Director, Clinical Pharmacology
The Director of Clinical Pharmacology, reporting to the Chief Medical Officer, will represent Clinical Pharmacology on development project teams. The qualified candidate will 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.
Primary Duties and Responsibilities
- 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, IMPD, IB, NDA CTD) 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.
- PharmD or PhD in pharmacology or pharmaceutical sciences.
- A minimum of 8–10 years work experience in an industry research and/or development environment is required. Post-doctoral work may serve as experience.
- 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.
Apollomics is an Equal Opportunity Employer and does not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class.
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.