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Director Clinical Pharmacology

Director Clinical Pharmacology

EPM ScientificSanta Rosa, CA, United States
30+ days ago
Job type
  • Full-time
Job description

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.