Director, Clinical Operations

Key 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
• 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
• Detail 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