Director, Clinical Pharmacology

Role Summary

Reporting to the Vice President, Translational Science, the Director, Clinical Pharmacology provides strategic and scientific expertise representing Clinical Pharmacology in cross-functional clinical development teams. The role acts as an independent contributor delivering CP subject matter support to new and ongoing programs, with the opportunity to contribute to the rapid growth of a biotech startup.

Responsibilities

• Develop and maintain comprehensive CP strategic development plans for all clinical development programs/studies.
• Provide expert-level CP support to the clinical study team/development team.
• Collaborate with Quantitative Pharmacology (QP) vendors or colleagues to develop and deliver quantitative strategies to support assigned development plans.
• Formulate and finalize CP-related report templates, as well as data handling and analysis standard operating procedures (SOP).
• Contribute to the drafting, review, and finalization of clinical study protocols and study analysis plans (SAP).
• Supervise and/or conduct pharmacokinetic/pharmacodynamic (PKPD) and biomarker analyses, ensuring high-quality and accurate results.
• Lead the drafting, reviewing, and finalizing CP study reports and publications, collaborating with Medical Writers to incorporate CP-related sections into CSR.
• Collaborate with Regulatory to provide CP support for regulatory documents, communications, and presentations as needed (IND, health authority inquiries, meetings, BLA sections, review inquiries, and advisory committee meetings).
• Support cross-functional teams, including Statistics, Data Management, Clinical, Preclinical/Nonclinical, Translational Science, as needed.

Qualifications

• Required: 5+ years of experience applying Clinical Pharmacology within drug development in the healthcare industry.
• Required: PhD, PharmD, or MD with training in CP, PK/PD, Pharmacology, and Pharmaceutical Sciences.
• Required: Expertise with PK, PD, immunogenicity, drug-drug interactions (DDI), bioavailability (BA)/bioequivalence (BE), special populations, and dose selection.
• Required: Hands-on experience with pharmacometrics (PMx) tools and software (e.g., WinNonlin, NONMEM or Monolix, and R) for noncompartmental analysis (NCA) and population PK/PD (PopPK/PD), modeling and simulations (M&S), and exposure–response (E-R).
• Required: Excellent written and oral communication skills with meticulous attention to detail.
• Required: Thrives in a dynamic, interactive, fast-paced, innovative, and entrepreneurial environment.
• Required: Natural collaborator who enjoys working on a cross-functional team.
• Preferred: Previous experience with monoclonal antibody (mAb) therapeutics in autoimmune diseases.
• Preferred: Knowledge of current practices and regulatory requirements in clinical development, bioanalysis, biopharmaceutics, pharmacology, toxicology, and formulation development.

Skills

• PK/PD analysis, pharmacometrics, and exposure–response modeling
• Pharmacokinetic/pharmacodynamic (PKPD) analyses and biomarker analyses
• Regulatory document preparation and health authority communications
• Cross-functional collaboration and scientific writing
• Modeling and simulations using PMx tools and R

Education

• PhD, PharmD, or MD with training in CP, PK/PD, Pharmacology, and Pharmaceutical Sciences

Additional Requirements

• Domestic or international travel may be required (less than 10%)