Head, Clinical Operations

Head, Clinical Operations

Position Summary  
The Head of Clinical Operations leads the operational execution of clinical trials for the company's RLT programs, ensuring timelines are met from investigational new drug (IND) filing to first patient in (FPI) and beyond. This role is essential for delivering high-quality, efficient trials in a regulated environment, with a focus on RLT challenges like site radiation handling and global coordination. Reporting to the CMO or Head of Clinical Development, the position oversees budgeting, vendor management, and milestone achievement to accelerate RLT clinical pipeline progression.

Key Responsibilities  
Timeline Ownership: Manage end-to-end timelines from IND submission to FPI, including site activation, patient enrollment, and all subsequent milestones (e.g., database lock, topline results). Develop Gantt charts and risk mitigation plans specific to RLT trials, accounting for radionuclide supply chains and radiation safety protocols.  

Trial Planning and Execution: Oversee study start-up activities, including feasibility assessments, site selection, and contract negotiations, with emphasis on RLT-capable sites (e.g., those with nuclear medicine expertise).  

Budget and Resource Management: Develop and monitor clinical operations budgets, allocating resources efficiently across global trials.  

Vendor and CRO Oversight: Select and manage contract research organizations (CROs) and other vendors, ensuring compliance with timelines, quality, and RLT-specific requirements like isotope handling.  

Process Optimization: Implement standard operating procedures (SOPs) for clinical operations, incorporating best practices for RLT (e.g., just-in-time manufacturing for short-half-life radionuclides).  

Milestone Tracking and Reporting: Track progress against milestones, providing regular updates to leadership and escalating issues promptly.  

Team Leadership: Build and lead a high-performing clinical operations team (including contractors and CROs), fostering a culture of accountability and innovation.  

Compliance and Quality: Ensure adherence to GCP, ICH, and radiation safety regulations (e.g., NRC/IAEA guidelines).  

Qualifications  
Bachelor's or Master's degree in life sciences or related field; PMP certification a plus.  
10+ years in clinical operations, with 5+ years in leadership roles at biotech/pharma companies, preferably in oncology or radiopharmaceuticals.  
Demonstrated success in managing timelines from IND to Phase III, including global trials.  
Strong knowledge of RLT operational nuances, such as cold chain logistics for radiotracers and site radiation certification.  
Proficiency in clinical trial management systems (e.g., Veeva, Medidata) and budget forecasting.  
Excellent leadership and negotiation skills, with experience in vendor management.  

Compensation
Actithera offers a competitive compensation package designed to reward both performance and expertise through market-based, results-driven pay.

For this role, the anticipated base salary range is $200,000 – $300,000, complemented by eligibility for an annual bonus, equity participation, and a comprehensive benefits program.

Your actual salary will be determined based on the scope of the role and your unique experience and capabilities—because we know great contributions come from great people.

Actithera is proud to be an Equal Opportunity Employer. Our goal is to have a diverse workforce. We do not discriminate on the basis of race, age, color, religion, national origin, gender, sexual orientation, gender identity or expression, veteran status or disability or any other status protected under federal, state or local law. All employment is decided on the basis of qualifications, merit and business need.