About the role

AI summarised

Associate Director / Director, Clinical Operations: Pharmacology and Biomarker Development role at Hummingbird Bioscience in Singapore, Singapore.

BiotechOnsiteClinical Development

Key Responsibilities

Incorporate quantitative endpoints and modelling approaches (PK/PD, exposure–response, biomarker-based) into clinical studies to demonstrate target engagement and pharmacologic mechanism Provide strategic oversight and recommendations on endpoints, study design, safety evaluations, and dose selection across clinical-stage assets Collaborate with biostatisticians to ensure high-quality data analysis, interpretation, and reporting to support internal decision-making Support clinical document preparation, including drafting PK/ADA and exploratory pharmacodynamic assessment plans for clinical protocols Alongside the research team, assist in developing and operationalization of biomarker strategies for patient selection, exploratory pharmacodynamic assessments, mechanism-of-action readouts, and regulatory submissions Contribute to regulatory submissions (draft/review relevant sections for IND, CTA, NDA/BLA) Partner with the Clinical Operations team to ensure clinical site readiness for PK, ADA, and biomarker analysis, sample management and data reconciliation Collaborate with the Bioinformatics team to support PK/ADA analyses Prepare and review PK, ADA and biomarker presentation materials for external stakeholders Maintain clear and consistent communication with senior management on clinical pharmacology and translational deliverables, risks, and timelines

Requirements

Education: Advanced scientific degree in molecular or cancer biology, or a similar field (Ph.D., Pharm.D., M.D.) Experience and skills 8+ years of relevant industry experience in Clinical Pharmacology with 4+ years in a leadership role driving strategy and execution.
Antibody experience strongly preferred; additional experience with biologics including ADC, TCE, immunotherapies, or targeted oncology agents is advantageous Demonstrated expertise in clinical pharmacology, including PK/PD modeling, dose selection/justification, safety margin assessment, and immunogenicity/ADA evaluation Experience in translational medicine and biomarker development (desirable) Strong track record of developing and implementing biomarker strategies, including assay development, validation, and incorporation into clinical trials for patient selection and pharmacodynamic assessments Direct experience with regulatory submissions (IND, CTA, NDA/BLA) and participation in health authority interactions Proven ability to work effectively with cross-functional teams (clinical development, regulatory, clinical operations, biostatistics, discovery research, and program management) Excellent strategic thinking skills with ability to translate complex scientific insights into actionable development decisions.
Outstanding written and verbal communication skills Strong organizational and project management skills, with demonstrated success managing multiple programs and priorities in fast-paced environments Commitment to mentorship and team development, fostering a collaborative and high-performance culture OUR MISSION & VALUES Our fast-growing biotechnology company is committed to discovering and developing important new drugs for cancer and autoimmune diseases, and living by our values: Excellence, Determination, Teamwork, Intellectual Integrity and Audacity.