Director, Clinical Pharmacology and Pharmacometrics

Posted 4 Hours Ago
Be an Early Applicant
5 Locations
In-Office
202K-274K Annually
Senior level
Healthtech
The Role
The Director is responsible for clinical pharmacology support for radiopharmaceutical programs, overseeing strategy, analyses, and regulatory filings while leading a team in drug development efforts.
Summary Generated by Built In

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.

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 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.

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.

This is an exciting time at BMS and your work will help people prevail over serious diseases. From the scientists behind the microscope to the analysts behind the data, everyone at BMS is working to make an impact. And while our work transforms the lives of patients, it also transforms the lives and careers of our people.  

#LI-Hybrid

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Compensation Overview:

Brisbane - CA - US: $226,130 - $274,021 Cambridge Crossing: $226,130 - $274,021 Princeton - NJ - US: $201,910 - $244,666 San Diego - RayzeBio - CA: $218,060 - $264,236 Seattle 1000 Dexter - WA - US: $218,060 - $264,236

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. 
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.
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.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [email protected]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Top Skills

Nonmem
R
SAS
Splus
Winnonlin
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The Company
HQ: Lawrence Township, NJ
40,384 Employees

What We Do

At Bristol Myers Squibb, we work every day to transform patients’ lives through science. That work inspires some of the most interesting, meaningful, and life-changing careers you’ll experience. Join us and pursue innovative ideas alongside some of the brightest minds in biopharma, collaborating with a team rich in diversity of experiences, and perspectives. We have built a sustainable pipeline of potential therapies and are leveraging translational medicine and data analytics to understand how we can deliver the right medicine to the right patient, at the right time, to achieve the best outcome.

Whether in a scientific, business or supporting function, a career at BMS means you’ll be inspired every day to grow and thrive through opportunities that are uncommon in scale and scope. Here, you’ll be on the cutting edge of powerful innovation in oncology, hematology, immunology, cardiovascular disease, and fibrosis, with colleagues united in the mission to help patients.

Through the Bristol Myers Squibb Foundation, we also promote health equity and seek to improve health outcomes of populations disproportionately affected by serious diseases and conditions. Our mission is to give new hope to help patients prevail over serious disease – it drives everything we do.

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