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Director of Pharmacoepidemiology (Immunology), Princeton, New Jersey

Created10/07/2020
ReferenceR1529730
CategoryMedical and Regulatory Affairs
Job typeFull-Time
CountryUnited States
StateNew Jersey
CityPrinceton
Zip08540
SalaryCompetitive

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.

Job Summary:
  • Participate in the development of the vision and implements operational model for the pharmacoepidemiology group and translates these to high quality pharmacoepidemiology activities to support development programs in Immunology therapeutic area
  • Lead and manage health authority negotiation on post-marketing epidemiology study requirement or commitment
  • Lead and manage health authority issued post-marketing requirements in one or more disease areas within Immunology, including management of external consultants and collaborate with internal cross-functional technical staff.
  • Participate in regulatory filing and interaction as part of a cross functional team
  • Prioritize activities across multiple projects in the assigned disease area and effectively negotiate project plans with cross-functional stakeholders on different clinical development teams.
  • Advise cross-functional R&D colleagues on pharmacoepidemiology principles and utility of real world data and real world evidence.


QUALIFICATIONS:

Education Preferred:
  • PhD in epidemiology required (or MD with master degree in clinical epidemiology or specialized in pharmacoepidemiology or data science background)
  • Demonstrated ability at executing most types of pharmacoepidemiology studies conducted internally and by external epidemiology groups
  • Demonstrated ability at managing and building relationship with external real world data partners or academic research institutions
  • Mastery of the strategies and tactics of pharmacoepidemiology within the pharmaceutical industry.


Years of Experience Preferred:
  • While the specific experience requirement will depend on the demonstrated achievements of the individual, 5+ years in the field of epidemiology, 5+ years of pharmaceutical industry experience and 3+ years of safety epidemiology experience preferred.
  • Two + years of experience in the immunology therapeutic area or other complex chronic disease area preferred


Major Skills Required:
  • Ability to lead multiple projects supporting different compounds in the same therapeutic area
  • Strong execution skills, knowledge of planning processes and implementation
  • Excellent communication skills, both written and oral
  • Demonstrated ability at executing most types of pharmacoepidemiology studies conducted internally and by external epidemiology groups
  • Mastery of the epidemiology methods and regulatory standards used for pre-and post-approval drug risk assessment and the evaluation of risk management activities
  • Demonstrated experience working within a matrix environment, in particular working within safety teams, with clinical and marketing teams.
  • Good knowledge of clinical safety methods, regulations, and evolving issues.


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.
EmployerBristol-Myers Squibb

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