Bristol Myers Squibb Company

Medical Director, Medical Safety Assessment

Princeton, NJ, United States
Sep 15, 2020
Required Education
Position Type
Full time
At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Functional Area Description

The Worldwide Patient Safety group is responsible for ensuring the safety of our medicines: The Worldwide Patient Safety group is responsible for pharmacovigilance and pharmaco-epidemiology deliverables including single case and aggregate safety monitoring, safety reporting, contribution to benefit-risk assessment, risk management planning and strategy, and execution of certain post-marketing commitments and ensuring compliance with global regulatory requirements.

Position Summary
  • Leads all medical safety assessment and related activities for assigned assets

Position Responsibilities
  • Leads Safety Management Teams (SMTs),
  • In the area of Signal Detection/Safety surveillance, evaluate and integrate data from multiple sources, including clinical, non-clinical and real-world, to understand and manage safety signals
  • Accountable for risk strategy, risk assessment and risk minimization for BMS products in partnership with other BMS functions.
  • Serve as safety consultant for product development activities.
  • Leader or key contributor to safety query responses.
  • Medical safety lead for aggregate safety reports and strategic documents
  • Serve as a trusted partner to other R&D functions in representing the view on product safety
  • Lead in a highly matrixed environment through scientific competency and organizational influence and impact.
  • Contributes to WWPS and BMS cross-functional improvement initiatives.

Degree Requirements
  • Required: MD or Equivalent degree. Has completed a Board certification and/or relevant higher medical training.

Experience Requirements
  • Generally, has 3 or more years previous experience as medical safety assessment physician (MSAP)
  • Experience requirement may vary based on relevant experiences and accomplishments, such as roles in:
    • Pharmaceutical or biopharmaceutical industry
    • Government (eg, US Food and Drug Administration)
    • Clinical research
    • Observational research
    • Clinical practice experience
    • Medical educator
    • Medical administrator
    • Medical quality assessment/improvement

Key Competency Requirements:
  • Clinical knowledge base as demonstrated by clinical practice experience, or comparable activity
  • Strong written and oral scientific communication skills
  • Strong scientific analytical reasoning skills
  • Behavioral competencies necessary to work within a complex highly matrix environment
  • Understanding of drug development process, with knowledge of design and execution of randomized clinical trials
  • Knowledge of pharmacovigilance and ability to apply knowledge to evaluation of safety concerns and minimization of patient risk throughout the life cycle of a drug product
  • Understanding of regulatory requirements for safety assessment and action through the life cycle of a drug product.
  • Ability to leverage the range of available tools to investigate safety concerns, including the science of observational research.
  • Microsoft suite

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.