AVP/ Head, Quantitative Pharmacology & Pharmacometrics - Oncology

MSD Malaysia; Rahway (NJ); On-site; USD 282,000 - 444,000; Full time

Job summary

Merck & Co., Inc. in Rahway, NJ seeks a Head of Quantitative Pharmacology & Pharmacometrics (QP2) to lead oncology pharmacology strategy and model-informed drug development across discovery through lifecycle management.

You will oversee a team of scientists, shape dose and regimen strategies, and advise regulatory interactions to inform program decisions. The role emphasizes strategic leadership, cross-functional collaboration, and innovative use of AI/ML-enabled approaches to accelerate

Qualifications

• Drug development expertise in oncology with impact on model-informed strategies.
• Experience with multiple modalities (ADC, small molecules, biologics).
• Publications or presentations in quantitative pharmacology for oncology.
• Experience authoring regulatory filings (NDA/MAA) for more than one modality.
• Ability to lead interdisciplinary teams and supervise scientists.
• Experience in population PK/PKPD analyses with standard software.
• Knowledge of biopharmaceutical and ADME properties of small molecules and biologics.
• Excellent written and verbal communication; cross-functional collaboration.
• Ability to embed MIDD early in asset strategy.

Responsibilities

• Lead pharmacology strategy for oncology portfolio and guide program design.
• Provide strategic leadership, supervision, and mentorship to QP2 scientists.
• Shape regulatory strategy and governance, and interact with regulators.
• Drive data-integrated decision-making across discovery, development, and lifecycle management.

Skills

Oncology

Model-informed drug development

PK/PD analysis

Regulatory strategy

AI/ML in pharmacology

Team leadership

Interdisciplinary collaboration

Biopharmaceutics

Biomarkers

Translational modeling

Education

Ph.D. or equivalent degree

Job description

Our company is seeking a head of Quantitative Pharmacology & Pharmacometrics (QP2) to lead pharmacology strategy for our oncology pipeline. Our QP2 organization uses trial and external data, advanced analytics, model-informed drug development, and deep therapeutic-area expertise to inform the safety, efficacy, dose, schedule, patient‑selection, and benefit-risk strategies for the pipeline. The QP2 team integrates clinical pharmacology, pharmacometrics, quantitative systems pharmacology, exposure-response analysis, translational modeling, biomarkers, real-world data, and emerging AI/ML-enabled approaches to support decision‑making across discovery, early clinical development, registration, and life‑cycle management. The Head of QP2 Oncology will serve as the enterprise point of accountability for QP2 strategy, ensuring quantitative science is used to shape program design, dose and regimen strategy, regulatory interactions, governance recommendations, and portfolio decisions. The leader will provide strategic leadership and scientific oversight, supervise and mentor other scientists, directly shape strategy for priority programs and business‑development opportunities, and build a modern quantitative operating model for oncology development.

Education

• Ph.D. or equivalent degree

At least 15 years of experience in drug development, including at least 5 years in oncology in industry educational background in biopharmaceutics, pharmaceutical sciences, pharmacometrics, mathematics, statistics/biostatistics, computational biology/chemistry, chemical/biomedical engineering, or a related field.

Required Experience and Skills

• Drug development expertise within the oncology therapeutic area, including a record of both internal and external impact in driving model‑informed drug development strategies
• Experience with multiple modalities such as ADCs, small molecules, TCEs and/or biologics
• Track record of publications or presentations in quantitative pharmacology for oncology
• Ability to influence regulatory strategies including experience independently authoring and defending regulatory filings for marketing authorization (NDA/MAA) for more than one modality (biologics, ADCs, small molecules, cell therapy)
• Demonstrated ability to participate in and to lead an interdisciplinary team, and to oversee the work of other scientists
• Experience in performing population PK/PKPD analyses using standard pharmacometric software
• Up to date on emerging trends/works in field (peer intelligence, methodology emerging analyses Scientific understanding of biopharmaceutical and ADME properties of both small molecules and biologics
• Proficiency in written and verbal communication, interdisciplinary collaboration, and problem scoping and planning
• Ability to formulate and articulate scientific strategy to support portfolio decisions
• Ability to embed MIDD early in asset strategy, including population PK, PK/PD, exposure‑response, dose optimization, simulation‑based trial design, model‑based meta‑analysis, quantitative systems pharmacology, disease‑progression modeling, and translational modeling
• Ability to recommend and defend dose and regimen decisions supported by integrated evidence packages that address efficacy, safety, tolerability, exposure, biomarkers, patient selection, and regulatory expectations
• Comprehensive understanding of global regulatory expectations for oncology development for dose and pharmacology; contributing to cross‑functional regulatory strategy; reviewing INDs, CSRs, CTDs, NDAs/BLAs/MAAs; and representing QP2 leadership at regulatory interactions
• Willingness and experience to apply AI/ML, automation, real‑world data, biomarker, translational, and digital data‑stream approaches where they improve prediction, accelerate learning, or strengthen development decisions
• Ability to serve as a senior representative for QP2 in cross‑functional teams, governance discussions, portfolio reviews, and business‑development or licensing evaluations
• Experienced in team building and maintaining a high‑performing, modality‑agile organization in close collaboration with discovery oncology and with strong oncology expertise, technical excellence, regulatory credibility, consistent modeling standards, and the ability to influence across functions
• Must be able to lead with influence to partner with others to build effect models and datasets, Must have excellent communication and collaboration skills

Required Skills

• Business Intelligence (BI)
• Business Intelligence (BI)
• Cellular Therapies
• Clinical Development
• Clinical Pharmacology
• Clinical Reporting
• Clinical Research
• Clinical Trial Development
• Database Design
• Data Engineering
• Data Modeling
• Data Science
• Data Visualization
• Drug Development
• Drug Research
• Machine Learning (ML)
• Matrix Management
• Mechanism of Action
• Model Development
• Model Driven Design
• Oncology
• Pharmaceutical Sciences
• Pharmacodynamics
• Pharmacokinetics
• Pharmacology {+ 5 more}

Preferred Skills

US and Puerto Rico Residents Only

Equal Employment Opportunity Statement

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: 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. Learn more about your rights, including under California, Colorado and other US State Acts.

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.

Salary Range

The salary range for this role is $282,200.00 - $444,200.00. 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.

Location Requirements

San Francisco Residents Only. Los Angeles Residents Only. US and Puerto Rico Residents Only.

Employee Status: Regular.

Application Deadline

The application deadline for this position is stated on this posting.

Job Posting End Date

Job Posting End Date: 10/19/2026. *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.

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.