We have a current opportunity for an Snr/ Medical Director, Clinical Development Oncology on a permanent basis. The position will be based in California.
Job Duties and Responsibilities
Responsibilities may include, but are not limited to:
• Partner with cross-functional program- and study-level teams with minimal oversight by senior clinicians to oversee the design and conduct of clinical studies, including operational feasibility, data management deliverables, preparation of meeting materials, communication plans, safety and medical monitoring, preparation of status update reports, and study close-out activities.
• Perform medical and related safety/efficacy data reviews with minimal senior clinicians. May be responsible for analytical support of clinical trial data, including gathering, analyzing, reviewing, interpreting, and providing preliminary assessments and recommendations. Analyze information to assess issues relating to protocol conduct and/or individual subject safety. Prepare and communicate a clear overview of trial results.
• Provide organizational support for Data Monitoring Committees other applicable data review committees including operationalizing the charter, preparing updates and data reviews, execution of meetings and adjudications, and communication of synthesized data reports.
• Author protocols and contributes to authoring of clinical study reports, IBs, ICFs, training documents, and other clinical and regulatory documents.
• Interact with internal and external stakeholders (study sites, vendors, committees, etc.) in support of program-level development strategy as well as clinical trial objectives; responds to or triages questions for appropriate escalations.
• Act as recognized clinical expert for assigned programs
• Write and/or review collaborative abstracts, posters, and content for scientific meetings, conferences and publications. Support publication strategy execution including collaboration with investigators, KOLs, medical affairs and other internal/external stakeholders. Present at investigator meetings and scientific conferences.
• Conduct literature reviews as needed.
• Line management of junior members of the clinical team.
• At least 3 years of experience at a pharmaceutical, CRO or biotechnology company as a clinical scientist or related role – title will be commensurate on experience.
• MD or MD/PhD with experience in patient care at the graduate medical level and beyond.
• Experience in oncology or immunotherapy clinical trials preferred. Early drug development experience highly desirable.
• Experience with data analysis and interpretation as an understanding of safety and pharmacovigilance principles required.