, contract negotiation, sales and operations planning (S&OP), inventory management, third-party logistics (3PL), process improvement, and strategic planning. A flexible and innovative problem solver who formulates and executes creative and strategic initiatives to adapt to changing market trends and complex global challenges. \nThe position will report to the Head of Chemistry, Manufacturing, and Controls (CMC).\n\n\n\nRoles and Responsibilities:\n* Establish the end-to-end global commercial supply chain strategy for Prileniaโs lead product in preparation of launching first approved product. \n* Lead packaging, shipping, and serialization validation in preparation for launch. \n* Provide direction and leadership of Prileniaโs CDMOs and other external partners to ensure on-time delivery of products that comply with regulatory, legal and quality standards. \n* Serve as internal SME for matters related to commercial manufacturing, demand planning and global logistics. \n* Management of 3PL operations, including distribution and inventory management. \n* Lead and oversee commercial drug product manufacturing plans. \n* Review manufacturing related documentation: production record, protocols, reports. \n* Ensure on-time production and distribution across Drug Substance, Drug Product, Packaging and Labeling. \n* Develop strategies to ensure that commercial supply chain is robust and create risk mitigation plans to ensure that manufacturing timelines are consistent with the company program Responsible for establishing and monitoring manufacturing and demand planning key performance indicators (KPIs). \n* Develop and implement short- and long-term procurement planning strategies toward ensuring 100% availability of raw materials to manufacturing. \n* Manage clinical supply chain in collaboration with relevant internal teams and external vendors (e.g. CROs). \n\n\n\nQualifications:\n* M.Sc. or BA in science and/or engineering (chemistry, pharmacy, engineering or related sciences). \n* 10+ years of extensive experience and demonstrated leadership in clinical and commercial Supply Chain Management and manufacturing. \n* 5+ yearsโ management experience in a GMP environment with oral solid small molecule products. \n* Ability to manage 3PL provider/s. \n* Experience in EU supply chain and first launch highly preferred. \n\n\n\nSkills:\n* A flexible and innovative problem solver who formulates and executes creative and strategic initiatives to adapt to changing market trends and complex global challenges. \n* Capability to build cross-functional alignment including Quality, Regulatory, Finance, Commercial and Manufacturing partners. \n* Excellent oral, written and interpersonal communications skills to effectively interact, exercise discretion, judgment and diplomacy when dealing with internal and external stakeholders and executive leadership. \n* Demonstrated strong leadership capability with ability to make and act on decisions while balancing speed, quality, and risk. \n* Demonstrated ability to influence areas not under direct control to achieve objectives and effectively communicate challenging goals and objectives. \n* Team player with a positive attitude and solid leadership skills who can easily handle shifting priorities, multi-tasking in a deadline-oriented environment. \n* Ability to take initiative, be accountable for individual and team results, and motivate self and others to set and achieve very high-performance standards. \n* Must be able to work under pressure, manage time, set priorities and meet deadlines. \n* Experience working effectively in global virtual setting โ a must. \n\n\n\nLocation/Time Zones:\n* This is a full-time remote position in the East Coast of the United States (preference for Boston area) or Europe (preference for the Netherlands); occasional in-person/face-to-face meetings will occur.\n* Flexible schedule with interactions across Israel, North America and Europe time zones.\n\n\n\n\n \n\n#Salary and compensation\n
No salary data published by company so we estimated salary based on similar jobs related to Senior, Legal, Sales and Non Tech jobs that are similar:\n\n
$40,000 — $80,000/year\n
\n\n#Benefits\n
๐ฐ 401(k)\n\n๐ Distributed team\n\nโฐ Async\n\n๐ค Vision insurance\n\n๐ฆท Dental insurance\n\n๐ Medical insurance\n\n๐ Unlimited vacation\n\n๐ Paid time off\n\n๐ 4 day workweek\n\n๐ฐ 401k matching\n\n๐ Company retreats\n\n๐ฌ Coworking budget\n\n๐ Learning budget\n\n๐ช Free gym membership\n\n๐ง Mental wellness budget\n\n๐ฅ Home office budget\n\n๐ฅง Pay in crypto\n\n๐ฅธ Pseudonymous\n\n๐ฐ Profit sharing\n\n๐ฐ Equity compensation\n\nโฌ๏ธ No whiteboard interview\n\n๐ No monitoring system\n\n๐ซ No politics at work\n\n๐ We hire old (and young)\n\n
๐ Please reference you found the job on Remote OK, this helps us get more companies to post here, thanks!
When applying for jobs, you should NEVER have to pay to apply. You should also NEVER have to pay to buy equipment which they then pay you back for later. Also never pay for trainings you have to do. Those are scams! NEVER PAY FOR ANYTHING! Posts that link to pages with "how to work online" are also scams. Don't use them or pay for them. Also always verify you're actually talking to the company in the job post and not an imposter. A good idea is to check the domain name for the site/email and see if it's the actual company's main domain name. Scams in remote work are rampant, be careful! Read more to avoid scams. When clicking on the button to apply above, you will leave Remote OK and go to the job application page for that company outside this site. Remote OK accepts no liability or responsibility as a consequence of any reliance upon information on there (external sites) or here.
Prilenia is hiring a Remote Director Senior Director Quality
\nAbout Prilenia \nPrilenia Therapeutics, a clinical-stage biotech company focused on the urgent mission of developing novel therapeutics to slow the progression of neurodegenerative diseases and neurodevelopmental disorders, is looking for a Senior/Executive Director of Quality to join its team in Europe. \n\n\nWe are a flexible, fast-moving team that is quickly advancing a potential therapy poised to have major impact on the lives of patients and their families. Our lead product candidate, pridopidine, holds Orphan Drug Designation in both Huntingtonโs disease (HD) and Amyotrophic lateral Sclerosis Amyotrophic (ALS) in the U.S. and EU, as well as Fast Track designation from the FDA for the treatment of HD. Prilenia is working on preparing for a potential regulatory filing for HD and for starting a global phase 3 in ALS with pridopidine.\n\n\nPridopidine has the potential to be the first treatment to address HD disease clinical progression. Prilenia also believes pridopidineโs novel mechanism of action as a Sigma-1 receptor agonist gives it potential in numerous other neurological diseases. \n \nAbout the role\nWe seek a highly qualified and experienced professional to join our team as the Head of Quality. This position will provide both overall direction and hands-on operational execution in establishing, implementing, and maintaining a phase-appropriate and continuously evolving Quality Management System (QMS). The ideal candidate will have background in late clinical stage and first commercialization of products including GCP, GMP, GVP and other relevant GxP, with a pragmatic true fit-for-purpose approach.\nThe position will report to the Chief Operating Officer.\n\n\n\nRoles and Responsibilities:\n* Lead the development, implementation, and continuous improvement of a phase-appropriate Quality Management System (QMS), including policies, processes, and procedures.\n* Collaborate with internal functions to assure effective vendor selection, qualification, and oversight to ensure clinical trials and other outsourced GxP activities are conducted in accordance with all relevant laws, regulations, and guidelines.\n* Assess GMP and regulatory compliance risk areas and develop and implement risk mitigation measures.\n* Create, implement, and oversee audit plans for CROs, CDMOs and other GxP vendors. Assess and respond to audit outcomes.\n* Lead preparations for regulatory inspections and ensure ongoing inspection readiness.\n* Provide GCP advice and audit for clinical studies to ensure they are conducted in accordance with FDA, EMA, ICH and other applicable requirements, guidelines and laws.\n* Identify any training requirements to meet the quality standards and ensure training is completed.\n* Maintain and expand regulatory knowledge, to the ICH Principles of GCP, GMP, General Data Privacy Regulation and International GxPs; provide industry leading compliance guidance and quality assurance consultation to internal and external stakeholders.\n* Manage all relevant external QA vendors e.g. quality auditors, consultants, etc.\n\n\n\nQualifications:\n* 10+ years of experience in QA roles with a mix of Biotechnology/Pharmaceutical and/or CMO/CRO companies. At least part of the time should have been in a small to medium sized biotech or pharma company.\n* In-depth understanding and application of GxP principles, concepts, practices, and standards.\n* Demonstrated experience in establishing and managing quality systems in small to mid-sized companies.\n* Thorough understanding of GCP and GMP standards for late clinical and early commercialization stages; as well as of both US and EU requirements. \n* Prior experience and broad range of knowledge in Quality, Compliance, or a combination of experience such as Manufacturing, Quality, and Regulatory - required. In-depth knowledge in international regulatory landscape - preferred.\n* Proven experience in building key metrics, reporting, and enhancing recruitment technology and systems to influence decision-making and provide compelling story telling.\n\n\n\nSkills:\n* Excellent oral, written and interpersonal communications skills to effectively interact, and exercise discretion, judgment and diplomacy when dealing with internal and external stakeholders and executive leadership. \n* Demonstrated strong leadership capability with ability to make and act on decisions while balancing speed, quality, and risk. Demonstrated ability to influence areas not under direct control to achieve objectives and effectively communicate challenging goals and objectives.\n* Pragmatic and practical approach; understanding of โfit for purposeโ approach. \n* Team player with positive attitude who can easily handle shifting priorities, multi-tasking in a deadline-oriented environment. Must be able to work under pressure, manage time, set priorities and meet deadlines.\n* Highly independent. \n* Experience working in virtual and global setting.\n* Ability to take initiative, be accountable for individual and team results, motivate self and others to set and achieve very high-performance standards.\n\n\n\nLocation/Time Zones:\n* This is a full-time remote position in Europe. \n* Flexible schedule with interactions across Israel, North America and Europe time zones.\n* Occasional travel is expected.\n\n\n\n\n \n\n#Salary and compensation\n
No salary data published by company so we estimated salary based on similar jobs related to Senior and Senior jobs that are similar:\n\n
$40,000 — $80,000/year\n
\n\n#Benefits\n
๐ฐ 401(k)\n\n๐ Distributed team\n\nโฐ Async\n\n๐ค Vision insurance\n\n๐ฆท Dental insurance\n\n๐ Medical insurance\n\n๐ Unlimited vacation\n\n๐ Paid time off\n\n๐ 4 day workweek\n\n๐ฐ 401k matching\n\n๐ Company retreats\n\n๐ฌ Coworking budget\n\n๐ Learning budget\n\n๐ช Free gym membership\n\n๐ง Mental wellness budget\n\n๐ฅ Home office budget\n\n๐ฅง Pay in crypto\n\n๐ฅธ Pseudonymous\n\n๐ฐ Profit sharing\n\n๐ฐ Equity compensation\n\nโฌ๏ธ No whiteboard interview\n\n๐ No monitoring system\n\n๐ซ No politics at work\n\n๐ We hire old (and young)\n\n
\n\n#Location\nEurope
๐ Please reference you found the job on Remote OK, this helps us get more companies to post here, thanks!
When applying for jobs, you should NEVER have to pay to apply. You should also NEVER have to pay to buy equipment which they then pay you back for later. Also never pay for trainings you have to do. Those are scams! NEVER PAY FOR ANYTHING! Posts that link to pages with "how to work online" are also scams. Don't use them or pay for them. Also always verify you're actually talking to the company in the job post and not an imposter. A good idea is to check the domain name for the site/email and see if it's the actual company's main domain name. Scams in remote work are rampant, be careful! Read more to avoid scams. When clicking on the button to apply above, you will leave Remote OK and go to the job application page for that company outside this site. Remote OK accepts no liability or responsibility as a consequence of any reliance upon information on there (external sites) or here.
Alpine Immune Sciences is hiring a Remote Senior Director Executive Director Corporate Communications & Investor Relations
\nAlpine Immune Sciences is a leading clinical-stage biopharmaceutical company dedicated to discovering and developing innovative, protein-based immunotherapies for autoimmune and inflammatory diseases. Exciting challenges lie aheadโguided by our core values, weโll meet these challenges. Join us!\n\n\n\n\nAlpine Immune Sciences is seeking an energetic, passionate, and creative Senior Director/Executive Director, Corporate Communications and Investor Relations reporting to the Chief Business Officer. The successful candidate will work with senior management to develop and lead Alpineโs public relations, corporate communications, and investor relations strategy, manage the Companyโs relationships with the investor community, and assist in strategic planning. The Senior Director/Executive Director, Corporate Communications and Investor Relations will align with senior management to build a strategy that communicates and elevates the Companyโs mission, messaging, and key events to external stakeholders in the broader biotechnology community. The successful candidate thrives in a fast-paced, dynamic environment and will have proven experience in the design and execution of key events such as quarterly earnings calls and presentations, analyst conferences and events, road shows, press releases, social media, and other corporate activities. This is a critical and visible leadership position within the Company. As such, the successful candidate will work closely with the Chief Business Officer, Chief Financial Officer, and other executives to formulate Alpineโs overall corporate communications and investor relations strategy. \n \nDuties and responsibilities\n \nโข Lead creation of corporate and financial communications, including preparation of quarterly earnings press releases and scripts, earnings presentations, Q&A, content for investor presentations, road shows, and board presentations. \nโข Manage and update the Companyโs corporate presentation and press releases for data releases, scientific meetings, presentations, and publications in close collaboration with Scientific Communications.\nโข Manage external consulting relationships and ensure efficiency in external spending. \nโข Work collaboratively to establish corporate brand planning, including brand strategy and identity, through management of company website and creation of other branding materials. \nโข Oversee and lead all corporate social media activities for Company.\nโข Develop a deep and thorough understanding of the Companyโs pipeline and corporate strategy; support the delivery of this strategy to both internal and external audiences through clear and compelling written and oral communication, in compliance with corporate policies and securities regulations. \nโข Proactively engage with buy-side and sell-side research community. \nโข Lead the development and implementation of a targeted investor relations strategy to maximize the Companyโs long-term value creation and ensure the consistent presentation of that strategy across all messaging.\nโข Act as the liaison for Alpineโs investment banking equity research interactions to effectively leverage sell-side capabilities cross-departmentally while optimizing management time with these stakeholders.\nโข Conduct periodic, in-depth, investor targeting exercises and maintain a target investor list.\nโข Support financing activities, including implementation of financing strategy, managing relationships within the banking community, and executing financing activities. \nโข Maintain the IR calendar, which includes strategic decisions on Company and executive participation in investor conferences, non-deal roadshows and analyst/investor meetings.\nโข Ability to travel 10-25% of the time, including occasional off-hours and weekend work for events and medical meetings.\n \nQualifications\n \nโข Undergraduate degree in biological sciences and/or engineering.\nโข MD and/or PhD in life sciences preferred; MBA desirable.\nโข 6-11 years (Senior Director), 12+ years (Executive Director), of successful experience in biotech/pharma investment banking, equity research, management consulting, biotech/pharma corporate strategy, investor relations and/or corporate communications.\nโข In-depth understanding of the drug development process, small molecules, biologics, and other platforms in autoimmune and inflammatory diseases.\nโข Excellent project management and organizational skills with the ability to prioritize multiple work streams and deadlines, balance opposing priorities and communicate effectively.\nโข Excellent written and oral communications skills.\nโข Self-starter with initiative and ability to execute once strategies are set.\nโข Ability to work collaboratively with internal and external stakeholders in a fast-paced environment.\nโข Knowledge of MS Office applications and especially strong in Excel and PowerPoint. \nโข Experience/familiarity with social media strategy, tools, and technologies (e.g., X (Twitter), YouTube, and LinkedIn).\n\n\nLI-Remote\n\n\n\n\n\nAt Alpine we engage equitable workplace strategies to ensure fair compensation. Actual compensation is dependent upon current market data, experience, and pay parity within our organization. This position is a Senior Director level position up to an Executive Director, with a compensation range of $235,000 - $260,000 for a Senior Director, and $255,000 - $290,000 for an Executive Director. Note that there is a strong preference for candidates to be located in one of the following five states: CA, MA, NC, OR, or WA. We take care of our employees with a competitive benefits package that includes stock options, annual bonus, premium medical, dental, and vision coverage for employees and their dependents, as well as life and disability benefits, FSA, and 401(k) plans. We believe quality time outside the office is vital to our employeesโ satisfaction at work, so our flexible PTO plan of 160 hours, generous holiday time (generally 12 days), and parental benefits encourages team members to take time off so they can come back refreshed. Alpine team members enjoy competitive salaries and equity participation (stock options).\n\n\nAlpinists share a passion for meaningful work and are committed to solving the most complex problems in immunology to create new therapies for patients. We believe in innovative thinking, collaboration, flexibility, bias for action, and healthy debate. To foster our team of outstanding scientists and business professionals, we provide a premier work environment with a state-of-the-art lab and office spaces with truly inspiring views, and an open design to facilitate teamwork.\n\n\nOur treasured culture has been shaped by our diverse team who truly enjoys working and playing together. We nurture Alpineโs culture in many ways, including all-company social events and happy hours, lunch-and-learn and education opportunities, interest groups like book club and movie nights, peer-to-peer recognition programs, a robust wellness program to help support physical, mental, and emotional health, and more.\n\n\nAlpine is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. Alpine is also committed to compliance with all fair employment practices regarding citizenship and immigration status.\n\n\nOur office and lab are located in the blossoming biotech neighborhood of Eastlake in Seattle. Alpinists enjoy the flexibility to work onsite, remotely, or a hybrid schedule, with evolving options as we prioritize keeping Alpinists safe and healthy. Onsite employees enjoy an open-office layout with comfortable huddle rooms and Zoom Room-enabled conference rooms, a spacious breakroom and kitchen with a coffee bar and snacks, and rooftop access to enjoy gorgeous views of Lake Union and Gas Works Park.\n\n\nExciting challenges lie aheadโguided by our core values, weโll meet these challenges. Join us!\n \n\n#Salary and compensation\n
No salary data published by company so we estimated salary based on similar jobs related to Design, Consulting, Education and Senior jobs that are similar:\n\n
$45,000 — $85,000/year\n
\n\n#Benefits\n
๐ฐ 401(k)\n\n๐ Distributed team\n\nโฐ Async\n\n๐ค Vision insurance\n\n๐ฆท Dental insurance\n\n๐ Medical insurance\n\n๐ Unlimited vacation\n\n๐ Paid time off\n\n๐ 4 day workweek\n\n๐ฐ 401k matching\n\n๐ Company retreats\n\n๐ฌ Coworking budget\n\n๐ Learning budget\n\n๐ช Free gym membership\n\n๐ง Mental wellness budget\n\n๐ฅ Home office budget\n\n๐ฅง Pay in crypto\n\n๐ฅธ Pseudonymous\n\n๐ฐ Profit sharing\n\n๐ฐ Equity compensation\n\nโฌ๏ธ No whiteboard interview\n\n๐ No monitoring system\n\n๐ซ No politics at work\n\n๐ We hire old (and young)\n\n
\n\n#Location\nSeattle, WA or Remote
๐ Please reference you found the job on Remote OK, this helps us get more companies to post here, thanks!
When applying for jobs, you should NEVER have to pay to apply. You should also NEVER have to pay to buy equipment which they then pay you back for later. Also never pay for trainings you have to do. Those are scams! NEVER PAY FOR ANYTHING! Posts that link to pages with "how to work online" are also scams. Don't use them or pay for them. Also always verify you're actually talking to the company in the job post and not an imposter. A good idea is to check the domain name for the site/email and see if it's the actual company's main domain name. Scams in remote work are rampant, be careful! Read more to avoid scams. When clicking on the button to apply above, you will leave Remote OK and go to the job application page for that company outside this site. Remote OK accepts no liability or responsibility as a consequence of any reliance upon information on there (external sites) or here.
Erasca is hiring a Remote Sr Director Clinical Development
\nSenior Director, Clinical Science \n\nPositionโฏSummary:โฏ \n\nReporting to the SVP Early Clinical Development, the Senior Director, Clinical Development will support and may lead the clinical aspects of one or more clinical development studies. This person will work closely with cross-functional teams in the management and execution of the Clinical Development Plan (CDP), in developing innovative and efficient solutions to medical and scientific clinical trial issues, and in ensuring the successful execution and completion of clinical trials. The Senior Director, Clinical Science will also have individual study level responsibility for one or more trials. \n\n Essential Duties and Responsibilities: \n\n\nKey clinical deliverables include document development (INDs, Protocols, IBs, applicable regulatory documents, etc.), medical and scientific input into the development of deliverables required for study activation and study conduct (CRFs, SAP, data listings, etc.), data review, and other deliverables as needed. \n\nMay attend and contribute at meetings with Health Authorities (HAs) related to program; develop responses to HAs and IRBs on clinical/medical questions. \n\nRepresent Erasca externally at scientific meetings and congresses. \n\nIn collaboration with other functions and stakeholders, continue to create functional policies and procedures to provide strong and efficient clinical development processes that are scalable and fit for purpose. \n\nPerform all duties in keeping with the Companyโs core values, policies and all applicable regulations. \n\n\n\n\nRequired Education and Experience: \n\n\n* Undergraduate degree required; PhD, PharmD, or other relevant advanced degree in a health science field highly preferred. \n\n* At least 10 years of biotech or pharmaceutical industry experience as a clinical scientist or in a closely related clinical development function. \n\n* Experience in oncology clinical trials required; early development experience required, late-stage experience a plus. \n\n* Extensive experience in dynamic start up or small company environments required. \n\n* Demonstrated ability to contribute to strategic clinical planning and work effectively independently and onโฏcross-functional teams. \n\n* Demonstrated ability to evaluate, interpret, and present complex scientific data. \n\n* Deep knowledge of biostatistics, GCP, and regulatory requirements for clinical studies; extensive experience with data analysis and interpretation; understanding of safety and pharmacovigilance principles. \n\n* Proven track record of successfully delivering projects on time, to budget and required quality. \n\n* Excellent verbal and written communication and presentation skills. \n\n* Demonstrated ability to achieve high performance goals and meet deadlines in a fast-paced environment; a collaborative team player with a can-do attitude and the ability to identify and implement creative solutions to complex problems. \n\n* Flexibility, with the willingness and ability to manage through strategic shifts. \n\n* Strong learning orientation, curiosity, and passion for science and patients.โฏ \n\n\n\n\n \n\nThe anticipated salary range for this position is $200,000 to $275,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etcetera. In addition to base salary, the hired applicant will be eligible to receive an annual bonus and an equity grant at hire and annually in the form of the option to purchase stock in the future for a specified price. \n\n#Salary and compensation\n
No salary data published by company so we estimated salary based on similar jobs related to Education and Senior jobs that are similar:\n\n
$50,000 — $75,000/year\n
\n\n#Benefits\n
๐ฐ 401(k)\n\n๐ Distributed team\n\nโฐ Async\n\n๐ค Vision insurance\n\n๐ฆท Dental insurance\n\n๐ Medical insurance\n\n๐ Unlimited vacation\n\n๐ Paid time off\n\n๐ 4 day workweek\n\n๐ฐ 401k matching\n\n๐ Company retreats\n\n๐ฌ Coworking budget\n\n๐ Learning budget\n\n๐ช Free gym membership\n\n๐ง Mental wellness budget\n\n๐ฅ Home office budget\n\n๐ฅง Pay in crypto\n\n๐ฅธ Pseudonymous\n\n๐ฐ Profit sharing\n\n๐ฐ Equity compensation\n\nโฌ๏ธ No whiteboard interview\n\n๐ No monitoring system\n\n๐ซ No politics at work\n\n๐ We hire old (and young)\n\n
\n\n#Location\nSan Diego, California, United States
๐ Please reference you found the job on Remote OK, this helps us get more companies to post here, thanks!
When applying for jobs, you should NEVER have to pay to apply. You should also NEVER have to pay to buy equipment which they then pay you back for later. Also never pay for trainings you have to do. Those are scams! NEVER PAY FOR ANYTHING! Posts that link to pages with "how to work online" are also scams. Don't use them or pay for them. Also always verify you're actually talking to the company in the job post and not an imposter. A good idea is to check the domain name for the site/email and see if it's the actual company's main domain name. Scams in remote work are rampant, be careful! Read more to avoid scams. When clicking on the button to apply above, you will leave Remote OK and go to the job application page for that company outside this site. Remote OK accepts no liability or responsibility as a consequence of any reliance upon information on there (external sites) or here.
Alector is hiring a Remote Senior Director Biostatistics
\nOur mission is to develop therapies that empower the immune system to combat neurodegeneration and our team is focused on developing treatments for some of the most challenging diseases facing our society. We are supported in this mission by experienced and accomplished scientists and clinicians, a novel portfolio of programs, leading healthcare investors, and pharma company partners, who share in our commitment to bettering the lives of patients and realizing a world where we make brain disorders history \n\n\nWe are looking for a Senior Director, Biostatistics, reporting to the VP of Biostatistics and Analytical Programming. As the Biostatistics Senior Director, you will collaborate with R&D functions to support robust and efficient study designs, develop comprehensive analysis plans, and lead the delivery of study data analysis results. You will be the expert statistical leader providing oversight and strategic feedback for the clinical programs assigned to you. The Senior Director, Biostatistics, will drive the development and implementation of statistical strategy to effectively support drug development You will directly impact company success by increasing the strength of study designs, interpretability of results, Regulatory strategy & interactions, and by implementing innovative methods to improve efficiency & quality of clinical development.\n\n\n\n\n\nYour priorities will include:\n* As the lead Biostatistician for assigned projects and ensure effective, timely and compliant management and delivery of project goals and accountabilities.\n* Define the statistical strategy and ensure appropriate statistical methodologies are applied to study designs and data analyses for clinical trials.\n* Provide expert statistical input and consultancy to Phase I โ IV global clinical trials, lifecycle management activities as well as translational medicine research efforts.\n* Ensure a high degree of rigor is applied to the statistical and scientific decision-making process and outcomes.\n* Collaborate with internal and external collaborators in study design, analysis, reporting, interpretation, and communication of clinical trial results.\n* Author and review critical documents such as briefing documents, protocols, SAP, top-line reports, CSR, and integrated summaries.\n* Support the project team and clinical study team including the derivation of go/no-go criteria, summary reports, and results interpretation.\n* Participate in FDA and other regulatory body interactions (IND/CTA filings, safety reporting).\n\n\n\nWe'd love to hear from you if you have:\n* Ph.D. in Statistics or related discipline with 10+ years, or MS with 15+ years of proven experience in the biotechnology or related industry, including interaction and submission experiences with both FDA and EMA.\n* Successful project and people management and expertise in the development of CNS diseases.\n* Thorough knowledge of life cycle management; consistent track record of innovatively applying statistical principles, theories, and concepts to clinical drug development leading to regulatory approvals.\n* Deep hands-on operational experiences in Biostatistics deliverables, including study design, protocol development, CRFs, clinical databases, Statistical Analysis Plans (SAP), SDTM/ADaM datasets, and CSR Tables/Figures/Listings.\n* Up to date knowledge of industry and academic developments in the Neuroscience, and apply them to clinical study design and analysis.\n* Demonstrated innovative and flexible ability and mindset to work in a changing and demanding environment. Exercise good judgment in interpreting, modifying, and adapting procedures, practices, methods, etc. in accordance with existing policies and standards.\n* Demonstrated strong leadership, project management, collaboration, communication, and organization skills.\n* Advanced programming skills in SAS, R and other relevant statistical software solutions.\n* Detailed knowledge of adaptive designs, Bayesian methodology, trial simulation, and complex modeling.\n* Innovative problem-solving capabilities, the agility to respond promptly and completely to time-critical tasks.\n\n\n\n\n$250,000 - $290,000 a yearBase salary ranges will be determined by the candidateโs level, qualifications, skill set, and experience.\n\n#LI-BL1\n#LI-Remote\n\n\nAt Alector, our vision is bold, people are our priority, and our values are at the core of everything we do. Our dynamic and flexible environment encourages our teams to experiment, take ownership of decisions, and question convention to solve complex problems. We value shared wins, perseverance, and a growth mindset, which drives us forward, together. \n\n\nAlector was named on Fortuneโs "Best Workplaces in Biopharma" top list for small and medium-sized companies for the third consecutive year! And we moved up from #16 to #11 in 2022. \nAmong the things you'll discover at Alectorfrom your very first day are our committed and driven colleagues, a bold company vision, and new, modern offices designed to inspire innovation and collaboration in South San Francisco, right at the heart of Biotech Bay. Our benefits are thoughtfully designed around Alectorians and their loved ones and include flexible hybrid work options, competitive compensation, and comprehensive and unique benefits that enhance your health and well-being. Come join us! \n \nWe believe that hard-working teams include people from a wide variety of backgrounds and experiences who can challenge each otherโs assumptions with fresh perspectives and bring creative ideas to the table. We are committed to building an open, diverse, and inclusive environment for all employees. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, sexual orientation, age, marital status, veteran status, or disability status, or any other characteristics protected under applicable federal, state, or local laws. \n\n\nWe will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, perform essential job functions, and receive other benefits and privileges of employment. Please contact us to request accommodation. \n\n#Salary and compensation\n
No salary data published by company so we estimated salary based on similar jobs related to Design and Senior jobs that are similar:\n\n
$45,000 — $85,000/year\n
\n\n#Benefits\n
๐ฐ 401(k)\n\n๐ Distributed team\n\nโฐ Async\n\n๐ค Vision insurance\n\n๐ฆท Dental insurance\n\n๐ Medical insurance\n\n๐ Unlimited vacation\n\n๐ Paid time off\n\n๐ 4 day workweek\n\n๐ฐ 401k matching\n\n๐ Company retreats\n\n๐ฌ Coworking budget\n\n๐ Learning budget\n\n๐ช Free gym membership\n\n๐ง Mental wellness budget\n\n๐ฅ Home office budget\n\n๐ฅง Pay in crypto\n\n๐ฅธ Pseudonymous\n\n๐ฐ Profit sharing\n\n๐ฐ Equity compensation\n\nโฌ๏ธ No whiteboard interview\n\n๐ No monitoring system\n\n๐ซ No politics at work\n\n๐ We hire old (and young)\n\n
\n\n#Location\nUnited States
๐ Please reference you found the job on Remote OK, this helps us get more companies to post here, thanks!
When applying for jobs, you should NEVER have to pay to apply. You should also NEVER have to pay to buy equipment which they then pay you back for later. Also never pay for trainings you have to do. Those are scams! NEVER PAY FOR ANYTHING! Posts that link to pages with "how to work online" are also scams. Don't use them or pay for them. Also always verify you're actually talking to the company in the job post and not an imposter. A good idea is to check the domain name for the site/email and see if it's the actual company's main domain name. Scams in remote work are rampant, be careful! Read more to avoid scams. When clicking on the button to apply above, you will leave Remote OK and go to the job application page for that company outside this site. Remote OK accepts no liability or responsibility as a consequence of any reliance upon information on there (external sites) or here.