Head of Clinical Operations, Listed BioPharma, Onco

COMPANY AND OBJECTICES:

The recruiting company is a listed biopharmaceutical company focused mainly on oncology, autoimmune and ophthalmic diseases. It has strong global presence with R&D and manufacturing facilities in compliance with GxP standards under NMPA/FDA/EMEA.

The company is seeking an experienced Clinical Operations Executive Director who will be responsible for all aspects of assigned clinical trial portfolios compliance with GCP, SOP and ICH’s standards within established timelines, standards, and budgets:

• Lead study’s operational strategy and planning and oversee execution of clinical studies for assigned clinical program(s), responsible for clinical strategy defined in Clinical Development Plan.

• Lead the team to manage clinical studies in multiple Phases including, but not limited to, the development of study start-up materials, clinical supplies, case report forms, contracts and budgets, investigator meetings, and regulatory document filing in conjunction with the appropriate functions.

• Work with other team members to coordinate preparation of study protocols and final study reports when appropriate.

• Oversee the execution of studies in assigned clinical program(s) in compliance with quality standards (including ICH GCP, local regulations, and company SOPs), on schedule and on budget.

• Oversee Strategic Partners and/or other CROs and other 3rd party vendors to meet company's obligations described in ICH-GCP and company's business objectives.

• More than one study and/or more than one program may be assigned at a time

This is an exciting opportunity for an individual with demonstrated learning agility to work on multiple programs across multiple phases of development in Oncology. A detailed understanding of overall strategic direction, interrelationships and business needs is required.

ACCOUNTABILITIES:

• Accountable for the overall strategies and performance of the US study, response for planning and operational strategy and execution for assigned clinical trials.

•During Early Engagement with Strategic Partner(s) and/or other CROs, lead the development of the Operational Strategy in preparation for Operational Strategy Review; focus on ensuring accurate assumptions are applied and robust risk management plans are in place.

•Provide oversight/support/guidance to Strategic partners/CRO to ensure study issues are addressed and resolved rapidly.

• Responsible for study budget planning and management and accountable for external spend related to study execution. Works closely with internal departments to ensure on a regular basis that budgets, enrollment, and gaiting is accurate.

• Oversee Strategic Partners/CRO/vendor selection, budget and contract negotiation, and proper supervision of performance for all activities assigned to a Strategic Partner/CRO/vendor for assigned studies, including escalation of issues to governance committees when warranted, if needed.

• Confirm adherence to GCP compliance execution through all stages of clinical trial conduct including but not limited to core study execution documents, clinical trial sponsor oversight, deviation management and internal audit support.

• Managing all aspects of study progress from start-up to close-out activities and assuring adherence to intended timelines to achieve study goals while ensuring compliance with international GCP guidelines/regulations and SOPs/SWPs.

Qualifications：

• Bachelor’s degree in biological science, nursing, or pharmacy (or equivalent) as a minimum. Advanced degree preferred.

• Minimum 15 years of experience in the pharmaceutical industry in a position performing clinical operations functions, at least 5 years as Clinical Head.

• Must be a demonstrated self-starter and team player with strong interpersonal skills.

• Results oriented, able to use a variety of resources and abilities to solve problems.

• Able to build and maintain positive relationships with management, peers, and subordinates.

• 30% travel required.

• This position can be remotely based, or office based. If Remote, regular visit to main site will be expected.