Director, Clinical Pharmacology and Pharmacometrics

1 Days Old

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. Director, Clinical Pharmacology and Pharmacometrics The Director is responsible for ensuring clinical pharmacology support for a portfolio of assigned oncology therapeutic area projects. This role includes the creation and implementation of optimized Clinical Pharmacology plans, incorporating established and innovative approaches. Leads a team of clinical pharmacologists in advancing early development programs through IND to clinical POC, and late stage development programs through NDA, BLA and MAA and post approval activities. The role will support projects at various stages of development, playing an active role in our drug discovery and development efforts to advance RayzeBio’s radiopharmaceutical pipeline. Role and 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 R&ED, GDD, and Commercialization Directs clinical pharmacology scientists in the development of strategy and execution of 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. 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 Experience in Radiopharmaceuticals is a plus. The starting compensation for this job is a range from $200,000 - $237,000, plus incentive cash and stock opportunities (based on eligibility). The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation will be decided based on demonstrated experience. Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: 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.
Location:
Princeton

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