Associate Director / Director, Clinical Operations: Pharmacology and Biomarker Development
$120,000–$150,000 year
On-site · Singapore, Singapore
Job Summary
The Associate Director / Director of Clinical Operations will provide strategic and operational leadership in clinical pharmacology and biomarker development, focusing on bridging pre-clinical and clinical development. Key responsibilities include leading clinical pharmacology strategy, collaborating with CROs for assay development, incorporating quantitative endpoints in clinical studies, providing oversight on study design, and supporting regulatory submissions. Candidates must have an advanced degree (Ph.D., Pharm.D., M.D.), over 8 years of industry experience, and expertise in clinical pharmacology and biomarker strategies.
Required Qualifications
- 8+ years of relevant industry experience in Clinical Pharmacology
- 4+ years in a leadership role driving strategy and execution
- Demonstrated expertise in clinical pharmacology, including PK/PD modeling, dose selection/justification, safety margin assessment, and immunogenicity/ADA evaluation
- Proven ability to work effectively with cross-functional teams (clinical development, regulatory, clinical operations, biostatistics, discovery research, and program management)
- Outstanding written and verbal communication skills
- Strong organizational and project management skills
Desired Qualifications
- Antibody experience strongly preferred
- Experience with biologics including ADC, TCE, immunotherapies, or targeted oncology agents
- Experience in translational medicine and biomarker development
- Direct experience with regulatory submissions (IND, CTA, NDA/BLA) and participation in health authority interactions
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