Group Leader - Senior Director, Quantitative Pharmacology and Pharmacometrics – Oncology

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

Job summary

Merck & Co., Inc. in Rahway, NJ, seeks a Senior Director, Group Leader to lead Quantitative Pharmacology and Pharmacometrics (QP2 Oncology), guiding strategy and modeling across oncology programs from preclinical through registration.

The role drives MIDD, translational PK/PD, biomarker-informed dose selection, regulatory strategy, and cross-functional collaboration with Clinical Development, Translational Medicine, Biostatistics, and Regulatory to inform pivotal decisions.

Qualifications

• Pharmacometrics and quantitative pharmacology expertise required.
• Strong leadership of interdisciplinary teams and cross-functional collaboration expected.
• Experience with regulatory strategy development and NDA/MAA submissions preferred.

Responsibilities

• Lead and shape quantitative pharmacology strategy across oncology programs to inform key development decisions.
• Develop and implement integrated MIDD strategies to support decision-making across development stages.
• Ensure alignment of modeling strategies with regulatory expectations and business priorities.
• Maintain understanding of global regulatory expectations for small molecules, biologics and new modalities.

Skills

Clinical Development

Clinical Pharmacology

Communication

Cross‑Functional Collaboration

Drug Development

Leadership

Oncology

Oncology Drug Development

Pharmacometrics

Regulatory Responses

Stakeholder Relationship Management

Team Management

Education

Ph.D. in pharmacokinetics/pharmacodynamics, pharmacometrics, mathematics, statistics/biostatistics, chemical/biomedical engineering, or related discipline with ≥10 years of relevant pharmaceutical industry experience

Master’s, PharmD, or equivalent degree with ≥15 years of relevant pharmaceutical industry experience

Job description

We are seeking an accomplished scientific leader to join the Quantitative Pharmacology and Pharmacometrics – Oncology (QP2 Oncology) team as Senior Director, Group Leader. QP2 Oncology is part of the Global Clinical Development organization and has oversight of clinical pharmacology, mechanistic PK-PD modeling, and pharmacometrics for oncology programs from post-preclinical candidate (PCC) selection through registration.

Senior Directors are recognized scientific thought leaders who develop and implement clinical pharmacology strategies with a focus of utilizing MIDD strategies to advance drug development. This would include translational PK/PD strategies, biomarker-driven dose selection approaches, pharmacometric modeling and other quantitative approaches (e.g. QSP, AI/ML) for key development and regulatory decisions.

This role provides strategic leadership and scientific oversight across a significant portion of the oncology portfolio. The Senior Director, Group Leader will lead a team of QP2 scientists and serve as a key contributor to oncology program strategy by applying model-informed drug development (MIDD) approaches to support critical decisions.

Reporting directly to the QP2 Oncology Executive Director, the individual will collaborate closely with the QP2 Oncology Leadership team and broader organization to ensure consistent, high-value quantitative pharmacology contributions throughout the oncology portfolio. The role requires strong collaboration with cross‑functional partners, including Clinical Development, Translational Medicine, Biostatistics, and Regulatory, as well as alignment with preclinical partners to inform first‑in‑human and clinical development strategies.

Primary Responsibilities

Strategic & Scientific Leadership

• Lead and shape quantitative pharmacology strategy across oncology programs to inform key development decisions (e.g., dose selection, trial design, go/no‑go decisions)
• Develop and implement integrated MIDD strategies to support decision‑making across development stages
• Ensure alignment of modeling strategies with regulatory expectations and business priorities
• Maintain a comprehensive understanding of global regulatory expectations for small molecules, biologics including new modalities such as ADCs and TCEs

Team Leadership & Organizational Impact

• Lead, mentor, and develop a team of QP2 scientists, including performance management, hiring, retention, and talent development
• Provide scientific and operational oversight to team members, ensuring high‑quality and timely deliverables
• Contribute to broader QP2 and Oncology leadership initiatives, including talent strategies and organizational priorities
• Identify and support resource planning and allocation in partnership with senior leadership

Program & Cross‑Functional Leadership

• Serve as QP2 lead on assigned programs and represent QP2 in cross‑functional teams and governance forums
• Collaborate with Translational, Clinical, and Biostatistics teams to integrate quantitative insights into development strategies
• Partner with preclinical teams to ensure appropriate translation of nonclinical findings into clinical development plans
• Contribute to due diligence for business development and licensing opportunities

Regulatory & External Engagement

• Develop and contribute to regulatory strategies, including authoring and reviewing key documents (e.g., INDs, CSRs, CTD modules, NDA/BLA submissions)
• Ensure delivery of high‑quality clinical pharmacology and pharmacometric analyses and reports
• Represent the company in interactions with regulatory agencies, scientific conferences, and external collaborations

Minimum Education

• Ph.D. in pharmacokinetics/pharmacodynamics, pharmacometrics, mathematics, statistics/biostatistics, chemical/biomedical engineering, or related discipline with ≥10 years of relevant pharmaceutical industry experience

OR

• Master’s, PharmD, or equivalent degree with ≥15 years of relevant pharmaceutical industry experience, with a demonstrated record of increasing responsibility, independence, and leadership in similar roles.

Required Experience And Skills

• Educational background in biopharmaceutics, pharmaceutical sciences, pharmacometrics, chemical/biomedical engineering, mathematics, computational biology, or a related field
• Oncology therapeutic area or disease knowledge
• Demonstrated ability to lead an interdisciplinary team or taskforce, and/or to oversee the work of others
• Extensive experience in developing quantitative strategies for impacting pipeline decisions, and drug development expertise
• Ability to influence regulatory strategies including prior experience independently authoring and defending regulatory filings for marketing authorization (NDA/MAA)
• Record of ability to operate in an inclusive and high‑performance work environment applying enterprise ways of working principles including fostering collaboration and driving results, while managing ambiguity
• Relevant regulatory and quantitative pharmacology experience
• Proficiency in written and verbal communication, interdisciplinary collaboration, and problem scoping and planning

Required Skills

• Clinical Development
• Clinical Pharmacology
• Communication
• Cross‑Functional Collaboration
• Drug Development
• Leadership
• Oncology
• Oncology Drug Development
• Pharmacometrics
• Regulatory Responses
• Stakeholder Relationship Management
• Team Management

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.

Requirements

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: EEOC Know Your Rights, EEOC GINA Supplement. 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.

Salary

The salary range for this role is $210,400.00 - $331,100.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this 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.

Benefits

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.

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.

Search Firm Representatives Please Read Carefully

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre‑existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status

Regular

Flexible Work Arrangements

Hybrid

Job Posting End Date

10/3/2026

• 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

R412343