Bristol-Myers Squibb Company

Medical Director, Medical Safety Assessment, Immunology

Location
Princeton, NJ, United States
Posted
Jun 18, 2019
Ref
R1516113
Required Education
Doctorate/PHD/MD
Position Type
Full time
Summary

The Medical Director will function as a Medical Safety Assessment Physician (MSAP), supporting assets in the Immunoscience therapeutic area. The MSAP serves as the BMS expert on all aspects of medical drug safety for assigned assets in the BMS portfolio. The MSAP chairs the cross-functional Medical Surveillance Team (MST); MSTs conduct safety review and analysis and describe the safety profile of BMS assets. The MSAP works closely with partners within the pharmacovigilance department and the broad BMS organization.

Responsibilities
  • Lead all medical safety assessment and related activities for assigned assets in the Immunoscience therapeutic area
  • Chair the MSTs for assigned assets
  • Conduct proactive signal detection activities
  • Establish and maintain the risk profile of assigned assets
  • Evaluate data from multiple sources, including clinical, nonclinical and real-world, to understand safety signals
  • Characterize safety concerns to support risk assessment
  • Be accountable for risk strategy, risk assessment, and risk minimization in partnership with other BMS functions
  • Collaborate with colleagues to review protocols and study reports and contribute to proactive planning of studies related to safety assessments
  • Serve as a safety consultant for product development activities
  • Lead or act as a key contributor to medical safety query responses
  • Serve as the medical safety lead for aggregate safety reports and strategic documents; provide medical evaluation of aggregate safety data and develop and write medical sections of periodic reports (eg, PBRERs, DSURs)
  • Contribute to departmental and cross-functional improvement initiatives
  • Ensure that the above tasks are performed in the most efficient manner possible with quality and accuracy and in accordance with any relevant global regulatory requirements
  • Serve as a trusted partner to other functions in representing the view on product safety
  • Lead in a matrix environment through scientific competency and organizational influence
  • Promote collegiality and teamwork among peers, and mentor/support colleagues in the department as a positive change agent


Background/Experience
  • A Medical Degree is required
  • A doctoral degree and/or MPH is desirable
  • At least 3 years in pharmacovigilance or relevant pharmaceutical or biomedical field is strongly preferred
  • Postgraduate qualification or experience in immunology or related specialty is desirable
  • Other relevant experiences and accomplishments will be considered, such as roles in clinical and observational research and clinical practice experience


Competencies/Knowledge/Skills
  • Understanding of the drug development process
  • Knowledge of pharmacovigilance and ability to apply knowledgeto evaluation of safety concerns and minimization of patient risk throughout the life cycle of a drug
  • Ability to leverage the range of available tools to investigate safety concerns, including the science of observational research
  • Understanding of regulatory requirements for safety assessment and action
  • Strong scientific analytical reasoning skills
  • Ability to work on multiple complex projects in parallel
  • Exceptional attention to detail
  • Behavioral competencies necessary to work and lead within a matrix environment
  • Excellent verbal and written communication skills