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Vice President, Regulatory Strategy

5+ years
Not Disclosed
10 Nov. 26, 2024
Job Description
Job Type: Full Time Education: MD,/PhD/M.Sc Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Summary

Medpace is seeking a Head of Regulatory Strategy to join its growing clinical and regulatory team. This leadership role will be accountable for the development and implementation of regulatory strategies for specific sponsor projects, ensuring rapid approvals through interactions with the FDA. The position requires expertise in North American (US FDA) regulatory science, drug/biologic development processes, and knowledge of therapeutic areas to facilitate strategic decision-making and cross-functional collaborations.

Responsibilities

  • Provide Expert Regulatory Strategy: Develop strategies that meet industry standards and address regulatory requirements, guidelines, and precedents.
  • Advise Project Teams: Guide project teams on regulatory strategy throughout the clinical development process.
  • Collaborate on Strategic Projects: Work with regulatory teams and broader development teams on gap analyses, regulatory meetings, protocol development, and other deliverables.
  • Maintain Regulatory Knowledge: Keep up to date with changes in regulatory requirements and advise teams accordingly.
  • Interact with Regulatory Agencies: Engage with national/regional government agencies, particularly the FDA, to address regulatory issues.
  • Develop Proactive Solutions: Identify regulatory challenges and create solutions to overcome them.
  • Lead a Team: Manage a team of physicians and regulatory staff, providing strategic regulatory expertise.
  • Provide Regulatory Guidance: Offer regulatory advice to teams across Clinical Operations, Medical Writing, Clinical Safety/Pharmacovigilance, Data Management, and Biostatistics.

Qualifications

  • Advanced Degree: MD, PhD in Life Sciences, or similar advanced degree.
  • Experience: Minimum of 5 years in regulatory drug development. Expert knowledge in one or more therapeutic areas is required.
  • FDA Experience: Prior professional experience at the FDA (e.g., Clinical Team Leader) is preferred.
  • Regulatory Affairs Expertise: In-depth knowledge of regulatory affairs, particularly in FDA processes, is essential.

Medpace Overview

Medpace is a global, full-service contract research organization (CRO) providing clinical development services for the biotechnology, pharmaceutical, and medical device industries. Headquartered in Cincinnati, Ohio, Medpace employs more than 5,000 professionals in over 40 countries. The company's mission is to accelerate the development of safe and effective medical therapeutics globally.

Why Medpace?

  • People. Purpose. Passion: Medpace strives to make a difference by positively impacting patients' lives across key therapeutic areas.
  • Perks: Flexible work environment, competitive PTO packages, company-sponsored events, health and wellness initiatives, and career growth opportunities.
  • Awards: Recognized by Forbes as one of America’s Most Successful Midsize Companies and a Top Workplace in 2024.

What to Expect Next

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