Job description

Our clinical and regulatory activities are growing, and we are currently seeking a full-time Vice-President, Regulatory Strategy to join our team. This position is responsible for the interactions with FDA, accountable for the development and implementation of the regulatory strategy for specific Sponsor projects and ensuring that the strategy is designed to deliver a rapid approval. We are seeking a strategic leader with experience in North American (US FDA) regulatory science, and overall drug/biologic development processes and strategies. Experience and knowledge of therapeutic areas and drug development is an important enabler to influence cross-functional discussions with Sponsors and relevant stakeholders.

Responsibilities

Provide expert regulatory strategy to satisfy expected industry standards, applying in-depth knowledge of regulatory requirements and guidelines, procedures, and agency precedent;
Advise project teams regarding the development and implementation of regulatory strategy throughout the clinical development processes;
Collaborate with regulatory and broader development teams on strategic projects including gap analyses, meetings with regulatory authorities, protocol synopsis development and review, and other strategic deliverables;
Maintain advanced knowledge of changing regulatory requirements and advise teams as appropriate;
Interact with appropriate national/regional government regulatory agencies;
Review pertinent regulations and guidance to develop proactive solutions to regulatory issues and challenges;
Lead a team of physicians and regulatory staff with strategic regulatory expertise; and
Provide regulatory advice and guidance to Clinical Operations, Medical Writing, Clinical Safety/Pharmacovigilance, Data Management, and Biostatistics.

Qualifications

MD, PhD in Life Sciences, or other advanced degree.
Minimum of 5 years of experience or equivalent of regulatory drug development. Expert knowledge of regulatory affairs within one or more therapeutic areas; and
Professional experience working at the FDA such as Clinical Team Leader, preferred.

Medpace Overview

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.

Why Medpace?

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.

Medpace Perks

Flexible work environment
Competitive PTO packages - starting at 20+ days
Company-sponsored employee appreciation events
Employee health and wellness initiatives
Competitive compensation and benefits package
Structured career paths with opportunities for professional growth
Discounts for local businesses

Awards

Named a Top Workplace in 2024 by The Cincinnati Enquirer
Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024
Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility

What To Expect Next

A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

EO/AA Employer M/F/Disability/Vets

Required profile