Reporting to the Director / V.P. Clinical Operations in Hangzhou China, this position is responsible for the design, execution and leadership and implementation of Clinical Pharmacology strategy across the Apollomics’ China portfolio of agents and programs. He/she will represent Clinical Pharmacology on development project teams and contribute to the development of clinical study concepts and protocols, execution of clinical pharmacology studies, population PK/PD analyses, clinical study reports, and relevant components of regulatory submission documents. He/she will review non-clinical as well as clinical pharmacology development plans and assist in the interpretation of preclinical data and extrapolation of implications for human clinical development. Responsible for submitting Clinical Pharmacology sections for regulatory filings with strong communication skills and ability to cross-collaborate with U.S. team and senior executives. This is a full-time position.
- Lead in developing and applying clinical pharmacology and translational medicine strategies for candidate drug products from early development (pre-IND) through late stage development (Phase 3 and NDA filings) using pharmacokinetic, pharmacodynamic, DMPK, and drug therapeutic principles, and knowledge of drug regulatory processes.
- Design and direct clinical pharmacology studies, and work cross-functionally to establish clinical protocols.
- Provide scientific leadership in the preparation, conduct and reporting of clinical pharmacology studies. Independently draft clinical pharmacology study reports and summarize them for regulatory submission documents.
- Working cross-functionally, assist in integrating and interpreting nonclinical and clinical pharmacology, DMPK, and translational medicine knowledge.
- Lead the preparation of nonclinical and clinical pharmacology write-ups and regulatory documents (IND, IB, NDA, MAAs) and defend the package in interactions with regulatory agencies.
- Lead the modeling of emerging PK and PK/PD data.
- Participate in writing publications and making scientific presentations consistent with development strategies.
- Maintain knowledge of relevant scientific and regulatory practices and ensure that clinical pharmacology aspects of development programs are contemporary.
- Establishing and maintaining relationships and agreements with contract vendors.
- Evaluating departmental and broader organizational SOPs as fit for purpose, in compliance with current scientific standards and regulatory requirements
- Ensuring adherence to agreed timelines and budgets to insure prompt and accurate execution of deliverables from clinical pharmacology studies and programs
- D. or Ph.D. with emphasis in pharmacology or pharmaceutical sciences.
- Fluent in Chinese, native speaker preferred. Good command of English.
- 10+ years of experience in the support of clinical studies management and/or related work experience in a biotechnology or pharmaceutical company, or similar environment (e.g., CRO). Post-doctoral work may serve as experience.
- 6+ years managing people.
- Demonstrate significant success in technical proficiency, scientific creativity, collaboration with others and independent thought.
- Experience with leading, conducting and analyzing clinical pharmacology/pharmacokinetic studies in humans.
- In-depth understanding of PK/PD, drug metabolism and clinical research concepts with demonstrated sound judgement and problem-solving capabilities.
- Ability to clearly communicate scientific information both written and oral.
- Ability to present technical information to both technical and non-technical audiences is required.
- Strong organizational skills are required. Experience working in an FDA regulated environment and knowledge of current GMPs as they apply to laboratory practices are highly desired.
- Hands-on experience with data analysis, non-compartmental and compartmental PK/PD analysis and using data processing software such as Phoenix WinNonlin, R, NONMEM, or MONOLIX.
- Working knowledge of graphing software such as SigmaPlot, Prism, JMP, R or Origin is required.
- Experience in immunology, hematology, and or oncology studies preferred.
- Experience with regulatory interactions (FDA or EMA or NMPA).
About Apollomics, Inc.
Apollomics, Inc. is an innovative biopharmaceutical company committed to the discovery and development of oncology combination therapies that harness the immune system and target specific molecular pathways to eradicate cancer globally. The company’s existing pipeline consists of five development-stage assets including two novel, humanized monoclonal antibodies that restore the body’s immune system to recognize and kill cancer cells, and three targeted therapies against uncontrolled growth signaling pathways.