Vice President, Clinical Pharmacology
HUYA is seeking a self-motivated, goal-oriented individual to take an active role in the drafting of plans for clinical trials and the creation of guidelines for prescribing drugs in development by the Company. You will report to the Global Head of Research and Development, and will be responsible for the planning and direction of Clinical Pharmacology components of clinical programs (including clinical development plan/life cycle plan) and studies (including synopsis and protocol preparation; clinical phase oversight, reporting). Responsibilities include but are not limited to, representing Clinical Pharmacology and Pharmacokinetics on development project teams, leading the development of clinical pharmacology strategies and the execution of clinical pharmacology studies and exposure-response and population pharmacokinetics/pharmacodymanics (PK/PD) analyses and contributing to the development of clinical study concepts and protocols, clinical study reports, and relevant components of regulatory submission documents.
This is an office-based position that works in a cross-functional and dynamic environment. Clear, timely, professional, and effective communication with all HUYA functional areas and global office sites is essential.
Primary Duties and Responsibilities
- Represent Clinical Pharmacology and Pharmacokinetics on development project teams
- Lead the development of clinical pharmacology strategies and the execution of clinical pharmacology studies and exposure-response and population pharmacokinetics/pharmacodymanics (PK/PD) analyses
- Contribute to the development of clinical study concepts and protocols, clinical study reports, and relevant components of regulatory submission documents
- Represent Clinical Pharmacology in interactions with and responses to regulatory agencies
Job Qualifications and Requirements
- In-depth understanding of PK/PD, drug metabolism and clinical research concepts
- Strong theoretical background and hands-on experience interpreting clinical dose-response and PK-PD data to inform clinical study designs and drug development decision making
- Proficiency with state of the art PK/PD modeling software
- Knowledge of regulatory guidance related to clinical pharmacology
- Excellent oral and written communication skills and a proven track record of working effectively in a dynamic, collaborative, team-oriented setting
Education and Expererience
- An advanced degree (PhD, MD, or PharmD) in pharmacology, pharmaceutical sciences, pharmacy, life sciences, or other related fields
- 4-6 years relevant experience in the biotech/pharmaceutical industry
- Experience with regulatory interactions
- Experience with oncology and immunology drug development
- Experience with both small molecule and biologics drug development
The position is full‐time and the candidate must be within commuting distance to HUYA’s Del Mar, CA headquarters.