Responsibilities:
- Provide subject matter expertise in the design, conduct, and reporting of clinical trials
- Lead clinical pharmacology studies and perform PK and PK/PD analyses
- Preparation of standalone PK/PD section of Clinical Study Report (CSR), in NDA/BLA submissions
- Present PK findings and represent clinical pharmacology in cross-functional study team settings, oversee CROs and external service providers, and management of Phase I-III studies
- Interact with regulatory authorities to ensure the quality and supportiveness of pharmacology study data for regulatory agency review and inquiry
Skills:
- Extensive and strong clinical pharmacology knowledges and research skills, including study design, data retrieval, problem solving and results analysis • Deeply understanding with relevant experience in PK/PD/ADME/BA for Phase I-III clinical studies.
- Problem-solving skills and the ability to find and employ creative solutions
- Time management and organizational skills, and attention to detail
- Leadership experiences and the skills to manage and motivate others
- Ability to translate pharmacokinetic findings into potential clinical impact is highly desirable
- Related business development experience and capability is a significant plus.
Qualifications:
- MD, PharmD or PhD degree or equivalent in Pharmaceutics, Pharmacology, Pharmacokinetics, or related scientific fields
- Minimal 8 years working experience as a clinical pharmacologist in drug development for the pharmaceutical/biotech industry
- A strong working knowledge of clinical pharmacology and related biological sciences
- Work in a global operations mode in different time zones, able to travel on business needs
Please note these job descriptions are not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
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