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.