Director, Clinical Development
BeiGene
Summary
The Director, Clinical Development will support BeOne Clinical and Medical assets by successful execution of clinical development programs and deliverables in partnership across the organization; with external vendors; and with external academicians and collaboration partners. As a leader in the organization, the incumbent will be accountable to jointly develop clinical program strategy and help assure that activities are executed within expected scope, budget and timelines.
Job description
Essential Functions of the Job
- Facilitate generation of, author, update, and/or review key documents, including protocols, informed consent documents, Investigator Brochures, clinical study reports, abstracts, posters, manuscripts, clinical sections of INDs, NDAs, Annual Reports, and Developmental Safety Update Reports, Health Authority Briefing Documents, Orphan Drug applications, and Clinical Development Plans
- Partner with clinical operations and other functional areas for the successful implementation and execution of clinical studies
- Provide scientific expertise for selection of investigator and vendors
- Train BeiGene colleagues, CRO staff, and study site staff on the therapeutic area, molecule, and/or clinical protocol
- Provide scientific and medical support throughout conduct of a clinical trial; respond to clinical questions from sites, IRBs/IECs, Health Authorities, and CROs
- Review, query, and analyze clinical trial data; interpret and present clinical trial data both internally and externally
- Represent a clinical study or development program on one or more teams or subteams
- Create clinical study or program-related slide decks for internal and external use
- Build and maintain opinion leader/investigator networks; organize and present at key opinion leader advisory boards and investigator meetings
- Contribute to or perform therapeutic area/indication research and competitor analysis
- Build strong relationships with internal experts
- Identify continuous process improvement opportunities
- Identify incremental organizational resource needs – staff, budget, and systems
- Develop, track, execute and report on goals and objectives
- Support budget planning and management
- Be accountable for compliant business practices
Requirements
- MD, DO, PhD, PharmD or international equivalent degree required
- 5 plus years of experience and success within other biotech/pharmaceutical companies
- Previous participation in a clinical development program is essential, including involvement in all stages of clinical trials
- Clinical oncology experience; candidates with exceptional experience in other therapeutic areas would be considered if they demonstrated clear potential to apply their existing skills to oncology
- Expert understanding of global clinical study design and drug development process from discovery to registration and post-marketing
- High level of communication (written and verbal), interpersonal, organizational, and cross functional collaboration skills
- Knowledge of GCP and ICH Guidelines
- Flexibility to work with colleagues in a global setting
- Able to engage in work-related travel approximately 25%
- Strategic leader with demonstrated success building, managing and developing individuals and teams is preferred
- Experience with the development and support of related SOPs and policies is expected
- Knowledge of industry standard Clinical Development IT solutions expected
Benefits
- Medical, Dental & Vision
- 401(k)
- FSA/HSA
- Life Insurance
- Paid Time Off
- Wellness
- Annual bonus plan
- Discretionary equity awards
- Employee Stock Purchase Plan
Company overview
BeiGene, Ltd., now rebranding as BeOne Medicines, is a global commercial-stage biotechnology company specializing in the discovery, development, manufacturing, and commercialization of innovative oncology medicines. Founded in 2010 by John V. Oyler and Xiaodong Wang, the company has grown into a multinational organization with headquarters in Cambridge, Massachusetts, Beijing, China, and Basel, Switzerland. BeiGene focuses on developing targeted and immune-oncology therapies for cancer treatment, with a diverse pipeline that includes internally discovered products like BRUKINSA (zanubrutinib), a Bruton's tyrosine kinase inhibitor, and Tevimbra (tislelizumab), a PD-1 inhibitor. The company operates across six continents with over 45 countries participating in clinical trials and has enrolled more than 30,000 patients in its research programs. With approximately 12,000 employees worldwide, BeiGene has established itself as a significant player in global oncology, particularly with strong market presence in China and expanding operations in the United States and Europe. The company's mission centers on expanding access to high-quality cancer therapies worldwide through persistent innovation and challenging traditional approaches to drug development.