Director / Associate Director, Clinical Operations Redwood City, USA

Director / Associate Director, Clinical Operations

Job Description

The Clinical Operations (Director / Associate Director) is a key member of the Clinical Operations team leading the successful execution of clinical trials. The Clinical Operations Director provides trial operational oversight of CROs and vendors and is responsible for all aspects of Phase I through pivotal clinical oncology trials. This role also assures adherence to GCP, regulations and applicable procedures, in addition to protocol compliance and that of study related plans.

We are seeking a highly motivated Clinical Operations Director. The position is full-time, and based at our headquarters in Redwood City, CA. The ideal candidate is an individual who is interested in working in a fast‑paced, dynamic, and highly collaborative biotech environment with a willingness and ability to successfully take on new challenges. The candidate will be part of a cross‑functional project team working on early phase clinical trials.

Essential Functions and Responsibilities

Responsible for growing and managing projects, and daily work activities for the Clinical Team.

Independently manage all components of complex oncology clinical trials, leading a cross‑functional management team.

Ensure clinical trial activities and deliverables are completed on‑time and within budget.

Vendor oversight (e.g., CRO, PK / Central Lab, Drug Supply, IXRS, eTMF) for adherence to budget, timelines, and organizational objectives of individual protocols / programs.

Develops strong vendor relationships and ensures continuity of relationships through all phases of the trial.

Involved in the identification, evaluation, selection, and oversight of all clinical trial sites.

Oversee and participate in development of study documents and tools including study protocols, consent forms, and project plans.

Obtains and maintains in‑depth understanding of the study protocol and related procedures to contribute strongly to study team knowledge by sharing best practices, making recommendations for continuous improvement, and providing training as appropriate / required.

Partner efficiently and effectively with clinical trial sites to ensure smooth study conduct.

Coordinates & manages various tasks in collaboration with other sponsor roles to achieve site readiness, such as study materials and approval for drug shipping / receipt according to procedure.

Performs timely review of monitoring reports from CRO and associated deliverables demonstrating sponsor oversight.

Oversee ongoing study data reviews and data cleaning activities.

Responsible for inspection readiness at all times. Perform periodic reviews of the CRO eTMF / TMF to ensure adherence with standards and compliance with the relevant regulations and guidelines.

Works with vendors to revise scope of service agreements, budgets, plans and detailed timelines, and ensure that performance expectations are met.

Supports financial management of the study which includes review and approval of site and vendor invoices.

Conduct / attend internal / external meetings for assigned clinical trials.

May develop SOPs, best practices, and facilitate their implementation.

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