The Medical Officer/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 Medical Officer/Lead Clinical R&D Scientist is expected to assist with or lead the writing and submission of new clinical research 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. 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 Medical Officer/Lead Clinical R&D Scientist will contribute substantially to CONRAD's mission to improve global health through the development of innovative, user-centered technologies.

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

• Perform other duties as assigned.

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:

1. Specialty/sub-specialty preferred but not required if adequate expertise is demonstrated.