- BeiGene (San Mateo, CA)
- **General Description** + The Senior Director , Global Regulatory Lead will be responsible for developing, implementing, and advising on global ... and implementation of department policies. **Responsibilities** + Uses extensive knowledge of global regulatory environment and the ability to apply knowledge… more
- BeiGene (San Mateo, CA)
- **Position Summary:** The Senior Director is responsible for setting the vision and mission for the Global Regulatory Operations &GRA Excellence ... BeiGene's corporate vision, mission, and values. As the Head of Global Regulatory Operations, the SD will lead key functions (Submission Operations Management… more
- Gilead Sciences, Inc. (Foster City, CA)
- …in more than 35 countries worldwide, with headquarters in Foster City, California._ ** Senior Director - Analytical Regulatory Science** KEY RESPONSIBILITIES ... The Sr Director , Analytical Regulatory Science, is responsible for supervising a team of...analytical flexibility the incumbent will support "right first time" global approvals for CMC control strategies and maintain "right… more
- BeiGene (San Mateo, CA)
- **General** **Description** **_:_** **The Executive Director , Global Regulatory Portfolio Lead will be responsible for developing, implementing, and advising ... on global regulatory strategies for development programs to...senior management.** **Interacts with external business partners and Regulatory Agencies.** **Behavioral Competencies:** **Integrity** **- Ability to demonstrate… more
- BeiGene (San Mateo, CA)
- **General Description** **_:_** + The Director , Global Regulatory Lead, will be responsible for developing, implementing, and advising on global ... management and advice on Health Authority interactions. + Uses extensive knowledge of global regulatory requirements and the ability to apply knowledge both… more
- Gilead Sciences, Inc. (Foster City, CA)
- … senior -level cross-functional teams + Communicates to highest levels of senior management key pharmacovigilance findings + Provides global medical leadership ... create possible, together. **Job Description** + Serves as a senior scientific and clinical expert for safety profile of...safety profile of products in therapeutic areas + Defines global product safety strategy and routinely manages and leads… more
- Taiho Oncology (Pleasanton, CA)
- …globally except for Japan and Asia. For assigned projects and products, the Senior Director , Regulatory Affairs Strategy is responsible for strategic ... or two high priority late-phase clinical development programs as Global Regulatory Lead (GRL), responsible for leading...and Europe. Position Summary: The incumbent is the most senior regulatory person on project teams and… more
- Ascendis Pharma (Palo Alto, CA)
- … Regulatory Affairs will be responsible for developing and implementing global regulatory strategies encompassing clinical, non-clinical and CMC disciplines. ... regulatory colleagues . Contributes to the development of global clinical regulatory plans and strategies; identifies...reports . Work is performed under direction of a Senior Regulatory Affairs professional Contribute to internal… more
- J&J Family of Companies (Santa Clara, CA)
- Senior Director , Franchise Health Economics and Market Access - Robotics, Endomech and Energy Platforms - 2406170506W **Description** Johnson & Johnson MedTech ... Surgery is recruiting for a Senior Director , Franchise Health Economics & Market...Surgery Franchise HEMA, will work in close collaboration with Global Strategic Marketing, Research & Development, Medical, Clinical &… more
- Gilead Sciences, Inc. (Foster City, CA)
- …compliance with global cGMP and Gilead's Quality Management System. The Senior Director collaborates with cross-functional teams, fosters a culture of ... 35 countries worldwide, with headquarters in Foster City, California. **TITLE:** ** Senior Director , Commercial Analytical Operations - Biologics Quality Control… more
- BeiGene (San Mateo, CA)
- …including individual study design and filing plans. + Experienced in global regulatory requirements for pharmacovigilance + Appropriate experience with ... **General Description:** The Senior Medical Director serves as the...programs and creates and maintains a single interpretation of global safety data for developmental and marketed products. With… more
- Gilead Sciences, Inc. (Foster City, CA)
- …advancing the care of patients with life-threatening diseases. We are seeking a dynamic Senior Director of Scientific Publications with a focus on Oncology to ... the development and execution of publication plans across the oncology product lifecycle. The Senior Director will play a critical role in shaping the scientific… more
- GRAIL (Menlo Park, CA)
- …Plans. + Connect with respective colleagues in the Clinical, Medical Affairs, Global Regulatory Affairs, and Quality for the implementation and compliance ... and risk management, and ensure compliance of safety activities and processes with global legislation and regulatory requirements. + Develop a robust safety… more
- Gilead Sciences, Inc. (Foster City, CA)
- …(RWD) to help transform innovations to life-changing medicines for patients. The Senior Director , RWE innovation methods and external partnerships reports to ... the Executive Director , RWE Generation and is accountable for the development...as an in depth understanding of the pharmaceutical industry, regulatory strategy and evidence generation. **What will you be… more
- BeiGene (San Mateo, CA)
- **General** **Description:** The Senior Director of CMO and Distribution Logistics, Clinical Supply Chain is responsible for overseeing the Clinical Supply Chain ... CMC, Regulatory , etc.) stakeholders. + Demonstrates advanced knowledge of global clinical trials and the drug development process. + Experience in vendor… more
- Meta (Menlo Park, CA)
- …through new and emerging regulatory obligations. **Required Skills:** Director and Global Head, Corporate Responsibility Responsibilities: 1. Oversee ... **Summary:** Meta is seeking a Director and Global Head of Corporate...7. Provide regular briefings to key internal stakeholders, including senior leadership and the Audit and Risk Oversight Committee… more
- Gilead Sciences, Inc. (Foster City, CA)
- …that will improve the lives of patients with life-threatening illnesses worldwide. As a ** Senior Director , LEN for PrEP Launch,** you will be an integral part ... all functional teams in the US. Back-up for Executive Director as needed. .Supports harmonization of Launch Plans/Strategy in...of Launch Plans/Strategy in the US and coordinates with Global .Ensures key milestones are achieved .Acts as a… more
- BeiGene (San Mateo, CA)
- General Description: The Senior Medical Director , Hematology will support BeiGene Clinical and Medical Hematology assets by successful execution of clinical ... and collaboration partners. The candidate will report to the Vice President, Global Clinical Development. As a leader in the organization, the incumbent will… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Gilead and help create possible, together. **Job Description** **Key Responsibilities** Director , Global External Manufacturing Bulk Drug Substance (BDS) ensures ... and commercial products through execution of manufacturing campaigns within our global external contract manufacturing network, while ensuring compliance with cGMP, … more
- BeiGene (San Mateo, CA)
- **Job Summary:** We are seeking a highly experienced Senior Director with a strong background in Clinical Biomarker Science for Oncology and Immuno-therapy to ... cell therapy, mRNA et al. **Key Responsibilities:** + Develop and implement global clinical biomarker strategies for our oncology and immuno-therapy programs. + Work… more