Vice President, Clinical Operations

Location
92130, San Diego
Posted
Aug 03, 2018
Discipline
Clinical
Required Education
Bachelors Degree
Position Type
Full time

This position reports to HUYA’s President. Responsibilities include complete oversight of clinical study, start up and conduct (e.g., enrollment) including leading internal and external (CRO) teams and sub-teams, study planning, budgeting, and financial oversight, vendor/partner management, monitoring study and program timelines, and ensuring compliance with Quality Systems and GCP. This position works in a cross-functional environment with representatives from other involved functions. He or she will contribute to, and support, corporate goals to progress the company’s portfolio of products across therapeutic areas.

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

  • Actively participates in 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
  • Oversees and guides clinical operations staff responsible for the implementation and execution of all studies, whether local or international.
  • Ensures that clinical studies are properly resourced, managed, and executed following the study plan and in accordance with established timelines and quality standards. Works directly with project management to communicate the status, progress and issues related to tracking the achievement of milestones. 
  • Provides high level oversight of clinical study data, e.g., flow from the sites (CRF completion), data entry (data entered into database), and data listings/tables/figures including safety data and pharmacovigilance. Responsible for the appropriate archiving of all clinical trial data and documentation.
  • 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. Works with Quality and is responsible for the development of SOPs and operational compliance.
  • Develops work processes or fosters an environment that enhances the cross-functional effectiveness and ensures successful clinical operations with other functions such as biostatistics, data management, CMC/drug supply, medical writing, regulatory, finance, and legal, whether these functions are internal or external to HUYA. Directly responsible as the interface with CMC on drug supply.
  • Develops and/or utilizes appropriate metrics to assess performance, compliance, and cost effectiveness
  • Ensures audit readiness at all times
  • Selects and oversees, effectively manages, and collaborates with CROs/vendors/partners and build strong relationships at the senior levels within those organizations.
  • Ensures adherence to vendor/partner scopes of work, including timelines and budgets, while providing insight and guidance around potential study changes to ensure efficiency and mitigate against fluctuating study costs or study delays.
  • Responsible for all aspects of contracts including negotiation, budgeting and performance.  
  • May be responsible for direct supervision or line management
  • Creates a positive and productive work environment for attracting and retaining highly qualified clinical professionals

Job Qualifications and Requirements

  • Pharmaceutical, biotechnology, or clinical research experience for a minimum of 10 years, with more than 5 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
  • International experience is a plus

Education and Experience

  • Bachelors Degree in Biological Science 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

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