Bristol-Myers Squibb Company

Head-Regulatory Sciences IMD

Location
Princeton, NJ, United States
Posted
Sep 08, 2019
Ref
R1515072
Required Education
Doctorate/PHD/MD
Position Type
Full time
Summary

Provides regulatory guidance that shapes the direction of BMS teams (e.g., Regulatory Team, Multi functional Development team, and strategy teams) based on a solid understanding of the disease, science, and regulations; Recognized as a Leader in Regulatory Science and credible representative of GRS voice to senior management. Provides management oversight and leadership to the IMD regulatory strategists for all the IMD TAs and HA liaisons across multiple projects. This covers all phases of development, including early and late development, diagnostics, and devices, when applicable. Ensures successful negotiation strategies and execution of interactions with direct responsibility for the FDA and in collaboration with regulatory senior leaders for other regions and countries (Europe, China, Japan, Intercon). Establishes close working relationships with regional strategist and collaborates in strategic meetings with health authorities outside US/EU. Guides the preparation of effective, persuasive presentations to regulatory authorities and creates clear and concise documents regarding regulatory strategy for senior management; Represents the Company in key interactions with HAs; Provides strategic direction of dossier content to ensure that knowledge of the drug, disease, regulatory requirements, and idiosyncrasies of regulatory authorities are incorporated; Maintains oversight providing leadership for vendors/partners that support IMD, including all operational support (such as Medical Writing, Submission Management). 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.

Qualifications

Advanced scientific (mainly clinical) knowledge related to the TA projects. The incumbent will have 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 general and TA specific intelligence of regulatory environment across key regions, anticipation of future trends and impact; Ability to create, develop and communicate well reasoned development and negotiation strategies; Strategic vision and time horizon; ability to integrate various perspectives and transform complexity into actionable action plans; ability to generate alternatives and assess benefits and risks; Recognized as a leader in Global Regulatory Science field and/or with senior management in the BMS operating committees. Successful track record of NME approvals in the US and globally; experience with biologics and chemical NME registration preferred; Expertise in a range of therapeutic areas and the regulatory process; Expert liaison with USFDA able to interact with senior FDA review officials, and guide negotiation strategy with other health authorities; Mastery of US and global regulatory processes/practices and the idiosyncrasies of various global health authorities; Successful track record of leading cross-functional teams; PhD or MD, with 15+ years of relevant exp.