Vice President, Clinical Operations

Location
92130, San Diego
Posted
Apr 29, 2021
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time

Come join our world-class team evaluating, in-licensing, and developing innovative therapeutic products internationally.

HUYA Bioscience International is a biopharmaceutical company focused on globalizing products from China and Asia for the world markets in multiple therapeutic areas. The Company’s lead compound in oncology, HBI‐8000, which is already approved for lymphoma in China, is in late-stage clinical development in Japan and Korea. In the United States, the compound is being developed in immune oncology (IO) in multiple tumor types and disease settings. HUYA has a pipeline of IO compounds as well as two other compounds for cardiovascular diseases. More information can be found at www.huyabio.com

Job Summary

HUYA is seeking a self-motivated individual to take a position in a fast-paced environment as a Vice President, Clinical Operations.  This position reports to HUYABIO’s Head of R&D. Responsibilities include oversight of clinical study implementation, execution, and completion.  Accountability includes leading study teams (internal and external service providers), study planning, budgeting, vendor/partner management, clinical trial material supply chains, monitoring timelines and fiscal spent, and compliance with Corporate Quality Systems and GXP applicable to clinical trial conduct globally and regionally. He or she will contribute to corporate goals to advance the company’s product portfolio.

This is an office-based position that works in a cross-functional and dynamic environment.  Clear, timely, professional, and effective communication with all HUYABIO functional areas and global office sites is essential.

Primary Duties and Responsibilities

  • Actively contributes, such as hands-on writing and editing, to protocol development, amendments, CRF, informed consent forms, Investigator Brochures, annual progress reports, clinical study reports and other documents as needed or requested.  Review required clinical documents, if developed by vendors/partners
  • Responsible for the development of, and the oversight for, clinical study milestones to support program objectives
  • Supervises, mentors, trains clinical operations staff responsible for the implementation and execution of clinical studies
  • Ensures that clinical studies are properly resourced, managed, and executed following the study plan and in accordance with established timelines and quality standards.
  • Appraises trials status to company executives, examples include budget spend to finance, subject enrollment issues, regulatory/ GCP compliance to medical, CRO performance issues to legal/finance
  • Provides regular reports of study matrix, such as enrollment against milestone targets, clinical trial data entry queries, safety reporting/resolution, compliance issues to SOPs to Head of R&D.
  • Ensures that clinical studies follow guidelines and necessary processes and procedures, as applicable (e.g., Code of Federal Regulations, ICH Guidelines and Good Clinical Practices, FDA, EMA, PMDA) and appropriate industry standards.
  • Develops work processes that enhances the cross-functional effectiveness. Directly interfaces with CMC on drug supply.
  • Ensures audit readiness at all times
  • Selects, manages, and collaborates with CROs/vendors/partners
  • Creates and maintains a positive work environment and builds a high performance clinical team

 

 

Job Qualifications and Requirements

Job Qualifications and Requirements

  • Pharmaceutical, biotechnology, or clinical research experience for a minimum of 15 years, with more than 10 years in the pharmaceutical or biotechnology industry involving oncology drug development
  • Strong Project Leadership skills including a collaborative and team-oriented approach
  • Excellent oral and written communication skills
  • Fluency in written and verbal English

Education and Experience

  • Matriculation in Biological Sciences or equivalent in allied healthcare, e.g., pharm D and nursing.
  • Advanced degree is desirable (e.g., Pharm.D, MBA, PhD, MD)
  • Experience in resource management
  • Strong Project Leadership skills including a collaborative and team-oriented approach
  • International experience is a plus

The position is full‐time, and the candidate must be within commuting distance to HUYA’s Del Mar, California office. Interested candidates should submit resumes to: recruit@huyabio.com.

To learn more about HUYA Bioscience, please visit www.huyabio.com. HUYA Bioscience is an equal opportunity employer.