General Description:
The VP, Clinical Development, Breast Franchise, will provide overall clinical scientific leadership for assigned diseases and portfolio of programs, have responsibilities for our end-to-end clinical development strategy and execution of clinical trials in these areas. 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 clinical research. The incumbent will lead multi-disciplinary clinical teams charged with guiding and executing clinical development strategies and subsequent regulatory submissions.
This incumbent will have primary accountability for building the Breast disease area strategy across various assets to advance research and development by fully exploring the potential of the portfolio, external opportunities and combinations. Monitors changes and trends in the therapeutic landscape of the tumor types within the disease area and provides end-to-end strategic leadership and disease area expertise across the portfolio plus emerging multiple assets.
The VP, Clinical Development, Breast Franchise will report directly to CMO, Solid Tumor, providing leadership to support talent acquisition, talent development, cross functional collaboration, high performing team effectiveness.
Key Roles & Responsibilities:
The incumbent will provide overall clinical scientific leadership for assigned diseases or portfolio of programs, have responsibility for developing disease area strategies to guide our end-to-end clinical development plans and oversight of clinical trials execution in these areas. Develops innovative clinical strategies to significantly optimize the development cycle in the face of an evolving regulatory and competitive landscape.
Build a deep understanding of the disease areas under accountability and lead the organization to impact-maximizing decisions for product, program, and portfolio development.
Accountable for establishing disease area strategies that provide guidance and prioritization to asset teams about opportunities and areas of unmet medical need and generate strategically aligned development strategies.
Work in partnership with clinical development team, Global Product Teams (GPT), commercial team to ensure that the disease strategic expertise and input is integrated into the strategies, and make sure they are appropriately implemented in organization.
Evaluate external markets, business development landscape and emerging issues to identify opportunities to grow the portfolio.
Oversees end-to-end clinical development strategy and plan across assets and associated clinical programs to ensure they are aligned with the overall integrated disease area strategy plan.
Leading, coaching, and motivating development colleagues in the pursuit of excellence, ensuring that key talent across the organization is properly identified, retained, and developed. This role will also have management responsibility, managing a number of Medical Directors and Clinical Scientists responsible for the design and execution of assigned studies.
Acts as medical expert and leader in interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, advisory boards, patient advocacy groups), internal stakeholders (e.g., Research, Early Clinical Development, Global Medical Affairs, Regulatory, Commercial, Market Access, HEOR), and internal decision governance boards.
Qualifications Requirement:
Critical Experience / Educations
Minimum 12 years of experience within other biotech/pharmaceutical or relevant academic credentials companies.
Advanced degree (MD or MD equivalent) with subspecialty training in hematology/oncology
Deep Disease Strategy and Clinical Development Expertise
Has experience to build a deep understanding of the disease area.
Has experience in creating the short- and long-range, end-to-end strategy for the disease area.
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)
Portfolio and Program Leadership
Experience in building a robust product pipeline in early and late-stage development programs.
Has experience leading and managing a portfolio of programs at different clinical stages and has demonstrated the ability to collaborate with both commercial and research organizations.
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.
Having direct accountability for driving clinical development programs and enjoys the accountability of working in a fast-paced, entrepreneurial environment.
Exceptional Leadership and Credibility
Develop strong cross-functional working relationships with a diverse team of senior leaders.
Effective scientific and team communication (written and verbal), interpersonal, organizational, and cross functional collaboration skills.
Able to grow and develop the talents and build high performing team.
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.