Vice President, Regulatory Science - Clinical Pharmacology SME

When our values align, there's no limit to what we can achieve. At Parexel , we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel , contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. About Parexel Parexel is a leading global clinical development partner delivering insights-driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient-focused clinical trials that broaden access and make research a care option for anyone, anywhere. We work with focus, agility, and shared purpose - moving with urgency to address patient needs and accelerate the delivery of new therapies. We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research. We are expanding our team and seeking talented individuals to help drive industry-leading innovation, With Heart(R). About the Role 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. Key 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 Candidate Profile You'll