Director, Clinical Pharmacology and Pharmacometrics

Bristol Myers Squibb•Seattle, WA

23d•$201,910 - $274,021•Hybrid

About The Position

Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. 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. Read more: careers.bms.com/working-with-us . Director, Clinical Pharmacology and Pharmacometrics The Director, a member of Clinical Pharmacology group at BMS, is responsible for ensuring clinical pharmacology support for a portfolio of radiopharmaceutical programs in the oncology therapeutic area. This role includes the creation and implementation of optimized Clinical Pharmacology plans, incorporating established and innovative approaches, to help advance early development programs through IND / clinical POC, and late stage development programs through NDA, BLA and MAA and post approval activities. The Director will play an active role in our drug discovery and development efforts to advance RayzeBio’s (a BMS company) radiopharmaceutical pipeline. This role has oversight over a critical Portfolio and as our Portfolio grows so do opportunities for growth and development. The location of this opportunity can align to any of our BMS geographic locations including various locations in NJ, Cambridge, MA, San Diego, CA, Brisbane, CA, and Seattle, WA.

Requirements

Ph.D. in pharmacokinetics/pharmaceutical science or relevant field; OR PharmD with post-doctoral training; Ph.D and PharmD should have at least 8-10+ years’ experience working in clinical pharmacology; OR MS in pharmacokinetics/pharmacology or relevant field with 12-15 years experience working in clinical pharmacology.
Extensive expertise in the application of clinical pharmacology in early and late stage drug development.
Experience leading/managing a clinical pharmacology team/group
Experienced in applying advanced quantitative analysis and model informed drug development (MIDD) approaches
Track record of regulatory interactions and deliverables, e.g., IND, NDA, BLA and MAA filings.
In-depth knowledge of current practices and issues in Clinical Pharmacology and Pharmaco-metrics
Strong written and oral communication skills necessary to report on and deliver scientific presentations
Demonstrated ability to work in a dynamic team-oriented environment
Manage a team of CP&P scientists and provide mentorship and guidance to staff
Independently serve lead for one or more assets in the BMS drug development program
Demonstrated leadership abilities, expanded sphere of influence, and stakeholder management in a matrix environment
Programming experience is required (e.g., NONMEM, R, and WinNonlin. SAS, Splus, etc.)
Quantitative data analysis, POP PK/PD, and data visualization skills are highly desired

Nice To Haves

Experience in Radiopharmaceuticals is a plus.

Responsibilities

Serves as a key member of the CP&P leadership team
Responsible and accountable for assigned clinical pharmacology strategy within assigned projects
Contributes to integrated strategy with Research, Drug Development, and Commercialization
Develops and executes clinical PK, PK/PD, pharmacometric analyses, and modeling & simulation (MS) plans
Drives decision-making and strategy over the entire portfolio through effective partnership with partner functions and senior leaders
Oversees scientific output, conduct and resourcing of clinical pharmacology, PK/PD, working in concert with pharmacometrics and QSP functional partners
Supports strategy for dose selection, dose justification and regulatory filings
Reviews and approves relevant scientific data and reports for regulatory filings
Develops technical/leadership skills of clinical and MS scientists
Participates in, or assigns qualified delegates to support in-licensing and out-licensing business development activities
Represents Clinical Pharmacology on relevant governance committees and works streams.
Oversees planning, execution of clinical pharmacology trials in concert with clinical operations
Represents the ClinPharm department on cross-functional disease strategy teams and on relevant governance forums
Provides input to Phase 2/3 clinical study design and registrational strategy
Supervises the development of the Clinical Pharmacology Plan(s)
Supervises design of Clinical Pharmacology studies and manages data analysis, interpretation, and reporting
Collaborates on cross-functional drug development teams, regulatory submissions, and departmental initiatives; serves as Clinical Pharmacology subject matter expert
Represents the CP&P line and as Subject matter expert in interactions with health authorities
May work on key internal initiatives and serves as department representative on relevant external initiatives
Builds a team that is collaborative, supportive learning environment.

Benefits

Medical, pharmacy, dental and vision care.
Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP).
Financial well-being resources and a 401(K).
Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support.
Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility.
Parental, caregiver, bereavement, and military leave.
Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources.
Other perks like tuition reimbursement and a recognition program.

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