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.
Position Summary /Objective
- Accountable for the development and implementation of the model-informed drug development (MIDD) strategy for drugs and other therapeutic agents in clinical development in the oncology therapeutic area (TA).
- MIDD has emerged as a powerful complement to conventional drug development whereby pharmacometric (PMx: pharmacokinetic, exposure-response, and disease progression) models are developed with data from a variety of sources are utilized to inform drug development decisions and regulatory assessments. MIDD informs dose and regimen selection and hypotheses to be investigated in clinical studies; and supports regulatory assessments of the clinical pharmacology, and benefit-risk profile of a therapeutic agent by complementing data from clinical studies. Additionally, PMx analyses may also inform approval decisions, and in some cases be the primary basis for the approval.
- PMx is a rapidly evolving discipline, and this individual will also be responsible for collaborating with academic centers to develop, implement, and apply innovative PMx methodologies.
- Partners with CP&P TA Head to develop MIDD strategy for assets in TA
- Accountable for managing the PMx book-of-work for TA
- Supervises PMx scientists in accountable TA
- Supports CP&P Lead in planning, executing, and reporting on exploratory PMx analyses in support of drug development decisions
- Accountable for planning, executing, and reporting of formal PMx analyses included in CSRs, HA submissions, and responses to questions from HAs
- Serves as MIDD SME for a TA, and advises CP&P TA Head on MIDD developments and opportunities
- Responsible for maintenance and refinement of PMx infrastructure
- Leads or contributes to CP&P and cross-functional initiatives
- Manages PMx budget for accountable TA, and ensures adequate supervision of PMx analyses performed by vendors
- Participates in interactions with health authorities as MIDD SME
- Drives collaborations with internal and external SMEs, and academic centers to develop and enhance innovative MIDD methodology and capability, with a focus on MIDD methodologies for accountable TA
- Provides mentorship to CP&P scientists on PMx and MIDD
- Represents PMx on asset teams and at governance for accountable TA
- Advanced degree(s) in relevant field: MS, PhD, PharmD
- For Ph.D. 7+ years’ experience with demonstrated progression clinical pharmacology and Pharmacometrics
- For MS 10+ years’ experience with demonstrated progression clinical pharmacology and Pharmacometrics
- Quantitative data analysis: Data wrangling (merging and transforming data), visualization, advanced PPK and E-R
- Programming: R, NONMEM, and Monolix (optional)
- Expertise in general drug development process
- Expertise in small molecule or biologic drug property characterization
- Recognized internally and externally as a subject matter expert, with a broad peer-reviewed publication record
Key Competency Requirements
- 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
- 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.
- Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to email@example.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
- Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Click the link to apply