Posted on 20 Jul 2026

Director of Clinical Operations

United States (Remote/Hybrid)
Permanent
$200,000 - $250,000

Key Responsibilities

Strategic Leadership & Program Management

  • Provide operational leadership and strategic direction for the clinical operations program.
  • Develop and manage comprehensive clinical program timelines, budgets, and resource plans.
  • Lead the selection and management of Contract Research Organizations (CROs), vendors, and other external partners, ensuring performance and quality standards are met.
  • Identify, assess, and mitigate operational risks across the clinical portfolio.
  • Represent Clinical Operations in cross-functional leadership meetings and provide updates to senior management.

Clinical Trial Execution

  • Oversee the end-to-end execution of multiple clinical trials, ensuring they are delivered on time, within budget, and in compliance with quality standards.
  • Review and provide critical input on clinical trial protocols, informed consent forms (ICFs), study manuals, and other key documents.
  • Manage the study start-up process, including site feasibility, selection, and activation.
  • Monitor study progress, including patient recruitment, data quality, and key performance indicators (KPIs).
  • Ensure timely and accurate study close-out activities.

Team Leadership & Development

  • Recruit, mentor, manage, and develop a high-performing team of Clinical Trial Managers and associated staff.
  • Foster a collaborative, accountable, and results-driven culture within the team.
  • Provide guidance on complex project issues and support professional growth.

Quality, Compliance & Inspection Readiness 

  • Ensure all clinical activities adhere to ICH-GCP, FDA/EMA regulations, and company SOPs/
  • Oversee the TMF to ensure it is always inspection-ready.
  • Lead or support health authority inspections and internal audits.
  • Implement corrective and preventive actions (CAPAs) as needed.

Vendor & Budget Management

  • Lead the RFP process and negotiate contracts with the CROs and other service providers.
  • Manage the clinical operations budget, including forecasting and tracking spend against approved budgets.
  • Review and approve vendor invoices and change orders. 

Qualifications & Experience

Education

  • Bachelor's degree in a Life Sciences or related field required
  • Advanced degree (e.g., MS, PhD, PharmD) highly preferred

Experience

  • 10+ years of experience in clinical operations within the biotech or pharmaceutical industry.
  • Extensive experience managing clinical trials, with a strong preference for rare disease experience.
  • Demonstrated success in selecting and managing global CROs and other vendors.
  • Full lifecycle experience from study start-up through to CSR.
  • Strong familiarity with FDA and ex-US (e.g., EMA) regulations and ICH-GCP guidelines. 

Skills & Competencies 

  • Strategic Thinker: Ability to develop high-level strategy and execute tactically.
  • Leadership: Inspirational leader with excellent people management skills.
  • Financial Acumen: Proficient in budget development, forecasting, and financial management.
  • Problem-Solver: Excellent risk management and problem-solving skills in a fast-paced environment.
  • Communicator: Outstanding verbal and written communication skills, with the ability to present effectively to senior leadership.
  • Collaborative: A team-oriented leader who thrives in a cross-functional matrix environment. 

Benefits

  • 20% Bonus
  • Equity available 
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