MEDICAL DIRECTOR

Job Responsibilities:

Establish and chair the Medial Surveillance Team, conduct proactive signal
detection activities, and lead the development and execution of risk management
plans for assigned products according to the most current FDA, ICH and EMEA
guidelines. Make presentations as requested to senior medical review board.
Collaborate with nonclinical, clinical discovery, clinical research,
regulatory, epidemiology and medical affairs colleagues to review protocols and
study reports, and contribute to proactive planning of all studies related to
safety assessments. Perform safety data analyses, develop conclusions, and
write safety expert reports and medical evaluations for aggregate safety
reports. Obtainplan appropriate pharmacoepidemiology analysesstudies in
conjunction with pharmacoepidemiology colleagues. Make labeling recommendations
based on proactive signal detection and signal assessment activities. Ensure
that the above tasks are performed in the most efficient manner possible
commensurate with quality, accuracy, and timeliness andin accordance with
current global regulatory requirements and BMS SOPs. Providea medical
perspective into departmental standards, and support process improvement
initiatives as needed. Promote collegiality and teamwork among peers, and
mentorsupport colleagues in GPVampE as a positive change agent. Take
responsibility for professional development of self and others, and share
accountability for successful achievement of departmentwide goals and
objectives.

Job Requirements/Education:

Knowledge and skill in medicine and pharmaceutical product safety assessment,
preferably related to both clinical and postmarketing safety, with demonstrated
success working in a highly matrixed environment. Proficiency in medical
evaluation of adverse events individual cases and aggregate data. Ability to
develop andwrite risk management plans, medical sections fo periodic reports,
and adhoc reports, including benefitrisk assessments. Demonstrated ability to
lead crossdisciplinary teams focused on safety assessment, and to make oral and
written presentations summarizing critical safety issues and risk assessment
plans. Knowledge of techniques and tools for signal detection using clinical
trial and postmarketing data. Familiarity with the application of
pharmacoepidemiology to risk assessment.

Salary will be commensurate with experience.
Bristol-Myers Squibb is an equal opportunity employer. M/F/V/D