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Nonclinical Drug Development Strategist - Pharmacology, Pharmacokinetics, Toxicology
- Regulatory Affairs
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.
Our corporate activities are growing rapidly, and we are currently seeking full-time, office-based Pharmacology, Pharmacokinetics, or Toxicology Subject Matter Experts (SMEs). This person will work on a Regulatory Affairs (RA) project team to accomplish tasks and projects that are instrumental to the company’s success. With this opportunity, you will be able to leverage previous expertise and continue to develop and grow your career even further within the drug development industry.
- Responsibility and accountability for the development and execution of global nonclinical strategy in support of RA project team goals;
- Act as nonclinical point-of-contact within the RA project team, Medpace, and with Sponsors to provide end-to-end support and guidance within the contracted scope of the project;
- Seamlessly collaborate with the project manager, project lead, other SMEs, medical writing, and regulatory publishing to deliver world-class RA strategy and execution
- Maintain up-to-date knowledge and understanding of global regulatory requirements, guidance, conventions, and technologies as it applies to nonclinical drug development strategy;
- Lead the development of nonclinical summary documents including Module 2.4 and 2.6 documents for INDs, NDAs, BLAs, and MAAs, as well as the nonclinical sections of other regulatory documents, including briefing documents, Investigator's Brochure, waiver requests, whitepapers, literature, and protocols as needed;
- Ensure that all nonclinical documents and document sections are completed within the agreed upon timelines and developed with full compliance to all internal review and quality control processes;
- Respond to Regulatory Authority nonclinical queries and participate at meetings and teleconferences with Regulatory Agencies as needed
- Represent Medpace RA on relevant bid defenses and general capabilities discussions as well as provide nonclinical expertise to RA senior management in support of Sponsor interactions to meet business targets; and
- Function as RA project lead on RA projects as needed assuming responsibility and accountability of project success, delivering scientific leadership in conjunction with other SMEs, and demonstrating effective communication within Medpace, the project team and with the Sponsor.
- Masters, PhD, PharmD, or MD and minimum of 3 years of Pharmacology, Pharmacokinetics, or Toxicology experience in the CRO, Biotechnology, or Pharmaceutical industries;
- Direct experience working on multidisciplinary drug development project teams and comprehensive knowledge of drug development strategy is essential;
- Demonstrated experience writing or contributing to the development of nonclinical summary documents including Modules 2.4 and 2.6 of INDs, NDAs, BLAs, etc. or nonclinical sections of regulatory documents including briefing documents, Investigator's Brochures, study waivers, whitepapers, etc.
- Demonstrated comprehensive knowledge of nonclinical study designs, data interpretation, concepts within pharmacology, pharmacokinetic, and toxicology focus areas, and familiarity with the nonclinical regulations and practices of FDA, EMA, ICH, and other international regulatory agencies and scientific advice bodies;
- Demonstrated strong communication (both written and oral) and interpersonal skills to positively influence internal and external teams; and
- Ability to work independently with little to no guidance as well as demonstrate ability to act as a team player.
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.
- 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.