Job Information
BeiGene Vice President, Clinical Development, Hematology in San Mateo, California
General Description:
The VP, Clinical Development Zanubrutinib will provide overall clinical scientific leadership for Zanubrutinib and has responsibilities for clinical development strategy and execution of clinical trials in this area. This role requires a highly passionate leader who serve as a clinical role model for the team and demonstrates outstanding clinical scientific knowledge applicable to hematology clinical research. The incumbent will lead multi-disciplinary clinical teams charged with guiding and executing clinical development strategies and subsequent regulatory submissions.
The incumbent will lead the Development Core Team (DCT) which is a global, cross functional leadership and management team at BeiGene for asset specific programs. DCT is accountable for the development of program strategy and successful execution of all associated cross-functional program activities according to approved timelines, budgets & value.
The VP, Clinical Development Zanubrutinib will report directly to VP, Clinical Development, Hematology, and partner with Global Product Team Leader (GPTL) closely.
Key Roles & Responsibilities:
The Incumbent will be responsible for developing, updating and overseeing global development strategy, clinical development plans
In collaboration with key cross-functional leads, develop an integrated program & clinical development strategy that incorporates cross-functional considerations:
Clearly defined strategies to support clinical development in partnership with Global Product Team Leader and GPT teams, including scientific rationale, development strategy (Clinical Development Plan/Overview (CDP/CDO) Target Product/Early Profile (TPP/TEP), PTRS, clinical, regulatory, stats analysis etc.) and operational plans.
Proposing any changes to CDP/CDO/TPP/TEP/PTRS in the context of new data, i.e., internal or external study read-outs
Create an integrated development timeline, including key milestones and decision points where appropriate
This role will also have management responsibility, managing a number of Medical Directors responsible for the design and execution of assigned studies, grow and develop the talents, and provide medical training to the stakeholders
Ensures quality of all clinical documents (e.g., Investigators’ Brochure, protocol, study report, clinical components of regulatory submissions, safety related documents)
Develops written responses to regulatory agency questions and regulatory submission documents. Provide scientific and medical support throughout conduct of a clinical trial; respond to clinical questions from sites, IRBs/IECs, Health Authorities, and CROs
Be responsible for execution on Clinical Development Plan (CDP) and cross-functional activities to deliver on program objectives and goals
Propose changes in clinical development strategy, value, risk, schedule and resources responding to emergent data and changing landscape
Experience or Qualifications
Minimum 12 years of experience within other biotech/pharmaceutical or relevant academic credentials companies.
Advanced degree (MD or Pharm D) with subspecialty training in hematology/oncology.
Demonstrated strong track record in a range of leadership roles that include working with senior clinical development staff, establishing credibility with external stakeholders such as opinion leaders and regulators, and demonstrating substantial experience in drug development (including experience with both IND and BLA/NDA submission)
Experience in managing study start-up, directing and guiding study team execution, data cleaning, medical review, database locks, managing health authority responses are also required.
Effective scientific and team communication (written and verbal), interpersonal, organizational, and cross functional collaboration skills.
A strong commitment to hematology clinical research and the ability to work well within a team setting are essential.
Strategic leader with demonstrated success tracking record, able to grow and develop the talents and teams.
Able to lead the cross functional, matrix team in the global setup, demonstrated strong collaboration.
Experience with the development and support of related SOPs and policies is expected.
Knowledge of industry standard Clinical Development IT solutions expected.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.