Vice President, Late Stage Clinical Development - Breast Oncology TA Development Head
Pfizer
- San Francisco, CA
- Training
- Full-time
- Provide executive leadership of late-stage development programs for designated therapeutic area across Pfizer Oncology governance committees, as well as clinical development partnerships and collaborations.
- As the senior drug development expert for their assigned therapeutic area, the incumbent will drive innovative drug development strategies and plans in their portfolio by leveraging deep expertise and insights from key stakeholders and team members.
- Apply oncology drug development and disease-area knowledge to ensure that the programs are managed in an efficient and rigorous manner as reflected in the design, conduct, and prioritization of initial and lifecycle indications with a high likelihood of clinical, regulatory, and commercial success.
- Ensure continuity in development plans and identify gaps to be addressed through clinical development. Enable effective decision making based upon objective clinical safety and efficacy response measures.
- Actively monitor progress of all studies and maintain alignment to strategic objectives for therapeutic area and broader oncology portfolio. Proactively identify and mitigate potential risks, escalating for awareness as appropriate.
- Lead a team of Global Development Leads and Medical Directors to deliver excellence and quality throughout all phases of the late-stage development process.
- Effectively align resources (direct & indirect) to facilitate lightspeed development of high-quality, cost-effective programs in alignment with clinical development and commercial priorities for Pfizer Oncology.
- MD, MD/PhD or equivalent with extensive clinical experience.
- 10+ years of oncology development experience within the Biotech or Pharmaceuticals industry
- Extensive experience and strong understanding of biopharmaceutical drug development, the competitive landscape / oncology market dynamics / evolving treatment landscape and HCP and patient insights, bringing deep clinical and external stakeholder insights to decision making from pre-POC to post-POC and commercialization.
- Direct experience in preparation of regulatory submissions as a functional or matrix leader (preferred). Candidates with outstanding individual contributions to one or more regulatory submissions will also be considered. Track record of Health Authority interactions and committee presentations (e.g., ODAC) preferred.
- Direct experience managing and leading marketing authorization applications in the US, EU and globally.
- Clinical and/or drug development in breast cancer preferred.
- Experience in other function areas (e.g., medical affairs or drug safety) preferred
- Experienced leader who can work collaboratively across a complex cross functional team of stakeholders. Must be able to lead with a lightspeed, innovative, and entrepreneurial mindset.
- Understanding of related disciplines (e.g. biostatistics, regulatory, pre-clinical pharmacology, pharmaceutical sciences).
- Demonstrated scientific productivity (publications, abstracts, etc.).
- A thorough understanding of Oncology and cancer biology and its relationship to drug development.
- Experience in functioning effectively as a member of a matrixed/multidisciplinary team.
- Insight into and understanding of principles related to evaluating business deal structures including commercial collaborations, acquisitions, and divestitures.
- Experience in budgetary management and decision making.
- Proven expertise in fostering employee development and well-being through effective people development, and motivational team leadership.
- A strong ability to influence all levels of the organization, including both senior-level colleagues and leaders across the company.
- Must have executive leadership skills; able to lead and motivate a team of experienced professionals and experts that have deep knowledge in oncology and are leaders within Oncology Late-Stage Development and the broader Oncology division.
- Ability to build and maintain productive working relationships with key opinion leaders in therapeutic area.
- Exceptional verbal and written communication and presentation skills.