Clinical Science Director (Oncology/Biotech) (San Francisco, CA)Summary
In collaboration with clinical and project teams, the Clinical Science Director designs, plans, and develops studies in early and/or late-phase clinical oncology. This role includes preparing and authoring clinical development documents, summarizing study results for regulatory filings and publications, and providing scientific information to support project teams. The Clinical Science Director plays a critical role in ensuring the successful execution of clinical studies, maintaining compliance with federal regulations, Good Clinical Practice (GCP), and good medical practices.
Responsibilities Design, prepare, and initiate study protocols and other required documentation in compliance with project plans, federal regulations, GCP, and good medical practices.Interact with investigators and oncology thought leaders to facilitate the design of clinical synopses and protocols.Conduct literature research and assist in selecting investigators for clinical studies.Collaborate with clinical operations to develop Informed Consent Forms, Case Report Forms (CRFs), and CRF instructions.Serve as the primary contact for medical monitor inquiries, providing guidance and oversight.Develop agendas, training materials, and presentations for site visits, investigator meetings, and other study-related events.Participate in safety meetings to analyze and report potential safety events.Collaborate with team members to review and interpret study data, supporting the preparation of reports for regulatory filings and study close-out documentation.Contribute to abstracts, publications, and presentations for scientific meetings.Monitor emerging clinical and competitive trends in oncology.Build and maintain strong relationships with study investigators to coordinate and facilitate clinical oncology studies.Deliver high-quality scientific presentations to physicians and key stakeholders.Provide clinical education support to internal teams.Maintain clinical and technical expertise in the oncology therapeutic area.Requirements Pharm.D., PhD, or M.D. with a minimum of 8 years of related experience, or an equivalent combination of education and experience.5-8 years of clinical development experience in the biotechnology or pharmaceutical industry, or a combination of academia and industry experience.Experience in clinical oncology studies, particularly involving molecular targeted or immunological therapies.Comprehensive knowledge of clinical trial implementation and the drug development process.Proven ability to design, execute, and report on clinical trials in oncology involving small and large molecule drug candidates.Strong analytical and business communication skills, with public speaking and presentation expertise.Highly organized, with the ability to manage complex problems and tight timelines.Demonstrated leadership capabilities, including managing projects and guiding teams effectively.Proficiency in performing a variety of tasks with technical expertise and creativity.Networking ability with key contacts outside of own area of expertise.Willingness to travel up to 25%.
#J-18808-Ljbffr