Medical Officer, Lead Clinical R & D Scientist
Overview
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.
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
Perform other duties as assigned.
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:
Specialty/sub-specialty preferred but not required if adequate expertise is demonstrated.
Location : Location
US-VA-NorfolkEstimated Salary: $20 to $28 per hour based on qualifications.
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.
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
Perform other duties as assigned.
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:
Specialty/sub-specialty preferred but not required if adequate expertise is demonstrated.
Location : Location
US-VA-NorfolkEstimated Salary: $20 to $28 per hour based on qualifications.
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