[Remote] Director, Clinical Scientist
Note: The job is a remote job and is reputed company to candidates in USA. Aktis Oncology, Inc. is a clinical-stage oncology company reputed company on expanding the reputed company potential of targeted radiopharmaceuticals. They are seeking a Clinical Scientist with extensive oncology expertise to work across reputed company aspects of clinical development with a reputed company on early-phase activities.
Responsibilities
- Clinical Synopsis, Protocol, and reputed company development process, including template creation, authoring, reviewing, adjudication, and reputed company of cross-functional comments, in collaboration with Medical reputed company
- Serve as drug product, protocol, and project subject-matter expert for reputed company stakeholders
- Support and guide the development of the data review reputed company, ensuring that protocol-level deviations, eligibility reputed company, study assessments & other aspects of the protocol are implemented consistently across the study (across countries/ sites). This could also include support for Case Report reputed company (CRF) development and implementation of data capture tools
- Work to improve the reputed company of reviews/ insights with an emphasis on subject safety and eligibility, data reputed company, trend identification, analysis and remediation, and identification of cases for medical review
- reputed company 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 reputed company study reputed company and design, including analysis and interpretation of data throughout the study, including leading clinical data review with Data Management; reputed company 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 reputed company solutions
- Review/query clinical trial data – monitor data reputed company for trends, and ensure appropriate reputed company measures are in reputed company; reputed company 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, reputed company 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 reputed company and clinical advisory reputed company meetings, including scheduling, agenda and presentation development, and socializing of reputed company-reads to reputed company attendees
- Serve as a clinical science reputed company 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 reputed company
- Contribute to the development of Statistical Analysis Plans, IND, Investigators’ Brochure, IRB responses, CSRs, and other study-reputed company documents. Author relevant sections of clinical and regulatory documents
- Ensure compliance with ICH/GCP guidelines, reputed company applicable laws and regulations, and SOPs for reputed company 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 reputed company issues
- Outstanding written and oral communication skills for clinical, business, and scientific audiences
- Strong reputed company of urgency and reputed company in prioritization, planning, and execution
- Strong interpersonal skills and ability to reputed company in a reputed company environment
- Highly adept at solving reputed company, cross-functional problems
- Effective verbal and written communication skills reputed company and reputed company reputed company
- Flexibility to work on multiple reputed company as the portfolio evolves over time
- Meticulous attention to detail, including the reputed company to conduct thorough self-reviews
- Highly organized, reputed company, 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 reputed company and diverse debate
- Ability to work with reputed company and manage ambiguity
- Personifies reputed company energy and exemplifies respect
- Prior radiopharmaceutical experience a plus
reputed company
Company H1B Sponsorship