Senior Director, Advanced Pharmacometrics, Quantitative Pharmacology and Pharmacometrics – Immuno-Oncology (Hybrid or Remote)

Job Description

We are seeking an accomplished scientific leader to join the Quantitative Pharmacology and Pharmacometrics – Immuno-Oncology (QP2‑IO) team as Senior Director, Advanced Pharmacometrics. QP2‑IO is part of the Global Clinical Development organization and is responsible for clinical pharmacology and pharmacometrics strategy and execution for oncology assets, from candidate nomination through registration.

Our Senior Directors are recognized experts in quantitative drug development and possess a deep, integrated understanding of both the science and the strategic, end‑to‑end dimensions of oncology drug development. Reporting directly to Executive Director and Section Head, QP2‑IO, the Senior Director will lead advanced pharmacometrics strategy and implementation to inform key oncology portfolio decisions.  

The ideal candidate is an accomplished scientific leader with deep expertise in oncology drug development and has a proven track record in shaping and delivering impactful oncology MIDD strategies. This individual must have extensive experience in population PK/PD, tumor dynamics and survival modeling, Bayesian inference, and model-based meta-analysis (MBMA), along with strong cross-functional influencing skills in a matrixed environment. The role includes substantial internal and external engagement, including with vendors and regulatory agencies.

Primary Responsibilities

Strategic Leadership

• Lead quantitative pharmacology strategy across the oncology portfolio, ensuring alignment with program goals and organizational priorities.
• Develop and implement long-range plans for integrating MIDD, pharmacometrics, data science, and Bayesian modeling approaches to accelerate and de-risk oncology drug development.
• Partner with senior leaders in Clinical Development, Translational Medicine, Biostatistics, Regulatory, and Data Science to define modeling strategies that influence program design and key decisions.

Scientific & Technical Leadership

• Oversee development of advanced pharmacometrics modeling including but not limited to population PK/PD, tumor dynamics and survival modeling, advanced models to inform dose selection, clinical design, and benefit–risk assessments.
• Champion the use of Bayesian methods including hierarchical and joint modeling, and prior-data integration to strengthen oncology decision-making.
• Ensure high-quality, regulatory grade pharmacometric deliverables for submissions, label negotiations, and scientific advice meetings.
• Stay at the forefront of emerging methodologies including AI/ML and promote innovation in modeling tools, computational frameworks, and analytics platforms.

Team Leadership & Development

• Lead, mentor, and develop a team of quantitative scientists in a matrixed role.
• Foster a culture of scientific rigor, excellence, collaboration, and innovation.

Cross-Functional Collaboration

• Collaborate with QP2 leads to design efficient, model-informed clinical trials
• Work closely with Translational, Clinical, Biostatistics functions to integrate advanced modeling into decision frameworks.

Regulatory & External Engagement

• Contribute to regulatory strategy through preparation of pharmacometric reports, briefing documents, and presentations.
• Represent the company at scientific conferences, external collaborations, consortia, and industry working groups.

Minimum Education

• Ph.D. in pharmacokinetics/pharmacodynamics, pharmacometrics, mathematics, statistics/biostatistics, chemical/biomedical engineering, or a related discipline with at least 10 years of pharmaceutical drug development experience, including substantial experience in pharmacometrics roles.

OR

• Master’s, PharmD, or equivalent degree with at least 15 years of pharmaceutical drug development experience, with a demonstrated record of increasing responsibility, independence, and leadership in similar roles.

Required Experience and Skills

• Extensive and in‑depth experience in application of MIDD in oncology drug development to drive impactful development decisions.
• Deep proficiency in advanced pharmacometrics methods such as:
  • Bayesian hierarchical models, joint models of tumor and survival, drop-out models, MBMA, advanced clinical trial simulation methods, integrating PROs and RWD into traditional NLME approaches.  
  • Hands-on experience with software such as NONMEM, Pumas, Stan, R, and/or other Bayesian platforms.
• Advanced analytical skills, including designing and interpreting clinical trials, problem solving, critical data analysis, interpretation, and decision making.
• Understanding of oncology biology, translational pathways, and clinical endpoints (e.g., ORR, PFS, OS, tumor dynamic modeling).
• Demonstrated impact across multiple therapeutic modalities, including, for example, antibody–drug conjugates (ADCs), T cell engagers (TCEs) monoclonal antibodies (mAbs), cytokines, and small molecules.
• Experience integrating AI/ML methods into clinical pharmacology and pharmacometrics workflows to advance model‑informed drug development, optimize study design, and support regulatory decision‑making is preferred.
• Excellent written and verbal communication skills, with a track record of effective cross‑functional collaboration, stakeholder management in a matrixed environment and ability to influence at senior levels.

#QP2

#Eligible for ERP

The remote position is only applicable for those that are not within commutable distance to primary sites noted in posting.  If commutable, the position will be hybrid. Please note that standard commute is (less than) <50 miles.

Required Skills:

Biopharmaceutical Industry, Clinical Development, Cross-Functional Collaboration, Data Modeling, Data Science, Data Visualization, Drug Development, Effective Written Communication, Model Driven Development, Modeling Software, Nonlinear Mixed Effects Modeling (NONMEM), Oncology Drug Development, Pharmacodynamics, Pharmacokinetics, Pharmacometrics, Verbal Communications

Preferred Skills:

Artificial Intelligence (AI), Bayesian Models, Machine Learning (ML), Multiple Therapeutic Areas, PKPD Modeling, Population Pharmacokinetics

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US and Puerto Rico Residents Only:

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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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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.

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.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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

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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

Relocation:

No relocation

VISA Sponsorship:

Yes

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

07/31/2026

*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.