Rho, a privately held contract research organization (CRO) located in Durham, provides a full range of drug development services from program strategy through clinical trials and marketing applications. For over 35 years, Rho has been a trusted partner to some of the industry’s most innovative pharmaceutical, biotechnology and medical device companies, as well as academic and government organizations. Rho’s cross-functional collaborative approach, therapeutic expertise, and commitment to strong site relationships changes what it means to work with a CRO.
Learn more about Rho: https://www.rhoworld.com/
Senior Medical Officer, Neurology
The Medical Officer will provide medical, clinical, and scientific advisory expertise across multiple therapeutic areas, to Rho project teams, Rho clients, and Investigators as requested. This position is responsible for interacting with senior management, customers, and project teams to ensure the safety of subjects in clinical trials; ensure the scientific and ethical integrity of clinical trial design and conduct; provide medical input to clinical programs; and provide clinical development and regulatory input as needed. This position is based in Research Triangle Park in Durham, NC.
Responsibility and Qualifications
– Serves as Medical Advisor on assigned projects.
– Functions as an active member of assigned project team
– Provides medical support to investigative sites and project staff for protocol-related issues.
– Performs review and clarification of trial-related Adverse Events (AEs) and coding.
– Performs medical case review of Serious Adverse Events (SAEs), including review of case documentation and patient narratives.
– Performs medical review of the protocol, Investigative Drug Brochure (IDB), and/or Case Report Forms (CRFs).
– Performs 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.
– Serves as Scientific Advisor and provides guidance to Project Managers on the medical and scientific aspects of assigned projects.
– Provides project team with training on therapeutic indication and/or treatment modality
– Assists with site selection and networking for potential investigators for study participation, and aids in review and final selection
– Participates in the development of Medical Monitoring portion of client proposals including the budgeting process.
– Supports 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.
– Undertakes literature searches to acquire background information for study proposals, preparation of training sessions, and interpretation of clinical data, report writing, etc.
– Assists with drafting of standard operating procedures and working practices regarding Medical Officer and Product Safety activities
– Participates in a variety of quality improvement efforts as necessary
– Reports to the senior medical officer and sector head.
– Ability to travel both domestically or internationally as required, up to 25%
– A medical degree from a fully accredited (LCME or ex-US equivalent) medical school, along with an active state or provincial medical license is required.
– Experience as a Medical Officer of clinical trials, preferably from the CRO environment. Medical Board Certification or Eligibility in Neurology is required.
– In addition, a minimum of 7 years of experience in clinical medicine beyond residency and at least 5 years of clinical development experience – ideally in the pharmaceutical or closely related industries are required.
– Specialty board certification is required.
– 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 communications and interpersonal skills, ideally with experience/expertise in public speaking and engaging external stakeholders