VP, Head of Late Clinical Development - Oncology

Role Summary

Vice President, Head of Late Clinical Development - Oncology. This senior executive role is critical to the sustainability and success of the BMS R&D pipeline, reporting to the Head of Late Development HOCT (Hematology, Oncology, Cell Therapy) and responsible for the clinical development strategy across the entire BMS Oncology portfolio. This includes oversight of clinical monitoring, interpretation and analysis of all clinical trials and protocols in late-stage development, lifecycle management, and all global clinical development components of regulatory documents. Preferred locations are New Jersey, USA or Boudry, Switzerland.

Responsibilities

• Serving as a talent champion for BMS and building, recruiting, developing, and retaining a world-class oncology and immuno-oncology clinical development organization.
• Creating and articulating a vision for an innovative and expert Clinical Development organization that enables the design and execution of clinical research plans with both speed and rigor across a broad oncology/immune oncology portfolio.
• Supervising development and clinical execution, monitoring, interpretation, and analysis of all late-stage trials and protocols and lifecycle management (with registrational intent).
• Interfacing with key thought leaders and experts in oncology and immuno-oncology drug development.
• Managing all clinical components of regulatory documents, including filings for initial registration and lifecycle management indications.
• Serving as the organization's senior oncology clinical development expert and partnering strategically with the Early Clinical Development team to ensure a seamless transition from Phase 1 to Phase 2.
• Partnering with key matrix stakeholders to advise the Head of Integrated Oncology on critical development decisions and oncology portfolio management.
• Providing strategic clinical expertise to the business development group; accountable for clinical development planning and due diligence for post-proof-concept assets considered for in-licensing or acquisition.
• Representing BMS in discussions with health authorities on interpretation of clinical data, trial design, and safety and efficacy profiles of our compounds.
• Collaborating with global cross-functional matrix leaders and supporting the matrix structure of Development Teams.
• Developing and promoting a workplace culture that values diversity of thought, promotes integrity, and fosters coaching and accountability.

Qualifications

• Required: MD; Board Certification in Oncology preferred.
• Required: Significant clinical research and drug development expertise and leadership experience (10+ years) in oncology.
• Required: Deep understanding of early-to-late-stage drug development issues and challenges, and extensive experience designing and conducting innovative Phase 2 and Phase 3 trials within related areas.
• Required: Global drug filing expertise and regulatory interaction experience (e.g., NDA, ODAC, oral explanations).
• Required: Knowledge, experience and professional relationships with external oncology thought leaders.
• Required: Successful experience building, leading, and motivating teams of clinical research professionals, including MDs, PhDs, and/or PharmDs.
• Required: Documented success navigating a highly matrixed work environment and cross-functional collaboration across research, development, and early commercial.
• Required: Global experience interfacing with clinical development leaders across Europe, Asia, Latin America, and the US.
• Preferred: Knowledge or experience in immuno-oncology is desired.
• Preferred: Experience interacting with business development and licensing, evaluating technical and franchise aspects for potential in-licensing opportunities that shape the oncology strategy.