Head, MSA Immune-Oncology and GPV&E Scientific Capabilities

Role / Responsibilities:

BMS' vision is to build and sustain an industry-wide best-in-class Global Pharmacovigilance and Epidemiology ("GPV&E") organization by advancing the science of drug safety and nurturing an unmatched culture of employee engagement and commitment. The Head, Immune-Oncology (IO) and GPV&E Scientific Capabilities will oversee the safety assessment of compounds within the Company's IO portfolio. These assets currently have a major impact on BMS' revenues and will play a critical role in driving growth of the company in the future. The individual will lead a group of physicians who oversee medical surveillance teams which monitor and proactively assess the safety and benefit/risk of our assets. Ultimately, the individual, in close collaboration with leaders in Clinical / Medical, Regulatory, and other functions, is accountable for driving the evaluation of safety issues and the identification of risk mitigations for these issues as appropriate for compounds in these areas.

The incumbent will also lead GPV&E's scientific capabilities by advancing the science of drug safety and nurturing an unmatched culture of employee engagement and commitment. The BMS portfolio has evolved in recent years to focus on specialty medicines to treat conditions with substantial unmet need. Development advances, which are increasingly reliant on translational medicine, biomarkers, and innovative biology, have resulted in a number of breakthrough medicines. These advances have also brought new, challenging safety-related issues in the context of ever-evolving regulatory requirements. In order to create and sustain an operational model focused on PV scientific excellence, there is a need to advance capabilities in medical safety assessment to enable the rigorous, timely, scientific-founded evaluation of safety-related issues. As a department, we will need to focus on understanding the fundamental mechanisms of disease, developing state of the art safety-science evaluative strategies, fostering close inter-departmental collaboration, and applying advances in safety analytics to identify, evaluate, and mitigate safety-related issues. This latter responsibility will be done in close collaboration with the Head of Epidemiology particularly with respect to Safety Analytical tools.

In addition to his/her responsibilities for IO products and as Head, Scientific capabilities, the incumbent will be a key member of the GPVE Senior Leadership Team, which manages the business of the department. The Department aspires to have a non-hierarchical, nimble, collaborative, and innovative culture, more typical of a small company than a traditional large pharma. This individual should expect to have opportunities to take on responsibilities beyond the stated scope of the position.

They will be the BMS I-O Safety Lead for all R&D functions: Development, Medical and Regulatory

Representative responsibilities will include, but not necessarily be limited to, the following:

• Build the safety physician and Scientific Capabilities strategy. Attract, develop and retain the highest quality talent in line with BMS' GPV&E vision.
• Build and Strengthen engaging connectivity across The BMS Enterprise by partnering with the area heads in
• Other Research & Development (R&D) functions, in particular Heads of Global Clinical Research, Regulatory and Medical, as well as Translational medicine and the Discovery functions.

At Bristol-Myers Squibb, we're creating innovative medicines for patients who are fighting serious diseases. We're also nurturing our own team with inspiring work and challenging career

• Work with other GPV&E leaders to develop advanced techniques for signal detection, including active safety surveillance, risk management and mitigation, and benefit/risk.
• Ensure that appropriate risk management strategies are built into the IO portfolio and together with The Head of GRSM to advance BMS' expertise and capabilities for risk management.
• Strengthen, enhance and integrate cross-matrix capabilities across the department in the following areas:

a. Drug-induced disease, through application of recent scientific advances, definition of expert rosters (internal and external), and communication across GPVE and beyond;

b. Signal detection and risk management methodologies through development of innovative, transformative solutions in conjunction with other functional experts;

c. Use of translational medicine and biomarkers to increase our fundamental understanding of safety-related issues through innovative predictive modelling techniques.

• Develop a framework to address safety evaluation challenges associated with combination therapies. Assist the operational chairs of the MRG and MRG-HESC in the optimization of safety evidence presented during discussions to enable clear decision-making by leadership.
• Support efforts to meet requirements from FDA IND reporting guidance, including aggregate assessment of adverse events and represent IO at Regulatory Hearings
• Model the BMS biopharma vision, including the cultural attributes of speed and rigor in decision making, collaboration, innovation, continuous improvement, and employee engagement and growth.
• Commit to driving culture change.

Qualifications / Requirements:

• Energized by the BMS vision for Pharmacovigilance as a science based function working as a trusted partner with R&D to influence product discovery, development, and commercialization choices. Capable of significant contribution to the realization of this vision.
• MD with completion of clinical residency required. PhD in pharmacology, biochemistry, immunology, molecular biology or other relevant discipline is highly desired. Subspecialty fellowship training in oncology, hematology, Internal Medicine is a plus with a minimum of 10 years pharmaceutical experience.
• Demonstrated ability and experience leading high-performing teams in a highly matrixed and collaborative environment.
• Significant experience and deep knowledge in Drug Development and a clear understanding of Pharmacovigilance are required. Medical and/or regulatory experience is a desired plus.
• Capable of influencing in a complex matrix environment and exhibiting productive matrix behaviors as a role model for their employees.
• Demonstrated ability and experience in leading high-performing teams in a highly matrixed, collaborative environment. Early and full development experience required. International market experience highly preferred. Capable of influencing in the complex matrix and role modeling these behaviors for employees.
• Must have demonstrated proficiency in authorship and review of the full range of regulatory safety documents such as Clinical Overviews, Summaries of Clinical Safety, DSUR, PBRER, and Investigator Brochures.