The Senior Director/Director level clinical pharmacologist in the Department of Translational Medicine and Early-Stage Clinical Development plays a central role in both clinical development and in support of nonclinical development. He/she will represent Clinical Pharmacology function and provide subject matter expertise on cross-functional project teams. Clinical pharmacology experience with both small and large molecules in oncology/immuno-oncology therapeutics is highly desired.
A core scientific responsibility is ensuring optimal doses and dosage regimens in patients, and as such, the successful candidate must have advance understanding and should be able to integrate the knowledge of PK/PD, quantitative modeling and simulation, drug development, TK, and nonclinical PK (ADME and DMPK). Working within the clinical development organization, the role supports multiple programs through participation on internal project working teams and serves as a liaison between chemistry, life sciences, regulatory and clinical operations. Essential Areas of Responsibility: The incumbent may design, conduct and/or manage internal and external IND-enabling studies (eg: in vitro and in vivo nonclinical metabolism and PK), design and review clinical pharmacology study protocols and support clinical trials, conduct pharmacokinetic/pharmacodynamic modeling and analyses, and incorporate findings into study report and regulatory documents as well as participate directly in regulatory interactions. A strong background in clinical pharmacology and pharmacokinetics combined with excellent leadership and communications skills are essential in this dynamic role. Knowledge of, and direct experience with pharmacokinetic/pharmacodynamic modeling, bioanalytical analysis, and nonclinical ADME are desirable attributes.
The candidate is expected to be an active contributor to the multi-disciplinary project teams, providing innovative and progressive thinking to projects and where appropriate guidance to other team members.
- Ph.D. or Pharm D in Pharmaceutical Sciences, Pharmacometrics, or related field with 10+ years (Director), 15+ years (Senior Director) of experience in pharmaceutical industry. Demonstrated experience in serving as clinical pharmacology lead on development programs.
- Experience in non-compartment and model-based PK and PK/PD analyses and inclusion of data in the preparation of manuscripts, study reports and sections of regulatory submission documents (eg: INDs, NDAs, CTDs) is required.
- The incumbent should have a strong understanding of pharmacokinetic theory, compartmental modeling and simulation, and statistical approaches utilizing the latest computational approaches and tools
- Hands-on experience in utilizing WinNonLin, NONMEM and/or other modeling software is required. Experience with population PK, mechanistic PK-PD modeling/systems pharmacology and PBPK modeling is a plus. Familiarity with statistical approaches and programs for data analysis.
- Scientific writing and presentation skills are essential; peer reviewed publications in a relevant field required.
- Current knowledge of FDA regulatory guidance related to nonclinical and clinical pharmacology; experience having direct interaction with FDA, including submission of IND, NDA and other regulatory documents is required.
- Understanding of, and compliance with, regulatory, protocol, standard operating procedures, and Good Laboratory Practices (GLP) and Good Clinical Practices (GCP) as appropriate.
- Excellent interpersonal, leadership, communication and time-management skills are essential; demonstrated direct management of internal and external personnel (outsourced projects) is required.