Associate Director, Clinical Operations

Overview

This position is for an Associate Director of Clinical Operations based in the United States, focusing on the operational leadership and delivery of early-phase clinical trials centered on innovative therapies for rare diseases. The role is pivotal in steering Phase 1 clinical pharmacology studies to completion on schedule, within defined scope, and adhering to regulatory compliance. It requires close collaboration with interdisciplinary teams, research partners, and vendors to ensure trial success within a dynamic biopharmaceutical landscape.

Key Responsibilities

• Lead and oversee operational execution of Phase 1 clinical pharmacology trials, including studies such as first-in-human, SAD/MAD, DDI, QTc, Human ADME, food effect, and organ impairment assessments.
• Manage daily study activities coordinating with internal departments, CROs, clinical sites, and specialty vendors.
• Supervise pharmacokinetic/pharmacodynamic sample collection, processing, reconciliation, and shipment processes.
• Organize and manage meetings for Safety Review Committees and Dose Escalation Committees when necessary.
• Collaborate with Clinical Pharmacology, Bioanalytical, Clinical Supply, Biometrics, and Nonclinical teams to maintain alignment across studies.
• Identify operational risks and develop mitigation strategies for early-phase trials.
• Guide Study Management Teams to meet milestones and adhere to clinical operations plans.
• Review and contribute to essential clinical documentation including protocols, informed consent forms, study plans, operational guides, and site materials.
• Monitor Phase 1 units, central labs, and specialty vendors ensuring compliance with budgets and forecasts.
• Drive continuous improvement in clinical operations processes and best practices.
• Mentor and develop junior staff fostering collaboration and accountability.

Qualifications and Experience

• Bachelor's degree in life sciences, nursing, pharmacy, or related field, or equivalent education and experience.
• Minimum of 8 years progressive clinical trial experience including at least 2 years in a leadership capacity within clinical operations.
• Comprehensive experience managing Phase 1 clinical pharmacology and healthy volunteer studies.
• Strong knowledge of global clinical research regulations (US CFR, EU CTD, ICH E6 R2 GCP).
• Proven leadership in managing cross-functional teams and CRO relationships.
• Expertise in developing and managing complex clinical project timelines, budgets, and critical paths.
• Analytical and problem-solving skills to handle challenges and implement effective solutions rapidly.
• Excellent communication and presentation skills to senior stakeholders.
• Flexibility to adapt to shifting priorities while ensuring study objectives and schedules remain intact.
• Proficiency with clinical systems such as IRT, eTMF, and project management tools (MS Project, Smartsheet).
• Strong organizational ability to manage multiple concurrent tasks in a fast-paced environment.
• Experience in mentoring and people management preferred.
• Willingness to travel approximately 10-20% domestically and internationally.

Compensation and Benefits

• Competitive base salary ranging from 150000 to 195000 USD annually, commensurate with experience, skills, education, and location.
• Opportunities for short-term incentives and long-term compensation including stock programs.
• Comprehensive medical, dental, and vision insurance benefits.
• Retirement plans with employer matching contributions.
• Life insurance and disability coverage.
• Paid time off and programs supporting work-life balance.
• Employee wellness initiatives and support resources.
• Professional development and career advancement opportunities.
• Work environment focused on collaboration and a mission to advance rare disease therapies.

Additional Information

This job listing is managed by a partner organization responsible for the application process and subsequent steps. The selection uses an AI-driven candidate matching system to ensure fair, objective consideration based on key role criteria, with hiring decisions made by the employer's internal team. Applicants should note their data privacy rights and that AI tools may support recruitment tasks but not replace human decision-making.