Job Description
Job Title: Senior Manager / Associate Director, Clinical Operations
Location: Fully Onsite – San Diego, CA
Position Overview:
We are seeking a driven and detail-oriented Senior Manager or Associate Director of Clinical Operations to support the planning and execution of our early-stage clinical trials , with opportunities to contribute to late-stage programs as we advance our pipeline. This individual will play a pivotal role in ensuring the operational excellence of our clinical development activities and will collaborate closely with cross-functional teams and external partners.
Key Responsibilities:
- Manage day-to-day operations of early-phase clinical trials (Phase 1–2) from study start-up through closeout.
- Support select late-phase activities as programs progress, gaining broader exposure across the development lifecycle.
- Work closely with CROs, vendors, and internal stakeholders to ensure trial execution is on time, within scope, and on budget.
- Contribute to protocol development, site selection, study timelines, and risk mitigation planning.
- Ensure compliance with ICH-GCP, regulatory requirements, and internal SOPs.
- Participate in cross-functional clinical team meetings and support clinical strategy execution.
Qualifications:
- 5–10 years of experience in clinical operations, with hands-on experience in early-stage (Phase 1–2) trials .
- Some exposure to late-phase studies (Phase 3 or pivotal trials) is preferred.
- Excellent communication, organizational, and vendor management skills.
- Ability to work effectively in a fast-paced, onsite environment.
Why Join Us?
- Be part of a collaborative and innovative team advancing a pipeline with strong scientific promise.
- Enjoy meaningful work in a growing biotech environment where your impact is visible and valued.
- Fully onsite role in San Diego —work shoulder-to-shoulder with passionate experts driving transformational science forward.
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