Director Of Clinical Operations

Job Title:

Director of Clinical Operations

We are seeking proactive candidates for an upcoming Director of Clinical Operations position. The Director of Clinical Operations will lead the planning, execution, and oversight of clinical programs across our oncology portfolio. This role is central to driving high‑quality, timely, and compliant clinical trial delivery in a fast‑moving biotech environment. You will partner closely with Clinical Development, Regulatory, Biometrics, CMC, and external partners to ensure our studies advance efficiently and with scientific and operational excellence.

This is a strategic and hands‑on leadership position suited for someone who thrives in an innovative, mission‑driven organization working to bring transformative cancer therapies to patients.

• Provide strategic operational leadership for all clinical programs, from first‑in‑human through late‑stage oncology trials.
• Translate clinical development plans into executable operational strategies, timelines, and budgets.
• Serve as a key member of cross‑functional program teams, representing Clinical Operations in strategic decision‑making.

• Oversee end‑to‑end clinical trial operations, including site selection, study start‑up, enrollment strategy, monitoring, data collection, and close‑out.
• Ensure trials are conducted in accordance with ICH‑GCP, regulatory requirements, and internal SOPs.
• Lead vendor selection, contracting, and ongoing oversight (CROs, labs, imaging vendors, eCOA, etc.).
• Anticipate operational risks and proactively implement mitigation strategies.

• Build, mentor, and lead a high‑performing Clinical Operations team, including Clinical Trial Managers, Clinical Research Associates, and contractors.
• Foster a culture of accountability, collaboration, and continuous improvement.

• Partner with Clinical Development, Medical Affairs, Regulatory, Biometrics, and CMC to ensure alignment across program objectives.
• Work closely with Quality to support audits, inspections, and CAPA implementation.
• Collaborate with Finance on forecasting, budgeting, and resource planning.

• Ensure data integrity, patient safety, and operational quality across all studies.
• Drive inspection readiness and support regulatory submissions (INDs, CTAs, NDAs/BLAs).
• Champion operational best practices and process optimization.

Bachelor’s degree in life sciences or related field; advanced degree preferred.

8+ years of clinical operations experience in biotech/pharma, with at least 5 years in oncology.

Proven track record leading global clinical trials, including early‑phase oncology studies.

Strong understanding of ICH‑GCP, FDA/EMA regulations, and oncology‑specific operational considerations (e.g., biomarker‑driven enrollment, imaging endpoints, complex safety profiles).

Experience managing CROs and external vendors.

Demonstrated leadership ability with experience building and developing teams.

Excellent communication, problem‑solving, and organizational skills.

This position is hybrid. Must be located in San Diego, CA.

This is a Contract position based out of San Diego, CA.

The pay range for this position is $90.00 - $120.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre‑tax and Roth post‑tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long‑term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

This is a fully remote position.

This position is anticipated to close on Feb 24, 2026.

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