Director of Clinical Affairs — Regulatory Trials Leader
Eight Sleep
Eight Sleep is seeking a Director of Clinical Affairs to own end-to-end regulatory-driven clinical studies for FDA-regulated medical devices and SaMD/digital health products. This hands-on role requires standing up studies, managing sites, IRB/ICF documents, data management, and regulatory submissions. You'll bridge internal teams with CROs, IRBs, and regulatory bodies, ensuring on-time, on-budget delivery while maintaining high standards of compliance and research integrity in a fast-paced #J-18808-Ljbffr Eight Sleep
- Maze Therapeutics is a clinical-stage biopharmaceutical company seeking a Senior Medical Director to lead the Clinical Sciences team... ...first‑in‑human and early‑stage trials, starting with the SLC6A19... ...development, trial monitoring, regulatory documentation, and CRO/vendor...Regulatory
- We're seeking a Director of Clinical Affairs to own end-to-end execution of regulatory-driven clinical studies for a growing medical device company. This is a hands-on... ...from earliest-stage concept all the way through trial completion and into post-market surveillance — not...RegulatoryContract work
$200k - $250k
...this isn't it. The Role We're looking for a Director of Clinical Affairs who will own the end-to-end execution of our regulatory-driven clinical studies. This is a hands-on,... ...specialists, and KOL advisory committees to ensure trials lead to successful clearance, payor coverage...RegulatoryFull timeContract workImmediate startWorldwideNight shift- ...California, San Francisco (UCSF) seeks a Senior Clinical Research Coordinator in the Pediatric... ...over staff. The role includes regulatory oversight, study testing, patient recruitment... ...compliant operations across multicenter trials and biorepository work. #J-18808-Ljbffr...Regulatory
$250k - $320k
About the DepartmentThe Clinical, Medical and Regulatory (CMR) department at Novo... ...optimally manage key opinion leader/organized providers/... ...to Senior Director Medical Affairs. Has direct supervisory... ...participate in clinical trials and identify key areas of...RegulatoryInterim roleLocal areaWork from homeHome officeFlexible hoursNight shift- ...Senior Manager, Clinical Trials Job Location: Irvine, USA | SanFrancisco, USA | Boston, USA... ...within budget, and in compliance with regulatory, ethical, and company standards. This role... ...works cross-functionally with Medical Affairs, Clinical Development, Regulatory...RegulatoryTemporary workLocal areaFlexible hours
- ...The Scientific Director / Senior Medical Director... ...medical affairs activities such as... ...interactions; generation of clinical and scientific... ...Study Reports, and Regulatory Submissions and... ...execution of clinical trial safety;... ...solicits opinion through leader interactions related...RegulatoryTemporary workLocal area3 days per week
- ...The Scientific/Medical Director, Global Hematology Pipeline, Medical Affairs provides specialist medical... ...with asset strategy, clinical development, value and... ...discovery, statistics, regulatory) as they relate to on‑... ...Knowledge of clinical trial methodology, data analysis...RegulatoryWork at office
- ...Vice President of Regulatory Affairs, Founding Regulatory Leader, Ophthalmology & Retina About the Company Well-funded clinical-stage biotech in ophthalmology developing a novel retina-focused therapeutic. Industry Biotechnology Type Privately Held, VC...Regulatory
- Trebla Talent is seeking a Sr./Medical Director to lead clinical strategy and execution for a cutting-edge biotech in... ...MD will shape development plans, oversee trial design, interpret data for publications and regulatory submissions, and represent the company in dialogues...Regulatory
$208k - $256k
...Position Overview : The Director of Clinical Affairs will specifically focus on... ...the execution of clinical trials aligned with company... ...relationships with key opinion leaders in the field (KOLs) and... ...fully compliant with global regulatory standards. What you'll...RegulatoryLocal areaFlexible hoursShift work$276.12k - $322.14k
...dysfunction. The Medical Director, US Medical Affairs, Hypertrophic... ...the Commercial and Clinical departments in the strategic... ...with key opinion leaders, academic... ...Development, Commercial, Regulatory, Safety, HEOR, Market... ...interpret clinical trial data, peer‑reviewed...RegulatoryWork at officeLocal area- ...Description Greetings from IT Engagements Role : Global Clinical Trial Leader (Contract Role) Location : South San Francisco, CA (... ...: Working knowledge of GCP/ICH requirements, international regulatory guidelines, and the end to end drug development process....RegulatoryContract workLocal areaRemote workFlexible hours
- ...and a promising development pipeline. Overview The Global Clinical Trial Leader (CTL) is accountable for the execution and delivery of early... ...: Working knowledge of GCP/ICH requirements, international regulatory guidelines, and the end-to-end drug development process. #J...RegulatoryLocal areaFlexible hours
$299k - $349k
...California is seeking a Senior Medical Director to lead late-stage clinical development programs in Oncology.... ...experience, emphasizing pivotal trials. Responsibilities include medical leadership... ...cross-functional teams to ensure regulatory compliance. The pay range is...Regulatory$220k - $245k
Olema Oncology, based in San Francisco, is seeking a Director of Clinical Science. This role involves leading clinical studies in a collaborative environment. Candidates must have a PhD or PharmD and extensive experience in oncology clinical development. The ideal candidate...$200k
A leading biopharmaceutical company is seeking an Associate Director of Medical Affairs for the West Coast. This position focuses on building relationships with experts in pediatric neurology and epilepsy. The ideal candidate will have an advanced scientific degree and...$242k - $347k
...Position Title Senior Director / Medical Director - Clinical Trial Lead Department Clinical... ...working closely with Medical Affairs colleagues Support... ...review of clinical parts of regulatory submissions, regulatory... ...Works with Key Opinion Leaders to incorporate their...Regulatory3 days per week$235.5k - $329.5k
...Biotechnology, Inc. is a clinical-stage... ...looking for a Senior Director, Clinical Research... ...Research, this senior leader will serve as the... ...components of global regulatory submissions (e.g.,... ...with Regulatory Affairs, Biostatistics,... ...Phase II/III clinical trials and integrated...RegulatoryFull timeWork at officeWork visa3 days per week- Zai Lab Limited seeks an Associate Director of Regulatory Affairs for onsite work in South San Francisco. This role leads regulatory strategy and execution for clinical programs, coordinating IND submissions and health authority interactions with cross-functional teams....Regulatory
- Felix is seeking a Licensing & Regulatory Affairs Manager to lead the company’s licensing and regulatory reporting across the United States. This individual will own the day-to-day management of Felix’s licensing portfolio, support expansion into new jurisdictions and...Regulatory
- Cytokinetics is seeking a Medical Director, US Medical Affairs, Hypertrophic Cardiomyopathy, to lead medical strategy and external... ...aficamten in the US. You will collaborate with Clinical Development, Commercial, Regulatory, and Safety teams to shape evidence plans and...Regulatory
- PROCEPT BioRobotics Corporation in San Francisco is seeking a Regulatory Affairs professional to lead regulatory efforts for core product development teams. The ideal candidate should have extensive experience in regulatory submissions for medical devices, particularly...Regulatory
- ...Pliant seeks a Vice President, Regulatory Affairs & Quality (GxP) to lead global regulatory and quality across oncology... ...an early phase lead candidate. This hands-on leader will design scalable GxP infrastructure in clinical, manufacturing and lab settings while ensuring...Regulatory
- ...these patients. The AD, Medical Affairs role presents a unique opportunity... ..., engaging with top thought leaders, and collaborating cross-functionally... ...: Collaborate with the Clinical Development, Translational Sciences, and Regulatory teams to translate clinical insights...RegulatoryTemporary workFlexible hours
- ICON Strategic Solutions is seeking a Clinical Trial Assistant to support delivery of clinical studies within a sponsor. You will help manage study documentation, TMF setup, eTMF, CTMS, and regulatory compliance across ICH/GCP guidelines. You will coordinate communication...RegulatoryWork from home3 days per week
- Enigma Search is looking for a Director of Regulatory Affairs to spearhead regulatory strategies in South San Francisco. The ideal candidate will possess a Master’s degree in a life science discipline, with a preference for a PhD, along with at least 10 years in regulatory...Regulatory
- ...Medicines is seeking an Associate Director, study level statistician, to lead... ...requires expertise in late-stage oncology trials, strong communication, and... ...programming, data management, and clinical operations to drive regulatory submissions and data #J-18808-Ljbffr...Regulatory
- ...underway, we are building the clinical and operational... ...company. THE OPPORTUNITY The Director / Senior Director of Clinical... ...responsible for making the trial happen. Reporting to the VP... ...pharmacovigilance, bioanalytical, and regulatory affairs Drive study startup activities...RegulatoryWorldwide
- AgFunder is looking for an experienced Clinical Data Manager to lead data management activities across clinical trials. The position requires overseeing vendor deliverables, ensuring quality, and maintaining regulatory compliance. The ideal candidate will have a Bachelor...RegulatoryRemote job
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