Vice President, Preclinical

Location
San Diego, CA
Posted
Sep 25, 2018
Discipline
Clinical, Science/R&D
Required Education
Bachelors Degree
Position Type
Full time

HUYA is seeking a self-motivated, goal-oriented individual to take an active role to support clinical development of company portfolio projects from IND enabling to NDA submissions in U.S. and key strategic regions globally. This position will report to the Global Head of Research and Development,  and will be responsible for the strategy and development of clinical pharmacology elucidating mechanism of action, pharmacodynamics and pharmacokinetics and preclinical toxicology including animal toxicology and/or pharmacology to enable IND and NDA.  Responsibility includes the study design, execution, and prioritizing non-clinical development projects according to life cycle stage of the compound in support of company business needs. Writing CTD sections for Module 2 required.

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 non-clinical pharmacology on development project teams
  • Design and execute non-clinical studies to support IND filing for the clinical development of HUYA Bioscience International’s lead candidates, including but not limited to ADME, drug-drug interactions, animal toxicology
  • Lead the development of clinical pharmacology strategies and the execution of clinical pharmacology plan
  • Contribute to the development of clinical study concepts, correlative biomarker studies, and preclinical evidence justification for clinical trials
  • Represent pharmacology in interactions with and responses to clinical investigators, Key opinion leaders and regulatory agencies
  • Manage vendors and external collaborators for non-clinical projects
  • Perform other duties as required

Job Qualifications and Requirements

  • In-depth knowledge of PK/PD, drug metabolism and pharmacology
  • Strong scientific background and hands-on research experience in fields of drug mechanism of action, toxicology 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 and requirements related to non-clinical and pre-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 Experience

  • An advanced degree (PhD, 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
  • Preferred experience with oncology and/or cardiovascular drug development
  • Experience with both small molecule and biologics drug development