Director Clinical Pharmacology

Role Overview: The Director of Clinical Pharmacology & Pharmacometrics will leverage their scientific, technical, and leadership expertise to craft and execute strategies in clinical pharmacology and modeling & simulation, propelling drug candidates through various development stages. Collaborating closely with discovery and development teams, this role provides strategic and technical insights as a key member of the project development team. The Director also plays a pivotal role in departmental growth and may mentor or manage junior clinical pharmacologists.Key Responsibilities:Formulate and implement clinical pharmacology and pharmacometrics strategies to advance programs from research to post-marketing.Act as the clinical pharmacology lead on project teams, offering expertise in PK/PD, biopharmaceutics, drug-drug interactions, and quantitative pharmacology.Guide the development of small molecules and biologics through milestones such as IND/CTA, EOP2, and marketing applications.Conduct and oversee PK/PD and exposure-response analyses using advanced modeling and simulation techniques to support human PK predictions, dose selection, trial designs, risk/benefit assessments, regulatory submissions, and publications.Collaborate with various functional partners, including Clinical Development, Biostatistics, Discovery, Translational Medicine, CMC, Toxicology, DMPK, Clinical Operations, and Regulatory, to achieve project and corporate goals.Enhance external scientific visibility and publication efforts.Engage with internal and external scientific experts to evaluate and adopt new methods, ensuring cutting-edge techniques and capabilities.Ensure compliance with SHE policies, GXPs, and regulatory standards in clinical pharmacology programs.Supervisory Responsibilities:Mentor and potentially supervise 1 or 2 regular employees.Qualifications:Education/Experience:PhD or PharmD in pharmaceutical sciences, pharmacology, or a related field, with at least 8 years of drug development experience; or an equivalent combination of education and experience.Experience:Minimum of 8 years in clinical pharmacology and pharmacometrics.Experience with small and/or large molecules and new modalities.Experience with IND/NDA/BLA and global marketing applications.Preferred experience in the Oncology therapeutic area.Contributions to translational science and precision medicine.Skills:Deep understanding of clinical and quantitative pharmacology principles.Proficiency in modeling and simulation software such as NONMEM, R, and others. Experience with population PK models, advanced mechanistic PK/PD models, disease models, and PBPK models is highly preferred.Current knowledge of regulatory guidance for nonclinical and clinical pharmacology for small molecules and biologics.Excellent interpersonal, verbal, and written communication skills, with the ability to convey complex technical information clearly.Ability to communicate and collaborate cross-functionally.Proven track record of supporting drug candidates at various development stages within the clinical pharmacology function.Demonstrated impact on drug development decisions through quantitative approaches, with strong leadership skills and the ability to influence.Ability to develop and deliver effective presentations and written/oral communications.Thrives in a fast-paced business environment.Applied knowledge of GLP and GCP regulations.Job Complexity:Operate effectively in a highly matrixed team environment.Develop creative solutions to unique and complex problems.

Created: 2025-01-29