Executive Director, Global Regulatory Strategy - Oncology
Provides strategic leadership to Global Regulatory Sciences. This is a dual role position; the first is to provide leadership of the Immuno-oncology (I-O) Full Development Teams (FDT’s) across indications. This requires coaching and mentoring of Global Regulatory Team Leaders (GRTL) responsible for the leadership of their respective FDTs. The second role is the lead GRTL for the lung/ head and neck cancer FDT. In this role, one will provide overall leadership and regulatory guidance across the I-O lung and head/neck portfolio that shapes the direction of BMS teams (e.g., Global Regulatory Team) based on a solid understanding of the disease, science, and regulations. Ensures successful negotiation strategies and execution of interactions with US, EU, Japan, China and ROW regulatory agencies. Provides guidance to the regional strategists and collaborates in strategic meetings with health authorities.
Represents BMS in key interactions with Health Authorities. Provides ongoing feedback, coaching, and career development support to staff in order to maximize their potential. Remains on the forefront of the relevant science and competitive landscape including detailed competitive intelligence and is viewed as an expert in its application to the regulatory process. Serves as an influential leader across R&D, and develops strong and productive working relationships with key stakeholders throughout BMS. Provides guidance on planning, writing, and review of key dossier documents for submission globally. Ensure Global Regulatory Sciences representation as needed in governance or strategic teams or committees.
Advanced scientific knowledge related to immuno-oncology. Demonstrated understanding of the science underlying oncology and its impact on the regulatory process. Diverse and sufficient technical expertise to be a credible interface to all development and business partners (CMC, preclinical, clinical, statistician, market access specialists, legal, etc.) In depth experience in pharmaceutical product development. Significant direct experience in liaison activities. Broad intelligence of the regulatory environment across key regions, and anticipation of future trends and impact. Strong understanding of the drug development process. Strong track history of innovative regulatory direction, consistent and substantial NDA/BLA submission and approval track record. Proven ability to coach and mentor other leaders as a coach, while being an individual contributor to projects. Successful track record of leading through influence and working across complex, global organizational matrices. MD or PhD preferred, with 10 years of relevant industry experience. Experience working with senior R&D and commercial leadership teams.
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