Associate Director, Project Management

The Associate Director, Clinical Operations provides strategic and operational leadership across clinical trial execution, with responsibility for overseeing day-to-day clinical operations activities and ensuring high-quality delivery of oncology clinical studies. This role partners closely with cross-functional stakeholders, including Clinical Operations, Data Management, Regulatory, Safety, Quality, and Business Operations, to ensure trials are executed efficiently, compliantly, and aligned with organizational objectives. This role is responsible for managing and developing operational teams, overseeing vendors and external partners, contributing to operational strategy, and supporting scalable processes that enable future growth and evolving organizational needs.

Essential Functions:

• Provide leadership and oversight of project management and clinical operations activities across assigned portfolio, ensuring studies are executed in alignment with contracted services, timelines, quality standards, regulatory requirements, sponsor expectations, and internal SOPs.
• Manage and develop project management personnel, including providing direction, coaching, performance feedback, career development support, and ensuring appropriate onboarding and training.
• Partner cross-functionally with Clinical Operations, Data Management, Regulatory Affairs, Safety, Quality, and Business Operations to support effective study planning, execution, and issue resolution.
• Oversee third-party vendors, CROs, consultants, clinical sites, and other external partners, ensuring contractual scope, timelines, budgets, and performance expectations are met.
• Monitor trial progress, enrollment, site performance, and operational metrics; support project teams with proactively identify risks, lead mitigation efforts, and support problem-solving as trials progress.
• Participate in and lead study-level and cross-functional meetings as needed, including interactions with Sponsors to provide operational updates and ensure alignment on trial status and priorities.
• Ensure compliance with FDA regulations, ICH GCP guidelines, sponsor requirements, and internal policies across all clinical operations activities.
• Contribute to the development, implementation, and continuous improvement of clinical operations policies, SOPs, systems, and working practices to support scalability and operational excellence.
• Maintain audit readiness and support internal and external audits, including preparation of documentation, staff readiness, and timely response to findings.
• Support clinical operations budget development, financial forecasting, and scope management in collaboration with Finance and Business Operations, including identification of out-of-scope activities.
• Participate in resource planning, study allocation, and capacity forecasting to ensure appropriate staffing across current and future clinical programs.
• Support recruitment, interviewing, hiring, and onboarding of clinical operations staff, and ensure training documentation and personnel files are accurate and current.
• Perform other responsibilities as assigned.
• Travel as necessary to support business needs

Job Requirements:

• This position requires at least a bachelor’s degree, with preference in a health science field, or equivalent education and experience.
• Oncology clinical trial experience required.
• Minimum of 8 years of clinical research experience, including leadership or management experience within clinical operations.
• Minimum of 5 years of project management experience in clinical research.
• Experience with line management and development of direct reports.
• Strong preference for experience in advanced therapy medicinal products (ATMPs) and radioligand therapy / radiodiagnostics.

Required Specialized/Technical Skills:

• Strong working knowledge of FDA regulations, ICH GCP, and clinical research standards.
• Experience managing complex, multi-center clinical trials.
• Broad understanding of clinical trial operations, including study start-up, site management, safety oversight, data management interfaces, and study close-out.
• Demonstrated ability to lead cross-functional teams and manage external vendors.
• Strong communication, problem-solving, and decision-making skills.
• Proficiency in MS Office applications (Word, Excel, PowerPoint); experience with clinical systems.
• Ability to manage multiple priorities and operate effectively in a fast-paced environment.

TD2 is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, creed, disability, veteran’s status, gender, sexual orientation, gender identity, or gender expression.

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