Bristol Myers Squibb WWHEOR Lead, Real World Evidence (RWE) in Princeton, New Jersey
The incumbent will ensure that RWE strategies are aligned with product strategic plans from matrix teams to achieve the BMS’ vision of shaping the portfolio, demonstrating real-world benefit and securing and maintaining patient access. He or she will also provide strategic leadership to therapeutic area teams regarding the development of the RWE strategy, promotional and regulatory opportunities, support of DEX (early input to Development approaches/decisions), working with stakeholders in R&D and Commercial.
The incumbent should have deep knowledge and extensive experience in RWE, to provide essential specialist guidance and direction to project teams, senior leaders, and other colleagues, ensuring optimal management of high-impact RWE opportunities and risks. The Lead RWE will lead development of consensus among diverse scientific, technical, and business experts at the global level to ensure scientific quality and timely, cost-effective project delivery while adhering to ethical requirements and responding to business needs.
These responsibilities require an extensive experience in the pharmaceutical industry with broad and deep knowledge of RWE activities and how they relate to product development and commercialization processes at all life-cycle stages and the ability to influence internal partners and external stakeholders. The successful candidate will be able to demonstrate strong leadership capabilities and will also a play a key role in disseminating the findings of RWE through scientific journals, regulatory dossiers, and press releases. External engagement to help shape standards and policies for effective RWE delivery on a global basis is a priority.
Internal stakeholders/customers include global Development Teams, Global Clinical, Global Biometric Sciences, Medical, WW HEOR and Value Access and Pricing (VAP), Business Insight and Analytics, Worldwide Commercial and priority Markets.
Continuously improve internal processes and planning to capture RWE in Oncology and/or Innovative Medicines development and commercialization programs.
Identify touch-points in processes and aid program leads in deciding on integration of RWE measures in programs/studies.
Ensure visibility of the RWE by becoming a “go to” point to ensure optimal integration of RWE in development and commercialization programs.
Define best practices relating to the integration of RWE practices.
Identify, track, and participate in global external collaborations regarding policies, standards, and use of RWE.
Working with stakeholders, help identify data sources and methods of data collection appropriate for the BMS portfolio to deliver cutting-edge RWE.
Lead and integrate WW HEOR/VAP efforts to deploy RWE in the regulatory approval processes world wide.
Participate in creating and delivering education on RWE for internal business partners.
Continuously improve processes for working with vendors and set standards for preferred suppliers to ensure quality and timely deliverables.
Ensure standards are in place for all deliverables.
Promote vision of the RWE throughout the organization.
Preference will be given to candidates with a PhD. or equivalent degree in a relevant discipline (e.g., epidemiology, health service research, outcomes research, health economics) or those who possess a clinical doctorate (M.D., Pharm.D.) coupled with a master’s degree. The candidate should possess a minimum of 7 years of related experience (10 or more if highest level of education is master’s degree), including a minimum of 5 years of pharmaceutical industry or CRO experience.
Experienced with RWE requirements for regulatory and HTA/reimbursement agencies, including FDA/EMA RWE policies.
Strong record of publication in RWE.
Experience in the development and validation of RWE standards.
Understanding of health care markets and regulatory and reimbursement decision making, especially in relation to the global use of real-world data.
Understanding of evolving concepts in the development and use RWE, especially in the context of health economics and outcomes research.
Knowledge of the drug development process with the BMS portfolio being strongly preferred and some experience in multiple disease areas required.
Technical competency in econometrics or statistics with ability to translate analytic skill into strategic vision of relevance to internal and external stakeholders.
Excellent interpersonal and communication skills, both written and oral, with ability to engage stakeholders from operations through executive levels.
Ability to work effectively in small teams or independently.
Ability to interact with and manage internal and external networks.
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled