Overview

Eastern Virginia Medical School, the OBGYN department and CONRAD are recruiting an faculty/clinical scientist to serve as CONRAD’s Lead Clinical R&D Scientist to provide technical leadership (from study design conception through CSR and publication) and medical safety oversight to CONRAD’s dynamic and highly collaborative international clinical research portfolio supporting women’s and global health. We are seeking a highly motivated scientific investigator with medical expertise in women’s health and/or infectious diseases, and a keen passion for designing and conducting innovative clinical research of new, often first-in-class, investigational products, many in the areas of reproductive health, infectious diseases and maternal health.

The faculty/Lead Clinical R&D Scientist will be responsible for developing and elaborating new concepts, designing clinical research protocols, leading clinical research team meetings, analyzing data, preparing clinical study reports and manuscripts, co-authoring grant proposals, writing/reviewing clinical portions of regulatory documents (e.g. IND, IRB, IB), and attending and participating in scientific conferences and meetings on behalf of CONRAD and study teams. S/He will contribute to 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 (collaborations) and liaise with public and private sector organizations interested in CONRAD’s women’s health portfolio. The faculty/Lead Clinical R&D Scientist is expected to assist with or lead the writing and submission of new clinical research funding applications. CONRAD will support professional development and mentorship. 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. Seeing patients is not required. Together, through excellence in clinical research, strong writing/communication skills capable of targeting multiple audiences, and capacity to lead interdisciplinary programs and serve as a role model to others, the faculty will contribute substantially to CONRAD’s mission to improve global health through the development of innovative, user-centered technologies.

Responsibilities

• Lead CONRAD’s clinical research strategies and R&D project teams including clinical/human research.
• Responsible for the conception and development of clinical study designs and protocols, reviewing consent forms, case record forms, laboratory procedures, randomization procedures, recruiting materials, analysis plans and investigators brochures.
• Prepare final clinical study reports (CSRs) 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-II studies on CONRAD’s research priority areas such as HIV/STI prevention methods, novel and existing contraceptives, and diagnosis, treatment and prevention of reproductive and maternal health disorders.
• Lead the conception and 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; serve as CONRAD/EVMS representative and speak on behalf of CONRAD clinical scientific leadership.
• Prepare clinical development plans for 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))
  • Chair Safety Monitoring Boards or Committees
• See patients within a division of the OBGYN department (optional)
• Teach students, residents and fellows (optional)

• Perform other duties as assigned.

MANAGEMENT AND SUPERVISORY RESPOSIBILITIES:

CONTACTS:

Students, vendors, faculty, staff, administrators, and public.

BUDGETARY RESPONSIBILITY: Oversight of specific project/study budgets

EDUCATION RESPONSIBILITY: Teaching and mentoring fellows, students, residents, staff

RESEARCH RESPONSIBILITY: Carry out clinical projects from conception to data dissemination

CLINICAL RESPONSIBILITY: Seeing patients on a regular basis is not required.

Qualifications

Degree in Medicine (MD/DO) with specialization in OB/GYN, Women’s Health, Infectious Diseases, Internal Medicine or other 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 (GCP) guidelines. Experience with developing clinical study designs, synopses and protocols, drafting clinical study reports, and manuscript writing (proof required). Experience conducting/participating as investigator 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.

REQUIRED LICENSURE/CERTIFICATION: