Director, Clinical Science
remoterocketship
- Remote, Oregon, United States
- Remote, Oregon, United States
À propos
Develop study concepts, including study design, schedule of assessments, objectives/endpoints, and eligibility criteria. Collaborate cross-functionally to develop Protocol and ICF documents / amendments and present these to governance committee and early clinical development team meetings as required. Provide protocol training and contribute to CRF design. Ensure study manuals align with protocol and engage investigators in study design. Seek input from key investigators on study design and methodology to ensure alignment with research objectives, and actively participate in pre-site selection discussions, site initiation visits, and investigator meetings to support successful study execution. Contribute to and oversee real-time clinical data reviews (including oversight of CROs when applicable). Serve as a clinical science representative on internal and external meetings. Develop clinical project execution timelines and provide status updates to senior management to ensure the timely delivery of program milestones. In collaboration with Data Management will develop Data Review Plan, and monitor clinical data for specific trends, ensure CRF design adequately supports data collection in alignment with the protocol in collaboration with Data Management/Programming. Support meetings (advisory boards, etc) and deliver presentations. Drive clinical research plans, including company and investigator-initiated studies. Effectively interact with senior members in other functional areas for strategic planning to ensure optimized clinical development in accordance with corporate objectives. Build relationships with KOLs, consortiums, and sites. Provide scientific input into design & implementation of clinical trial(s), their delivery, clinical data review and data cleaning, interpretation of results, reporting successfully on time, and activities required for registration of the product. As appropriate, participates in ongoing enhancements/development of team processes, structures, systems, tools, and other resources; As appropriate, coaches and guides less experienced Clinical Scientists. Manage one or more direct reports including being responsible for hiring, training, developing, and retaining talent on staff, as needed. As appropriate, participates in competitive intelligence and/or other market/industry assessment activities and projects. Maintains scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment. Ensure HIPAA/PHI compliance and maintain training requirements. Requirements:
Advanced degree in Life Sciences (MD, PhD, Pharm D, MS, RN or similar scientific field) preferred. 10+ years of pharma/biotech industry experience in clinical development in oncology clinical trials. Deep understanding and preferably experience in oncology molecular diagnostics, oncology companion diagnostics or early cancer detection. Experience in data review, data cleaning, managing and interpreting clinical trials results as well in writing clinical trial protocols. Possesses sound foundational knowledge of FDA and other major country regulations and detailed knowledge of Good Clinical Practice other regulations governing clinical research. Experience with managing direct reports, ensuring that roles are performed in accordance with job descriptions and that training is conducted and maintained appropriately. Benefits:
Comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. Free testing for employees and their immediate families. Fertility care benefits. Pregnancy and baby bonding leave. 401k benefits. Commuter benefits. Generous employee referral program.
Compétences linguistiques
- English
Avis aux utilisateurs
Cette offre provient d’une plateforme partenaire de TieTalent. Cliquez sur « Postuler maintenant » pour soumettre votre candidature directement sur leur site.