Director, Clinical Pharmacology & Pharmacometrics

Location
Princeton, NJ, United States
Posted
Sep 16, 2020
Ref
R1524852
Required Education
Doctorate/PHD/MD
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.

Clinical Pharmacology & Pharmacometrics plays a key role in the drug development process such that we plan, design and execute clinical pharmacology studies while maximizing the potential for model-based drug development to drive decisions that inform the course of the clinical development program. This group focuses on 4 therapeutic areas including Immunology, Cardiovascular, Fibrosis, and Neuroscience.

Job Description

The vision for Directors in the group is to be able to function in a blended role that includes both classical clinical pharmacology skillsets combined with quantitative analysis skills. Given the breadth of the portfolio, Directors in this group would have the opportunity to serve as the clinical pharmacology & pharmacometrics leader on compounds in both early and late stages of development as well as assets that are small and large molecules. Based on the person's interest and capabilities, there would be opportunities to stretch beyond one therapeutic area and work on an array of molecules. BMS is committed to people development and we foster a learning environment to build scientific and leadership skills. In addition to scientific projects, scientists will also be able to participate in and lead company initiatives and scientific forums. We are seeking someone who is passionate to develop medicines that help patients and experienced in clinical pharmacology & pharmacometrics who expresses strong communication skills to be able to build strong relationships with cross-functional members as well as be able to lead within a matrix team.

Job Responsibilities
  • Contribute to the development of compounds developed across multiple therapeutic areas including but not limited to immunology, cardiovascular, virology, fibrosis, and oncology
  • Responsible for the creation of CP&P development plans that is aligned with compound strategy and execution of clinical pharmacology deliverables outlined by the development teams
  • Lead / Contribute to the design of clinical studies to characterize the pharmacokinetic, pharmacodynamic, and drug metabolism properties, as well as analyze, interpret and report data from such studies
  • Provide strategic input into the design of Phase 2/3 clinical studies and world-wide registrational strategy in line with the CP&P strategy for the compound
  • Plan, execute, and report on model-based pharmacokinetic and exposure-response analyses of data from clinical studies
  • Represent the CP&P function on cross-functional drug development teams, contribute to design drug development strategies, regulatory submissions, and participate in interactions with health authorities
  • Lead and participate in departmental initiatives and represent CP&P on cross-functional initiatives / workstreams / taskforces
  • Work with Business Development teams and provide critical expertise to assess external acquisitions
  • Supervise and mentor a group of CP&P scientists, if needed
  • Manage and provide mentorship and guidance to staff and CP&P function
  • Independently serve as the CP&P lead for one or more assets in the BMS drug development program


Required Qualifications
  • A PharmD with post-doctoral training or PhD in pharmaceutical sciences, pharmacology, biomedical engineering, or a related field
  • 7+ years of experience in clinical pharmacology and pharmacometrics, including experience in characterizing the pharmacokinetic and pharmacodynamic (biomarker/safety/efficacy) properties of small molecule and biologics drugs
  • In-depth knowledge of current practices and issues in clinical pharmacology and pharmacometrics
  • Strong written and oral communication skills necessary to report on and deliver scientific presentations
  • Demonstrate the ability to work in a dynamic team oriented environment


Preferred Qualifications
  • Experience with the following software is highly desired: R, NONMEM, MONOLIX, and WinNonlin


Travel Required
  • Local and international travel for conferences and regulatory meetings may be required depending on project needs up to 5-10% of the time


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.