Associate Director, TMF & Clinical Compliance
Amylyx Pharmaceuticals
Amylyx Pharmaceuticals in Cambridge, MA is seeking an Associate Director of Clinical Compliance & Records responsible for ensuring compliance with clinical study regulations. The ideal candidate will have extensive experience in the pharmaceutical industry, guiding Study Management Teams on ICH/GCP standards, and overseeing Trial Master File processes. A bachelor's degree in a science discipline is required, along with strong interpersonal and organizational skills. #J-18808-Ljbffr Amylyx Pharmaceuticals
$171k - $192k
Associate Director, Clinical Compliance & Records Cambridge, MA Amylyx has an audacious mission to usher in a new era for treating diseases with high unmet... ...role will participate in SMTs, providing leadership for TMF strategy and process, and partnering with internal and...SuggestedLocal areaRemote work$148k - $236.5k
...Pioneering Medicines is seeking an Associate Director or Director, Clinical Development Operations to join our... ...patient enrollment, monitoring, protocol compliance, and study close-out activities... ...samples, and lab results; maintain TMF quality and audit readiness. Lead...SuggestedFor contractors$175k - $240k
...of Position: Scholar Rock is looking for an associate director level subject matter expert to build clinical operations compliance while upholding our core values and staying... ...support department compliance objectives. Develop TMF standards and oversight in support of...SuggestedWork at officeFlexible hours$142.5k - $256.5k
The Role Moderna is seeking an Associate Director of Clinical Operations to manage studies within the Therapeutics/Oncology Therapeutic Area. This... ...phase 4 trials, depending on lifecycle of program, in compliance with ICH/GCP, local regulations, and Moderna SOPs Manage...SuggestedPermanent employmentWork at officeLocal areaWork from home- Moderna is seeking an Associate Director of Clinical Operations to manage studies within the Therapeutics/Oncology Therapeutic Area, leading trials... ...to the development programs with strong leadership and compliance with ICH/GCP and Moderna SOPs. #J-18808-Ljbffr BioSpaceSuggested
$200k - $240k
...Merida Biosciences is seeking an experienced and motivated Associate Director, Clinical Operations to play a key role in the planning, execution,... ...progress of milestones. Ensure trials are conducted in compliance with ICH-GCP, company SOPs, and applicable regulatory...Local area$175k - $215k
...in Watertown, MA. Disc Medicine is a clinical-stage biopharmaceutical company committed... ...that empowers and inspires. The Associate Director (AD) Clinical Financial Planning & Analysis... ..., budget vs. actual analysis and compliance with internal controls. Partner with...Remote workFlexible hours- BlueRock Therapeutics in Cambridge, MA is seeking an Associate Director of FP&A to serve as the lead finance partner for Development and G&A and program teams. You will own clinical trial budgeting, the annual operating plan, and quarterly forecasts, ensuring forecasts...
$142.17k - $213.25k
...of AI and digital health strategies & solutions that accelerate clinical development and enhance patient outcomes. This dynamic role... ...digital health strategies, with the ability to develop into project director, owning engagement delivery. ~ Digital Health Strategy &...Hourly payTemporary workWork at officeRemote work3 days per week$177.7k - $240.3k
Overview: The Associate Director (AD), Clinical Science will be a member of the global clinical development team, working closely with other members... ...; leads protocol deviation trends review Ensures TMF compliance for clinical documents Provides clinical input and review...Full timeTemporary workLocal areaFlexible hours- Moderna seeks an Associate Director, Clinical Supplies Project Management to lead end-to-end clinical supply activities, including demand planning... ...to sites while maintaining quality and regulatory compliance. The role emphasizes cross-functional leadership and process...
$175k - $210k
...Therapeutics is seeking a highly experienced Clinical Operations professional to lead the... ...the Head of Clinical Operations, the Associate Director, Clinical Operations will be... ...with the highest ethical standards in compliance with internal SOPs, ICH/GCP, and local...Interim roleWork at officeLocal area$146.3k - $234.1k
...Your Contribution: Lead the analysis, interpretation, and reporting of clinical pharmacokinetic data Drive PKPD modeling, exposure-response analyses, and translational quantitative pharmacology activities to support optimal dose and dose selection decisions Plan, design...$174k - $196k
...Associate Director, Clinical PharmacologyAssociate Director, Clinical PharmacologyCity Therapeutics is advancing a next-generation platform for RNAi medicines designed to unlock the full therapeutic potential of gene silencing. By combining innovative delivery technologies...Work at officeWork from homeFlexible hours$146.3k - $234.1k
...At BioNTech, we are committed to revolutionizing medicine through cutting-edge science and innovation. As Associate Director, Clinical Pharmacology & Pharmacometrics, you will play a pivotal role in advancing our drug development pipeline. With limited supervision...Hourly payWorldwide$133.04k - $199.56k
...Job Title: Clinical Regulatory Writer, Associate Director / Manager Location: Boston, MA OR Gaithesrburg, MD- Hybrid (3 days onsite) Introduction to role: Are you ready to be part of the solution, turning drug development strategies into reality? As an Associate Director...Hourly payTemporary workWork at officeFlexible hours3 days per week- ...Associate Director, Clinical Scientist How you'll make an impact: Serve as the study lead Clinical Scientist in immunology, actively participating in program team meetings, scientific advisory boards, and data/safety monitoring committees. Support the design...
$175k - $226k
About eGenesis eGenesis is a clinical-stage biotechnology company developing human-compatible... ...headquartered in Cambridge, MA. The Associate Director, Clinical Science is responsible for... ...study progress, and ensure protocol compliance Lead data review, evaluation, and...$163k - $225k
About This RoleAs the Associate Scientific Director, Clinical Genetics, you will join our Human Genetics team within Research and Development and help bring human genetics insights into late-stage research and clinical development programs. This role is focused on applying...Temporary workLocal area- Summary We are seeking an Associate Director / Director of Clinical Imaging who will be expected to take on a highly visible role with internal and external stakeholders through development of the strategy and management of imaging and dosimetry for clinical protocols in...For contractors
$194.4k - $291.6k
...Fenway area of Boston, Massachusetts.SummaryThe Medical Director/Medical Reviewer, Pharmacovigilance will be... ...medical oversight. The Medical Reviewer will ensure clinical accuracy, consistency, quality, and compliance with applicable pharmacovigilance requirements.Your...- Alnylam, Cambridge, MA, seeks an Associate Director of Clinical Science to join the global clinical development team. You will support study design, protocol development, and collaboration across medical leads, safety, statistics, and QA to advance therapeutic programs...
$150k - $195k
Department: 107600 Clinical Pharmacology Location: San Diego, USA- Remote Be a part of a global team that is inspired to make a difference... ...science and service for rare patients. Position Summary The Associate Director, Clinical Pharmacology will be responsible for the design,...Temporary workRemote workShift work- ...in Boston, Massachusetts and San Francisco, California. Position Summary CRISPR Therapeutics is searching for an Associate Director, Clinical Scientist to provide scientific input for early and late stage clinical development programs. Responsibilities...Remote work
- ...The Senior Associate Athletics Director serves as a strategic member of the senior administrative team, working closely with the Director of Athletics... ...initiatives. Oversees and directs all academic, compliance, social and community related activities for student-...Full timeFor contractorsWork at office
$142.17k - $213.26k
...Description Are you a visionary expert in clinical drug development, possessing the... ...join us! We are currently seeking an Associate Director Clinical Scientist, Immunology Cell Therapy... ...for your program. You will operate in compliance with GCP, AstraZeneca quality systems...Hourly payTemporary work- ...Job Description Job Description Associate Director, Global RA Labeling Lead – W2 - BB1309... ...guidance to internal stakeholders, including Clinical, Pharmacovigilance, Legal, Scientific,... ...and consistency across products and compliance with regu- latory labeling guidance....2 days per weekEarly shift
$165k - $200k
Department: 1440GL - Clinical OperationsLocation: Waltham, MACompany Overview:Dyne Therapeutics... ..., budget and milestones while ensuring compliance applicable SOPs, guidelines and... ...maintenance and evaluate completeness of the TMF by performing periodic QC reviews to ensures...Local area- Associate Director, Clinical Program Management, Cambridge, MA Cambridge, MA Isomorphic Labs is applying frontier AI to help unlock deeper scientific insights, faster breakthroughs, and life-changing medicines with an ambition to solve all disease. The future is coming...Work at office3 days per week
$110k - $135k
...responsibilities, and activities may change at any time with or without notice. The employer will make reasonable accommodations in compliance with the American with Disabilities Act of 1990. The job description will be reviewed periodically as duties and responsibilities...Local area
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