Vice President, Regulatory Science - Clinical Pharmacology SME

Parexel•Southport, NC

2d•Remote

About The Position

We are seeking a Clinical Pharmacology SME to join our Regulatory Consulting team as a Vice President, Regulatory Science. If you have built your career at the FDA as a Clinical Pharmacology Reviewer, Master Reviewer, Team Lead, or other senior role as a subject matter expert in Clinical Pharmacology, this role offers a unique opportunity to leverage your regulatory expertise across a diverse portfolio of innovative development programs. As a Clinical Pharmacology VP Regulatory Science, you will serve as a strategic advisor to biopharmaceutical companies, applying your Health Authority perspective to guide clinical pharmacology strategies, regulatory development plans, and Health Authority interactions. You will work remotely while partnering with innovative biotech and pharmaceutical companies to shape development programs across therapeutic areas and product lifecycles. You'll join a fast-paced, growth-oriented environment where you can continue impacting patient access to innovative therapies, apply regulatory knowledge across multiple therapeutic areas, influence drug development strategies earlier in the product lifecycle, and serve as a trusted advisor to industry leaders. With diverse teams and continuous learning opportunities, this role offers the chance to expand your influence and maintain visibility within the scientific and regulatory community through publications, presentations, and thought leadership.

Requirements

MD or PharmD. A PhD is a benefit.
Extensive experience in Clinical Pharmacology, Drug Development, Translational Medicine, Clinical Development, or Regulatory Science
Significant experience within a regulatory agency (FDA, EMA, MHRA, Health Canada, PMDA, or other major global Health Authority)
Strong expertise in one or more areas such as Clinical Pharmacology, PK/PD, Pharmacometrics, Translational Medicine, Clinical Development Strategy, or Regulatory Strategy
Excellent communication, strategic thinking, and client engagement skills

Nice To Haves

Prior experience as a Clinical Pharmacology Reviewer, Master Reviewer, Team Lead, Medical Officer, or Division Leadership representative at the FDA or other Global Health Authority
Experience in oncology and one or more therapeutic areas such as Neuroscience, Rare Disease, Immunology, Endocrinology & Metabolism, Cardiovascular Disease, or Cell & Gene Therapy
Demonstrated thought leadership through publications in peer-reviewed journals, presentations at scientific conferences, or participation in professional organizations and task forces
Willingness to travel domestically and internationally for client engagements, Health Authority meetings, scientific congresses, and industry conferences

Responsibilities

Provide expert-level consulting in Clinical Pharmacology, Translational Medicine, Clinical Development, and Regulatory Strategy to guide sponsors through complex regulatory and scientific decision-making
Lead complex client engagements, representing clients before regulatory agencies when appropriate
Advise on clinical pharmacology strategies including first-in-human development, dose selection, exposure-response analyses, population PK strategies, pediatric development plans, and special population studies
Serve as a trusted advisor to executive-level client stakeholders, presenting strategic recommendations to senior leadership and helping clients navigate novel or precedent-setting regulatory challenges
Assess development plans and identify potential regulatory considerations, advising on clinical pharmacology components of INDs, CTAs, NDAs, BLAs, MAAs, and supplemental applications
Contribute actively to industry advancement through presentations at scientific and regulatory conferences, publications in peer-reviewed journals, participation in professional organizations, and internal mentoring and knowledge-sharing initiatives