Associate Director, Clinical Operations

ASSOCIATE DIRECTOR, CLINICAL OPERATIONS

Overview of Role:

The Associate Director, Clinical Operations provides operational leadership for clinical trial execution, overseeing the clinical operations team and vendor performance. This role ensures effective study delivery through cross functional collaboration, proactive risk management, and strong execution oversight. This role leads vendor strategy and oversight ensuring external partners deliver against scope, timelines, quality expectations, and operational objectives.

The ideal candidate thrives in a fast-paced, entrepreneurial environment, demonstrates exceptional operational leadership, and possesses strong business acumen with an understanding of the competitive landscape, capital allocation, and value creation throughout drug development.

Role and Responsibilities:

• Oversees the clinical operational strategy, planning, and execution of one or more global clinical trials.
• Ensures internal clinical and external teams deliver on time, within budget and in compliance with GCP, ICH guidelines, applicable regulations and are always inspection-ready.
• Drafts, reviews and approves internal and external study-related plans, processes, and documents including Informed Consent Forms, Investigator Agreements (CTA), CRFs, CRF Guidelines, statistical/pharmacokinetic analysis plans, monitoring plans, data management plans, and safety monitoring activities.
• Manages CROs, vendors, and strategic partners through robust governance, performance metrics, and risk management.
• Identifies operational risks early and implement proactive mitigation strategies escalating to leadership.
• Drives financial accountability through effective budget management and resource utilization.
• Oversees maintenance, quality, and completeness of the Trial Master File (TMF) and ensures all TMF quality reviews are completed.
• Manages CRO proposals, vendor contracts/change orders, and outsourcing strategies ensuring delivery with a focus on value and return on investment.
• Partners with Finance to provide oversight of vendors costs, supporting prudent operational decisions that align with budgets and financial plans.
• Oversees preparations for regulatory inspections, supports inspection management activities, and ensures the project is always inspection-ready.
• Manages, mentors and provides guidance to CTMs, CRAs, and other Clinical Operations team members.
• Drives continuous improvement initiatives and contributes to development of Clinical Operations processes and standards.
• Represents Clinical Operations on cross-functional study teams and governance meetings.
• Fosters collaboration with external partners, Regulatory Affairs, Clinical Science, Data Management, Biostatistics, Pharmacovigilance, Quality Assurance, CMC, and Commercial teams.
• All other duties as assigned

Experience, Education and Specialized Knowledge and Skills:

• Bachelor's degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical-related areas
• 10+ years of direct clinical trial management experience overseeing phase II/III international oncology clinical trials
• Ability to travel internationally to visit clinical sites and study meetings. Amount will vary upon project needs (up to 20%)

Preferred Experience, Education and Specialized Knowledge and Skills:

• Consistently demonstrates ability to solve problems and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical programs
• Excellent planning, leadership, communication, negotiation, and organizational skills when working with both internal and external teams.
• Expert knowledge of the drug development process, ICH guidelines/GCP with a deep understanding of all phases of clinical trial execution and the ability to apply this knowledge to complex, global studies.