Director, Clinical Operations

Location
San Diego, California
Posted
Apr 18, 2018
Discipline
Clinical
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

This position reports to Global Head of R&D and responsibilities include oversight for clinical study conduct including leading internal and external (CRO) sub-teams, study planning, budgeting, and financial oversight, vendor/partner management, monitoring study and program timelines, and ensuring compliance with 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.

Primary Duties and Responsibilities

  • Actively participates in developing and drafting protocols, amendments, CRF, informed consent forms, Investigator Brochures, annual progress reports, clinical study reports and other documents as needed or requested.  May also 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 international 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
  • Provides high level oversight of clinical study data, i.e., flow from the sites (CRF completion) to data entry (data entered into database) to data listings/tables/figures
  • 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 or fosters an environment that enhances the cross-functional effectiveness of clinical operations with other functions such as biostatistics, data management, CMC, medical writing, regulatory, finance, and legal, whether these functions are internal or external to HUYA
  • 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 
  • May be responsible for direct supervision or line management
  • Creates a positive and productive work environment for attracting and retaining highly qualified clinical professionals
  • Perform other duties as required

Job Requirements

  • Excellent communication (verbal and written) and interpersonal skills with the ability to communicate clearly with all levels within the organization
  • Well versed in GCP/ICH guidelines, applicable FDA/EMA/PMDA, MFDS regulations
  • Experienced in managing clinical trial site/vendor relationships and resource management
  • Direct experience with overseeing audits/inspections, leading multi‐functional teams and maintaining timelines
  • Demonstrates strong problem‐solving and leadership skill-sets
  • San Diego-based position
  • Strong Project Leadership skills including a collaborative and team-oriented approach
  • International experience is a plus
  • Travel, as needed

Education and Experience

  • Bachelor Degree in Biological Science or equivalent in allied healthcare, e.g., pharm D and nursing
  • Pharmaceutical, biotechnology, or clinical research experience for a minimum of 10 years, among which, more than 5 years are in Pharmaceutical and Biotechnology industry

The position is full‐time and the candidate must be within commuting distance to HUYA’s Del Mar, CA headquarters

More searches like this