Medical Director – Senior Medical Director, Pain Experience
United States
Full Time
2 hours ago
H1B Sponsor
Key skills
BudgetingCommunication
About this role
Role Overview
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
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) with specialty in Pain Management (Anesthesia, ER Medicine or Surgery).
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
Benefits
Rho provides a comprehensive benefits package for all benefit-eligible employees, which includes medical, vision, dental, HSA, FSA, EAP, life & disability insurance and 401(k).
All employees are eligible for paid time off, holidays, parental leave and bereavement leave.
Flexibility: We encourage a work-life balance that allows employees to bring their best selves to work while being passionate about their lives outside work.