Clinical pharmacology (Sr.) Director

The Clinical pharmacology (Sr.) Director will lead the design and execution of clinical pharmacology strategies to support the development of drugs. This role is critical in driving pharmacokinetic/pharmacodynamic (PK/PD) analyses, dose optimization, and regulatory submissions across global markets. The ideal candidate will have deep expertise in translational medicine, quantitative pharmacology, and regulatory interactions (FDA/EMA/PMDA).

1. Clinical Pharmacology Strategy & Study Design
   • Develop and implement clinical pharmacology plans for all pipeline assets 
   • Design and oversee first-in-human (FIH), proof-of-concept (POC), and dose-ranging studies.
   • Apply model-informed drug development (MIDD) approaches (e.g., PBPK, QSP, PopPK) to optimize dosing regimens.
2. PK/PD & Biomarker Integration
   • Lead PK/PD analyses to establish exposure-response relationships and guide trial design.
   • Collaborate with translational medicine teams to integrate biomarker strategies into clinical studies.
3. Regulatory & Compliance Leadership
   • Serve as the clinical pharmacology expert in interactions with CFDA, FDA, EMA, PMDA, and other global health authorities.
   • Author and review clinical pharmacology sections of INDs, IBs, NDAs/BLAs, and orphan drug applications.
   • Ensure compliance with GCP, ICH guidelines, and regional regulatory requirements.
4. Cross-Functional Collaboration
   • Partner with Biostatistics, Toxicology, and DMPK teams to integrate preclinical data into clinical plans.
   • Support CRO selection and oversight for clinical pharmacology studies.

• Education:
  • PhD, PharmD, or MD in Clinical Pharmacology, Pharmacometrics, or related field.
• Experience:
  • 8+ years in clinical pharmacology (biotech/pharma preferred).
  • Strong track record in global regulatory submissions (CFDA/FDA/EMA/PMDA).
• Skills:
  • Expertise in MIDD, PopPK, PBPK, and QSP modeling.
  • Strong leadership in cross-functional teams.
  • Excellent communication for investigator meetings, KOL engagements, and regulatory defenses.