Associate Director Clinical Operations

Skills Alliance; United States; On-site; USD 150,000 - 190,000; Full time

Job summary

Skills Alliance is seeking an Associate Director, Clinical Operations to lead planning and execution of multiple early-stage clinical trials in immunology and autoimmune disease. This role reports to the VP Clinical Operations and will help build the function from the ground up in a growing biotech setting.

You will oversee vendors/CROs, manage trial budgets, and establish investigator/site relationships, while mentoring junior team members and developing SOPs to scale operations as the pipeline

Qualifications

• Bachelor's degree required.
• 7+ years of clinical trial management experience in biotech/pharma.
• Experience at a small biotech company strongly preferred.
• Early-stage clinical trial experience required (Phase 1/2).
• Experience in immunology, autoimmune disease, or rare disease preferred.
• Demonstrated experience with CRO/vendor oversight and outsourced trial models.
• Proven ability to establish and manage site and investigator relationships.

Responsibilities

• Lead planning, management, and execution of multiple concurrent clinical trials, serving as study team lead.
• Provide vendor/CRO oversight, including selection, management, and performance accountability within an outsourced operating model.
• Own fiscal management of clinical trials, including budgets, forecasting, and vendor spend.
• Establish and maintain relationships with investigators and clinical trial sites.
• Build and mentor a team of junior FTE staff and consultants, with growth into broader people management responsibilities over time.
• Develop and implement SOPs and operational processes to support a scaling clinical operations function.
• Partner with the VP of Clinical Operations on study strategy, resourcing, and team-building initiatives.
• Collaborate cross-functionally with Clinical Development, Regulatory, Data Management, and Quality to support trial execution.

Skills

Clinical Operations

Vendor Oversight

Project Leadership

Cross-functional Collaboration

Education

Bachelor's degree

Job description

Our client is a well-funded, fast-growing biotechnology company advancing an early-stage clinical pipeline in immunology and autoimmune disease. Backed by strong institutional investors, the company offers significant runway to support long-term pipeline growth and is scaling its Clinical Operations function. With one study already in the clinic and two additional studies on the near-term horizon, this is a genuine opportunity to join at a pivotal stage and help build the function from the ground up.

The Role

The Associate Director, Clinical Operations will lead the planning and execution of multiple clinical trials, serving as study team lead and driving day-to-day operational delivery in a small biotech, outsourced-vendor model. Reporting directly to the VP Clinical Operations, this individual will play a key role in building team infrastructure, processes, and SOPs as the pipeline expands, with a people management component developing further down the road as the team grows.

Key Responsibilities

• Lead planning, management, and execution of multiple concurrent clinical trials, serving as study team lead
• Provide vendor/CRO oversight, including selection, management, and performance accountability within an outsourced operating model
• Own fiscal management of clinical trials, including budgets, forecasting, and vendor spend
• Establish and maintain relationships with investigators and clinical trial sites
• Build and mentor a team of junior FTE staff and consultants, with growth into broader people management responsibilities over time
• Develop and implement SOPs and operational processes to support a scaling clinical operations function
• Partner closely with the VP of Clinical Operations on study strategy, resourcing, and team-building initiatives
• Collaborate cross-functionally with Clinical Development, Regulatory, Data Management, and Quality to support trial execution

Qualifications

• Bachelor's degree required
• 7+ years of clinical trial management experience in the biotech/pharma industry
• Experience at a small biotech company strongly preferred
• Early-stage clinical trial experience required (Phase 1/2)
• Experience in immunology, autoimmune disease, or rare disease preferred
• Demonstrated experience with CRO/vendor oversight and outsourced trial models
• Proven ability to establish and manage site and investigator relationships