Aktis Oncology is seeking a Clinical Scientist with extensive oncology expertise to work across all aspects of clinical development with a focus on early-phase activities.
Responsibilities- 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 drug product, protocol, and project subject-matter expert for all stakeholders.
- Support and guide the development of the 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.
- Support pharmacovigilance activities (e.g., contributing to aggregate reports, patient narratives, attendance of pharmacovigilance monitoring meetings).
- 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 in 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 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 the 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- Advanced degree in Life Sciences with 10+ years of experience.
- Prior radiopharmaceutical experience a plus. Solid tumor study experience required.
- 6+ years as a Clinical Scientist or comparable role in Clinical Development, with a minimum of 2 years Sponsor experience.
- Working knowledge of GCP/ICH, drug development process, study design, statistics, and clinical operations.
- GCP/ICH experience, including writing and/or reviewing study protocols, procedures manuals, ICFs, and clinical study reports.
- Ability to understand assigned clinical protocol(s), their requirements, and support program-specific data review and trend identification.
- Strong project management capabilities with demonstrated ability to problem-solve and mediate complex issues
- Outstanding written and oral communication skills for clinical, business, and scientific audiences.
- Strong sense of urgency and excellence in prioritization, planning, and execution
- Strong interpersonal skills and ability to thrive in a matrix environment.
- Highly adept at solving complex, cross-functional problems.
- Effective verbal and written communication skills within and outside the company
- Flexibility to work on multiple projects as the portfolio evolves over time.
- Meticulous attention to detail, including the capacity to conduct thorough self-reviews.
- Highly organized, collaborative, and motivated in a fast-paced startup environment.
- Strong desire to be part of a mission-oriented company leading transformative changes for patients.
- Proven demonstration of transparent communication and fostering open and diverse debate.
- Ability to work with agility and manage ambiguity.
- Personifies positive energy and exemplifies respect.
