\nWhy join Freenome?\n\nFreenome is a high-growth biotech company developing tests to detect cancer using a standard blood draw. To do this, Freenome uses a multiomics platform that combines tumor and non-tumor signals with machine learning to find cancer in its earliest, most-treatable stages. \n\nCancer is relentless. This is why Freenome is building the clinical, economic, and operational evidence to drive cancer screening and save lives. Our first screening test is for colorectal cancer (CRC) and advanced adenomas, and it’s just the beginning. \n\nFounded in 2014, Freenome has ~400 employees and continues to grow to match the scope of our ambitions to provide access to better screening and earlier cancer detection.  \n\nAt Freenome, we aim to impact patients by empowering everyone to prevent, detect, and treat their disease. This, together with our high-performing culture of respect and cross-collaboration, is what motivates us to make every day count.\n\nBecome a Freenomer\n\nDo you have what it takes to be a Freenomer? A “Freenomer” is a determined, mission-driven, results-oriented employee fueled by the opportunity to change the landscape of cancer and make a positive impact on patients’ lives. Freenomers bring their diverse experience, expertise, and personal perspective to solve problems and push to achieve what’s possible, one breakthrough at a time.\n\nAbout this opportunity:\n\n\nAt Freenome, we are seeking a Director of Cloud Infrastructure to lead our Infrastructure team that is providing the services for early cancer detection blood tests as well as other company wide initiatives.  The ideal candidate is a servant-leader that is comfortable managing a growing team, focused on meeting the needs of internal customers, navigating ambiguity and adapting to rapid change.  You are passionate about building a healthy, collaborative work environment and are a steward of our cultural values.  You have demonstrated the ability to lead teams in building infrastructure in a regulatory industry and you have the potential to have a significant impact on the continued growth of a high profile technology organization that is changing the landscape on early cancer detection.\n\n\nThis role reports to our Vice President, Software Engineering.\n\n\nWhat you’ll do:\n\nExecution Excellence\n\n\n* Provide direct, strategic and tactical leadership to your department \n\n* Provide leadership in developing new strategies, methodologies, and solutions to improve execution towards department- and company-level objectives\n\n* Partner with our QA Department to ensure the highest level of regulatory compliance with recognized quality best practice\n\n* Translate business segment strategy into cross-functional plans and guide plan execution\n\n* Accountable for the performance and results of your department (Monitoring performance and initiating action to strengthen results)\n\n* Proactively communicate cross-functionally with key stakeholders to adapt as needed through reprioritization and alignment \n\n* Ensure budgets, resourcing and timelines meet company requirements\n\n* Empowers department to take calculated risks and make mistakes as a team but collectively learn from these experiences, ensuring institutional knowledge is retained and applied in the future\n\n* Comfortable navigating ambiguity, using trial and error to thoughtfully iterate towards the best solution balancing time and resource constraints\n\n* Anticipate factors that could cause issues that have departmental or cross-functional impact and formulates preventive strategies \n\n\n\n\nCommunication and Collaboration\n\n\n* Proactively requests feedback from others and are open to continuous feedback\n\n* Consistently delivers actionable and timely feedback to people at all levels in a way that strengthens relationships and enables functional initiatives to advance more quickly\n\n* Provide consistent communications to key functional and cross-functional stakeholders on progress and updates \n\n* Guides department in effective communication and collaboration, avoiding triangulation or churn and fostering direct communication\n\n* Adapts communications to audience requirements to optimize understanding and results, adapting to diverse communication styles\n\n* Build and maintain strong, healthy relationships with cross-functional peers \n\n* Provide representation for your department to executive leadership through reporting, presentations and Quarterly Business Review type meetings\n\n\n\n\nCulture\n\n\n* Lead by example, integrate and reinforce our Values and Principles as much as possible\n\n* Coaches and provides guidance to direct reports to foster our Values and Principles across departments\n\n* Recognizes Values and Principles gaps in your department on an ongoing basis and implement solutions and creates opportunities to grow in those areas\n\n\n\n\n\nPeople Leadership\n\n\n* Actively identifies internal transfer and growth opportunities, empowering team members to pursue them\n\n* Perform quarterly talent reviews \n\n* Addresses performance issues with direct, constructive and actionable feedback\n\n* Provides inspiration and leads department towards the company mission, vision, and culture\n\n* Gives direction and organizational clarity in roles and responsibilities to execute on department and company OKRs more effectively\n\n* Effectively cascades organizational strategy and contributes to the development of organizational procedures\n\n* Actively involved in recruitment, attracting and retaining top talent to build high performing teams\n\n\n\n\n\nMust haves:\n\n\nBS, MS or Ph.D. in Computer Science, Engineering or a related field; or equivalent training, fellowship, or work experience\n\n5+ years of experience in engineering leadership and management\n\n3+ years of infrastructure experience with a track record of building and deploying infrastructure as part of a high-functioning team\n\nMulti-public cloud experience (AWS, Azure, GCP)\n\nDeep knowledge and proven working experience in managing Kubernetes and cloud infrastructure services, networking, security\n\nProven experience in leveraging automation tools and infrastructure-as-code techniques as a key strategy for managing infrastructure\n\nProven experience implementing Site Reliability Engineering (SRE) practices\n\nProven expertise in building high performance teams\n\nA demonstrated ability to structure, grow, and optimize a team for execution, including attracting top talent and filling in gaps in the existing team quickly to accommodate growth\n\nExperience with project management and prioritization, risk management, problem-solving, and resource planning\n\nExcellent verbal and written communication skills up, down, and peer to peer\n\nStrong leadership and collaboration skills\n\n\n\n\n\nNice to haves:\n\n\n* Experience in biotechnology, bioinformatics, regulated software, or similar field \n\n* Experience in a startup environment\n\n* Experience leading teams in a highly regulated environment\n\n* Experience leading teams developing infrastructure as part of a Medical Device\n\n* Exposure to big data, especially biological and clinical data\n\n\n\n\n\nBenefits and additional information:\n\nThe US target range of our base salary for new hires is $197,20 - $304,000. You will also be eligible to receive pre-IPO equity, cash bonuses, and a full range of medical, financial, and other benefits depending on the position offered.  Please note that individual total compensation for this position will be determined at the Company’s sole discretion and may vary based on several factors, including but not limited to, location, skill level, years and depth of relevant experience, and education. We invite you to check out our career page @ freenome.com/job-openings/ for additional company information.  \n\nFreenome is proud to be an equal-opportunity employer, and we value diversity. Freenome does not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.\n\nApplicants have rights under Federal Employment Laws.  \n\n\n* Family & Medical Leave Act (FMLA)\n\n* Equal Employment Opportunity (EEO)\n\n* Employee Polygraph Protection Act (EPPA)\n\n\n\n\n#LI- Remote \n\n#Salary and compensation\n No salary data published by company so we estimated salary based on similar jobs related to Cloud and Cloud 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\nBrisbane, California, United States

\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 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 – 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 Alzheimer's Disease and Neuroscience programs (change to Neuroscience or Rare Disease programs).\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\n$280,000 - $303,000 a yearBase salary ranges will be determined by the candidate’s 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 other’s 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 $57,500 — $90,000/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

\nAbout Formation Bio\n\nAt Formation Bio, we are building the pharma company of the future , redefining drug development with our proprietary, tech-driven platform, focused on bringing new treatments to patients faster and more efficiently.\n\nAt Formation Bio we license clinical stage drug assets and develop them in-house using our proprietary, technology-driven platform. Over the past few years, we have been able to significantly expedite the drug development process, evidenced by our acceleration of over 300 clinical trials and reducing trial durations by up to 50%. This innovation translates to getting life-saving drugs to market 1-3 years faster, where we specialize in partnering with and nurturing in-house clinical-stage drugs. Our diverse team of experts come from across multiple industries, combining the best of tech and pharma talent.\n\nJoin our culture of innovation where your work directly contributes to transforming patient care in areas such as rheumatology, dermatology, CNS, and cardiometabolic diseases. Our dynamic environment blends advanced technology with strategic drug development, speeding up the delivery of new treatments. Here, every role plays a part in our mission to bring new treatments to patients faster and more efficiently.\n\nAbout the Role\n\nAchieving this goal of the growth of Formation Bio will require an energetic, highly motivated, experienced and creative world class Clinical Development Team. We need you to be part of that journey:  As a key member of  the clinical development team as the project physician, you will be responsible for providing strategic clinical  input to the development and execution of the clinical development plan in dermatology. This would include activities such as  protocol development and medical monitoring.\n\nA key success factor for Formation Bio is our desire to make drug development even more efficient through incorporation of tech and AI to our daily work. Therefore, your ability to understand and navigate the complexities of healthcare data and clinical trials and partner with the tech team to develop tools for the development process will be essential to your success and the success of Formation Bio.  In addition, the ability to work effectively in a matrix environment and to communicate efficiently across multiple stakeholders is essential.  It will also be essential that you are a creative problem solver with the ability to drive new ways of doing drug development, particularly related to the deployment of AI.\n\nResponsibilities\n\nClinical Development Planning and Execution: \n\n\n* Development of protocol concepts, protocols and clinical development plans \n\n* Clinical leadership in the execution of clinical trials - risk assessment, operational considerations, safety and efficacy considerations as well as commercial needs.\n\n* Based on the clinical trial design landscape contribute to study design and planning strategy\n\n* Medical monitoring and oversight of phase 2-4 trials\n\n\n\n\nOperational Excellence:\n\n\n* Partner with the Development Operations team to develop innovative ways to ensure excellence in study execution, particularly around the deployment of tech solutions Drive/contribute to trial operations and medical processes to achieve continued innovation and improvement\n\n* Partner with the Development Operations team to conduct feasibility and assess the suitability of sites  for the particular study input into patient recruitment tools\n\n* Maintain close relationships with the sites to provide input for innovative recruitment ideas.  \n\n* Utilize your clinical development and trial execution experience to develop creative ways to speed up clinical trials in an efficient manner \n\n\n\n\nTraining:\n\n\n* Clinical training for internal stakeholders and clinical trial sites  (e.g. overviews of specific disease areas, drug mechanisms of action, protocol requirements, etc.\n\n\n\n\nAI and Tech deployment\n\n\n* In partnership with the Development and Tech Teams provide input to the development of  AI tools to ensure we achieve our goal of being a tech enabled drug development company of the future.\n\n\n\n\nBusiness Development:\n\n\n* Work closely with the BD team to develop deal models through your experience in clinical development \n\n* Based on review of the scientific landscape contribute to cardiovascular therapy area strategy\n\n\n\n\nAbout You \n\n\n* At least 5 years experience in biotech (preferred) or pharma to include preparation of the Clinical Development Plan, protocol development and medical oversight/monitoring of phase 2-4 studies (final title to be determined by experience level)\n\n* MD/DO degree (or equivalent) required\n\n* Board certified by accredited speciality board- Internal Medicine or Dermatology preferred\n\n* Experience with health authority interactions and contributions to regulatory filings preferred\n\n* Excellent written and verbal communication skills\n\n* Strong analytical skills\n\n* A “roll-up-your-sleeves” attitude\n\n* Track record of cross functional leadership\n\n\n\n\n \n\nWe offer competitive compensation because we want to hire the best people and reward them for their contributions to our mission. We pay all employees competitively relative to the New York City market, regardless of their location. In compliance with NYC’s pay transparency law and in pursuit of pay equity and fairness, we publish salary ranges for all open roles at Formation Bio. The target salary range for this role is $270,000 - $340,000.\n\nOn top of base salary, we also offer equity, generous perks, location flexibility, and comprehensive benefits – learn more about them and our compensation philosophy here.\n\nIf this range doesn’t match your expectations, please still apply because we may have something else for you.\n\n#LI-hybrid\n\n\nYou 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.\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 and Design jobs that are similar:\n\n $70,000 — $100,000/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

\n \n\nOrganization 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\n \n\nThe Role:\n\nThis exciting, newly created role in Procurement will be responsible for leading the category management, sourcing, negotiations, and supplier management for all outsourced services related to the company’s clinical development pipeline and operations, while working cross functionally with internal stakeholders to ensure effective sourcing strategy, selection, contract negotiations, spend management, and resolution of supplier related issues. This leadership role requires keen business facing skillsets and acumen, as well as significant experience interfacing with, and managing, CROs and ancillary vendors across clinical development areas (e.g., Clinical Operations, Pharmacovigilance, Biostatistics, Data Management, Central Lab, TMF, etc.). Driving cross-functional collaboration with Immunovant’s leadership, this role will lead procurement initiatives, requests for proposals, supplier selection, contract negotiations, and ongoing business oversight for new and existing vendors.\n\n \nKey Roles and Responsibilities:\n\nBusiness Partnership:\n\n\n* Interface with and facilitate (as needed) across Immunovant’s functional areas to develop requirements and provide guidance/training to Business Owners (BOs) and stakeholders on the end-to-end sourcing process.\n\n* Partner early in cross-functional (Development, Legal, Finance, Program Management, etc.) business planning by effectively fostering relationships internally to maximize timely Procurement support for clinical programs, initiatives, and outcomes.\n\n* Establish clear external outcomes, deliverables/milestones, and payment structures within outsourced services and partners to effectively support the clinical programs and functions.\n\n* Ensure applicable vendors execute services as committed, and support issue resolution for clinical outsourced\n\n* Contribute and support the planning of clinical programs, supplier budgets, timelines, risk management, and financial implications for new or current programs.\n\n\n\n\n \n\nSourcing Process & Supplier Management Leadership:\n\n\n* Develop and execute sourcing strategies for outsourced services in the clinical pipeline.\n\n* Facilitate vendor selection across clinical development and operations teams (e.g. CROs and ancillary vendors).\n\n* Engage with BOs, stakeholders, vendors, and legal team to facilitate review of CDAs, CTAs, MSAs, Consulting Agreements, SOWs, Amendments/Change Orders, and other documents as required.\n\n* Lead the RFx and vendor bidding process for outsourced services, including RFP development, bid comparison analysis, bid defense meetings, and vendor scorecards, as well as manage any changes to existing programs (change orders, scope, etc.).\n\n* Manage the contracting process end-to-end working with key BOs, Legal, and Finance by optimal facilitation, review, and negotiations for outsourced services leveraging appropriate tools and guidance to support the functional areas.\n\n* Manage communication with outsourced vendors with respect to new and/or ongoing procurement support for programs, trials, etc.\n\n* Utilize expertise in total cost of ownership to facilitate and provide stellar negotiations leadership while focusing on “win-win” solutions between Immunovant and outsourced partners.\n\n* Manage supplier enablement/onboarding and purchase orders in system of record.\n\n* Support or lead (as needed) supplier relationship management needs, including metrics/KPI development, scorecards, etc. for business review meetings with key partners.\n\n\n\n\n \n\nProcurement Operational Excellence:\n\n\n* Foster clear, consistent, and open collaboration internally and externally.\n\n* Identify and pursue continuous improvement and constructive change to support higher levels of procurement execution, including development of best practices and timely communication of key learnings.\n\n* Support the issue escalation process at the operational level and ensure timely escalation to senior\n\n* Collaborate with BOs, Legal, and Finance to drive the development of key document templates, training / awareness, negotiation / escalation parameters, processes, systems & tools to support Procurement growth and the clinical pipeline.\n\n* Collaborate with the Clinical and Quality organizations on developing updated procedures on selection, onboarding, and maintenance of outsourced partners.\n\n\n\n\n \nRequirements:\n\n\n* Bachelor’s or Master’s degree with an emphasis on biotech/pharma, life sciences, outsourcing, supplier management, or business partnering.\n\n* 10+ years’ experience in the pharmaceutical/biotech/CRO industry preferred, with a minimum of seven (7) years of direct end-to-end clinical outsourcing\n\n* Must have experience in the procure-to-pay (P2P) process and working in a P2P system. Coupa experience is a plus.\n\n* Excellent interpersonal skills and demonstrated ability to be independently business facing and influence across all levels.\n\n* Ability to build consensus and strong partnerships internally and externally. Must be highly team oriented and comfortable working with cross-functional teams.\n\n* Excellent analytical skills and effective written and verbal communication skills.\n\n* Experience working on clinical trials and working knowledge of GCP preferred.\n\n* Knowledge in clinical budgeting/forecasting and eRFx systems a plus.\n\n* People management experience highly desirable.\n\n* Demonstrated ability to drive oversight, performance and relationship management with CROs and other clinical service providers.\n\n* Highly skilled in establishing effective business relationships with internal and external customers, demonstrating strong collaboration skills, commitment to relationship building, and focus on delivery and commitments.\n\n* Excellent leadership and influencing skills including ability to prioritize critical needs, act decisively, and handle a high volume of complex tasks within a given timeframe.\n\n* Flexibility to adapt to the dynamic needs of a rapidly growing biotech company.\n\n* Strong understanding of the drug development lifecycle.\n\n\n\n\n \nWork Environment\n\n\n* Immunovant’s headquarters is located in New York, New York. This position is flexible for remote work.\n\n* Dynamic, interactive, fast-paced, and entrepreneurial environment.\n\n* Domestic or international travel may be required (<10%).\n\n\n\n\n \n\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 Consulting, Travel, Finance and Legal jobs that are similar:\n\n $70,000 — $165,000/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

\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 (AIS) is seeking an Associate Director-Clinical Documents (eTMF) to serve as an operational lead for management and oversight of the trial master file (TMF) system at AIS.  This person works in partnership with the study teams in order to ensure trial documents are complete, high quality, and appropriately filed within the TMF system. \n \nDuties and responsibilities:\n·         Establish strategy for development and management of paper and electronic Trial Management File (eTMF) system through project management and hands-on participation in the configuration and maintenance of the eTMF for each study.\n·         Support authoring of TMF Management Plans and provide TMF Indices; work with study teams to check and verify these plans.\n·         Provide guidance on best practices for clinical trial records handling, retrieval, and archival procedures.\n·         Prepare and maintain manuals, training materials, policies and procedures and other quality documents as they apply to TMFs.\n·         Participate in and oversee the quality control of documents (paper and electronic) submitted to the TMF.\n·         Support the coordination of the transfer of study specific TMF from CROs into the AIS TMF, if applicable.\n·         Educate and support study teams and designated study team content owners in understanding their TMF-related responsibilities, requirements, and expectations; act as an ad-hoc member of the study team, as necessary.\n·         Act as a point person for study team TMF questions and manage close-out of TMF related issues.\n·         Provide TMF metrics: timeliness, completeness, and quality of TMF documentation and content, and the risk level of outstanding items as requested.\n·         Identify any corrective actions which must be assigned and addressed.\n·         Provide document records to users (e.g., internal staff and/or auditors) for review including archived records.  \n·         Oversee the provision of the required documents at the time of regulatory authority inspection or internal audits.\n·         Respond to TMF and non-TMF internal and external information inquiries related to clinical trial records.\n·         Identify opportunities for continuous improvement.\n·         Manage in-line QC functions for TMF documentation including site regulatory documentation to evaluate and report whether deliverables are completed per contracted services and are in compliance with all appliable local, federal, and international regulations, guidelines, AIS policies, SOPs, and work instructions.\n·         Manage, mentor and train individuals reporting into this position, if applicable.\n·         Actively support inspections and audits.\n·         Resource planning to support TMF activities.\n·         Perform other duties as assigned.\n \nQualifications:\n·         Bachelor’s degree preferred, or equivalent knowledge/experience gained through a minimum of 8 years’ experience in the clinical trial setting required.\n·         Must have strong knowledge of clinical drug development processes. \n·         Understanding of the planning, launching, maintenance, and closure of Phase I-IV clinical trials, including global clinical trials. \n·         Experience in successfully working with TMF systems.\n·         Demonstrated successful setup and management of TMF systems. \n·         Thorough knowledge of CFR, ICH/GCP, and GDPR/data privacy requirements. \n·         Self-starter comfortable working in a hybrid work environment with department and cross-functional colleagues based in different geographies.\n·         Resourceful with keen critical thinking skills; ability to successfully research a variety of topics, including obtaining input from colleagues to drive solutions. \n·         Ability to anticipate issues and outcomes and respond strategically, proposing “outside the box”, goal-oriented solutions to challenges in alignment with project and company objectives and values.\n·         Ability to prioritize urgent and important tasks and take necessary actions to inform/escalate to management and stakeholders as appropriate.\n·         Proven leadership and interpersonal skills with the ability to work collaboratively as a member of a cross-functional team; excellent communication and organizational skills and the ability to work effectively in a high paced, fast changing environment.\n·         Ability to review and analyze performance metrics through various systems.\n·         Proficiency with MS Word, Excel, PowerPoint, SharePoint; Smartsheet experience a plus.\n·         Experience giving presentations in both department and multidisciplinary settings. \n \nEssential Traits: \n·         Leads by example and learns from mistakes.\n·         Effectively pivots to meet changing demands in priorities when business needs dictate.\n·         Completes tasks on time to meet milestones, comfortable proactively communicating to stakeholders if timelines are at risk.\n·         Clearly communicates milestones, risks, mitigations, and essential feedback.\n·         Values the input of colleagues. \n·         Works efficiently without compromising quality.\n·         Continually seeks self and team improvement.\n·         Innovates and eliminates redundant, inefficient, and manual processes where feasible.\n\n\n#LI-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 has a compensation range of $165,000 - $200,000. In order to be considered for a position, candidates must 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 and Education jobs that are similar:\n\n $60,000 — $100,000/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

\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 – 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 candidate’s 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 Fortune’s "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 other’s 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 💰 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