Distinguished Scientist, Pharmacokinetics

Merck • Boston, MA

10d • $210,400 - $331,100 • Hybrid

About The Position

The department of Pharmacokinetics, Dynamics, Metabolism and Bioanalytics (PDMB) is seeking a Distinguished Scientist to serve as a Drug Metabolism and Pharmacokinetics (DMPK) submission expert. The role supports the development pipeline by ensuring consistent, high-quality filings from first-in-human studies through marketing applications and lifecycle management.

The Distinguished Scientist contributes to PDMB portfolio support strategy and DMPK priorities across therapeutic areas and modalities. The role ensures nonclinical pharmacokinetic submission packages are robust and aligned with program objectives, and presents drug disposition properties in the context of benefit-risk and drug interaction potential in target populations, consistent with regulatory guidelines.

As a member of the DMPK Leadership team, the Distinguished Scientist influences portfolio decisions and contributes to regulatory filings, labeling discussions, approvals, global scientific and portfolio strategy, and talent development. The role calls for exemplary ways of working, strong ethics, negotiation skills, and an enterprise mindset.

Requirements

• PhD or M.Sci. in Pharmaceutical Sciences, Pharmacology, or a related field.
• At least 15 years of DMPK experience, including extensive experience as a team representative in drug discovery and development programs.
• Strong scientific acumen and understanding of drug development processes and relevant regulatory guidelines, with a track record supporting clinical candidates and first-in-human execution.
• Experience collaborating with and mentoring program team representatives on a range of nonclinical and clinical issues.
• Strong leadership skills and ability to collaborate with and influence scientists across scientific disciplines to influence strategic direction.
• Efficient organizational skills and excellent verbal and written communication skills, including the ability to develop and deliver clear, concise documents and presentations.
• Experience authoring and critically reviewing nonclinical PK packages and clinical sections of regulatory documents, including IBs, INDs, CTAs, NDAs, BLAs, MAAs, PIP/PSPs, Scientific Advice, weight-of-evidence risk assessments, regulatory responses, and product labels.
• Demonstrated experience navigating issues and regulatory requirements for advancing drug development candidates across modalities from preclinical through Phase 4, regulatory approvals, and/or post-approval commitments.
• Required skills listed: Drug Development, Drug Metabolism, Pharmacokinetics, Portfolio Strategies, Regulatory Filings, Regulatory Strategies, Regulatory Submissions, Scientific Leadership, and Small Molecules.

Nice To Haves

• Extensive experience in early development and product development teams.
• Experience in Scientific Advisory Committee meetings with the FDA and/or other regulatory agencies.
• Deep understanding of filing and labeling requirements across major world markets.

Responsibilities

• Monitor late-stage and post-marketing programs to ensure nonclinical packages supporting original marketing applications and supplemental applications are robust, timely, consistent with filing strategy, and aligned with clinical safety and efficacy positions.
• Represent PDMB in Label Approval Strategy Teams and other discussions or teams requiring DMPK expertise, including clinical safety and risk management, nonclinical safety mechanistic investigations related to regulatory filings, ICH guidance, and label updates.
• Review investigator brochures, clinical trial applications, INDs, NDAs, regulatory responses, and other legal or scientific documents supporting global clinical trials and registration.
• Provide scientific and strategic oversight for development candidates across therapeutic areas, collaborating with PDMB program representatives, subject-matter experts, management, and partners in other functions to align regulatory strategy and mechanistic investigation input.
• Contribute to Clinical Pharmacology strategy discussions, including starting dose, dose escalation, timing, design and interpretation of Phase 1 studies, drug interactions, special populations, and human ADME studies, using nonclinical data generated by PDMB.
• Ensure DMPK data and documentation practices maintain quality as regulatory expectations change across countries and regions.
• Lead internal and cross-departmental initiatives to improve policies, procedures, and strategic direction in line with company portfolio strategy and regulatory expectations.
• Oversee and/or conduct critical due diligence reviews for in-licensing assets across therapeutic areas and serve as integration lead.
• Serve as program representative for high-priority development programs.
• Contribute to developing future leaders and building organizational experience in drug development, regulatory processes, risk assessments, and regulatory guidelines.

Benefits

• Medical, dental, and vision healthcare benefits and other insurance benefits for employees and family.
• Retirement benefits, including 401(k).
• Paid holidays, vacation, compassionate days, and sick days.
• Eligible for an annual bonus and long-term incentive, if applicable.
• Relocation assistance is indicated as domestic/international relocation.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior