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.