Clinical Pharmacology (Sr.) Director

Job Summary

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).

Key Responsibilities

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.

1. PK/PD & Biomarker Integration

• Lead PK/PD analyses to establish exposure-response relationships and guide trial design.
• Lead clinical PK analyses, including concentration-time data review, noncompartmental analysis (NCA), PK parameter derivation, dose proportionality, accumulation, time dependency, and evaluation of intrinsic and extrinsic factors.
• Define fit-for-purpose PK sampling strategies and analysis plans; oversee PK data transfers, dataset specifications, quality control, interpretation, and integration of results into clinical study reports and regulatory submissions.

1. Bioanalytical Strategy & Oversight

• Oversee bioanalytical method development, validation, transfer, and sample analysis, including review of validation plans and reports, analytical plans, assay performance, incurred sample reanalysis, and bioanalytical reports.
• Ensure bioanalytical activities are conducted in accordance with applicable GCP/GLP requirements, ICH M10, and relevant regional regulatory guidance.

1. 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.

1. Cross-Functional Collaboration

• Partner with Biostatistics, Toxicology, and DMPK teams to integrate preclinical data into clinical plans.
• Support CRO and bioanalytical laboratory selection, qualification, contracting, and oversight for clinical pharmacology studies.

Qualifications & Requirements

• 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).
  • Hands-on experience with clinical PK analysis, NCA, PK data review, and interpretation, including preparation of analysis plans, clinical study reports, and regulatory submission content.
  • Demonstrated experience in bioanalytical strategy, method validation, clinical sample analysis oversight, and management of external bioanalytical laboratories or CROs.
• Skills:
  • Expertise in clinical PK analysis, NCA, MIDD, PopPK, PBPK, and QSP modeling; proficiency with relevant PK and pharmacometric software (e.g., Phoenix WinNonlin, NONMEM, and R) is preferred.
  • Strong working knowledge of bioanalytical method validation and regulated sample analysis, including application of ICH M10 and relevant global regulatory expectations.
  • Strong leadership in cross-functional teams.
  • Excellent communication for investigator meetings, KOL engagements, and regulatory defenses.
  • Excellent command of English, both written and spoken.