[Remote] Director, Clinical Scientist

Note: The job is a remote job and is open to candidates in USA. Aktis Oncology, Inc. is a clinical-stage oncology company focused on expanding the breakthrough potential of targeted radiopharmaceuticals. They are 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

Skills

• Advanced degree in Life Sciences with 10+ years of experience
• 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
• Prior radiopharmaceutical experience a plus

Company Overview

Company H1B Sponsorship