Director, Clinical Operations
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POST DATE 9/14/2016
END DATE 10/15/2016
HUYA Bioscience International
San Diego, CA
JOB DESCRIPTIONAPPLY Come join our world-class team evaluating, in-licensing and developing innovative therapeutic products internationally.
HUYA Bioscience International is a leader in enabling and accelerating the global co-development of novel biopharmaceutical product opportunities, with the largest Chinese compound database covering all therapeutic areas. HUYA has emerged as the partner-of-choice for building and maximizing the value of biopharmaceutical innovation from China. HUYA is jointly headquartered in San Diego, CA, and Shanghai, PRC.
In the continued development of our biopharmaceutical product portfolio, HUYA is seeking a self-motivated individual to work in a fast-paced environment to take an active role as a Director, Clinical Operations.
This position reports to Chief Medical Officer 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