AVP/ Head, Quantitative Pharmacology & Pharmacometrics - Oncology

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 for 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

Has a 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:

Current Employees apply HERE

Current Contingent Workers apply HERE

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. Please click here if you need an accommodation during the application or hiring process.

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 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.

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