Associate Director Pharmacometrics
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Responsible for the development and implementation of the model-informed drug development (MIDD) strategy for drugs and other therapeutic agents in clinical development.
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 implementing and applying innovative PMx methodologies.
- Partners with CP&P lead to specify MIDD components of CP&P plan
- Supports CP&P Lead in planning, executing, and reporting of exploratory PMx analyses in support of drug development decisions
- Responsible for planning, executing, and reporting of formal PMx analyses included in CSRs, HA submissions, and responses to questions from HAs
- Serves as MIDD SME, and supports CP&P lead in the development of therapeutic agents
- Contributes to maintenance and refinement of PMx infrastructure
- Leads or contributes to CP&P and cross-functional initiatives
- Manages PMx analyses performed by vendors
- Participates in interactions with health authorities as MIDD SME
- Collaborates with internal and external SMEs to develop and enhance innovative MIDD methodology and capability
- Provides mentorship to CP&P scientists on PMx and MIDD
Advanced degree(s) in relevant field: Ph.D., PharmD or MS
- For Ph.D. and PharmD, 5+ years’ experience with demonstrated progression clinical pharmacology and Pharmacometrics. For MS Degree, at least 7 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)
- Experience with general drug development process
- Experience with small molecule or biologic drug property characterization
- Subject matter expertise demonstrated by peer-reviewed publications
- 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
- Demonstrated ability to work in a dynamic team-oriented environment
#LI-Hybrid (for roles 50% remote/50% on-site);
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.
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 an inclusive culture, promoting diversity 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.
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it 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.
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