Director, Clinical Scientist

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 retention while minimizing the side effects of treatment. This approach would enable clinicians to visualize and verify target engagement prior to exposure to therapeutic radioisotopes.

We are seeking a clinical scientist with extensive oncology expertise to work across all aspects of clinical development with a focus on early-phase activities, working on-site in our Boston office 2-3 days / week.

RESPONSIBILITIES

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

• Clinical Synopsis, Protocol, and ICF development process including template creation, authoring, reviewing, adjudication, and resolution of cross-functional comments, in collaboration with Medical Writer
• Serve as a drug product, protocol, and project subject matter expert for all stakeholders
• Support pharmacovigilance activities (e.g. contributing to aggregate reports, patient narratives, attendance of pharmacovigilance monitoring meetings)
• Supports and guides the development of data review strategy, ensuring that protocol-level deviations, eligibility criteria, study assessments & other aspects of the protocol are implemented consistently across the study (across countries / sites). This could also include support for Case Report Form (CRF) development, and implementation of data capture tools
• Work to improve the quality of reviews / insights with an emphasis on subject safety and eligibility, data integrity, trend identification, analysis and remediation, and identification of cases for medical review
• Provide guidance on clinical protocol, procedures, and the development of eCRF design and study plans
• Clinical Site facing activities : Assist in the development of site and CRA training materials and present at SIVs and Investigator meetings
• Deliver quality study strategy and design, including analysis and interpretation of data throughout the study, including leading clinical data review with Data Management; develop, and review clinical narratives; and monitor clinical data for specific trends
• Liaise with clinical monitors to understand any trends on data management issues and work to develop solutions
• Review / query clinical trial data - monitor data quality for trends, and ensure appropriate quality measures are in place; provide trends and escalate questions to the Medical Monitor
• Ensure consistency of study execution to facilitate data analysis and regulatory filing
• Support study-specific vendor interaction and coordination
• Contribute to clinical study and program timelines, review study feasibility, perform risk assessments, and identify and execute mitigation and contingency planning efforts, with Program Management and Clinical Operations functions
• Maintain an understanding of therapy competitors and clinical developments in relevant therapeutic areas by attending scientific meetings, maintaining relationships with KOLs, and tracking literature
• Support execution of Safety Review Committee / Data Safety Review Board and clinical advisory board meetings, including scheduling, agenda and presentation development, and socializing of pre-reads to all attendees
• Serve as a clinical science lead on study team meetings and contribute to program-level activities
• Review and enhance the technical and scientific robustness of program-level clinical development plans
• Contribute to development of end-to-end clinical development strategy
• Contribute to the development of Statistical Analysis Plans, IND, Investigators' Brochure, IRB responses, CSRs, and other study-related documents. Author relevant sections of clinical and regulatory documents
• Ensure compliance with ICH / GCP guidelines, all applicable laws and regulations, and SOPs for all products and services delivered for designated studies
• Support regulatory interactions, including through briefing documents, presentations, questions, and responses

QUALIFICATIONS

Aktis Oncology is an Equal Opportunity Employer and does not discriminate on the basis of race, religion, color, sex, gender identity or expression, sexual orientation, age, disability, national origin, veteran status, or any other basis covered by appropriate law. Aktis Oncology is committed to promoting and maintaining a work environment in which all applicants, employees, and other individuals are treated with dignity and respect free from unlawful harassment, discrimination, or retaliation.