• Develop and maintain comprehensive CP strategic development plans for all clinical development programs/studies. • Provide expert-level CP and expert 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 the Medical Writers to incorporate CP-related sections into clinical study reports (CSR). • Collaborate closely with Regulatory to provide CP support of regulatory documents, communications, and presentations as needed (IND, health authority inquires, preparation/participation in meetings with health authorities, preparation of relevant BLA sections, addressing review inquiries, health authority sponsored Advisory Committee Meetings). • Support cross-functional teams, including Statistics, Data Management, Clinical, Preclinical/Nonclinical, Translational Science, as needed.