Sr./Clinical Trial Manager – Clinical Operations

Aktis Oncology, Inc. is a clinical-stage oncology company focused on expanding the breakthrough potential of targeted radiopharmaceuticals to large patient populations, including those not addressed by existing platform technologies. Aktis’ most-advanced program, AKY-1189, is a miniprotein radioconjugate targeting Nectin-4, with multi-indication potential across multiple tumor types, including locally advanced or metastatic urothelial cancer, breast cancer, non-small cell lung cancer, colorectal cancer, cervical cancer, and head and neck cancer. Aktis’ second pipeline program, AKY-2519, is a miniprotein radioconjugate targeting B7-H3 expressing tumors, including prostate, lung and other solid tumors. Aktis has a strategic collaboration with Eli Lilly and Company to leverage its miniprotein platform to develop novel radioconjugates outside of Aktis’ proprietary pipeline.

Responsibilities

• Leads and responsible for overall clinical trial management from start-up to database lock for assigned clinical studies.
• Reviews and authors applicable sections of clinical protocols, CRFs, study reports, IB, informed consent forms and study plans/manuals; implements and monitors progress against project timelines.
• Proactively identifies project risks and develops resolution plans.
• Participates in the selection of Investigators and vendors.
• Chairs and leads multi-disciplinary internal and external study team meetings.
• Maintains close communications with internal staff and oversight of CROs and clinical sites to ensure assigned projects meet timeline, budget, and quality goals.
• Participates in study data review and assists with site management to ensure data quality/timely data entry.
• Responsible for managing approved study budget(s) against trial. Review and approve vendor invoices, including investigator grants and pass-through costs.
• Assists with the negotiation & establishment of contracts and budgets with external clinical sites and vendors.
• Collaborates with CMC and clinical supply colleagues to properly project for drug supply needs.
• Broad understanding of operations including those in related development functions.
• Demonstrates ability to effectively interface with key medical personnel at clinical site(s).
• Demonstrates ability to flag processes that may not be appropriate for study based on phase, design, and/or use of data.
• Maintains a flexible, proactive approach to plan for and address issues.
• Possesses excellent written and oral communication skills.
• Trains/mentors junior staff.

Qualifications

• B.S. degree or equivalent, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy).
• Minimum of 3-5 years (or 5+ if Senior) of clinical trial management experience in the pharmaceutical, biotech and/or CRO industry.
• Oncology therapeutic area experience is required for this position.
• Radiopharmaceutical experience is preferred.
• Strong knowledge of ICH Good Clinical Practice guidelines.
• Requires clinical research operational knowledge, computer literacy, and strong project planning/management including oversight of CROs/vendors.
• Experience and ability to manage global or regional teams in a virtual environment.
• Proven track record in successfully managing trials from start-up to database lock.
• Strong decision-making and communication/collaboration skills are essential to this position, as are analytic skills and effectiveness in seeking solutions to issues.
• Willingness to travel up to 10-20% of time (e.g., site visits, conferences, etc.).
• Strong desire to be part of a patient-centric company.
• Proven demonstration of transparent communication and fostering open and diverse debate.
• Ability to work with agility and manage ambiguity.