Medical Director - Clinical Pharmacology Unit

Job Description

Overview

Medpace is a scientifically-driven, global, full-service clinical contract research organization (CRO) providing Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Medpace’s mission is to accelerate the global development of safe and effective medical therapeutics through its high-science and disciplined operating approach. We leverage local regulatory and deep therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, Medpace employs approximately 2,700 people across 36 countries.

Job Summary

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, s/he 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)”

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;

Qualifications

• 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.

Why Medpace?

When you join Medpace, you become part of a team dedicated to supporting the development of ground breaking drugs and devices. Our employees provide hope for those living with debilitating diseases. We invite you to be a part of something that is impacting millions of people around the globe while enjoying a competitive total compensation and benefits package and internal growth opportunities.

Awards

• Medpace Named a Top Cincinnati Workplace for 2015, 2016, 2017 and 2018 by the Cincinnati Enquirer
• Winner of the ACRP-Avoca CRO Quality Award in 2018
• Recognized with six CRO Leadership Awards from Life Science Leader magazine
• Eagle Award winner - which recognizes outstanding leadership, professionalism, integrity, and dedication to advancing the clinical research profession through strong site partnerships

What to Expect Next

We look forward to receiving your application. A member of our recruitment team will review your qualifications and if interested, you will be contacted for an interview.

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*WARNING: Please beware of phishing scams that offer opportunities with Medpace in exchange for sending money. These scammers pose as legitimate employees from actual companies. Please be advised that a Medpace employee will never ask you for a credit card, send you a check, or ask you for any type of payment as part of consideration for a role with our company. All of our careers require that you first complete an online application and go through some sort of interview process.