Associate Director / Director, Clinical Pharmacology & Biomarker Development

Our client, a well-funded clinical-stage biotherapeutics company developing innovative antibody therapies across oncology and autoimmunity, is seeking an experienced Clinical Pharmacology leader to support its growing pipeline. The position can be based in Singapore or Shanghai.

Reporting to a senior clinical development leader, this individual will provide strategic and operational oversight across clinical pharmacology, translational science and biomarker development.

Key responsibilities

• Lead clinical pharmacology strategy across clinical-stage programs
• Guide PK/PD, exposure–response, dose selection and safety-margin assessments
• Evaluate the impact of immunogenicity/ADA on PK, efficacy and safety
• Oversee CROs and laboratories responsible for PK/ADA modelling, assays and sample analysis
• Develop biomarker strategies supporting patient selection, target engagement and pharmacodynamic assessment
• Provide input into study design, clinical protocols and regulatory submissions
• Collaborate across clinical development, operations, regulatory, biostatistics, bioinformatics and research

Hands-on PK/PD modelling is not required, but candidates must have sufficient technical expertise to direct external partners, assess their analyses and translate the results into clinical-development decisions.

Candidate profile

• Advanced scientific or medical degree: PhD, PharmD, MD or equivalent
• 8+ years relevant industry experience in clinical pharmacology
• Experience leading clinical pharmacology strategy and execution
• Strong expertise in PK/PD, dose selection, safety margins and ADA/immunogenicity
• Experience with antibodies or other biologics; exposure to ADCs, T-cell engagers or immunotherapies would be advantageous
• Biomarker and translational medicine experience preferred
• Experience contributing to IND, CTA, NDA/BLA submissions and health-authority interactions
• Strong cross-functional leadership and communication skills

Why apply

This is a rare opportunity to join a rapidly growing, innovation-led biotherapeutics company at a pivotal stage of its development. You will play a central role in shaping an exciting biologics pipeline while working alongside an experienced executive and scientific leadership team.

Apply

If you would like to be considered for this opportunity, please click Apply or contact me directly at [Confidential Information] for a confidential discussion.