Vice President, Regulatory Science - Clinical Pharmacology SME

Regulatory Toolkit; United States; Remote; USD 220,000 - 380,000; Full time

Benefits offered by this job

Health, Vision & Dental Insurance

Tuition Reimbursement

Vacation/Holiday/Sick Time

Flexible Spending & Health Savings

Work/Life Balance

401(k) with Company match

Pet Insurance

Job summary

Parexel is seeking a Clinical Pharmacology SME to join its Regulatory Consulting team as Vice President, Regulatory Science. The role leverages your regulatory expertise across diverse development programs, working remotely with biotech and pharma clients to shape pharmacology strategies and regulatory plans.

You will interact with Health Authorities, guide IND/CTA/NDAs, and influence product lifecycle decisions while contributing to thought leadership and industry collaboration.

Qualifications

• MD or PharmD required; PhD a plus.
• Extensive experience in Clinical Pharmacology, Drug Development, Translational Medicine, Regulatory Science.
• Experience with FDA/EMA/MHRA or other major Health Authority is essential.

Responsibilities

• Provide expert-level consulting in Clinical Pharmacology, Translational Medicine, Clinical Development, and Regulatory Strategy.
• Lead complex client engagements and represent clients before regulatory agencies as needed.
• Advise on clinical pharmacology strategies including first-in-human development and dose selection.
• Serve as trusted advisor to executive stakeholders on regulatory and scientific decisions.
• Contribute to industry advancement through publications and presentations.

Skills

Clinical Pharmacology

Regulatory Strategy

Health Authority decision-making

Education

MD or PharmD

Job description

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

• Deep expertise in Clinical Pharmacology, regulatory strategy, and Health Authority decision-making from your professional experience
• Strategic thinking and the ability to guide sponsors through complex regulatory and scientific decision-making
• Strong client relationship and executive communication skills, with the ability to serve as a trusted advisor to senior leadership
• A commitment to thought leadership and industry advancement through publications, presentations, and professional engagement
• A patient-focused mindset and passion for advancing innovative therapies across the global biopharmaceutical industry

Required Qualifications

• 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

Preferred Qualifications

• 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

Benefits and Compensation (US)

• Health, Vision & Dental Insurance
• Tuition Reimbursement
• Vacation/Holiday/Sick Time
• Flexible Spending & Health Savings Accounts
• Work/Life Balance
• 401(k) with Company match
• Pet Insurance

For a complete list of benefits, please visit www.parexel.com/us-benefits.

Some roles may also be eligible for additional incentives, bonuses, or other compensation programs. Our Talent Acquisition team will provide details on applicable bonus plans or incentive structures for eligible positions.

We offer a comprehensive benefits package to eligible employees, which includes paid time off, a 401(k) match, life insurance, health insurance, and additional benefit offerings in accordance with the terms of our applicable plans.

We believe in flexibility, growth, and creating space for people to do their best work. Join us and be part of a team where your contributions help shape the future of clinical research.

EEO Disclaimer

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.