- BeOne Medicines (Emeryville, CA)
- **General Description:** The Director , Global Regulatory Project...etc.). + Serve as a principal advisor to the Global Regulatory Lead (GRL) and ... US, EU, China, and other international requirements. + Act as the "COO" to the Global Regulatory Lead , translating strategic regulatory vision into… more
- BeOne Medicines (Emeryville, CA)
- …US, EU, China, and other international requirements. + Act as the (COO) to the Global Regulatory Lead , translating strategic regulatory vision into ... **General Description:** The Associate Director , Global Regulatory Project...strategies accordingly. ** Global Project Management Excellence** + Lead and manage complex regulatory submissions (IND/CTA,… more
- BeOne Medicines (Emeryville, CA)
- …English native speaker is preferred + **Location:** US (remote). **Reports To:** Executive Director , Global Regulatory Strategy, Dx/CDx and Medical Devices. ... **General** **Description:** The Regulatory Affairs Director Dx/CDx and Medical...plans. + Act as the representative of the US regulatory team at the global regulatory… more
- BeOne Medicines (Emeryville, CA)
- …and operational delivery. The Senior Director , Resource Management will lead the end-to-end global budget & resource management/utilization within GCO ... ensure optimal resource allocation. **Leadership and Change Enablement** + - Build and lead a small, high-performing global resource management network across … more
- BeOne Medicines (Emeryville, CA)
- **General Description:** The Director , Global Clinical Operations, Compliance builds, collaborates and manages key relations to better support and understand the ... needs of the business and drive the compliance activities within Global Clinical Operations. Provides quality guidance, direction and expertise to GCO… more
- BeOne Medicines (Emeryville, CA)
- The Executive Director , Global Infrastructure and Cloud Computing is a key leader in the GTS Enterprise Technology and Architecture team. They will lead the ... and delivery of enterprise infrastructure, network and cloud services across our global organization. This role is responsible for ensuring secure, scalable, and… more
- BeOne Medicines (Emeryville, CA)
- …from a technology and security perspective across the organization. Working closely with the Director of Global GTS GRC, this position will be responsible for ... **General Description:** BeOne is seeking an Associate Director of GTS Governance, Risk, & Compliance (GRC)...specific functional domains as well as regional SOPs under global Information Security Management System. Lead and… more
- BeOne Medicines (Emeryville, CA)
- **General Description:** **The Head of Global Clinical Process Management is responsible for designing, implementing, and optimizing processes across multiple ... functionally. You will partner with all functions across Clinical Development and Global Process Owners (GPOs) to shape and execute a continuous improvement plan… more
- BeOne Medicines (Emeryville, CA)
- **General Description:** The Director , Information Protection Management is a global strategic leadership role responsible for designing, implementing, and ... our data remains our greatest asset. This role will lead a global team for Data Loss...Data Security, Data Governance, and Data Classification methodologies. + ** Regulatory Knowledge:** Strong familiarity with global privacy… more
- BeOne Medicines (Emeryville, CA)
- …mission. Leveraging deep therapeutic and functional area expertise, the Clinical Operations Lead in Biotech Unit is accountable for the planning, budget, and ... for annual budget and resource forecasts, as well as lead to define CST goals for the assets +...+ Provide guidance to Execution Unit at regional and global level and ensure timely, quality, and efficient study… more
- BeOne Medicines (Emeryville, CA)
- …R&D system category strategy development, like CTMS, Safety system, and regulatory system, etc., vendor selection and supplier relationship management. This position ... trends in R&D system evolving in the industry + Lead and support Business engagement to understand their digitalization...+ English, with preference for bilingual in Chinese **BeOne Global Competencies:** When we exhibit our values of Patients… more
- BeOne Medicines (Emeryville, CA)
- …Lead analysis of safety data and author relevant safety sections of global regulatory inquiries and periodic reports including Development Safety Update ... including individual study design and filing plans. + Experienced in global regulatory requirements for pharmacovigilance. **Education Required:** + PharmD,… more
- BeOne Medicines (Emeryville, CA)
- **General Description:** Reporting to the Head/ Director of Clinical Trial Diversity, the Associate Director will operationalize BeOne's clinical trial diversity ... representative patient enrollment. This role collaborates across Clinical Operations, Regulatory , Development, and corporate functions to embed diversity into study… more
- BeOne Medicines (Emeryville, CA)
- …the associated program(s) in the Breast and Women's Cancers Franchise(s). The Franchise Head will lead and manage the Global Clinical Program Lead (GCPL)/ ... Leveraging deep Therapeutic Area/Asset expertise, solid global program management skills, global view,...team of GCO P&SM, participate in shaping P&SM strategy, lead the functional management activities, and apply strategic thinking… more
- BeOne Medicines (Emeryville, CA)
- BeOne Medicines is a global oncology biotechnology company committed to transforming cancer care through science, technology, and human connection. Guided by our ... and technology - those who thrive where meaningful impact meets scale. As ** Director , Product Management - Customer Experience, Oncology** , you will define and … more
- BeOne Medicines (Emeryville, CA)
- …Job:** + The individual should collaborate internally with Quality, Supply Chain, Regulatory Affairs and externally with CDMO to ensure timely and successfully ... to establish tech transfer plan and project timeline + Lead the collaboration with all relevant functions to implement...sites in domestic and international region is required. **BeOne Global Competencies:** When we exhibit our values of Patients… more
- BeOne Medicines (Emeryville, CA)
- …This position will report to the Vice President, Intellectual Property and lead a global team of IP attorneys and professionals. **Responsibilities** ... - Lead an IP team in the US and China...managing IP attorneys and professionals. - Deep understanding of global biopharmaceutical patent law, regulatory data protection,… more
- GRAIL (Menlo Park, CA)
- …North Carolina, and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information, ... grail.com . The Senior Clinical Data Manager (CDM) will lead data management activities for one or multiple diagnostic...Plan with External Data Providers or collaborators. + Assist Director of Clinical Data Management and other GRAIL staff… more
- BeOne Medicines (Emeryville, CA)
- **General Description** **_:_** + The Director , Global Regulatory Lead , will be responsible for developing, implementing, and advising on global ... global development, regulatory , and registration strategies. + The Director , Global Regulatory Lead supporting programs within BeOne's Hematology… more
- BeOne Medicines (Emeryville, CA)
- …for product(s) in line with business objectives, and in coordination with the global regulatory leader and key internal stakeholders. This individual will manage ... **General Description:** The Director , Regulatory Affairs will be responsible...the global strategy as determined by the global regulatory leader. + Reviews sections of… more
