Sr. Director Clinical Operations

Senior Director, Clinical Operations – GI

Location: Remote

Reports to: Vice President Clinical Operations

Salary: $210-250k base plus bonus and equity

Join a well-funded, clinical-stage biotechnology company advancing innovative therapies for patients with serious immunology and inflammatory diseases. Backed by significant long-term investment and led by an experienced team with a track record of successfully developing and commercializing medicines, this organization combines the scientific rigor of large pharma with the agility and speed of a biotech startup. With multiple programs advancing across respiratory and gastrointestinal indications, this is a unique opportunity to play a highly visible leadership role and directly impact the development of potentially transformative therapies.

Position Summary

The Senior Director, Clinical Operations will provide strategic and operational leadership across gastrointestinal clinical development programs, overseeing the execution of Phase 1–3 clinical trials. This individual will partner closely with executive leadership and cross-functional teams to drive study execution, vendor oversight, and operational excellence while helping build scalable processes to support future growth.

Key Responsibilities

• Lead operational strategy and execution for Phase 1–3 GI clinical trials.
• Oversee study timelines, budgets, enrollment plans, and key milestones to ensure successful delivery.
• Manage CROs and external vendors, establishing clear expectations, KPIs, and accountability.
• Identify and mitigate operational risks while maintaining compliance with ICH-GCP and regulatory requirements.
• Partner cross-functionally with Clinical Development, Biometrics, Regulatory, Medical Writing, Clinical Supply, and Quality to ensure seamless trial execution.
• Contribute operational expertise to protocol development, study feasibility, and development planning.
• Drive inspection readiness and maintain high-quality standards throughout study conduct.
• Support the continued evolution of Clinical Operations infrastructure, processes, and best practices within a growing biotech environment.
• Mentor team members and help foster a collaborative, high-performance culture.
• Present program updates, milestones, risks, and operational strategies to senior leadership.
  
  

Requirements

• Bachelor’s degree required; advanced scientific or healthcare degree preferred.
• 8 years of clinical operations experience within biotech, pharmaceutical, or CRO environments.
• Experience leading Phase 1–3 clinical trials.
• GI, immunology, inflammation, or related therapeutic area experience strongly preferred.
• Proven CRO and vendor management experience.
• Strong understanding of ICH-GCP, FDA regulations, and global clinical trial execution.
• Demonstrated success operating within fast-paced biotech environments.
• Excellent leadership, communication, and cross-functional collaboration skills.
• 5 years of people management experience preferred.
• Ability to travel up to 20%.
  
  

Why This Opportunity?

• High visibility role with direct interaction with executive leadership.
• Opportunity to shape and build clinical operations infrastructure in a rapidly growing organization.
• Strong financial backing and commitment to advancing innovative therapies.
• Expanding pipeline focused on areas of significant unmet medical need.
• Fully remote work environment with meaningful influence on corporate and clinical strategy.
  
  

How To Apply

We’d love to see your resume, but we don’t need it to have a conversation.

Email tom@scientificsearch.com or message me directly if you’d like to learn more. Please reference Job#19922