Director, Clinical Pharmacology - Shanghai
Proclinical are in search for a Director of Clinical Pharmacology to develop and apply clinical pharmacology and translational medicine strategies. The postholder will be expected to execute the strategies for candidate drugs products from early development through late stage development.
- 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 summarise 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 modelling 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 organisational 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
Skills and Requirements
- Pharm.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.
- Demonstrate significant success in technical proficiency, scientific creativity, collaboration with others and independent thought.
- Experience with leading, conducting and analysing 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.
- 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).
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.