\nTo support the continued growth of our clinical development capabilities, MindMed is seeking an experienced Data Manager or Senior Data Manager to oversee outsourced studies and be responsible and accountable for managing all Data Management deliverables at a consistently high standard concerning cost, quality, and timelines for all assigned indications within one or more Global Clinical Program(s)/Project(s).\n\nAdditionally, the position would involve managing Real-World Data management assets, including anonymized Electronic Health Records, Medical Claims, patient registries, national surveys, and other emerging data types, enabling company scientists to maximize the use of data for a wide range of applications. They will also manage and catalog Clinical data assets, including historical and ongoing clinical trial data.\n\nResponsibilities:\n\n\n* Serve as DM lead managing assigned study project(s) ensuring overall deliverables/timelines and vendor responsibilities are met and providing oversight of CROs, and other vendors\n\n\n\n\n\n* Represent Data Management on cross-functional study teams\n\n* Oversee multiple concurrent studies while participating in special projects or process improvement initiatives\n\n* Translate clinical protocols into electronic case report forms and develop in conjunction with CRO DM the associated data validation specifications (e.g., edit checks, custom functions and reports)\n\n* Work with multiple external data vendors and facilitate importation of multiple data types into MindMed’s database\n\n\n\n\n\n* Facilitate UAT for database builds and migrations to manage any impacts from mid-study updates to the EDC database and other data collection systems\n\n* Perform data reviews for quality issues, identify general data trends and facilitate data review meetings with relevant cross-functional team members\n\n* Develop technical specifications for data management programming and communicate needs to data management and other technology partners.\n\n* Perform ongoing review of study documentation in the trial master file (TMF) to always ensure audit readiness.\n\n* Participate in Protocol Deviation review meetings and other data cleaning activities.\n\n\n\n\nRequirements:\n\n\n* Bachelor's degree or equivalent\n\n* 3+ years of direct experience in clinical data management within the biotech or pharmaceutical industry\n\n* Proficient in multiple EDC platforms (InForm, RAVE, Oracle Clinical, or similar) and IRT, with strong understanding of database design, database concepts and related processes (database builds, updates, locks, etc.)\n\n* Knowledge of ePRO/eCOA instruments and their use in clinical studies.\n\n* Working knowledge of CDSIC Standards\n\n* Knowledge of international guidelines (ICH-GCP) for the conduct of clinical research projects\n\n* Knowledge of compliance, privacy, and safety pertinent to real-world data analytics\n\n* Ability to multi-task, work independently, and act with appropriate accountability\n\n* Readily adapt to new environment, technologies, and processes\n\n* Strong teamwork and collaboration skills\n\n* Excellent written and verbal communication skills\n\n\n\n\nDesired Skills:\n\n\n* Experience in data management or analysis using biomedical/patient health data/real world data/clinical data/novel data streams\n\n* Experience with Data hub platform and interfaces\n\n* Experience in manipulating large amounts of data\n\n* Experience working with privateb and sensitive personal information\n\n* Medidata accreditation\n\n* Experience with data visualization tools (eg, TIBCO Spotfire, elluminate, Power Bl, Tableau, SAS JMP etc.)\n\n* Computer programming skills in Python/Pyspark, R, SQL\n\n* Experience with cloud and high-performance computing environments (AWS, GCP)\n\n\n\n\nWorking Conditions and Travel:\n\n\n* This is a 100% remote position with ~10% travel requirement based on business needs\n\n\n\n\nThe starting base pay range for this position is $114,000.00 - $148,520.00. Compensation will be determined based on several factors including, but not limited to, skill set, years of experience, and the employee’s geographic location.\n\nEmployees in this role may be entitled to additional compensation, including bonus and equity. Benefits information is listed on our Jobs Page. The Company provides competitive benefits to employees including:\n\n\n* 100% paid health benefits including Medical, Dental and Vision for you and your dependents\n\n* 401(k) program with company match and immediate vesting\n\n* Flexible time off\n\n* Generous parental leave and some fun fringe perks!\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 Travel, Cloud and Senior jobs that are similar:\n\n $60,000 — $110,000/year\n
\n\n#Benefits\n 💰 401(k)\n\n🌎 Distributed team\n\n⏰ Async\n\n🤓 Vision insurance\n\n🦷 Dental insurance\n\n🚑 Medical insurance\n\n🏖 Unlimited vacation\n\n🏖 Paid time off\n\n📆 4 day workweek\n\n💰 401k matching\n\n🏔 Company retreats\n\n🏬 Coworking budget\n\n📚 Learning budget\n\n💪 Free gym membership\n\n🧘 Mental wellness budget\n\n🖥 Home office budget\n\n🥧 Pay in crypto\n\n🥸 Pseudonymous\n\n💰 Profit sharing\n\n💰 Equity compensation\n\n⬜️ No whiteboard interview\n\n👀 No monitoring system\n\n🚫 No politics at work\n\n🎅 We hire old (and young)\n\n
\n\n#Location\nDurham, North Carolina, United States

\nOrganizational Overview:\n\nImmunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As 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\nThe Role:\n\nImmunovant is seeking an experienced IT System Administrator and Architect for our Veeva platform. In this role you will partner with Veeva and the business stakeholders to design, develop, implement and support Veeva solutions aligned with the best practices. The individual in this position will have the unique opportunity to participate in the rapid growth of a biotech startup.\n\nKey Responsibilities: \n\n\n* Understand business requirements and convert them into functional and non-functional requirements\n\n* Lead end-to-end solutioning for Veeva platform in partnership with the business stake holders and third-party service providers. Configure and troubleshoot lifecycle, workflows, documents, and objects\n\n* Setup and manage document type tree/ hierarchies\n\n* Design and administer security roles including Dynamic Access Control (DAC) records as appropriate\n\n* Define and manage user access provisioning and de-provisioning for the Veeva platform\n\n* Manage Veeva platform and end-user licensing in partnership with the business/ functional stakeholders\n\n* Act as single point of contact for resolution of Veeva platform issues by coordinating with the business, IT Managed Services Provider (MSP), Veeva Application Management Services (AMS) and other third-party service providers\n\n* Analyze, implement, and document change and service requests.\n\n* Manage high priority requests and application downtime (planned & unplanned)\n\n* Ensure all Veeva modules remain fully validated during scheduled updates\n\n* Mentor and train functional area engagement teams on Veeva platform adoption.\n\n\n\n\nRequirements:\n\n\n* 7 to 10 years of experience at a life sciences, biotech, or pharmaceutical company providing business analysis and application implementation/ support in a fast-paced, demanding environment\n\n* Subject matter expertise in at least two Veeva Vault modules such as QualityDocs, RIM, eTMF, MedComms and PromoMats; experience in at least one of the regulated Veeva Vault modules a must.\n\n* Experience with Veeva CRM strongly preferred\n\n* At least two full life cycle Veeva Vault implementations\n\n* Certifications in Veeva Vault and Veeva CRM strongly preferred\n\n* Expertise in solution architecture design, technical integration design and Vault platform best practices\n\n* Thorough understanding of system validation and change management\n\n* BA/BS in Information Technology, business, or science\n\n* Strong attention to detail\n\n* Strong analytical, consulting, and problem-solving skills\n\n* Understanding of drug development from Phase 2 to launch\n\n* Multitasking ability to work on several projects\n\n* Hands-on, roll-up-your-sleeves approach with high sense of urgency and drive for results\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* Natural collaborator who enjoys working on a cross-functional team\n\n* Experience in Start-ups a plus.\n\n* Excellent communication and interpersonal skills.\n\n* Ability to work collaboratively with cross-functional teams.\n\n* Strong analytical and problem-solving skills.\n\n\n\n\nWork Environment:\n\n\n* Remote-based\n\n* Dynamic, interactive, fast-paced, and entrepreneurial environment\n\n* Domestic or international travel are required 10%\n\n\n\n\n \nCompensation is based on several 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 $170,000.00 - $185,000.00.\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 Design, Travel and Senior jobs that are similar:\n\n $70,000 — $110,000/year\n
\n\n#Benefits\n 💰 401(k)\n\n🌎 Distributed team\n\n⏰ Async\n\n🤓 Vision insurance\n\n🦷 Dental insurance\n\n🚑 Medical insurance\n\n🏖 Unlimited vacation\n\n🏖 Paid time off\n\n📆 4 day workweek\n\n💰 401k matching\n\n🏔 Company retreats\n\n🏬 Coworking budget\n\n📚 Learning budget\n\n💪 Free gym membership\n\n🧘 Mental wellness budget\n\n🖥 Home office budget\n\n🥧 Pay in crypto\n\n🥸 Pseudonymous\n\n💰 Profit sharing\n\n💰 Equity compensation\n\n⬜️ No whiteboard interview\n\n👀 No monitoring system\n\n🚫 No politics at work\n\n🎅 We hire old (and young)\n\n
\n\n#Location\nNew York City, New York, United States

\nThe Role:\n\nReporting to the VP Finance, this position is responsible for the controller group, producing accurate and timely financial statements, overseeing the close process and all other accounting responsibilities such as T&E, chart of accounts etc. The Controller will be the ultimate reviewer of the CRO and CMO accruals. This role requires strong managerial capabilities to drive process improvement, system implementations and employee development.\n\nKey Responsibilities: \n\n\n* Finalize accurate and timely monthly, quarterly and annual financial statements (balance sheet and statement of income) in accordance with GAAP. Design and manage the monthly close process to ensure timely and accurate financial statements.\n\n* Design, implement and maintain a system of internal controls to ensure safeguarding of Company assets and accurate financial statements.\n\n* Establish and enforce accounting policies and procedures and operational strategies including the review and implementation of process and system improvements.\n\n* Ultimate reviewer of CRO and CMO accruals, overseeing improvements to CRO and CMO accruals processes to support growth of the business.\n\n* Manage a team including multiple direct reports and a larger group of indirect reports ensuring appropriate allocation of responsibilities and sufficient back-up support.\n\n* Serving as principal contact with independent auditors.\n\n\n\n\nRequirements:\n\n\n* Bachelor’s degree in accounting and Certified Public Accountant.\n\n* 15+ years of experience - some in public accounting (big four), at least 10 years of experience in the biotech industry and at least 6 years of experience as a controller.\n\n\n\n\n\n* Experience with financial reporting at a publicly traded company.\n\n* Experience with CRO and CMO +accruals is a must.\n\n* Demonstrated ability to organize an efficient and effective monthly closing process.\n\n* Demonstrated ability to work in a dynamic and rapidly changing environment and the flexibility to handle multiple priorities simultaneously.\n\n* Team player, able to garner the respect of direct reports, peers, and superiors throughout the organization.\n\n* Strong communications and analytical skills.\n\n* Experience with NetSuite, Coupa, Expensify, Auxilius/Condor is preferred.\n\n\n\n\nWork Environment:\n\n\n* Remote-based\n\n* Dynamic, interactive, fast-paced, and entrepreneurial environment\n\n* Domestic or international travel are required (20%)\n\n\n\n\n \n\nCompensation is based on several 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 $250,000.00 - $265,000.00.\n\n  \n\n#Salary and compensation\n No salary data published by company so we estimated salary based on similar jobs related to Design, Travel, Accounting and Senior jobs that are similar:\n\n $82,500 — $155,000/year\n
\n\n#Benefits\n 💰 401(k)\n\n🌎 Distributed team\n\n⏰ Async\n\n🤓 Vision insurance\n\n🦷 Dental insurance\n\n🚑 Medical insurance\n\n🏖 Unlimited vacation\n\n🏖 Paid time off\n\n📆 4 day workweek\n\n💰 401k matching\n\n🏔 Company retreats\n\n🏬 Coworking budget\n\n📚 Learning budget\n\n💪 Free gym membership\n\n🧘 Mental wellness budget\n\n🖥 Home office budget\n\n🥧 Pay in crypto\n\n🥸 Pseudonymous\n\n💰 Profit sharing\n\n💰 Equity compensation\n\n⬜️ No whiteboard interview\n\n👀 No monitoring system\n\n🚫 No politics at work\n\n🎅 We hire old (and young)\n\n

\nOrganizational Overview:\n\nImmunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As 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\nThe Role:\n\nReporting to the Senior Director, Biostatistics, this position is responsible for collaborating with both internal and external stakeholders to deliver the tactical execution of our Biostatistics strategy. The individual in this position will have the unique opportunity to participate in the rapid growth of a biotech startup.\n\nKey Responsibilities: \n\n\n* Provide statistical inputs into protocol and clinical study report development, statistical analysis plans, interpretation of statistical analysis results, randomization plans.\n\n* Provide oversight and review of statistical documents for multiple clinical trials, including TLF shells, eCRFs, specifications of variable derivations, and all deliverables from outside vendors or internal programmers.\n\n* Develop effective collaborations with others within clinical teams and partner lines (such as Statistical Programming, Data Management, Medical, Clinical Operations, and Regulatory).\n\n* Ensure that all study level statistical activities are conducted in compliance with relevant regulatory requirements and Immunovant standards.\n\n* Provide planning, delivery and communication of statistical analyses, data presentations, and scientific reports.\n\n* Oversight statistics and programming vendors.\n\n* Open to opportunities to utilize innovative statistical methodology to streamline the clinical development process and facilitate optimal decision-making.\n\n\n\n\nRequirements:\n\n\n* PhD or MS in Statistic, Biostatistics, Mathematics, or related field\n\n* 5+ years (7+ years for MS) of experience in biotechnology, pharmaceutical or health related area\n\n* Knowledge of relevant FDA, EU, ICH guidelines and regulations\n\n* Understanding of drug development\n\n* Demonstrated ability to collaborate with diverse sets of stakeholders\n\n* Strong written and oral communication skills with attention to detail\n\n* Desire to work in a fast-paced, innovative environment\n\n* Natural collaborator who enjoys working on a cross-functional team\n\n\n\n\nWork Environment:\n\n\n* Remote-based; access to Immunovant’s NYC and North Carolina offices available\n\n* Dynamic, interactive, fast-paced, and entrepreneurial environment \n\n* Domestic or international travel may be required (~10%)\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 💰 401(k)\n\n🌎 Distributed team\n\n⏰ Async\n\n🤓 Vision insurance\n\n🦷 Dental insurance\n\n🚑 Medical insurance\n\n🏖 Unlimited vacation\n\n🏖 Paid time off\n\n📆 4 day workweek\n\n💰 401k matching\n\n🏔 Company retreats\n\n🏬 Coworking budget\n\n📚 Learning budget\n\n💪 Free gym membership\n\n🧘 Mental wellness budget\n\n🖥 Home office budget\n\n🥧 Pay in crypto\n\n🥸 Pseudonymous\n\n💰 Profit sharing\n\n💰 Equity compensation\n\n⬜️ No whiteboard interview\n\n👀 No monitoring system\n\n🚫 No politics at work\n\n🎅 We hire old (and young)\n\n
\n\n#Location\nNew York City, New York, United States

\n\n\n\n\nOverview\n\nLightship is a clinical trials service provider leading in increasing access and choice in taking part in research to improve equity for all. We design and conduct studies in partnership with biopharmaceutical companies to accelerate bringing new therapies to market. Our approach is to engage people where they are and support them across their journey in a clinical trial, from first contact to study completion. We work to make it easy, convenient, and safe for people to take part by offering visits in clinic, at home, using our mobile research units, and digital health tools. By transforming the way, we conduct clinical research, we can decrease study timelines and reduce dropouts to accelerate development of better therapies.\n\nThe Senior Client Partner, Strategic Accounts contributes to Lightship’s ongoing growth by supporting the design and implementation of solutions that increase patient access and choice in clinical trials. This individual is highly motivated and has an extensive understanding of clinical research from the perspective of clients, partners, and Lightship clinical teams. Additionally, the Senior Client Partner, Strategic Accounts is well-versed in technologies and systems used in clinical research. This individual leads the development of Lightship design concepts, study assessments, pricing development, and continued client engagement once a program or study has launched to ensure, measure, and manage project success.  The individual, as required by the business, leads strategic client accounts and relationships to identify, develop and grow business with pharmaceutical and biotech companies.\n\nGiven Lightship’s distributed model and the remote nature of this position, the Senior Client Partner, Strategic Accounts must possess a willingness and desire to work independently without significant oversight. Lightship expects each individual to anchor their availability in the standard operating hours for their geographic location, however, true to our values of inclusion and flexibility, this role, along with all others at Lightship, may be asked to flex work hours to accommodate US West Coast, US East Coast, and UK-based time zones, based on business and/or patient needs. In practice, this may translate to days that have a slightly earlier start or evenings that have a slightly later end. Culturally, we aim to balance the ability to operate across time zones with respect for each individual's daily life.  Additionally, this position will require significant travel for client visits and key meetings.\n\nSenior Client Partner, Strategic Accounts is responsible for:\n\n\n* Driving strategic client relationships from both a business and delivery perspective. Forging new relationships and developing existing relationships with Pharmaceutical, Biotechnology and CROs\n\n* Leading efforts to design, assess, price, and contract Lightship projects, while working cross-functionally with internal teams and externally with sponsors, partners, and vendors, ensuring seamless communication and collaboration among all parties\n\n* Carrying out market research and analysis to inform design concepts at program and study levels\n\n* Developing, leading, and improving client interactions, engagement, and presentations\n\n* Leading consultations with client study teams to result in contracted Lightship projects which meet client expectations and operational commitment on deliverables\n\n* Build and maintain a business development funnel of opportunities through a solid understanding of strategy, industry and competitive landscape.\n\n* Supporting efforts to complete program assessments and capability building programs with clients\n\n* Continuously developing and evaluating opportunities to improve, enhance, or expand Lightship services, offerings, and client engagement\n\n* Engaging clients once a study has launched to ensure customer success, identify opportunities for process improvement, contract amendments, and communicate feedback effectively to internal stakeholders\n\n* Partnering with clinical operations to ensure that design of each program or study opportunity includes development of study-level metrics, clinical trial processes, guidelines, and requirements which can be followed throughout the trial lifecycle\n\n* Partnering with proposals and budget team to develop proposal responses and budgets\n\n* Lead and/or participate in bid defense meetings with clients\n\n* Supporting Lightship’s various business units in assessing potential success factors and risks, including risk management plans for proposed trials\n\n* Assisting in development of clinical budget, expense review strategies, and other tools/processes for commercial team\n\n* Participating in development and review of Lightship’s Standard Operating Procedures (SOPs), guidelines, and training materials; assessing training program needs for various Lightship trials\n\n* Other duties as assigned\n\n\n\n\nSenior Client Partner, Strategic Accounts has:\n\n\n* Required knowledge, skills, and abilities:\n\n\n* Ability to successfully manage people and projects\n\n* Ability to build and lead collaborative research teams, with team members from various Lightship departments and outside organizations, including sponsors, partners, and vendors\n\n* Ability to adapt to a fast-paced start-up environment\n\n* Ability to critically review and assess protocols identifying opportunities to innovate\n\n* Ability to collaborate cross functionally with ease\n\n* Ability to influence others and drive clarity in ambiguity\n\n* Expertise in clinical operations and advanced knowledge of clinical research\n\n* Critical thinking and problem-solving abilities\n\n* Strong verbal and written communication skills; strong presentation skills\n\n* Strong negotiation skills\n\n\n\n\n\n\n\n* Education and experience\n\n\n* 10+ years of clinical operations, project management, client relationship and alliance management experience and / or clinical research background\n\n* 7+ years of management experience\n\n* Experience in Phases I-IV of clinical trials\n\n* Management experience in a clinical field\n\n* Bachelor’s Degree, required; advanced degree in healthcare-related field or MBA, preferred\n\n* Requisite combination of education, training, and experience\n\n\n\n\n\n\n\n\n\n\nWe would like to offer you: \n\n\n* An opportunity to help re-envision how clinical research is executed with inclusivity, increased diversity and accessible at the core\n\n* The chance to work with a patient-centered, clinically-oriented, collaborative team to support in the delivery of enterprise grade virtual-first clinical research solutions at scale\n\n* An unmatched opportunity to grow as part of an established startup with industry veterans, high-caliber investors, and a massive market opportunity\n\n* Great compensation\n\n\n\n\nGenerous benefits package, including:\n\n\n* Top notch healthcare (medical, dental, and vision) for you and your family.\n\n* Unlimited Paid Time Off (PTO), plus paid holidays and bereavement to help support work life balance.\n\n* A 100% 401(k) company match for up to 4% of eligible contributions with an immediate vesting.\n\n* A home office stipend to set yourself up for success in our distributed working environment\n\n* Company provided laptop, your choice of a PC or a Mac\n\n* Monthly stipend for internet and phone expenses\n\n* Generous paid parental leave\n\n* Short & long-term disability\n\n* Life insurance and More!\n\n\n\n\nThe base salary range for this role is dependent on education, skills, and experience.  To determine our compensation, we use a market-based approach that is geographically neutral. We believe that this demonstrates our company value of ‘believing in people’ – valuing the outputs and performance of each team member.\n\nPlease note: For the safety of our patients and each other, all positions at Lightship that require travel, in-person participation, or are patient-facing, do require vaccination against COVID-19.\n\nOur commitment to diversity & inclusion:\n\nLightship is an equal opportunity employer and promotes a diverse and inclusive workplace. Lightship considers all applicants without regard to race, color, religion, creed, national origin, age, sex, marital status, ancestry, disability, veteran status, gender identity, genetic information, sexual orientation, or any other status protected by applicable law.  EEO is the Law\n\nLightship is an E-Verify employer. Find out more here: Right to Work Poster E-Verify Participation Poster\n\n#jobs #careers #nowhiring #hiringnow #LI-remote\n\n      \n\n#Salary and compensation\n No salary data published by company so we estimated salary based on similar jobs related to Design, Mobile and Senior jobs that are similar:\n\n $50,000 — $110,000/year\n
\n\n#Benefits\n 💰 401(k)\n\n🌎 Distributed team\n\n⏰ Async\n\n🤓 Vision insurance\n\n🦷 Dental insurance\n\n🚑 Medical insurance\n\n🏖 Unlimited vacation\n\n🏖 Paid time off\n\n📆 4 day workweek\n\n💰 401k matching\n\n🏔 Company retreats\n\n🏬 Coworking budget\n\n📚 Learning budget\n\n💪 Free gym membership\n\n🧘 Mental wellness budget\n\n🖥 Home office budget\n\n🥧 Pay in crypto\n\n🥸 Pseudonymous\n\n💰 Profit sharing\n\n💰 Equity compensation\n\n⬜️ No whiteboard interview\n\n👀 No monitoring system\n\n🚫 No politics at work\n\n🎅 We hire old (and young)\n\n
\n\n#Location\nLondon, England, United Kingdom

\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 ahead—guided by our core values, we’ll 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 ALPN’s 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 \n• 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 ALPN’s clinical development programs. \n• Develop a strong understanding of clinical site practices to curate and deliver clinical site engagement strategies \n • Gathers and shares “Best Practices” and tactics for rapid patient enrollment among trial sites. \n • 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.\n• 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. \n• Establish process to ensure site staff requests are managed efficiently and effectively, positioning ALPN’s clinical studies as a high priority within investigational site operations.\n• Collaborates with ALPN Clinical Operations, Clinical Development, and external stakeholders to support study performance and progress.\n• 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.\n• Facilitates identification of clinical trial site and community educational needs for ALPN clinical trials.\n• Participates in ALPN community outreach and engagement activities for ALPN clinical trials.\n• 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 \n• At least 5 years clinical trials leadership experience\n• Previous experience in a CTL, MSL, or similar site-facing role preferred\n• Strong communication, interpersonal, and relationship management skills\n• Ability to travel domestically and internationally up to 70%; including travel to ALPN at least 6 times/year\n• Working knowledge of protocol and clinical drug development processes, clinical study design, study planning and management, and monitoring\n• High attention to detail\n• Ability to set priorities and juggle multiple demands\n• Ability to think critically and be a proactive problem-solver\n• Ability to work independently while exercising initiative, flexibility, and sound judgment\n• Comfortable working with various levels of the company including senior level management\n• Demonstrated proficiency in Microsoft Word, PowerPoint, and Excel\n• Ability to operate in alignment with ALPN’s 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 employees’ 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 Alpine’s 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 ahead—guided by our core values, we’ll 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 💰 401(k)\n\n🌎 Distributed team\n\n⏰ Async\n\n🤓 Vision insurance\n\n🦷 Dental insurance\n\n🚑 Medical insurance\n\n🏖 Unlimited vacation\n\n🏖 Paid time off\n\n📆 4 day workweek\n\n💰 401k matching\n\n🏔 Company retreats\n\n🏬 Coworking budget\n\n📚 Learning budget\n\n💪 Free gym membership\n\n🧘 Mental wellness budget\n\n🖥 Home office budget\n\n🥧 Pay in crypto\n\n🥸 Pseudonymous\n\n💰 Profit sharing\n\n💰 Equity compensation\n\n⬜️ No whiteboard interview\n\n👀 No monitoring system\n\n🚫 No politics at work\n\n🎅 We hire old (and young)\n\n
\n\n#Location\nSeattle, WA or Remote

\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 Huntington’s 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 pridopidine’s 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 “fit for purpose” 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 💰 401(k)\n\n🌎 Distributed team\n\n⏰ Async\n\n🤓 Vision insurance\n\n🦷 Dental insurance\n\n🚑 Medical insurance\n\n🏖 Unlimited vacation\n\n🏖 Paid time off\n\n📆 4 day workweek\n\n💰 401k matching\n\n🏔 Company retreats\n\n🏬 Coworking budget\n\n📚 Learning budget\n\n💪 Free gym membership\n\n🧘 Mental wellness budget\n\n🖥 Home office budget\n\n🥧 Pay in crypto\n\n🥸 Pseudonymous\n\n💰 Profit sharing\n\n💰 Equity compensation\n\n⬜️ No whiteboard interview\n\n👀 No monitoring system\n\n🚫 No politics at work\n\n🎅 We hire old (and young)\n\n
\n\n#Location\nEurope

\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 ahead—guided by our core values, we’ll 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 Alpine’s public relations, corporate communications, and investor relations strategy, manage the Company’s 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 Company’s 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 Alpine’s overall corporate communications and investor relations strategy. \n \nDuties and responsibilities\n \n• 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. \n• Manage and update the Company’s corporate presentation and press releases for data releases, scientific meetings, presentations, and publications in close collaboration with Scientific Communications.\n• Manage external consulting relationships and ensure efficiency in external spending. \n• Work collaboratively to establish corporate brand planning, including brand strategy and identity, through management of company website and creation of other branding materials. \n• Oversee and lead all corporate social media activities for Company.\n• Develop a deep and thorough understanding of the Company’s 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. \n• Proactively engage with buy-side and sell-side research community. \n• Lead the development and implementation of a targeted investor relations strategy to maximize the Company’s long-term value creation and ensure the consistent presentation of that strategy across all messaging.\n• Act as the liaison for Alpine’s investment banking equity research interactions to effectively leverage sell-side capabilities cross-departmentally while optimizing management time with these stakeholders.\n• Conduct periodic, in-depth, investor targeting exercises and maintain a target investor list.\n• Support financing activities, including implementation of financing strategy, managing relationships within the banking community, and executing financing activities. \n• Maintain the IR calendar, which includes strategic decisions on Company and executive participation in investor conferences, non-deal roadshows and analyst/investor meetings.\n• Ability to travel 10-25% of the time, including occasional off-hours and weekend work for events and medical meetings.\n \nQualifications\n \n• Undergraduate degree in biological sciences and/or engineering.\n• MD and/or PhD in life sciences preferred; MBA desirable.\n• 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.\n• In-depth understanding of the drug development process, small molecules, biologics, and other platforms in autoimmune and inflammatory diseases.\n• Excellent project management and organizational skills with the ability to prioritize multiple work streams and deadlines, balance opposing priorities and communicate effectively.\n• Excellent written and oral communications skills.\n• Self-starter with initiative and ability to execute once strategies are set.\n• Ability to work collaboratively with internal and external stakeholders in a fast-paced environment.\n• Knowledge of MS Office applications and especially strong in Excel and PowerPoint. \n• 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 employees’ 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 Alpine’s 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 ahead—guided by our core values, we’ll 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 💰 401(k)\n\n🌎 Distributed team\n\n⏰ Async\n\n🤓 Vision insurance\n\n🦷 Dental insurance\n\n🚑 Medical insurance\n\n🏖 Unlimited vacation\n\n🏖 Paid time off\n\n📆 4 day workweek\n\n💰 401k matching\n\n🏔 Company retreats\n\n🏬 Coworking budget\n\n📚 Learning budget\n\n💪 Free gym membership\n\n🧘 Mental wellness budget\n\n🖥 Home office budget\n\n🥧 Pay in crypto\n\n🥸 Pseudonymous\n\n💰 Profit sharing\n\n💰 Equity compensation\n\n⬜️ No whiteboard interview\n\n👀 No monitoring system\n\n🚫 No politics at work\n\n🎅 We hire old (and young)\n\n
\n\n#Location\nSeattle, WA or Remote

\nAbout Karius\nKarius is a venture-backed life science startup that is transforming the way pathogens and other microbes are observed throughout the body.  By unlocking the information present in microbial cell-free DNA, we're helping doctors quickly solve their most challenging cases, providing industry partners with access to the microbial landscape to accelerate biomarker discovery and clinical trials, discover novel microbes, to ultimately reduce patient suffering worldwide.\n\n\nPosition Summary\nThe Senior Clinical Data Scientist plays a critical role in driving the extraction, analysis and interpretation of clinical data to support evidence-based decision making and drive the development of innovative healthcare solutions. This position requires a strong background in data analysis, statistical modeling, and clinical research methodologies. The ideal candidate will have a passion for leveraging data to improve patient outcomes and contribute to the advancement of medical knowledge.\n\n\nWhy Should You Join Us?\nKarius aims to conquer infectious diseases through innovations around genomic sequencing and machine learning. The company’s platform is already delivering unprecedented insights into the microbial landscape, providing clinicians with a comprehensive test capable of identifying more than a thousand pathogens directly from blood, and helping industry accelerate the development of therapeutic solutions. The Karius test we provide today is one of the most advanced solutions available to physicians who aim to deliver better care to many otherwise ineffectively treated patients. Our test is the result of some incredible work done by our scientists, statisticians, engineers, and physicians, all driven by the same mission. You, as part of the Karius team, will be able to see how directly your work has a life-changing impact on people, and at scale.\n \nReports to:    Vice President, Clinical Affairs\n \nLocation:  Redwood City, CA or Remote\n \nPrimary Responsibilities\n•   Responsible for the execution of statistical analyses of clinical and molecular data including initiating projects, overseeing execution, performing quality review, and leading cross-team communications.\n•   Collect, organize, and interpret statistical information from clinical databases, coded data, and other specified data sets.\n•   Uses appropriate statistical, visual, and narrative displays of data in a manner that is easily and appropriately interpreted by the target audience.\n•   Conduct statistical modeling to support both internal and external research projects.\n•   Collaborates on study protocols, statistical analysis or other project implementation plans with clinical development, scientific discovery, commercial, and product teams to address research questions and objectives.\n•   Identifies and advises on an appropriate statistical approach to a range of biomedical research questions.\n•   Carries out quality assurance and quality control procedures.\n•   Produces technical reports, peer-reviewed manuscripts, and presentations.\n•   Lead the integration of clinical trial data, electronic health record, insurance claims, disease, and patient data.\n\n\nWhat’s Fun About the Job?\nKarius is operating at the edge of what is now known to be possible in infectious disease diagnostics. With that, comes a wave of new and incredible challenges and opportunities. To deliver on that value, you will be tapping into some of the most advanced technologies, architecting and innovating where the current solutions simply don't suffice. You will get to see how much your work really matters.\n \nTravel:      Travel required up to 5%.\n \nPhysical Requirements\nSubject to extended periods of sitting and/or standing, vision to monitor and moderate noise levels. Work is generally performed in an office. \n\n\nPosition Requirements\n•   5+ years experience, preferably at a diagnostic, biotech or pharmaceutical company analyzing large datasets, proficient in SQL, Python, R, or SAS.\n•   Graduate degree in statistics, biostatistics, epidemiology, informatics, or a related field. Additional coursework in programming, analytics, or related disciplines is strongly desired. PhD preferred.\n•   Solid proficiency in statistical methodology, particular for statistical measures related to diagnostic test accuracy and power and sample size calculations.\n•   Experience with data visualization, translating clinical data and information into a visual context to support publication and results reporting.\n•   Familiar with ICD-10 and CPT codes, AHRQ quality indicators, and other similar healthcare related tools and data, especially to support clinical impact, cost, and HCRU studies.\n•   Outstanding verbal, written, and presentation skills with a strong ability to influence and communicate effectively throughout all levels of the organization and externally.\n\n\nPersonal Qualifications\n•   Excellent analytical skills to interpret complex clinical data, identify trends, and draw accurate conclusions.\n•   Attention to detail to ensure data quality and accuracy.\n•   Critical thinking to be able to identify and solve problems, develop innovative solutions and make informed decisions.\n•   Team player with the ability to collaborate effectively cross-functionally and work as part of a team.\n•   Strong communication skills with the ability to communicate complex data analysis results to both technical and non-technical stakeholders.\n•   Adaptability to new technologies and data sources, regulatory guidelines, and changing business needs.\n\n\nAt Karius, we value a diverse and inclusive workplace and provide equal employment opportunity for all applicants and employees and are committed to honor and invest in the full diversity of people, in our hiring, recruiting and development of employees across the Company.  All qualified applicants for employment are encouraged to apply and will be considered without regard to an individual’s race, color, sex, gender identity and gender expression (including transgender individuals who are transitioning, have transitioned, or are perceived to be transitioning to the gender with which they identify), religion, age, national origin or ancestry, citizenship, physical or mental disability, medical condition, family care status, marital status, domestic partner status, sexual orientation, genetic information, military or veteran status, or any other basis protected by federal, state or local laws. If you are unable to submit your application due to a disability, please contact us at [email protected] and we will accommodate qualified individuals with disabilities.\n\n\n\n\n\n\n$124,000 - $186,000 a year\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 $60,000 — $110,000/year\n
\n\n#Benefits\n 💰 401(k)\n\n🌎 Distributed team\n\n⏰ Async\n\n🤓 Vision insurance\n\n🦷 Dental insurance\n\n🚑 Medical insurance\n\n🏖 Unlimited vacation\n\n🏖 Paid time off\n\n📆 4 day workweek\n\n💰 401k matching\n\n🏔 Company retreats\n\n🏬 Coworking budget\n\n📚 Learning budget\n\n💪 Free gym membership\n\n🧘 Mental wellness budget\n\n🖥 Home office budget\n\n🥧 Pay in crypto\n\n🥸 Pseudonymous\n\n💰 Profit sharing\n\n💰 Equity compensation\n\n⬜️ No whiteboard interview\n\n👀 No monitoring system\n\n🚫 No politics at work\n\n🎅 We hire old (and young)\n\n
\n\n#Location\nUnited States