This position reports to the Chief Medical Officer and will provide leadership and advice on the development of optimum regulatory strategies in drug development, product lifecycle management, and clinical study planning. This position will also provide oversight for, and management of, clinical study-specific regulatory activities. The position works in a cross-functional environment with representatives from other involved line functions. He or she will contribute to, and support, corporate goals to progress the company’s portfolio of products.
Primary Duties and Responsibilities
Responsible for regulatory strategy in the design of clinical development plans and overall strategy for compounds, therapeutic classes of compounds, or indications in light of developments in the area of clinical and pharmaceutical oncology and other therapeutic areas, as needed. Provide regulatory expertise on cross-functional product development teams including country-specific, ethics or IRB, and regulatory or health authority requirements. Responsible for oversight of regulatory activities for clinical studies. Attend meetings with, or provide support for, interactions with regulatory authorities, as requested. Attends key scientific meetings or conferences and keeps abreast of relevant scientific publications to maintain awareness of current developments and progress in relevant therapeutic areas. Collaborate with cross-functional colleagues and senior management in assessing requirements for new product candidates. May be responsible for supervision or line management of others.
Bachelors degree (or equivalent) required.
Advanced degree preferred (MD, PhD, PharmD, Masters degree)
A thorough knowledge of clinical development and regulatory strategy gained from at least 10 years experience at a senior or managerial level within a pharmaceutical or biotechnology company
Fluency in written and verbal English
Excellent oral and written communication skills
The position is full-time and the candidate must be within commuting distance to HUYA’s Del Mar, CA headquarters. Interested candidates should submit a cover letter and resume.
To learn more about HUYA Bioscience, please visit www.huyabio.com. HUYA Bioscience is an equal opportunity employer.