Associate Director, Clinical Operations

Accountabilities: The Associate Director, Clinical Operations will oversee the planning, execution, and delivery of Phase 1 clinical pharmacology studies while ensuring alignment with timelines, budgets, quality standards, and regulatory requirements. The role requires strong leadership, cross-functional collaboration, and the ability to manage complex clinical programs from start-up through completion. Lead operational execution of Phase 1 clinical pharmacology studies, including first-in-human, SAD/MAD, DDI, QTc, Human ADME, food effect, and organ impairment studies. Manage daily study activities with internal teams, Contract Research Organizations (CROs), clinical sites, and specialized vendors. Oversee PK/PD sample collection, processing, reconciliation, and shipment activities. Coordinate Safety Review Committee and Dose Escalation Committee meetings when applicable. Partner with Clinical Pharmacology, Bioanalytical Sciences, Clinical Supply, Biometrics, and Nonclinical teams to ensure study alignment. Identify, assess, and mitigate operational risks associated with early-phase clinical trials. Provide leadership and guidance to Study Management Teams (SMTs), ensuring delivery of key milestones and adherence to clinical operations plans. Review and contribute to clinical study documents, including protocols, informed consent materials, study plans, operational playbooks, and site-facing materials. Oversee Phase 1 units, central laboratories, and specialty vendors while ensuring compliance with budgets and forecasts. Support continuous improvement of clinical operations processes and best practices. Mentor, coach, and develop junior team members while promoting collaboration and accountability. Requirements: The ideal candidate will bring extensive clinical trial leadership experience, strong knowledge of Phase 1 clinical pharmacology studies, and the ability to manage complex global programs in a highly regulated environment. Bachelor’s degree in life sciences, nursing, pharmacy, or a related discipline, or equivalent combination of education and relevant experience. 8+ years of progressive clinical trial experience, including at least 2 years in a clinical operations leadership role. Significant experience managing Phase 1 clinical pharmacology studies and healthy volunteer trials. Strong understanding of global clinical research regulations, including US CFR, EU CTD, and ICH E6 (R2) GCP requirements. 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: The organization provides a comprehensive rewards package designed to support employee well-being, professional growth, and long-term success. 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.