Contract Principal Investigator

Medpace, Inc.•Cincinnati, OH

20h

About The Position

Opening for Contractor/Part-Time: We are seeking a Medical Director to join our dynamic team in the Clinical Pharmacology Unit (CPU). This Medical Director will have overall responsibility for overseeing the conduct of clinical trials in the CPU as Principal Investigator. Furthermore, they will be providing medical, scientific, and strategic leadership for the successful planning, execution, and reporting of phase 1 clinical trials. Additionally, this role acts as the Medpace internal medical expert and may serve as a medical resource for the review, presentation, and interpretation of results in the Clinical Study Report. The Medical Director may also be involved in the development of new clinical projects, including study design and protocol plans as required. As Principal Investigator in the CPU, this physician will follow FDA and GCP guidance: “In conducting clinical investigations of drugs, including biological products, under 21 CFR part 312 and of medical devices under 21 CFR part 812, the investigator is responsible for: Ensuring that a clinical investigation is conducted according to the signed investigator statement for clinical investigations of drugs, including biological products, or agreement for clinical investigations of medical devices, the investigational plan, and applicable regulations Protecting the rights, safety, and welfare of subjects under the investigator’s care Controlling drugs, biological products, and devices under investigation (21 CFR 312.60, 21 CFR 812.100)” Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future.

Requirements

Must have an M.D. or D.O. with current medical licensure; board certification is desirable
Previous experience in pharmaceutical-related clinical research is preferred

Responsibilities

Provide medical oversight of clinical trials as Principal Investigator, including training of staff as necessary
Decides on eligibility of subjects for participation in clinical trials
Safeguards the well being of subjects during any clinical trial
Provides medical care as needed during conduct of clinical trial
Contributes as PI to study reports, regulatory documents, and manuscripts
Manage safety issues in clinical trials, report issues timely, and work closely with associates in evaluation and assessment of the trials
Follow specific research related protocol and lead others in strict adherence to the policies
Participate in new business development through involvement in proposal and sponsor meetings as requested