Director, Clinical Operations

The Director of Clinical Operations oversees all aspects of clinical trial execution, including start-up, monitoring, and close-out activities. This key role ensures that the company achieves study goals and objectives while maintaining high-quality clinical data and study integrity. The Director of Clinical Operations collaborates closely with cross-functional teams, including clinical development, project management, regulatory, quality, and translational and discovery research, to drive the successful execution of clinical study plans. This position will report to the Head of Clinical Operations.

Main Duties and Responsibilities

• Establish clear standards and expectations for the accurate, timely execution of clinical trials and the operations teams supporting them.
• Oversee study operational plans and execution from concept through close out and CSR writing, including site and vendor selection, data management, pharmacovigilance operations, imaging and laboratory assessments, and regulatory activities. 
• Assess and provide input into schedule of activities of study protocols from an operational and feasibility perspective. 
• Review DSUR, study protocols, annual reports, and IB submissions for accuracy and alignment to compound strategy. 
• Develop and execute clinical operations strategies and enrollment plans in close collaboration with internal stakeholders, alliance partners, and Clinical Research Organizations (CROs). 
• Manage CRO(s) performance to ensure adherence to the scope of work within timelines and budget at an overall study level.  
• Work with the existing clinical development and clinical operations team members to ensure trial delivery and success.
• Collaborate with the manufacturing and logistics teams for alignment on drug product delivery to clinical studies. 
• Work closely with the Head of Clinical Operations to develop the global clinical operations budget with a focus on operational excellence, cost efficiency, and quality. 
• Proactively assess potential risks to clinical studies and propose mitigation plans.  
• Collaborate with the Head of Clinical Operations to develop the clinical operations infrastructure and ensure operational alignment across clinical programs.
• Demonstrate high standards for scientific rigor, team behaviors, excellence and a culture of innovation that is fully aligned with company objectives.

Qualifications & Experience 

• Bachelor’s, Master's, or higher qualification in life sciences or nursing. 
• Minimum of 7 years of experience in clinical development, including at least 5 years in clinical operations of oncology clinical trials.  
• Prior clinical trial experience with radiopharmaceuticals preferred, but not required.

Knowledge, Skills & Abilities 

• Cross-functional understanding and technical knowledge of drug development processes and clinical trial methodology.  
• Thorough knowledge and understanding of Good Clinical Practices, ICH Guidelines, and applicable international regulations and guidelines.  
• Strong project management/organizational skills. 
• Excellent technical experience with MS applications (e.g., MS Project, Word, Excel).  
• Experience with study tools, including CTMS, eTMF, Medidata RAVE, and other EDC systems. 
• Desire to “roll up your sleeves” and move plans forward.
• Ability to lead, direct and support cross-functional teams.
• Ability to work with agility and manage ambiguity.
• Personifies positive energy and exemplifies respect.
• Willingness to travel up to 10-20% of time (eg site visits, conferences, etc)

About Aktis Oncology

Aktis Oncology is a biotechnology company pioneering the discovery and development of a new class of targeted alpha radiopharmaceuticals to treat a broad range of solid tumor cancers. Founded and incubated by MPM Capital, the company has developed proprietary platforms to generate tumor targeting agents with ideal properties for alpha radiotherapy. Designed for high tumor penetration and long residence time, Aktis Oncology's molecules will quickly clear other areas of the body, thereby maximizing tumor elimination while minimizing side effects of treatment. This approach would enable clinicians to visualize and verify target engagement prior to exposure to therapeutic radioisotopes.