Director, Clinical Operations

Role Summary

The Director, Clinical Operations will oversee the strategic and operational execution of clinical trials, leading cross-functional teams and collaborating with internal stakeholders and external vendors. This role includes managing trial budgets, vendor selection, and risk mitigation, while contributing technical input to key clinical documents. The position involves mentoring staff, building strong internal and cross-functional relationships, and adapting in a dynamic environment. The role supports trials from first-in-human single-site to global phase 3, as assigned.

Responsibilities

• Performs role of Clinical Operations trial lead for assigned trials and leads cross-functional Study Execution Teams
• Develops and executes trial operational strategies and partners cross-functionally to drive trial execution forward; provides strategic and technical recommendations to senior leadership
• Directs the selection of CROs and other vendors (IxRS, Central Lab, ancillary/tech vendors), directs development of vendor Scopes of Work (SOW), scope changes, budgets, and vendor payments and partners with CROs and other vendors to deliver on study execution
• Creates and tracks clinical trial budgets
• Directs risk mitigation, escalation, and resolution activities both internally and with sites and vendors
• Directs technical and strategic input into the development of clinical documents (protocols, monitoring plans, informed consent forms, investigator brochures, clinical study reports)
• Builds relationships with clinical sites, vendors, and key stakeholders and maintains an understanding of the external landscape and adjusts plans accordingly
• Represents Clinical Operations in cross-functional activities and supports development and management of the Clinical Operations function
• Mentors more junior team members such as Clinical Trial Associates
• Effectively builds strong internal teams and cross-functional relationships and demonstrates leadership and team building skills, along with success in proactive risk mitigation and problem solving
• Flexible and creative in meeting the needs and challenges of a growing, dynamic company and demonstrates excellent problem-solving abilities
• Strong financial acumen with outstanding track record of building budgets and managing expenses to budget
• Contributes to corporate activities, including preparation of materials for Executive Team and Board of Director meeting materials

Qualifications

• Bachelors + 15 years of related experience, or Masters + 12 years of related experience
• 10+ years of clinical research experience, including 7+ years of trial management within a biopharmaceutical company; 5+ years within a small/startup company is a plus
• Exceptional clinical trial management skills with a focus on strategic oversight of trial execution on time and on budget, study coordinator and/or site monitoring experience a plus
• Extensive phase 1 through phase 3, global trial management experience
• Immunology and/or rare disease trial management experience
• Extensive experience selecting and managing vendors, including CROs, labs, IxRS, EDC, and ancillary technology/applications (e.g. eDiaries, eConsent, apps, etc)
• Thorough knowledge and understanding of FDA and ICH Guidelines, GCP, medical terminology, and clinical trials
• Detailed understanding of all aspects of clinical protocol design, implementation, IND/BLA/NDA submissions, and overall drug development
• Experience managing, coaching, and mentoring personnel
• Excellent communication, organizational, negotiation, and interpersonal skills with a strong reputation for collaboration

Skills

• Strategic trial leadership
• Budget development and financial management
• Vendor management (CROs, labs, IxRS, EDC, ancillary tech)
• Regulatory knowledge (FDA/ICH, GCP)
• Cross-functional collaboration
• Mentoring and people management
• Risk management and problem solving

Education

• Not specified beyond degree requirements in Qualifications

Additional Requirements

• Position is remote with periodic travel to team and company events