EVMS

Medical Officer, Lead R & D Scientist Clinical

Position Number
2881901
Department
OB/GYN - CONRAD
Compensation Min
USD $120,000.00/Yr.
Compensation Max
USD $145,000.00/Yr.
Category
Management
Location : Location
US-VA-Norfolk
Type
Regular Full-Time

Overview

We are recruiting a Lead R&D Scientist/Medical Officer to provide technical leadership, advisory and clinical safety oversight of multiple national and international clinical studies under two new research programs supporting women’s and global health. The Lead Clinical R&D Scientist/Medical Officer is responsible for designing clinical research protocols, participating in the project team meetings conducting these studies, preparing clinical study reports and manuscripts, writing clinical portions of INDs, IDEs, NDAs and PMAs, and attending and participating in scientific conferences and meetings. S/He will serve as the Medical Officer for CONRAD, responsible for monitoring overall study integrity and the review, interpretation and communication of accumulating data pertaining to safety and efficacy. S/He will also oversee extramural clinical subprojects and liaise with public and private sector companies interested in CONRAD’s portfolio as well as assist with or lead the writing and submission of clinical R&D funding applications. S/He will stay current and maintain knowledge/excellence on the state of the art in women’s and global health clinical R&D in areas of priority to CONRAD’s mission and goals. Together, through excellence in clinical research, strong writing/communication skills capable of targeting multiple audiences, and capacity to lead and serve as a role model to others, the Lead R&D Scientist/Medical Officer will contribute substantially to CONRAD’s mission to improve global health through the development of innovative, user-centered technologies.

Responsibilities

  • Participate in or lead designated R&D project teams including clinical/human research.
  • Prepare study designs and protocols, reviewing consent forms, case record forms, laboratory procedures, randomization procedures, recruiting materials, analysis plans and investigators brochures.
  • Prepare final clinical reports and manuscripts. 
  • Author clinical portions of INDs, IDEs, NDAs and PMAs as application and assist with FDA meetings and correspondence. 
  • Design clinical research protocols for new  exploratory, Phase I-III studies on microbicides and HIV prevention methods, novel and existing contraceptives, and other methods of interest to CONRAD in Reproductive Health, Women’s Heath and Maternal and Child Heath. 
  • Drive the development of new clinical R&D concepts and research strategies, as well as related written proposals for funding applications.
  • Plan, attend and participate in scientific conferences and meetings and their follow up.
  • Prepare strategic plans for development of CONRAD supported leads.
  • Supervise and collaborate on extramural clinical subprojects.
  • Liaise with public and private sector companies interested in CONRAD’s portfolio and research activities.
  • Prepare position papers on the status of selected potential project leads and concept papers on innovative methods and technologies.
  • Medical Monitoring responsibilities:
    • Responsible for monitoring the conduct and progress of assigned clinical investigations (21 CFR 312.23(a)(1)(vi)).
    • Responsible under 21 CFR 312.32 for review and evaluation of information relevant to the safety of the drug (21 CFR 312.23(a)(1)(vii))
  • Perform other duties as assigned.

Qualifications

Degree in Medicine (M.D.) with specialization in OB/GYN, Women’s Health, Infectious Diseases or a related discipline. Medical degree from an accredited school in the US or abroad. License to practice in the US preferred. At least 5 years of experience in clinical research post-terminal degree.

 

 Knowledgeable of current Good Clinical Practice guidelines. Experience with developing clinical study designs, synopses and protocols, drafting clinical study reports, and manuscript writing (proof required). Experience conducting/participating in clinical trials. Experience writing grant applications (e.g., NIH or other external funding agencies) and communicating (both written reports and oral presentations) to diverse technical and non-technical audiences highly valued. Experience serving as medical monitor for IND-studies strongly preferred.

 

Demonstrated capacity for being learning agile, innovative, broadening R&D expertise, leading clinical R&D project teams from conception to completion, fostering cross-functional teamwork and collaboration, and contributing to achieving organization-wide strategic goals.

 

Location : Location

US-VA-Norfolk

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