Senior Director, Oncology CGT Regulatory Strategy
AstraZeneca
AstraZeneca in South San Francisco is looking for a Senior Director in Oncology Cell and Gene Therapy Regulatory Affairs. The role involves leading the global regulatory strategy for complex CGT products, ensuring efficient approval processes, and coaching other team members. The ideal candidate will have an advanced degree in a science-related field and extensive experience in regulatory affairs, especially related to cell and gene therapy, with a strong track record of stakeholder management and strategic thinking. #J-18808-Ljbffr AstraZeneca
$270k - $300k
Pliant Therapeutics, Inc. is looking for a Senior Director, Regulatory Affairs for Oncology Strategy in South San Francisco, CA. This remote role leads the development and execution of regulatory strategies across the product lifecycle. Candidates should have at least 1...SeniorRegulatoryRemote work$245k - $302k
...IDEAYA is a precision medicine oncology company committed to the... ...-organized, and skilled Senior Director, Medical Writing to provide... ...for delivering high-quality regulatory and clinical documents that... ...development and registration strategies. You will partner closely...SeniorRegulatoryContract workTemporary workFor contractorsWork at officeLocal areaWork from home- ...Position Title: Senior Director, Regulatory Affairs (Strategy, Hematology Oncology) Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines, the next...SeniorRegulatoryFor contractors
$270k - $300k
...Senior Director, Regulatory Affairs – Oncology Strategy (Remote*) Remote Pliant Therapeutics is a clinical‑stage biopharmaceutical company and leader in the discovery and development of novel integrin‑based therapeutics. Based in South San Francisco, California, Pliant...SeniorRegulatoryFull timeTemporary workWork at officeRemote work$281.01k - $363.66k
...Direct Reports: Director, Medical Strategy - Multiple Myeloma Additional... ...Role Purpose The Senior Director, US Medical Director... ...Access, Clinical Development, Regulatory, and Global Medical Affairs... ..., including hematology/oncology ~ Demonstrated experience...SeniorRegulatoryFor contractorsLocal area$182k
...areas including immunology, oncology and neuroscience - and... ...Description The Scientific Director / Senior Medical Director provides specialist... ...into core brand (product) strategies, and to support medical... ...Study Reports, and Regulatory Submissions and responses....SeniorRegulatoryTemporary workLocal area3 days per week- ...areas including immunology, oncology and neuroscience - and... ...journey. The Scientific Director / Senior Medical Director, Medical Affairs... ...into core brand (product) strategies, and to support medical... ...operations, discovery, statistics, regulatory, etc…) as they relate to on...SeniorRegulatoryWork at officeLocal area
$218.06k - $327.09k
...Senior Director, Oncology Cell and Gene Therapy Regulatory Affairs The Senior Director, Oncology Cell and Gene Therapy Regulatory Affairs, leads the development... ...and implementation of the global regulatory strategy for CGT products of high complexity and visibility and...SeniorRegulatoryHourly payTemporary workWorldwideFlexible hours3 days per week$300k - $340k
...Senior Director, Medical Affairs ORIC Pharmaceuticals is a clinical... ...developing and executing the GMA strategy and tactical plans with a... ...Development and Operations, Regulatory, Research, Finance, Legal, and... ...societies in the field of oncology. Work closely with the Clinical...SeniorRegulatoryWork at office$185k - $215k
...Senior Manager/Associate Director, Program Management Tenvie Therapeutics is developing precision... ...chemistry, translational sciences, regulatory, clinical, etc.), ensuring alignment... ...efficient execution of early development strategies. We are seeking a general athlete...SeniorRegulatoryLocal area$230k - $270k
...: Allogene Therapeutics is seeking Senior Director, Head of Process Sciences group within... ...robust, integrated BLA enabling control strategies Lead the development of robust risk... ...Technical Reports Contribute to Regulatory Filing strategy and content, and responses...SeniorRegulatoryInternshipLocal area$257k - $315k
The Opportunity As Senior Director of Pharmaceutical Development, you lead all small molecule... ...You bring strong cGMP expertise, support regulatory submissions, and collaborate across... ...regulatory approval. Shape and optimize CMC strategy, project plans, and execution. Monitor...SeniorRegulatory3 days per week- ...well‑organized, and skilled Senior Director, Medical Writing to provide... ...operational leadership across oncology programs spanning early‑ and... ...You’ll Do Lead authoring strategy and oversee the successful development of clinical and regulatory documents (e.g., INDs, NDAs,...SeniorRegulatoryTemporary workFor contractorsLocal area
- A Section Lead (Senior Director-level) position in Analytical Development & Quality Control (ADQC... ...analytical development and control strategy for biologics from preclinical to commercial... ..., including CQA assessments. Support regulatory submissions and Q&A; mentor authors....SeniorRegulatoryLocal areaRelocationRelocation package
- Initial Therapeutics, Inc. is looking for a Senior Director of Health Economics and Outcomes Research to shape and execute strategies related to the launch of darovasertib. This critical role involves collaboration with various teams to generate robust evidence and support...Senior
$205.9k - $382.5k
...position for Specialized Analytics and Capabilities (Senior Director‑level) is available within the Analytical Development... ...a complex biologics pipeline. Provide overarching MS strategy to ensure global regulatory alignment and direct response to health authority inquiries...SeniorRegulatoryLocal areaRelocation package$160.5k - $305k
...Director, Portfolio Insights AbbVie's mission is... ...including immunology, oncology and neuroscience - and... ...probability of technical and regulatory success) assessments,... .... Data strategy and benchmarking insights... ...offs, and scenarios to senior leadership. Prepare actionable...RegulatoryTemporary workWork at officeImmediate startRemote workMonday to FridayFlexible hours$200k - $270k
...Job Description About the Role The Senior Director of Centralized Feasibility & Operational Strategy leads the global feasibility and operational strategy... ...Development, Program Leadership, Data Science, Regulatory, and senior leadership to shape country and site...SeniorRegulatoryFlexible hours- ...Senior Medical Director - Clinical Development Position Summary A biotechnology... ...precision medicine in oncology is seeking a Senior... ...analysis, and preparation of regulatory documentation. The role may... ...successful execution of clinical strategy and study operations....SeniorRegulatory
$180k - $200k
...hands-on study/program contributor (Senior Manager) or a program-level leader influencing strategy and cross-functional execution (Associate Director). Essential Responsibilities... ...Generation, Analytical Insights, and Regulatory Engagement Develop and deliver data...SeniorRegulatoryRemote work$160.5k
...therapeutic areas - immunology, oncology, neuroscience, and eye care... ...The Scientific / Medical Director, Medical Affairs provides specialist... ...), and value and access strategies to support our evolving on-... ...Commercial, Market Access, Regulatory, HEOR and other functional...RegulatoryTemporary workLocal area- ...in San Francisco is seeking an Associate Director of Clinical Pharmacology. The ideal... ...oversee clinical pharmacology programs in oncology and other areas, requiring both strategic... ..., mentoring team members, and providing regulatory submission expertise. A PhD or PharmD and...Regulatory
$270k - $330k
...Job Description The Position We are seeking a Senior Director, Talent Acquisition & HRBP to lead hiring strategy and execution as the company advances its lead program... ...development, technical operations, scientific, regulatory, quality, and corporate functions ~ Strong...SeniorRegulatoryFor contractors$143.3k - $266.1k
...Development and Drug Delivery Systems. The Opportunity The Senior Principal Process Engineer and Strategy Realization Lead ensures robust clinical and... ...seamless commercialization Author and review relevant regulatory filing chapters and responses to information request...SeniorRegulatoryLocal areaRelocation package$257k - $286k
...our company culture! Position: The Senior Director, Medical and Scientific Writing plays a... ...the organization. Reporting to the SVP, Regulatory, Quality and Pharmacovigilance, you... ...internal and external) to develop crucial strategy, conclusions, and messaging. As needed,...SeniorRegulatoryFull timeWork at officeRemote workFlexible hours- ...experienced and strategic Senior Director of Toxicology to lead the nonclinical... ...function for our growing oncology pipeline. This individual will provide scientific and regulatory leadership across all... ...Responsibilities Nonclinical Safety Strategy Develop and execute...SeniorRegulatory
$161k - $299k
F. Hoffmann-La Roche AG, located in South San Francisco, is seeking an Enterprise Talent Strategy Partner. In this role, you will design and execute talent practices to develop a strong leadership pipeline. You'll work alongside Executive Recruiting and various partners...Senior$265k - $310k
...efficient, compliant, scalable, and aligned with Alumis' growth strategy. The Senior Director, Medical Strategy and Operations, will be responsible for... ..., Market Access, Commercial, Analytics, Compliance, and Regulatory to ensure alignment and integration of medical excellence...SeniorRegulatory$311k - $388k
...Senior Director, Biostatistics New York, NY; Boston, MA; San Francisco, CA; Raleigh, NC... ...developing the biostatistics team and strategy, driving impactful statistical initiatives... ...shaping innovative trial designs, supporting regulatory strategies, and ensuring high-quality...SeniorRegulatoryWork at officeLocal areaRelocation3 days per week$240k - $280k
...experienced and strategic Senior director of Biostatistics to provide... ...statistical leadership across oncology clinical development... ...advancing precision medicine strategies through innovative trial methodologies... ...development, and global regulatory engagement. This...SeniorRegulatoryInterim roleFlexible hours
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