[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.ResponsibilitiesClinical Synopsis, Protocol, and ICF development process, including template creation, authoring, reviewing, adjudication, and resolution of cross-functional comments, in collaboration with Medical WriterServe as drug product, protocol, and project subject-matter expert for all stakeholdersSupport 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 toolsWork 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 reviewProvide guidance on clinical protocol, procedures, and the development of eCRF design and study plansSupport 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 meetingsDeliver 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 trendsLiaise with clinical monitors to understand any trends in data management issues and work to develop solutionsReview/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 MonitorEnsure consistency of study execution to facilitate data analysis and regulatory filingSupport study-specific vendor interaction and coordinationContribute 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 functionsMaintain understanding of therapy competitors and clinical developments in relevant therapeutic areas by attending scientific meetings, maintaining relationships with KOLs, and tracking literatureSupport 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 attendeesServe as a clinical science lead on study team meetings and contribute to program-level activitiesReview and enhance the technical and scientific robustness of program-level clinical development plansContribute to the development of end-to-end clinical development strategyContribute 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 documentsEnsure compliance with ICH/GCP guidelines, all applicable laws and regulations, and SOPs for all products and services delivered for designated studiesSupport regulatory interactions, including through briefing documents, presentations, questions, and responsesSkillsAdvanced degree in Life Sciences with 10+ years of experienceSolid tumor study experience required6+ years as a Clinical Scientist or comparable role in Clinical Development, with a minimum of 2 years Sponsor experienceWorking knowledge of GCP/ICH, drug development process, study design, statistics, and clinical operationsGCP/ICH experience, including writing and/or reviewing study protocols, procedures manuals, ICFs, and clinical study reportsAbility to understand assigned clinical protocol(s), their requirements, and support program-specific data review and trend identificationStrong project management capabilities with demonstrated ability to problem-solve and mediate complex issuesOutstanding written and oral communication skills for clinical, business, and scientific audiencesStrong sense of urgency and excellence in prioritization, planning, and executionStrong interpersonal skills and ability to thrive in a matrix environmentHighly adept at solving complex, cross-functional problemsEffective verbal and written communication skills within and outside the companyFlexibility to work on multiple projects as the portfolio evolves over timeMeticulous attention to detail, including the capacity to conduct thorough self-reviewsHighly organized, collaborative, and motivated in a fast-paced startup environmentStrong desire to be part of a mission-oriented company leading transformative changes for patientsProven demonstration of transparent communication and fostering open and diverse debateAbility to work with agility and manage ambiguityPersonifies positive energy and exemplifies respectPrior radiopharmaceutical experience a plusCompany OverviewAktis Oncology is a biotechnology company that designs and develops novel class radiopharmaceuticals. It was founded in 2021, and is headquartered in Boston, Massachusetts, USA, with a workforce of 51-200 employees. Its website is https://www.aktisoncology.com.Company H1B SponsorshipAktis Oncology has a track record of offering H1B sponsorships, with 2 in 2024. Please note that this does not guarantee sponsorship for this specific role.