Vice President, Regulatory Science – Clinical Pharmacology SME

This is a fully remote position, open to applicants in United States.

📋 Description

• Deliver high-level consulting services in Clinical Pharmacology, Translational Medicine, Clinical Development, and Regulatory Strategy.

• Oversee intricate client projects and represent clients before regulatory bodies when necessary.

• Provide guidance on first-in-human development, dose selection, exposure-response analyses, population PK strategies, pediatric development plans, and research involving special populations.

• Act as a trusted advisor to executive stakeholders within client organizations.

• Offer strategic recommendations to senior leadership teams.

• Assist clients in addressing novel or precedent-setting regulatory challenges.

• Evaluate development plans and identify possible regulatory implications.

• Advise on clinical pharmacology aspects related to INDs, CTAs, NDAs, BLAs, MAAs, and supplemental applications.

• Contribute to the advancement of the industry through presentations at scientific and regulatory conferences, peer-reviewed publications, participation in professional organizations, internal mentoring, and knowledge sharing.

• Collaborate remotely with forward-thinking biotech and pharmaceutical firms across various therapeutic areas and product lifecycles.

⛳️ Requirements

• An MD or PharmD is required; a PhD is considered a plus.

• Extensive experience in Clinical Pharmacology, Drug Development, Translational Medicine, Clinical Development, or Regulatory Science.

• Significant experience working within a regulatory agency such as the FDA, EMA, MHRA, Health Canada, PMDA, or another major global Health Authority.

• Strong expertise in one or more areas, including Clinical Pharmacology, PK/PD, Pharmacometrics, Translational Medicine, Clinical Development Strategy, or Regulatory Strategy.

• In-depth knowledge of Clinical Pharmacology, regulatory strategy, and decision-making processes within Health Authorities.

• Exceptional client relationship management and executive communication skills.

• Strategic thinker with the ability to guide sponsors through complex regulatory and scientific decision-making processes.

• Dedication to thought leadership through publications, presentations, and professional engagement.

• A patient-centered mindset and a passion for promoting innovative therapies.

• Preferred: previous experience as a Clinical Pharmacology Reviewer, Master Reviewer, Team Lead, Medical Officer, or Division Leadership representative at the FDA or another Global Health Authority.

• Preferred: experience in oncology and other therapeutic areas.

• Preferred: demonstrated thought leadership through peer-reviewed publications, scientific conference presentations, professional organizations, or task forces.

• Willingness to travel both domestically and internationally for client engagements, Health Authority meetings, scientific congresses, and industry conferences.

🏝️ Benefits

• 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.

• Paid time off.

• Life insurance.

• Additional benefit offerings in accordance with the terms of applicable plans.

• Some roles may qualify for additional incentives, bonuses, or other compensation programs.

• Flexible work arrangements and remote work options.

• Continuous learning opportunities.