R

Rho

Comprehensive CRO for regulatory drug approvals

Medical Director - General Medicine

Biology & BiotechConfirmed live in the last 24 hours
Full-timeRemote in USANo salary listed

About the Job

Requirements

  • A medical degree from a fully accredited medical school and an active medical license in good standing, current or formerly held.
  • At least 5 years of clinical medicine experience beyond residency and at least 5 years of clinical development experience; pharmaceutical or closely related industry experience is preferred.
  • 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 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, along with initiative and flexibility.
  • Ability to establish and maintain cooperative and effective working relationships with coworkers, managers, and clients.
  • Excellent communication and interpersonal skills; public speaking and engaging external stakeholders experience or expertise is ideal.

Responsibilities

  • Serve as Medical Advisor on assigned projects.
  • Provide medical support to investigative sites and project staff for protocol-related issues.
  • Review and clarify trial-related Adverse Events (AEs) and coding.
  • Perform medical case reviews of Serious Adverse Events (SAEs), including reviewing case documentation and patient narratives.
  • Review medical aspects of the protocol, Investigative Drug Brochure (IDB), and/or Case Report Forms (CRFs).
  • Review medical aspects of the Clinical Study Report (CSR), patient narratives, and other high-profile documents, including marketing applications and clinical safety and efficacy summaries and overviews.
  • Serve as Scientific Advisor and guide Project Managers on the medical and scientific aspects of assigned projects.
  • Participate in developing the Medical Monitoring portion of client proposals, including the budgeting process.
  • Support Business Development by reviewing and providing medical and scientific input on Requests for Proposals (RFPs), and participate as a Rho representative in bid defenses and other sponsor meetings.
  • Support feasibility activities as required.
  • Provide medical, clinical, and scientific advisory expertise across multiple therapeutic areas, including Immunology, Pain Management, Neurology, and/or Respiratory, to project teams.
  • Consult with senior management, customers, and project teams to support subject safety in clinical trials, scientific and ethical integrity of trial design and conduct, medical input to clinical programs, and clinical development and regulatory input as needed.

Desired Qualifications

  • Clinical development experience in the pharmaceutical or a closely related industry.
  • Experience or expertise in public speaking and engaging external stakeholders.

About the Company

Rho

Comprehensive CRO for regulatory drug approvals

Rho is a contract research organization that provides end-to-end services for developing and gaining regulatory approval for drugs, biologics, and medical devices. It supports planning and executing clinical development, regulatory strategy, and marketing submissions, guiding projects from program strategy through NDAs, BLAs, and MAAs. An integrated team handles decentralized clinical trials and has infectious-disease programs, combining trial design, data management, and regulatory insight to move products toward approval. Its goal is to help clients bring products to market efficiently by navigating regulatory requirements and streamlining development and submission processes.

Company size
501-1,000
Company stage
Not listed
Total funding
Not listed
Headquarters
Durham, NC
Founded
1984

Recently Posted Jobs

Explore more opportunities at Rho

See more jobs