Bristol Myers Squibb
Pharmaceuticals
AssociateDirector,PatientSafety,EpidemiologyScienceandExecution
“Associate Director, Patient Safety, Epidemiology Science and Execution at Bristol Myers Squibb. Skills: Epidemiology, Patient Safety, Protocol Development, Regulatory Submissions, Scientific Leadership. Leading protocol development for epidemiology studies (EU Post-Authorisation Safety Studies, FDA Post-Marketing Requirements). Shaping the safety narrative for regulatory submissions (DSURs, PBRERs, Risk Management Plans, new drug applications)”
What You'll Achieve.
Improving patient outcomes; Informing critical decisions in drug lifecycle management; Ensuring patient safety
Industry & Context.
Making sound scientific judgements; Translating scientific strategy into real, operational outcomes
Travel approximately 5% of the time for key congresses, regulatory meetings, and select external engagements, Ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed (for field-based and remote-by-design roles)
What They're Looking For.
Must Have
Scientific or biomedical degree (MPH, PhD, PharmD, MD, RN, or relevant Master's), At least 6 years of relevant experience, Experience within pharmacoepidemiology or a closely related field, Understanding of observational study design and fundamental epidemiology concepts, Experience navigating pharma regulations, Clear, precise, and persuasive writing skills, Organizational skills to juggle multiple workstreams and manage timelines, Ability to collaborate well in a matrix environment
Nice to Have
Hands-on experience with AI tools, Hands-on experience with data programming
What You'll Do.
Leading protocol development for epidemiology studies (EU Post-Authorisation Safety Studies
FDA Post-Marketing Requirements)
Shaping the safety narrative for regulatory submissions (DSURs
Risk Management Plans
new drug applications)
Translating scientific strategy into operational outcomes
Supporting benefit-risk assessments through literature reviews and secondary data analyses
Mentoring junior scientists and fellows
Leading continuous improvement initiatives
Serving as the scientific and business lead for observational study review processes and cross-functional epidemiology liaisons
Driving execution of critical epidemiology programmes
How You'll Work.
Team & Collaboration
Bridging epidemiology and the wider cross-functional world; Collaborating with internal teams and external partners; Working alongside world-class epidemiologists and safety scientists; Collaborating well in a matrix environment
Communication Scope
Writing clearly, precisely, and persuasively; Communicating scientific strategy into operational outcomes; Representing BMS at congresses and regulatory meetings
Process & Methodology
Managing multiple workstreams, Managing timelines, Delivering quality work
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