** This has been designated as a remote based role. We can consider remote based employees in the below states. Please note that regardless of location, this position must be able to accommodate working Pacific business hours.

California

Arizona

Florida

Georgia

Idaho

Massachusetts

Missouri

Nevada

New Jersey

North Carolina

Pennsylvania

Texas

Virginia

Washington

Your Impact

In this role, you will lead our CAR-T oncology drug programs, leading cross functional development teams to successfully complete our clinical phase trails and deliver therapies with the capacity to cure cancer.

Position Summary

The Medical Director will lead clinical protocol development, enrollment to clinical studies, safety monitoring and review, biomarker development, implementation and analysis of data, manuscript writing and submission, as well as presentation of data at national and international meetings. The incumbent will partner with and lead cross functional development teams. This position will have a strong outward facing presence and will directly engage in protocol development, site evaluation and selection, trial conduct, data analysis and safety monitoring for clinical trials. The role functions internally as a medical expert and medical monitor to support the development and execution of an efficient and integrated global medical/scientific strategy, including scientific evidence generation and scientific information exchange with key stakeholders.

Responsibilities

These may include but are not limited to:

• Lead and demonstrate ownership of the design and implementation of clinical development programs in support of the overall product development plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, markets, business operations, and emerging issues.
• Oversee project-related education of investigators, study site personnel, and study staff.
• Cultivate and advance a clinical development strategy and integrated development plans, design, biomarker and implementation of Phase I-III clinical studies.
• Support R&D management and the business development team with input on clinical development issues related to the BD plan, and support the business development process by providing medical expertise for in- or out-licensing, partnering and acquisition activities.
• Responsible for the clinical content of clinical and regulatory documents, including protocols, INDs, CTAs, investigator brochures, CRF’s, annual IND reports, CSR’s, BLA’s NDA’s, ISS’s, ISE’s, and clinical expert reports.
• Lead and supervise clinical trials/registries, collaborating closely with the Clinical Operations team, and will be accountable for all deliverables of clinical trials under his/her direct responsibility.
• Serve as Medical Monitor and the Sponsor’s medical representative to multiple vendors and collaborators; CROs, PIs, core laboratories and other organizations involved in the implementation of clinical trials.
• Responsible for analysis of clinical data, including safety monitoring, and implement appropriate pharmacovigilance actions, if necessary.
• Develop and maintain relationships and serve as the main medical liaison with key opinion leaders and PIs.
• Organize and present at relevant clinical advisory boards and medical/scientific meetings as needed.
• Assist in the review of Investigator-Initiated studies and in the identification of clinical sites.
• Prepare and present documentation of clinical trial results to corporate committees, regulatory agencies, and outside audiences, and publish results of research projects.
• Help ensure Clinical Study Team compliance with FDA, EMEA, ICH and GCP guidelines and internal SOPs.
• Provide medical insight into Advisory Board meetings, learning materials for internal and external use.
• Contribute to business development efforts.
• Participate, as requested, as clinical expert on due diligence teams related to external in-licensing opportunities.
• Partner with the business development team to evaluate novel targets and platforms in the immuno-oncology and/or gene therapy space.