Aktis Oncology · 14 hours ago
Director, Clinical Operations
Massachusetts, United States
Full-time
Hybrid
Director/Executive
7+ years expAktis 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. The Director of Clinical Operations oversees all aspects of clinical trial execution, ensuring high-quality clinical data and study integrity while collaborating with cross-functional teams to drive the successful execution of clinical study plans.
BiotechnologyHealth CareLife ScienceOncology
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
Qualification
Required
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
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)
Preferred
Prior clinical trial experience with radiopharmaceuticals preferred, but not required
Company
Aktis Oncology
Aktis Oncology is a biotechnology company that designs and develops novel class radiopharmaceuticals.
11-50 employees
Funding
Current Stage
Public CompanyTotal Funding
$331MKey Investors
Eli Lilly
2026-01-09IPO
2024-09-30Series B· $175M
2024-05-21Corporate Round
Leadership Team
Matthew Roden
President and Chief Executive Officer, and member of the Board of Directors
Kyle Kuvalanka
Chief Financial Officer
Recent News
2026-01-14
2026-01-13
Company data provided by crunchbase