Director, Clinical Trial Management

$182,000 - $210,000/Yr

Xencor - San Diego, CA

Full-time - Senior

Remote - San Diego, CA

Chemical Manufacturing

About the position

The Director of Clinical Trial Management at Xencor is responsible for overseeing the tactical implementation of clinical development plans, managing timelines, resources, budgets, and staff involved in clinical activities. This role requires collaboration with various teams and vendors to ensure the successful execution of clinical trials, while also maintaining compliance with regulatory standards and company policies.

Responsibilities

• Direct tactical implementation of the clinical development plan by managing timelines, resources, budget, and staff.
• Guide study team in vendor selection and provide management oversight throughout clinical projects.
• Ensure operational feasibility of clinical development plans, including time, budget, and resource requirements.
• Analyze protocols to produce investigational product forecasts and identify regulatory issues.
• Work with senior management to develop and achieve corporate goals.
• Manage day-to-day clinical trial activities and deliverables, including data management and protocol review.
• Serve as Clinical Operations leader and main point of contact with vendors and trial sites.
• Conduct daily reviews to identify potential issues and communicate with the Clinical Lead/Project Team.
• Develop and maintain effective working relationships with internal and external stakeholders.
• Participate in Clinical Operations initiatives and recommend process improvements.
• Prepare and maintain Trial Master Files for multiple studies, ensuring compliance with ICH-GCP and FDA regulations.
• Lead review of key data to ensure ongoing quality of trial conduct.
• Develop tracking spreadsheets for clinical drug product supply to sites and vendors.
• Support financial oversight of clinical studies through invoice tracking and reconciliation.
• Assist in the development and review of key study documents.
• Provide oversight and direction to direct and indirect reports.

Requirements

• Bachelor's degree in a field of science (biology or chemistry preferred); nursing or pharmacy degree is a plus.
• At least 12 years of related experience, including 8 years in clinical trial management.
• Minimum of 5 years of people management experience.
• Experience in the biotech or pharma industry, preferably in a small company.
• Expert knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs.
• Excellent time management and organizational skills.
• Strong attention to detail and accuracy in work.
• Proficiency in Microsoft Outlook, Word, PowerPoint, and Microsoft Project.
• Ability to think critically and creatively to resolve complex problems.
• Competency in managing others through coaching and supervision.

Nice-to-haves

• Experience with autoimmune indications, including Irritable Bowel Disease and Ulcerative Colitis.

Benefits

• 401(k) matching
• Employee stock purchase plan
• Health insurance