Medical Director, General Medicine
Rho
Job Level
Lead
About the role
- Serve as Medical Advisor on assigned projects.
- Provide medical support to investigative sites and project staff for protocol-related issues.
- Perform review and clarification of trial-related Adverse Events (AEs) and coding.
- Perform medical case review of Serious Adverse Events (SAEs), including review of case documentation and patient narratives.
- Perform medical review of the protocol, Investigative Drug Brochure (IDB), and/or Case Report Forms (CRFs).
- Perform medical review of the Clinical Study Report (CSR), patient narratives, and other high-profile documents such as marketing application, clinical safety/efficacy summaries and overviews.
- Serve as Scientific Advisor and provides guidance to Project Managers on the medical and scientific aspects of assigned projects.
- Participate in the development of Medical Monitoring portion of client proposals including the budgeting process.
- Support Business Development activities by reviewing and providing medical/scientific input and guidance on Requests for Proposals (RFP), as well as being an active participant and Rho representative at bid defense and other meetings with sponsors.
- Support Feasibility activities as required.
Requirements
- A medical degree from a fully accredited medical school as well as holding (or having held) an active medical license in good standing; Board certification in Psychiatry
- 5+ years of experience in clinical medicine beyond residency and 5+ years of clinical development experience (ideally in the pharmaceutical or a closely related industry)
- Good understanding of research methodologies and clinical trial design, including biostatistics
- Good understanding of scientific and ethical regulations and guidelines pertaining to clinical research, including knowledge of federal drug development regulations and guidelines
- Ability to establish and meet multiple concurrent priorities, deadlines, strategic department goals and objectives
- Skills in providing consultation and advice on multiple assignments required, as well as initiative and flexibility
- Ability to establish and maintain cooperative and effective working relationships with coworkers, managers, and clients
- Excellent communication and interpersonal skills, ideally with experience/expertise in public speaking and engaging external stakeholders
