Position Summary:
Reporting to the VP Clinical Operations, the Director, Clinical Operations plans, implements, and manages clinical studies and clinical research projects from concept to completion. The position requires advanced knowledge of clinical trial processes and proficiency in all aspects of trial execution from study start-up to study close-out, including management of clinical vendors/CROs and providing oversight of resources, budgets, contracts, and timelines.
Note this position can be hybrid in our San Diego or South San Francisco locations or fully remote anywhere in the United States.
Essential Duties and Responsibilities:
- Manage global clinical trials (Phase 1-3) in oncology indications, ensuring that studies are carried out in accordance with the clinical development plan, ICH-GCP, and FDA/other regulatory agency requirements.
- Recruit global study sites and foster relationships with study investigators.
- Participate in the process of site and vendor selection, qualification, and activation.
- Develop Requests-for-Proposals and lead vendor selection efforts.
- Assist in review and negotiation of vendor contracts and study site clinical trial agreements.
- Manage study vendors (e.g., CRO, IRT, laboratories, core ECG/imaging).
- Monitor the progress of trials, including enrollment and clinical trial material inventory.
- Assist in packaging/labeling/distribution of clinical trial material.
- Monitor and track biological samples for applicable analyses.
- Provide progress updates to management and during program team meetings.
- Assist in departmental budgeting, including accruals and projections.
- Assist in development of protocols, consent forms, IRB/EC materials, and other trial documents.
- Assist in development of Clinical SOPs.
- Prepare/review/approve study materials such as CRFs, patient diaries, drug accountability forms, study and investigator manuals, project plans, and monitoring reports.
- Assist in electronic case report form design and development.
- Assist in IRT design and development.
- Participate in data cleaning activities and developing appropriate data outputs.
- Understand and help fulfill the needs of other Erasca departments (e.g., Finance, Research).
- Conduct oversight visits (pre-study, initiation, monitoring, and closeout) with contracted monitors/CRO, review trip reports, and implement training as needed to ensure compliance with the protocol and other study-related documents.
- Provide leadership and mentoring of other Clinical team members.
- Perform all duties in keeping with the Company's core values, policies, and all applicable regulations.
Education and Experience:
- Undergraduate degree in life sciences or professions (pharmacy, medicine, nursing, or other allied health sciences).
- At least 10 years of relevant experience in clinical operations in pharmaceutical company or CRO including trial set-up, monitoring, and close-out of US and non-US trials at all phases of pre-NDA clinical research (Phases 1-3).
- Extensive Oncology experience required.
- Experience in early clinical trials required.
- Experience leading internally-executed clinical trials required.
- Extensive sponsor-side experience required, with a combination of large company and small company experience highly preferred.
- Demonstrated excellence in trial management skills, with track record of successfully managing multiple projects, trials, and priorities.
- Experience with managing study vendors (e.g., CRO, IRT, laboratories, core ECG/imaging).
- Practical knowledge and implementation of ICH-GCP guidelines and US and ex-US regulations.
- Experience with electronic data capture and data management software.
- Direct line management experience preferred, with experience in the management of Clinical Trial Managers and/or CRAs or CTAs.
- Must be able to work independently and thrive in an entrepreneurial, fast-paced and dynamic work environment.
- Must be organized and be able to communicate effectively both orally and in writing.
- Proven ability to work well with global, multi-disciplinary teams.
- Strong learning orientation, curiosity, and commitment to science and patients.
The anticipated salary range for this position is $200,000 to $215,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. In addition to base salary, the hired applicant will be eligible to receive an annual bonus and an equity grant at hire and annually in the form of the option to purchase stock in the future for a specified price.
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