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: Associate Director / Director, Clinical Operations Cambridge, MA USA What if... We could... ...enrollment, monitoring, protocol compliance, and study close‑out activities with... ...samples, and lab results; maintain TMF quality and audit readiness. Lead...SuggestedFor contractors- ...-160/hr Summary of Position Looking for an associate or director-level subject matter expert to build clinical operations compliance while upholding our core values and staying... ...department compliance objectives. Develop TMF standards and oversight in support of inspection...SuggestedWork at officeFlexible hours
$170k - $190k
...Jade Biosciences Jade Biosciences is a clinical‑stage biotechnology company focused on... ...on LinkedIn. Role Overview The Associate Director, Clinical Site Budgets & Payments will... ...investigator grant strategy, transparency compliance, and site/vendor payment governance across...SuggestedContract workRemote work$174k - $212k
...Associate Director, Clinical Data Management Watertown, MA Company Overview Prime Medicine is a leading biotechnology company dedicated to creating... ...Detail‑oriented with high standards for data quality and compliance. Collaborative and cross‑functional mindset. Comfortable...Suggested$179k - $212k
...a meaningful difference worldwide. Could you be our next Associate Director, Clinical Assay Strategy-Flu? The job is in our Waltham, MA Office.... ...laboratories. Oversee assay transfers ensuring concordance, compliance, and data integrity. Establish vendor governance...Work at officeWorldwide3 days per week- Takeda is seeking an Associate Medical Director in Cambridge, MA to lead strategy for clinical studies within the Neuroscience Therapeutic Area. This role involves collaboration with global teams and decision-making impacting regulatory approvals. The ideal candidate holds...
$273.21k - $331.06k
...Associate Director, Global Clinical Physician, Neuroscience Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are... ...safety-related clinical considerations) Fulfills GCP and compliance obligations for clinical conduct and maintains all...Hourly payFull timeTemporary workPart timeFor contractorsSummer workWork at officeRemote workWorldwideFlexible hours$184k - $210k
...We’re looking for an experienced Associate Director, Trial Master File (TMF) Operations to lead the Trial Master... ...operations across our oncology clinical programs. This role is ideal for someone... ..., accuracy, and regulatory compliance across internal teams and external...Work at office2 days per week3 days per week$148k - $222k
Position: Associate Director, Trial Lead Clinical Operations (Contract to Perm) Location: Bedford, MA Job Id... ...site materials, etc.) and manages the TMF, as needed Drives study start‑up,... ...activities, clinical site compliance and data metrics from CROs and/or investigators...Permanent employmentContract workTemporary workFor contractorsLocal area$200k - $240k
Associate Director, Clinical Supply Chain At Merida Biosciences, we are pioneering true precision medicines for antibody-driven diseases. We specifically... ...practical mitigation plans to protect study continuity, compliance, and timelines. Establish fit‑for‑purpose processes,...Local area- Responsibilities Lead the strategic and operational management of complex clinical supply activities across all phases of development... ...distribution, and returns of IMP/CTM with external vendors in compliance with GMP and global regulations Develop Interactive Response...
- ...Biomedicines in Somerville, Massachusetts, is seeking an Associate Director, Supply Chain Operations to lead clinical supply chain strategies and ensure timely... ...vendors to enhance operational excellence and manage compliance. The ideal candidate has a Bachelor's degree in a...
- Zenith LifeScience is seeking a Clinical Regulatory Writing Associate Director to manage clinical regulatory writing activities across complex projects. You will author critical clinical-regulatory documents and provide strategic communication leadership. The ideal candidate...
- A leading global pharmaceutical company is seeking an Associate Director for Clinical & Quality Process Compliance. This role involves ensuring high-quality standards across processes and compliance with regulatory requirements. The ideal candidate will have significant...
$153.6k - $241.34k
Associate Director, Clinical & Quality Process Compliance Location: Cambridge, MA - Hybrid (not remote). Relocation benefit available. Job Description The Associate Director, Clinical & Quality Process Compliance is responsible for ensuring the quality of processes and...Temporary workLocal areaRelocation package- ...Cambridge, MA to oversee the strategic and operational management of clinical supply activities. This role requires expertise in supply chain strategy and vendor oversight while ensuring compliance with regulations. The ideal candidate will have extensive experience in...Flexible hours
$150k - $200k
...and operational management of complex clinical supply activities across all phases of... ...returns of IMP/CTM with external vendors in compliance with GMP and global regulations.... ...Quality Assurance & Regulatory on activities associated with labelling, packaging,...Flexible hours- Novartis Farmacéutica is seeking an Associate Director, Clinical Data Strategy to lead the development of clinical data strategies in Cambridge, Massachusetts. This strategic role will require collaboration with multiple stakeholders to ensure the successful execution...
$120 - $170 per hour
Associate Director, Clinical Program Quality Leader Base pay range: $120.00/hr - $170.00/hr Location: Cambridge, MA (Hybrid - 2 days onsite in... ...strategy, ensuring communication of significant quality and compliance risks to key stakeholders and Management and appropriate...Temporary workFor contractorsWork at officeImmediate startNight shift2 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...Flexible hours$156k - $234k
Associate Director, FP&A - Clinical Accounting & Data Analysis About Vertex Pharmaceuticals Vertex is a global biotechnology leader transforming lives... ..., and proactive risk management Champion GAAP compliance and governance excellence across all clinical accounting...Summer workRemote workFlexible hours2 days per week- Korro in Cambridge, MA is seeking a senior leader to direct the strategic and operational management of clinical supply across all development phases. You will ensure GMP-compliant, cost-effective delivery of investigational products to global sites and partner with Clinical...
$154.4k - $242.55k
...will inspire you and empower you to shine? Join us as Associate Director, Quantitative Clinical Pharmacology Lead in our Cambridge, MA office. At Takeda... ...Maintains a high standard for good clinical practice, compliance, and ethics. Mentors junior staff to promote...Minimum wageFull timeTemporary workWork experience placementWork at officeLocal areaRemote work- Vertex Pharmaceuticals is seeking a Clinical Study Quality Lead, Associate Director in Boston to oversee advanced quality assurance in clinical trials. Responsibilities include managing compliance with GCP standards, risk management, and coordinating with multiple stakeholders...
- ...is a global leader in influenza prevention and the world’s second‑largest influenza vaccine provider. This role is the Associate Director for Clinical Assay Strategy – Flu, based in Waltham, MA, and is hybrid (onsite three days a week) reporting to the Director of Clinical...3 days per week
$142.5k - $256.5k
...Assist in identifying resources required to manage programs and associated clinical studies. Provide leadership to junior colleagues, coaching... .... Maintain relationships with third‑party vendors for compliance. Coordinate and schedule drug labeling and packaging activities...Permanent employment$170k - $210k
Associate Director, Clinical Supply Chain Lead Sana Biotechnology is growing, and we are hiring new team members who believe in the potential of... ...stakeholders and sites. Continuous Improvement & Compliance: Contribute to deviation investigations and CAPAs in partnership...Temporary workImmediate startFlexible hours$200k - $300k
Overview Job Description The Patient Safety Associate Medical Director will provide medical safety expertise... ...Vertex products and maintenance of compliance with the Pharmacovigilance... ...Identifies, prioritizes and analyzes clinical safety signals, in accordance with GPS...Remote workFlexible hours2 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...
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