
Global Head of Modeling and Simulation, Pharmacokinetics Sciences
- Cambridge, MA
- Permanent
- Full-time
- Lead the M&S organization with responsibility for the management, allocation, and development of all M&S associates and resources and attracting and retaining top talent. Develop and champion a strategic vision to best implement and integrate the four M&S sub teams across data science, translational modeling and quantitative systems pharmacology (QSP), PBPK, and non-clinical statistics.
- Direct, supervise, and manage portfolio of M&S contributions to integrate relevant drug discovery and development, technical, and target / compound / disease area knowledge in the planning and execution of robust development programs and disease area strategies.
- In the Discovery & Preclinical Phases, M&S: M&S function to provide comprehensive support from early discovery to first-in-human clinical entry. Develops systems pharmacology platforms to guide early drug design for optimal therapeutic outcomes. Models biological targets and pathways to assess biomarkers, efficacy, and toxicity. Expands Artificial Intelligence approaches to optimize drug design across multiple therapeutic modalities and across therapy areas. Deploys statistical approaches to maximize impact of preclinical studies.
- In Clinical Ensure strong PBPK contributions to generate mechanistic insights on drug disposition and evaluate the impact of intrinsic and extrinsic factors on drug exposure. Expand PBPK applications beyond small molecules to support broader translational insights. Integrates preclinical and clinical biomarker and competitor data to develop mechanistic models to support FIH dose decisions. Expands the use of mechanistic models in clinical development to inform trial design and regulatory submissions through collaboration with the data and AI and pharmacometrics groups. Supports regulatory documentation and strategy.
- Drive the data strategy covering access, use, and storage of data used by and produced by M&S
- Anticipate organizational needs for M&S and strategic support based on in-depth understanding of the relevant issues and the drug development process. Identify opportunities and advocate and drive integration and implementation of innovation across the drug discovery and development continuum, such as next-generation M&S capabilities for new therapeutic modalities and emerging technologies such as digital twins & artificial intelligence. Lead infrastructure / process / scientific consulting improvement initiatives.
- Develop next generation M&S capabilities to serve new therapeutic modalities and emerging technologies such as digital twins and Artificial Intelligence.
- Provide on-boarding, training, mentoring and career development of staff, and oversee constructive and continuous performance evaluation.
- Member of the PK Sciences Leadership Team, contribute to overarching disciplinary and departmental strategy for PKS research and development across all Therapeutic Areas.
- Ph.D in pharmacology, biology, engineering, mathematics, statistics, computational science, or a field with significant modeling-related content (or equivalent Ph.D/MD)
- Broad, integrative experience and a driven approach to the use of modeling and simulation in drug research and development.
- Expert knowledge of drug discovery, drug development, and HA guidelines relevant to pre-clinical and clinical drug development. Substantial track record of identifying and leading contributions to policies that shape best practice in M&S.
- Internal and external strong and established track record of establishing M&S excellence.
- Excellent critical thinking and problem-solving skills. Strong record in leading global scientific improvement/change initiatives.
- Significant experience in coaching, development, and influencing scientists and physicians.
- Outstanding verbal and written communications and presentation skills and the ability to effectively represent M&S issues to a wide range of target audiences.
- Proven track record in working across a matrix organization and demonstrated expert skills in building partnerships, negotiating agreements; excels at collaboration