United States onlyBeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.
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.
BeiGene Global Competencies
When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
- Fosters Teamwork
- Provides and Solicits Honest and Actionable Feedback
- Self-Awareness
- Acts Inclusively
- Demonstrates Initiative
- Entrepreneurial Mindset
- Continuous Learning
- Embraces Change
- Results-Oriented
- Analytical Thinking/Data Analysis
- Financial Excellence
- Communicates with Clarity
BeiGene is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeiGene Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.
We are proud to be an equal opportunity employer and we value diversity. BeiGene does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.
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