Principal Scientist, Quantitative Pharmacology and Pharmacometrics ( MERCUSP-100417en_US)
Principal Scientist, Quantitative Pharmacology and Pharmacometrics (R5)
The Principal Scientist role is a Director equivalent position. Principal Scientists in Quantitative Pharmacology and Pharmacometrics (QP2) oversee and directly apply quantitative approaches to characterize clinical pharmacokinetics and pharmacodynamics of new chemical entities and biologics, inform dose selection and go/no-go decisions, and shape, present and defend regulatory strategies to support global regulatory submissions and post-approval expansions in indications.
Principal Scientists provide strategic leadership and oversight in supervising the work of other scientists and leading QP2 efforts on drug development programs. Principal Scientists are expected to have or be developing expertise in several areas, including:
• Overseeing a number of projects (including both program strategy and execution) across the portfolio
• Driving the development of mechanistic, disease progression and comparator modeling platforms to help drive portfolio decisions
• Serving as an expert representative for QP2 on drug development teams and in cross-functional and governance discussions regarding the TA specific portfolio, including business development and licensing evaluations
• Framing critical drug development questions for optimizing model-based development via translational PK/PD, population pharmacokinetic, exposure-response, quantitative system pharmacology (QSP) and disease progression models
• Influencing clinical trial design via trial simulations and comparator modeling
• Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics, authoring regulatory documents (INDs, CSRs, CTDs), and representing QP2 at regulatory meetings
• Mentoring and/or supervising junior colleagues to perform the above duties and to develop the above capabilities
The Principal Scientist is a skilled quantitative drug developer, with a strong, integrated understanding of the strategic elements of drug discovery and development that can represent the efforts of QP2 on teams and in governance. She/he develops strategies for quantitative analyses (and commensurate experiments/trials) within and across development programs and/or functions. In addition to the responsibilities described above, Principal Scientists demonstrate outstanding leadership and communication skills, collaborating across PPDM and with other functional areas, as well as with external vendors and partners to create a quantitative model-informed approach to impact program strategies and decision making on drug development teams.
• (a Ph.D. or equivalent degree with at least 7 years of experience) OR (a PharmD or equivalent degree with at least 9 years of experience) OR (an MS or equivalent degree with at least 11 years of experience), where “experience” means having a record of increasing responsibility and independence in a similar role in pharmaceutical drug development or academia.
• Educational background in biopharmaceutics, pharmaceutical sciences, pharmacometrics, mathematics, statistics/biostatistics, computational biology/chemistry, chemical/biomedical engineering, or a related field.
• Drug development expertise including a record of both internal and external impact in driving model-informed drug development strategies.
• Ability to influence regulatory strategies including independently formulating registration packages to support global filings, a strong understanding of clinical pharmacology studies to support intrinsic/extrinsic factors, ability to independently author, defend regulatory filings.
• Experience in performing population PK/PKPD analyses using standard pharmacometric software (e.g., NONMEM, R, Monolix, Phoenix, etc.)
• Scientific understanding of biopharmaceutical and ADME properties of both small molecules and biologics
• Proficiency in written and verbal communication, interdisciplinary collaboration, and problem scoping and planning.
• Demonstrated ability to participate in and to lead an interdisciplinary team, and to oversee the work of other scientists