Associate Director, Clinical Operations

Accountabilities

• Oversight of the planning, execution, and delivery of Phase 1 clinical pharmacology studies
• Management of daily study activities with internal teams, CROs, clinical sites, and specialized vendors
• Coordination of Safety Review Committee and Dose Escalation Committee meetings when applicable
• Collaboration with Clinical Pharmacology, Bioanalytical Sciences, Clinical Supply, Biometrics, and Nonclinical teams to ensure study alignment
• Identification, assessment, and mitigation of operational risks associated with early-phase clinical trials
• Leadership and guidance of Study Management Teams (SMTs) to ensure delivery of key milestones and adherence to clinical operations plans
• Review and contribution to clinical study documents, including protocols, informed consent materials, study plans, operational playbooks, and site-facing materials
• Overseeing Phase 1 units, central laboratories, and specialty vendors while ensuring compliance with budgets and forecasts
• Supporting continuous improvement of clinical operations processes and best practices
• Mentoring, coaching, and developing junior team members while promoting collaboration and accountability

Requirements

• Extensive clinical trial leadership experience
• Strong knowledge of Phase 1 clinical pharmacology studies
• Experience managing complex global programs in a highly regulated environment
• Proven ability to lead cross-functional teams, manage CRO relationships, and drive study execution
• Experience developing and managing complex clinical project plans, timelines, budgets, and critical paths
• Strong analytical and problem-solving skills with the ability to quickly evaluate challenges and implement solutions
• Excellent written and verbal communication skills, including experience presenting to senior leadership
• Ability to adapt to changing priorities while maintaining focus on study objectives and timelines
• Experience with clinical systems such as IRT, eTMF, and timeline/project management tools such as MS Project or Smartsheet
• Strong organizational skills with the ability to manage multiple priorities in a dynamic environment
• Previous people management, coaching, and mentoring experience preferred
• Ability to travel approximately 10-20% domestically and internationally

Benefits

• Competitive base salary range of $150,000 - $195,000, depending on experience, skills, education, and location
• Short-term incentive opportunities and long-term incentive compensation through company stock programs
• Comprehensive healthcare benefits, including medical, dental, and vision coverage
• Financial wellness benefits, including retirement plans with employer match
• Life insurance and disability coverage
• Paid time off and work-life balance programs
• Wellness initiatives and employee support resources
• Opportunities for professional development and career growth
• A collaborative, mission-driven environment focused on advancing treatments for rare disease communities