Sr./Clinical Trial Manager - Clinical Operations

Job Description

Job Description

About Aktis Oncology

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.

Description

Aktis Oncology is seeking a Clinical Trial Manager/Senior Clinical Trial Manager.

This role will report to the Senior Director of Clinical Operations.

Responsibilities

This role will drive several areas of strategic importance to Aktis:

• 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
• Maintain 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
• Collaborate 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
• Train/mentor 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 a 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 (eg 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.

Aktis Oncology is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.