Senior TMF Leader - eTMF & Inspection Readiness
Maze Therapeutics
Maze Therapeutics seeks a Trial Master File (TMF) Senior Manager for Clinical Operations to lead strategy, governance, quality, and execution of the TMF across our clinical development portfolio. You will partner with cross-functional study teams and QA to ensure inspection-ready TMFs, compliance with ICH-GCP and regulatory standards, and a scalable, AI-enabled TMF operating model. You will work with the Head of Clinical Operations to drive TMF readiness as Maze transitions TMF management #J-18808-Ljbffr Maze Therapeutics
- Maze Therapeutics seeks a Senior Manager, Trial Master File (TMF) to lead TMF strategy and governance across the clinical portfolio... ...drive the in-house TMF program, oversee eTMF platform implementation, and ensure inspection readiness in collaboration with QA and study teams....Senior
- ...Master File to provide strategic leadership for eTMF across the clinical portfolio. You will oversee vendor... ...support scalable, compliant trials. The role emphasizes inspection readiness, regulatory alignment, and mentorship of TMF staff, with #J-18808-Ljbffr structuretxSenior
- Rigel Pharmaceutical in the United States seeks a Senior Manager, QA, Quality Systems & Product Complaints to lead the Product... ...interfaces and external service providers, with an emphasis on inspection readiness. The position collaborates across functions to ensure cGMP...Senior
- ...seeking its first dedicated Investor Relations leader to establish a solid IR foundation and drive... ...You will own investor communications, build senior-level relationships, and guide the company toward public-market readiness. You will craft compelling narratives from...Senior
$159k - $221k
...and implement large-scale operational process improvement initiatives for the Mission Readiness program. The Mission Readiness team is responsible for charging, cleaning, inspecting, and performing other similar tasks where vehicle turn times are key. A successful candidate...SeniorFull timeTemporary workRelocation package- ...external partnerships. You will manage budgets, timelines, and governance with CMOs/CDMOs, ensuring timely NDA filings and launch readiness. The role requires an advanced degree and 9+ years in biopharma CMC, with strong leadership, financial acumen, and ability to navigate...Senior
- Veracyte seeks an experienced Senior Scientist to lead MRD assay development from concept to clinical lab implementation. You will guide... ...assays in regulated environments, with leadership and scientific innovation driving product readiness. #J-18808-Ljbffr Socket.devSenior
- Rigel Pharmaceuticals Inc is seeking a Senior Manager Quality Assurance Quality Operations to oversee GMP QA activities for commercial... ...and tested globally. You will ensure manufacturing readiness, batch disposition, change management and QC oversight across the...Senior
$171k - $200k
...clinical study activities.Assists with Inspection Readiness activities which may require the development... ..., Service Provider Oversight plans, TMF plan.Follows processes and procedures and... ...information in study specific systems EDC, CTMS, eTMF is current and accurate.May lead a...Senior$166k - $209k
...geographic location.Position Summary:The Senior Manager, Clinical Business Systems is... ...Vault QMS, QualityDocs, LMS, CTMS, and eTMF; Box; DocuSign; and other regulated systems... ...collaboration to keep platforms scalable, inspection-ready, and aligned with evolving business...SeniorContract workWork at officeRemote work- ...ocular nervous system. We are seeking an experienced Senior Clinical Trial Manager (Sr CTM). Reporting to the VP... ...mitigation and corrective action plans. Compliance: Ensure "inspection-ready" Trial Master Files ( TMF ) and compliance with ICH GCP and regulations. Cross...SeniorFull timeFlexible hours
- Kardigan is seeking a Director, GCP Inspection Readiness and Audits Strategy to lead Kardigan’s approach to regulatory inspections in the US and globally. Based in Princeton, NJ, on-site four days a week, you will partner with Clinical Quality Assurance and leads to design...
- ...and implement large-scale operational process improvement initiatives for the Mission Readiness program. The Mission Readiness team is responsible for charging, cleaning, inspecting, and performing other similar tasks where vehicle turn times are key. A successful candidate...SeniorTemporary workRelocation package
- Genentech is seeking a Launch Excellence Lead to own end-to-end launch readiness across Commercial, Medical Affairs, and Government Affairs. You will lead a team spanning Launch Excellence Managers, Squad Business Partners, Field Training Partners, Project Managers, and...
$162.5k - $301.7k
Senior Thought Leader Liaison (TLL) - Neuroimmunology We’re passionate about delivering on Our Promise to improve the lives of patients and... ...TAEs as advocates to accelerate product adoption and account readiness. Build trust and accelerate informed decision‑making with...SeniorLocal areaRelocation packageShift work$171k - $218k
...clinical study activities. Assists with inspection readiness activities, developing, modifying and... ..., Service Provider Oversight plans, and TMF plan. Follows processes and procedures... ...information in study‑specific systems (EDC, CTMS, eTMF) are current and accurate. May lead a...Senior$162.5k - $301.7k
Senior Thought Leader Liaison (TLL) - Malignant Hematology Geography: IL, OH, PA, DC, WI, MI, MD, DE Why Genentech We’re passionate about delivering... ...as advocates to accelerate product adoption and account readiness Enable appropriate demand by building trust and...SeniorLive inLocal areaRelocation packageFlexible hoursShift work$175k - $215k
...diseases. As Trial Master File (TMF) Senior Manager for Clinical... ...will serve as the operational leader responsible for the strategy... ...maintain complete, accurate, and inspection-ready Trial Master Files for... ...organization's electronic TMF (eTMF) platform. Develop and...SeniorFull time- ...across medicinal chemistry, analytical chemistry, computation, protein biochemistry and automation to move candidates toward study-ready material. You will develop and optimize bioconjugation methods, design automation-friendly protocols, and scale conjugations from mg...Senior
$171k - $223k
...clinical study activities. Assists with Inspection Readiness activities which may require the... ...plans, Service Provider Oversight plans, TMF plan. Follows processes and procedures... ...information in study specific systems (EDC, CTMS, eTMF) is current and accurate. May lead a...Senior- Rigel Pharmaceuticals, Inc. seeks a Senior Manager, Quality Assurance, Quality Systems & Product Complaints to lead the Product... ...Program and oversee CAPA activities. The role also supports inspection readiness, Health Authority inspections, and partner audits to ensure...Senior
- ...Sutro Biopharma in California is seeking a Senior Director of Information Technology to lead the enterprise IT function, aligning technology... ..., applications, data, and AI governance. This senior leader will modernize systems, build high‑performing teams, oversee budgeting...Senior
- GitHub is seeking a Senior Design Engineering leader to redefine the future of design in an agent-native world. You will set the technical and organizational... ...with Design, Product, and Engineering leaders, and craft executive-ready narratives to guide #J-18808-Ljbffr GitHubSenior
$261.38k - $338.25k
...next wave of passionate and ambitious people ready to make a direct impact.We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee... ...create possible, together.Job DescriptionThe Senior Director, Opinion Leader Programming HIV...SeniorFull timeTemporary workFor contractorsWork at officeLocal area- Mytra, located in Brisbane, California, is seeking a Senior Business Development Manager to shape our enterprise sales strategy. This role involves leading cross-functional initiatives, driving engagements, and establishing a scalable sales framework to enhance customer...Senior
$148.6k - $276k
F. Hoffmann-La Roche AG is seeking a product manager for their Data and Digital Catalysts department in California. You’ll define the product vision for a product family that aids in drug discovery, working with top scientists and cross-functional teams. The role requires...Senior- Planet Pharma Group seeks a Corporate and Clinical Contracts consultant in South San Francisco. The consultant will be responsible for negotiating and executing various contracts, ensuring efficient contracting processes, and working closely with the Legal team and internal...Senior
- Walmart is seeking a Senior Manager, Corporate Development and M&A to drive inorganic growth across Walmart U.S., Sam’s Club, and Walmart International. You’ll collaborate with senior leaders, manage complex financial modeling, and guide diligence and integration efforts...Senior
- Genentech in South San Francisco is seeking a Senior Clinical Operations Asset Director to provide strategic leadership across one or... ...scalable processes and innovative solutions, and partners with senior leaders to guide decisions while building a strong, inclusive #J-18808...Senior
$197.7k - $367.1k
Genentech is looking for an experienced leader to drive product strategies within the Pharma Technical Operations team in South San Francisco. The role requires extensive experience in the Pharma/Biotech field, including leadership in supply chain strategies and new product...Senior
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