Vice President, Regulatory Science - Clinical Pharmacology SME

Parexel; Geldern; Remote; USD 180.000 - 240.000; Vollzeit

Benefits dieser Stelle

Health Insurance

Vision Insurance

Dental Insurance

Tuition Reimbursement

Vacation Time

FSAs / Health Savings Accounts

Work-Life Balance

401(k) Match

Pet Insurance

Zusammenfassung

Parexel, a leading global clinical development partner, seeks a Vice President, Regulatory Science with expertise in Clinical Pharmacology to guide regulatory strategies across therapeutic programs. You will work remotely with biopharma clients to shape development plans and Health Authority interactions.

In this senior advisory role, you will mentor teams, lead complex engagements, and contribute to publications and industry forums, while advancing patient access to innovative therapies.

Qualifikationen

• MD or PharmD required; PhD beneficial as an asset.
• Extensive experience in Clinical Pharmacology, Drug Development, Translational Medicine, Clinical Development, or Regulatory Science.
• Significant regulatory agency experience (FDA/EMA/MHRA/Health Canada/PMDA or equivalent).
• Excellent communication, strategic thinking, and client engagement skills.

Aufgaben

• Provide expert-level consulting in Clinical Pharmacology, Translational Medicine, Clinical Development, and Regulatory Strategy to guide sponsors through regulatory and scientific decisions.
• 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, PK/PD, pediatric plans, and special populations.
• Serve as trusted advisor to executive-level client stakeholders, presenting strategic recommendations to senior leadership.
• Assess development plans and advise on regulatory considerations for INDs, CTAs, NDAs, BLAs, MAAs, and supplements.
• Contribute to industry advancement through conferences, publications, and mentoring.

Kenntnisse

Clinical Pharmacology

Regulatory strategy

Health Authority decision-making

Client engagement

Strategic thinking

Ausbildung

MD or PharmD

PhD beneficial

Jobbeschreibung

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 thrive in this role if you bring:

• 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.

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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.