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- ...13-160/hrSummary of Position:Looking for an associate or 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
$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. CRO,...SuggestedFor 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...Suggested- ...finance business partner for the Clinical R&D organization and associated functions, including Medical Affairs... ...the Executive Team and Board of Directors Improve the planning system and associated... ...analysis, and internal-controls compliance Partner with Program Management...
$192k - $215k
...Massachusetts. For more information, visit Position Purpose The Associate Director, Clinical Quality Compliance will be a primary quality contact for GCP and GCLP... ...strategies. Lead internal/external/Investigator site/TMF audits, as necessary, and work with Stoke staff to...Temporary work$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...
$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- ...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$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$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 wageLocal area$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- 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...
- ## 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
- The client seeks an Associate Director of Clinical Operations to provide key leadership supporting innovative advanced-therapy clinical trials in... ...help teams deliver studies safely, ethically, and in full compliance with ICH-GCP and applicable regulations, partnering with...Local area
- This Associate Director, Clinical Operations role is a key leadership position supporting advanced-therapy clinical trials in oncology. You will... ...clinical teams deliver studies safely, ethically, and in compliance with ICH-GCP and applicable regulations. The role...Local area
- ...Job Description Job Description Job Title: Associate Director Clinical Operations Location: Waltham, Massachusetts Type: Perm Work Model... ...KRIs, and SOPs; identify gaps and propose solutions for compliance and efficiency. Contribute to regulatory filings domestically...Permanent employmentLocal area
- Stoke Therapeutics, headquartered in Bedford, MA, seeks an Associate Director of Clinical Quality Compliance to oversee GCP/GCLP compliance across clinical studies. This role reports to the VP of Quality and collaborates with Clinical Development, Regulatory, and others...
$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$158.6k - $285.5k
...support Oncology Therapeutic programs, specifically supporting the Clinical Study Lead in the development, execution and evaluation of... ...Board meetings.Author and review clinical study documents in compliance with regulatory standards, including clinical protocols, informed...Permanent employmentFull timeWork at officeWork from home$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$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$174k - $196k
...Associate Director, Clinical Pharmacology Associate Director, Clinical Pharmacology City Therapeutics is advancing a next-generation platform for RNAi medicines designed to unlock the full therapeutic potential of gene silencing. By combining innovative delivery...Work at officeWork from homeFlexible hours- Reportingto:Sr. Director,Clinical Data Management Do you have the passion and commitment to join... ...clinical development programs. The Associate Director will oversee CRO partners and... ...deliver study objectives while maintaining compliance with regulatory requirements and...2 days per week
$142k - $213k
Are you a scientist with a passion for clinical drug development and a strong scientific foundation, who wants to learn the craft... ...and we make bold decisions driven by patient outcomes. The Associate Director, Clinical Scientist is a member of a multi-disciplinary study...Full timeTemporary work- ...developing innovative therapeutic solutions is seeking an experienced Clinical Science professional to support the advancement of its... ...ensure scientific rigor, operational excellence, and regulatory compliance.Key ResponsibilitiesContribute to the design, planning, and...
$160k - $240k
Who we are:Kymera is a clinical-stage biotechnology company pioneering the field of targeted protein degradation (TPD) to develop medicines that address critical health problems and have the potential to dramatically improve patients’ lives. Kymera is deploying TPD to...Contract work
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