Medical Director/Senior Medical Director
MEDICAL DIRECTOR/SENIOR MEDICAL DIRECTOR
Reporting to: Chief Medical Officer
Provides leadership role in the design and supervision of multiple late stage clinical research trials across all functional areas. Experience in cellular therapy, transplantation and/or rare disease clinical trials is preferred. Supervises relevant Clinical Operations team to assure goals and milestones are met or exceeded. Has the responsibility and accountability for ensuring that their trials are meeting the Program’s requirements, both for clinical execution and adherence to budgets. Periodically updates Senior Management on trial performance and execution to goals and milestones. Serves as oversight manager of Contract Research Organization (CRO). Responsible for design of Clinical Trials compliant with corporate goals and Regulatory Strategy. Develops and writes relevant sections of Study Protocols, IND, NDA/BLA and other Regulatory documents. Responsible for Medical review of safety and Adverse Event reporting from their clinical trials. Final role seniority will be determined by previous experience.
Duties and Responsibilities
• Lead Clinical Development Trial(s) for initial product indications in Renal transplantation.
• Responsibilities for evaluating, qualifying, and approving all clinical sites for Clinical Trial(s).
• Engage with scientific advisory board, key academic, community, and industry partners, and other thought leaders to innovate and refine clinical development strategies.
• Lead the design, data collection, review, execution of clinical studies in support of product development, ensuring rigorous and compliant study conduct with current health authority regulations.
• Assess clinical data and make clinical program recommendations regarding strategic direction, modification of study plans, go/no go decisions and changes in timelines.
• Works closely with CMO to review study progress, issues and scope of work considerations for Senior Management.
• Periodically briefs extended Senior Management team on Clinical Program progress, especially related to timelines and milestones.
• Provides direct supervision, guidance and mentoring to Clinical Operations team.
• Medical Doctor or non-US equivalent of a MD degree. Completion of a residency program strongly preferred with at least 8-10 years of experience in clinical development in the biotech or pharmaceutical industry.
• Excellent written and verbal communication skills.
• Phase II-III Clinical trial experience in the pharmaceutical industry, academia, or equivalent.
• Ability to run a complex clinical research program independently.
• Proven leadership skills and ability to successful guide and influence a cross-functional team.
• Ability to interact externally and internally to support a global scientific and business strategy.
• Extensive knowledge of clinical trial strategy, design, execution, regulatory and compliance (GCP, ICH, etc.) requirements governing clinical trials.
• Must possess excellent oral and written English communication skills.
• Ability to exercise good scientific and clinical judgment to proactively identify and address complex problems.
• Excellent verbal and written communication skills.
• Excellent organizational, record retention and time and personnel management skills.
• Excellent decision-making and creative problem-solving skills.
• Ability to develop, organize and manage multiple tasks.
• Ability to travel to study sites as required.
• Ability to work independently.
• Clinical experience in Transplantation, Hematology-Oncology or Immunology preferred, but not mandatory.
• Experience in Safety Monitoring and Reporting preferred, but not mandatory.