- Ascendis Pharma (Palo Alto, CA)
- …a dynamic workplace for employees to grow and develop their skills. The Associate Director , Regulatory Affairs will be responsible for developing and ... are technically complex and require extensive interaction with departments outside of regulatory affairs . + Excellent organizational skills and ability to work… more
- Ascendis Pharma (Palo Alto, CA)
- …Advanced degree desirable. + Minimum of 4 years of direct regulatory affairs experience in the biopharmaceutical industry. + Oncology regulatory ... the business, from drug development to marketing. The Manager, Regulatory Affairs will be responsible for supporting... will be responsible for supporting and developing global regulatory strategies for the oncology pipeline products… more
- AbbVie (South San Francisco, CA)
- …remarkable impact on people's lives across several key therapeutic areas - immunology, oncology , neuroscience, and eye care - and products and services in our ... The Product Safety Team (PST) lead for late stage oncology products, under the direction of the Group Lead...also closely collaborate with a PK and toxicology leads, regulatory and clinical development leads as well as medical… more
- Allogene (South San Francisco, CA)
- …with Clinical Operations to expedite execution of clinical trials * Support regulatory activities, medical affairs , and payer engagements; represent Allogene in ... LinkedIn. About the role: Allogene is seeking a Medical Director /Senior Medical Director for our allogeneic CAR...* Experience in the development of cellular therapy in oncology is desired * Understanding of the related disciplines… more
- AbbVie (South San Francisco, CA)
- …remarkable impact on people's lives across several key therapeutic areas - immunology, oncology , neuroscience, and eye care - and products and services in our ... strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie's customers, markets, business operations, and emerging issues.… more
- Pfizer (San Francisco, CA)
- …Lead will work with leaders from Biostatistics & Data Management, Global Regulatory Affairs , Clinical Pharmacology / Pharmacometrics, HEOR, Legal/Compliance, and ... Chief Medical Affairs Office's Real World Evidence (RWE), VP Lead Oncology is responsible for establishing global scientific leadership and stature through the… more
- BeiGene (Emeryville, CA)
- …and collaboration with functional area peers including Drug Safety, Quality Assurance and Regulatory Affairs , as well as thought leaders in order to meet ... The Associate Director (AD) Clinical Study Management leads both indirect...Consultants preferred + Therapeutic or medical knowledge preferred + Regulatory authority inspection experience a plus **Computer Skills:** Efficient… more
- BeiGene (Emeryville, CA)
- …while leveraging expedited pathways where appropriate. The individual will have regulatory affairs and cross-functional influence within the hematology ... **General** **Description** _:_ The Executive Director , Hematology North America Lead will be responsible...stakeholders. This individual will manage a minimum of 3 regulatory NA leaders (each who manage a group of… more
- Gilead Sciences, Inc. (Foster City, CA)
- …to help transform innovations to life-changing medicines for patients. The Associate Director , RWE Virology/Inflammation/ Oncology is part of a team that reports ... Gilead and help create possible, together. **Job Description** **Associate Director , RWE Inflammation** * This position can be based...to the RWE Virology/Inflammation/ Oncology Product Lead and contributes to the development and… more
- Ascendis Pharma (Palo Alto, CA)
- …clinical research resource for-cross-functional colleagues (eg in clinical operations, statistics, regulatory affairs , medical affairs , health economics ... Today, we're advancing programs in Endocrinology Rare Disease and Oncology . Here at Ascendis, we pride ourselves on exceptional...employees to grow and develop their skills. The Medical Director is involved in the design, safety monitoring, and… more
- AbbVie (South San Francisco, CA)
- …clinical development projects. A highly empowered, visible and collaborative role, the Director works in partnership with clinical and regulatory experts to ... experts + Statistical Programmers + Data Science experts + Global Medical Affairs experts + Regulatory experts Additional Information Applicable only to… more
- BeiGene (Emeryville, CA)
- The Director , Strategic Evidence, will possess an understanding of US market access priorities, evidence generation, and proficiency in AI technologies. As a key ... in collaboration with account teams and market access stakeholders (HEOR, medical affairs , fHEOR). This role is critical in identifying appropriate RWD sources and… more
- AbbVie (South San Francisco, CA)
- …remarkable impact on people's lives across several key therapeutic areas - immunology, oncology , neuroscience, and eye care - and products and services in our ... and reporting of biomarker data/activities in line with the development, regulatory , and commercial strategies + Lead asset-specific translational projects/teams in… more
- AbbVie (South San Francisco, CA)
- …Regulatory , R&D, or Industry-related experience. + Preferred Experience: 2-3 years Oncology Regulatory Affairs experience. + Demonstrates excellent ... with multiple driver indications within a Therapeutic Area and supports the Manager (Global Regulatory Lead (GRL), Associate Director , or Director ), in the… more