Associate Director, Clinical Operations

Job Description
The Associate Director of Clinical Operations will service the Clinical Program Director for assigned Global Development Team(s) (GDT); overseeing clinical trial execution and operational strategy. This role will have line management responsibilities for Clinical Operations team members including but not limited to Clinical Project Managers and Sr. CRAs and will foster a collaborative and high-performing environment while maintaining oversight of CROs, study execution, ensuring data integrity, regulatory compliance and adherence to budget parameters and timelines .

Job Responsibilities:

• Clinical Program Management: lead the planning, execution, and monitoring of clinical trials, ensuring that trials are conducted in accordance with clinical development planning, regulatory guidelines, and Good Clinical Practice (GCP).
• Clinical Trial Oversight: Oversee the clinical trial life cycle, from study design to study completion. This includes strategy development, trial progress monitoring, and risk management. Provide guidance and support to clinical teams on trial execution, risk mitigation and problem-solving.
• Risk Mitigation: Identify and address any operational risks, implementing corrective and preventative actions as necessary to keep trials on track.
• Vendor Management: Oversee the selection and maintain oversight of external vendors such as CROs and/or other service providers, ensuring adherence to timelines and quality standards. Manage assigned CRO relationships; serve as an escalation point for study teams (e.g. performance challenges, timeline delays etc) and drive resolution with CRO counterpart(s). Contribute to development of governance charters and participate in governance meetings.
• Collaboration: Work closely with cross-functional teams, including Regulatory, Safety, and Clinical Development to ensure alignment on clinical development strategy and execution.
• Budget & Resource Management: Monitor budgets and resource allocation for clinical trials, ensuring that trials are conducted efficiently and within budget. Responsible for annual (and quarterly updates) for assigned Clinical Program(s).
• Clinical Trial Reporting: Support the preparation of clinical trial reports, regulatory submissions, and other documents required for clinical trial progress or regulatory review.
• Process Development and Continuous Improvement: Contribute to process development and improvement initiatives, ensuring that clinical operations remain efficient, scalable, and adaptable to the evolving needs of the organization. Will be assigned as process owner for sub-set of department processes. Line Management: Will have line management responsibilities for Clinical Operations team members including but not limited to Clinical Project Managers and Sr. CRAs
  
  
  

All candidates must meet the following minimum requirements in order to be considered for this opportunity.
Minimum Qualifications:

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or related field required.
• A Master’s degree or advanced certification (e.g., Project Management, Clinical Research) is preferred.
• A minimum of 12 years of experience in Clinical Operations, with at least 1-3 years in a department leadership or Clinical Program Director role.
• Extensive experience in managing clinical trials, with a particular focus on early-phase development and radiopharmaceuticals or oncology therapies preferred.
• Proven experience in line management of clinical operations staff, with demonstrated leadership capabilities.
• Experience with global clinical trials and familiarity with international regulatory requirements.
• Differentiating Qualifications:
• Strongly preferred – prior start-up or biotech experience. Prior experience in radiopharmaceuticals.
  
  

Orano Med LLC
Orano Med is at the forefront of research in nuclear medicine and is developing new therapies against cancer. Based on its unique expertise in the production of lead-212 (Pb-212) and radiolabeling technologies, Orano Med is developing innovative radioligand therapies which consist of selectively destroying cancer cells while limiting the impact on surrounding healthy cells. With a solid portfolio of molecules in development capable of targeting various forms of cancer, and a reliable supply chain for Pb-212, Orano Med aims to become a leader in targeted alpha therapies, in particular for patients with currently unmet medical needs.

Find out more about Orano Med