Distinguished Scientist, Pharmacokinetics

Merck & Co.; Rahway (NJ); Hybrid; USD 210,000 - 331,000; Full time

Job summary

Merck & Co. in the United States seeks a Distinguished Scientist to serve as a DMPK submission expert, leading nonclinical PK strategies to ensure robust filings from FIH to post-approval extensions.

The successful candidate will influence regulatory strategy, contribute to global filings, and help shape portfolio decisions with cross-functional teams. Strong leadership, negotiation skills, and enterprise mindset are essential.

Qualifications

• 15+ years in DMPK with leadership in drug discovery and development programs
• Strong understanding of regulatory guidelines and successful support of clinical candidates and FIH
• Experience mentoring program team representatives on nonclinical and clinical issues
• Proven ability to influence strategic direction across disciplines and functions
• Excellent written and verbal communication for clear regulatory documentation and presentations
• Experience authoring and reviewing nonclinical PK packages and regulatory sections (IBs, INDs, NDAs, etc.)
• Experience navigating regulatory requirements across modalities from preclinical through post-approval

Responsibilities

• Monitor late-stage development programs and ensure nonclinical packages align with filing strategy
• Represent PDMB in Label Approval Strategy Teams and regulatory discussions
• Review investigator brochures, INDs, NDAs, regulatory responses to support trials and registrations
• Provide scientific oversight for development candidates across therapeutic areas and modalities
• Contribute to Clinical Pharmacology strategy including starting dose and dose escalation considerations
• Ensure DMPK data and documentation meet regulatory expectations
• Lead internal initiatives to improve policies and regulatory guidance
• Oversee due diligence for in-licensing assets and integration of programs
• Develop future leaders in drug development and regulatory science

Skills

Drug Development

Drug Metabolism

Pharmacokinetics

Portfolio Strategies

Regulatory Filings

Regulatory Strategies

Regulatory Submissions

Scientific Leadership

Small Molecules

Education

PhD or MSci in Pharmaceutical Sciences, Pharmacology or related field

Job description

Job Description

The department of Pharmacokinetics, Dynamics, Metabolism and Bioanalytics (PDMB) is seeking a Distinguished Scientist to serve as Drug Metabolism and Pharmacokinetics ( DMPK) submission expert. This leader will have broad responsibilities in support of our robust development pipeline to ensure consistent quality filings from FIH to marketing applications and through life-cycle management.

The Distinguished Scientist will contribute to the execution of PDMB portfolio support strategy and DMPK priorities across therapeutic areas and modalities. The successful candidate will ensure that submission packages as they pertain to nonclinical Pharmacokinetics ( PK) are robust and aligned with program objectives. They will bring forward drug disposition properties in the context of benefit/risk and drug interaction potential in target populations within the parameters of regulatory guidelines.

The Distinguished Scientist will be positioned to influence portfolio decisions, contribute to regulatory filings, labeling discussions and approvals. As a member of the DMPK Leadership team, the Distinguished Scientist will contribute to global scientific and portfolio strategy and talent development. They are expected to demonstrate exemplary ways of working, strong ethics, good negotiation skills and an enterprise mindset.

Key responsibilities

• Monitor the progression of programs in late-stage development and post-marketing to ensure nonclinical packages in support of original marketing applications (OMA) and supplemental applications (sNDA) are robust, prepared timely, according to filing strategy and aligned with clinical safety and efficacy positions
• Represent PDMB in Label Approval Strategy Teams and in ad-hoc discussions/ teams where DMPK expertise is required, such as Clinical Safety/Risk Management, nonclinical safety mechanistic investigations as they pertain to regulatory filings, ICH guidance or label updates.
• Reviewing investigator brochures, clinical trial applications, IND, NDAs, regulatory responses and other legal/scientific documents to support global clinical trials and registration.
• Provide scientific and strategic oversight for development candidates across therapeutic areas through close collaboration with PDMB program representatives, subject-matter experts and management as well as key partners in other functional areas, including but not limited to Nonclinical Safety, Translational Medicine, Quantitative Pharmacology, Regulatory Affairs, Formulation and others to ensure alignment on regulatory strategy and input for mechanistic investigations.
• Actively contribute to discussions regarding Clinical Pharmacology strategy, including starting dose, dose escalation, timing, design and interpretation of Ph1 studies, such as drug interactions, especial populations and human ADME amongst other studies, leveraging nonclinical data generated by PDMB.
• Ensuring DMPK data and documentation practices maintain quality in pace with changes in regulatory expectations across countries/regions.
• Leading internal and cross-departmental initiatives to improve policies, procedures, and/or strategic direction in line with company portfolio strategy and regulatory expectations.
• Responsible for overseeing and/or conducting 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 the development of future leaders to build organizational experience in drug development, regulatory processes, risk assessments and regulatory guidelines

Education

• PhD or M.Sci. in Pharmaceutical Sciences, Pharmacology or related field.

Required Experience and Skills

• Minimum experience of 15 years in DMPK with extensive experience as team representative in drug discovery and development programs.
• Strong scientific acumen, as well as understanding of the drug development process and relevant regulatory guidelines. with a track-record of successful support of clinical candidates and first-in-human execution.
• Previous experience collaborating with and mentoring program team representatives on an array of nonclinical and clinical issues.
• Strong leadership skills and ability to work, collaborate with and influence scientists across a wide range of scientific disciplines to effectively influence strategic direction.
• Efficient organizational skills and excellent verbal and written communications with ability to develop and deliver clear and concise documents and presentations.
• Experience in authoring and critically reviewing nonclinical PK packages and clinical sections of relevant regulatory documents (IBs, INDs, CTAs, NDAs, BLAs, MAAs, PIP/PSPs, Scientific Advice, weight of evidence risk assessments, regulatory responses, product labels, etc.).
• Demonstrated experience navigating issues and regulatory requirements for advancing drug development candidates across modalities from preclinical through Phase 4 development, regulatory approvals and/or post-approval commitments.

Preferred Experience and Skills

• 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

Required Skills

Drug Development, Drug Metabolism, Pharmacokinetics, Portfolio Strategies, Regulatory Filings, Regulatory Strategies, Regulatory Submissions, Scientific Leadership, Small Molecules

US and Puerto Rico Residents Only

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.

As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.

For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.

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The primary location for this posting is:

USA - Pennsylvania - West Point

Where required by law

The salary range for the primary location of this role is:
$210,400.00 - $331,100.00

This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits .

Additional location(s)

Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.

San Francisco Residents Only

We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only

We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance

Employee Status

Regular

Relocation

Domestic/International

VISA Sponsorship

Yes

Travel Requirements

10%

Flexible Work Arrangements

Hybrid

Shift

1st - Day

Valid Driving License

No

Hazardous Material(s)

N/A

Job Posting End Date

11/2/2026

*A job posting is effective until 11:59:59PM on the day BEFORE -the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID

R421412