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
$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.CRO,...SuggestedFor contractors$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
...Flagship Pioneering, 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. CRO,...SuggestedFor contractors- ...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... ...department compliance objectives. Develop TMF standards and oversight in support of inspection...SuggestedWork at officeFlexible hours
$142.5k - $256.5k
The Role Moderna is seeking an Associate Director of Clinical Operations to manage studies within the Oncology Therapeutic Area. This may include... ...through 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$192k - $215k
.... For more information, visit Position Purpose: The Associate Director, Clinical Quality Compliance will be a primary quality contact for GCP and GCLP compliance... ...strategies. Lead internal/external/Investigator site/TMF audits, as necessary, and work with Stoke staff to...Temporary work- 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...
$200k - $300k
...DescriptionGeneral Summary:The Patient Safety Associate Medical Director will provide medical safety expertise... ...Vertex products and maintenance of compliance with the Pharmacovigilance... ...TeamsIdentifies, prioritizes and analyzes clinical safety signals, in accordance with...Full timeSummer workRemote workFlexible hours2 days per week$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- 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...
- 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...
- ...Biosciences is seeking an experienced and highly motivated Associate Director, Clinical Operations to serve as a key operational leader across... ...Clinical, Regulatory, and Quality team members to ensure compliance of department/study activities with FDA regulations, guidelines...Temporary workWork at officeLocal areaImmediate startRemote work
$120k - $135k
...opportunities.Discover your purpose. Embrace innovation. Experience #LifeatRealChem.Job Summary:Real Chemistry is looking for an Associate Director, Medical Strategy tojoin our growing team!Our Associate Directors play a pivotal role in guiding the direction of projects...Work at officeLocal areaRemote work2 days per week$170k - $200k
...BlueRock? BlueRock Therapeutics LP is a clinical stage cell therapy harnessing the... ...Clinical Operations Study Lead (COSL)/Associate Director oversees the management and operations... ...mitigation/rescue actions as needed). Compliance & Process Improvement Ensures clinical...$179k - $212k
...meaningful difference worldwide. Could you be our next Associate Director, Clinical Assay Strategy-Flu? The job is in our Waltham, MA Office.... .... Oversee assay transfers ensuring concordance, compliance, and data integrity. Establish vendor governance frameworks...Work at officeWorldwide3 days per week$154.4k - $242.55k
...Strategic Planning Group within PharmSci Clinical Manufacturing Planning, which is... ...across Takeda’s clinical portfolio.The Associate Director contributes to the team’s delivery of... ...requirements and demonstrated ability to apply compliance principles, exception management, and...Minimum wageTemporary workLocal area- ...Job Title: Associate Director Clinical Operations Location: Waltham, Massachusetts Type: Perm Work Model: Hybrid – onsite and remote... ...KRIs, and SOPs; identify gaps and propose solutions for compliance and efficiency. Contribute to regulatory filings domestically...Permanent employmentFull timeLocal areaRemote work
- ...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
- ## Associate Director, Clinical Operations Study LeadApplyremote type: OnSitelocations: MA-Cambridgetime type: Full timeposted on: Posted 3 Days... ...rigor, and the highest standards of ethics and compliance. The company fosters an inclusive, collaborative environment...Worldwide
$198.5k - $311.85k
...will inspire you and empower you to shine? Join us as an Associate Medical Director in our Neuroscience Therapeutic Area Unit in our Cambridge... ...Associate Medical Director leads and drives strategy for clinical studies within the overall global clinical development for...Minimum wageTemporary workWork at officeLocal areaRemote workNight shift$194.1k - $262.5k
Alnylam Pharmaceuticals is looking for an experienced Associate Medical Director to support the execution of comprehensive medical plans focused on ATTR in the US. The role involves strategic planning, managing project developments, and ensuring effective communication...$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...$176.1k - $287.3k
...to lead projects across diverse therapeutic areas. As the Associate Director, Clinical Diagnostics (CDx), you will own the end-to-end strategy,... ...pre-submission interactions and labeling alignment. Ensure compliance with applicable standards and regulations (e.g., ISO 1348...- ...Nuvalent is seeking an Associate Director, Medical Strategy to develop and execute Medical Affairs strategies, align cross-functionally with Clinical Development, Commercial, Regulatory and Field Medical teams, and oversee advisory boards and ISR programs. You will...
- Job DetailExperience Level Associate DirectorDegree Type Doctor of... ...environment.Job DescriptionAssociate Director of Biostatistics OverviewThe... ...a pivotal role in driving clinical development strategies for... ...ensuring data integrity and compliance.Work with global teams...Interim role
$160k - $240k
...and our tenacity to overcome barriers, together.Opportunity OverviewAs the Associate Director, GCP/GLP/GVP QA, you will oversee GCP activities, ensure compliance and quality execution of clinical studies. You will assist in the development and management of GCP quality...Contract workWork at officeImmediate startNight shift$150k - $211k
...enabling manufacturing robustness, quality, and compliance across all product modalities and technologies.Role SummaryReporting to the Director of Drug Substance (Biologics), MSAT, this... ..., linker-payload development, HPAPIs for clinical/commercial ADC manufacturing is desirable...Temporary workRemote workWorldwideFlexible hours$118k - $128k
...life insurance applications.The primary responsibility of the Director, Life Underwriting is to accurately assess medical and financial... ...protected characteristic. The Company is also committed to compliance with all fair employment practices regarding citizenship and immigration...Full timeLocal areaImmediate startRemote workRelocation$120k - $160k
...of research locations, mobile clinics, and clinicians across the globe... ...Reporting to the Sr. Director of Study Feasibility & Clinical Partnerships, the Associate Director and Director of Study... ...regulatory and organizational compliance, and cultivates high-impact, high...Full timeTemporary workWork at officeLocal areaRemote workWorldwideVisa sponsorshipWork visaFlexible hours$174k - $196k
...Associate Director, Clinical Pharmacology Cambridge, Massachusetts, United States Associate Director, Clinical Pharmacology City Therapeutics is advancing a next-generation platform for RNAi medicines designed to unlock the full therapeutic potential of gene...Work at officeWork from homeFlexible hours
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