Merck & Co, Inc

Executive Director, Quantitative Pharmacology and Pharmacometrics

Merck & Co, Inc • $231K — $365K *
Rahway, NJ 07065In-Person
Pharmaceuticals & Biotech
11 - 15 years of experience
3 weeks ago
Job Overview by Ladders

Qualifications

  • Ph.D./PharmD or equivalent with 12+ years of progressively responsible experience in pharmaceutical drug development or regulatory roles.
  • In-depth knowledge of immunology and translational science.
  • Proven experience authoring and defending regulatory filings for marketing authorization in Immunology.
  • Expertise in developing quantitative strategies across various drug development phases, including complex modalities.
  • Strong grasp of functional deliverables in drug R&D to connect contributions to broader organizational needs.
  • Ability to lead interdisciplinary teams and drive results through effective collaboration.
  • Excellent written and verbal communication skills with a focus on problem-solving and planning.

Responsibilities

  • Lead and manage a team of up to 7 QP2 scientists, overseeing scientific and operational execution.
  • Provide day-to-day oversight to ensure high-quality scientific output from team members.
  • Shape clinical pharmacology regulatory strategies and ensure compliance with global regulatory expectations.
  • Develop enabling modeling platforms to enhance the immunology portfolio in collaboration with internal and external partners.
  • Implement quantitative pharmacology strategies to optimize drug discovery and development timelines.
  • Act as a representative in cross-functional governance discussions, including business development evaluations.
  • Set team priorities, manage performance, and contribute to talent management processes to foster high performance.

Benefits

  • Hybrid flexible work arrangements to support work-life balance.
  • Visa sponsorship available for eligible candidates.
  • Relocation assistance provided for domestic and international moves.
Full Job Description
Job Description

Our company's Quantitative Pharmacology and Pharmacometrics (QP2) Department is seeking a Team Leader (Executive Director) to support our rapidly expanding immunology pipeline.

Immunology has been a strategic growth area for our company during the last years including an exciting late-stage pipeline including tulisokibart and a deep emerging pipeline consisting of traditional and newer modalities.

This Team Leader brings deep disease area knowledge in immunology with strategic thinking to drive model-informed decision-making in our immunology portfolio in an end-to-end manner to gain competitive advantage. The individual has a strong understanding of the quantitative pharmacology global regulatory landscape to oversee and deliver on regulatory submissions, pediatric and life-cycle management strategies with QP2 pharmacometric partners.

The individual also develops translational strategies around optimal use of biomarkers and concomitant mechanistic/ QSP models to select and derisk drug candidates (including complex modalities) and drug combinations, to accelerate clinical development timelines in early and late stages of development, to demonstrate unambiguous differentiation over existing products and to implement personalized medicine, aligned with our partners.

The immunology Team Leader will oversee a team of QP2 scientists, provide guidance in personnel management, scientific oversight, and operational execution, and may serve as QP2 lead on complex projects. Reporting directly to the QP2 Immunology Therapeutic Area Head and serving as their delegate when needed, the individual will collaborate closely with the QP2 Immunology leadership team and broader organization to ensure consistent, high-value quantitative pharmacology contributions throughout the Immunology portfolio from discovery through life cycle management, and create a culture of collaboration and high performance in the group. This role is also part of the extended QP2 leadership team and expected to bring leadership and active contributions to one or more business or talent facing workstreams.

Primary Responsibilities:
  • Leading a team of up to 7 QP2 scientists including people management, scientific and operational oversight, under the direction of the Therapeutic Area Head of Immunology
  • Leveraging end-to-end drug discovery/development and disease area expertise to independently provide day-to-day scientific oversight to individual contributors
  • Maintaining a comprehensive understanding of global regulatory expectations for all relevant modalities, shaping the clinical pharmacology regulatory strategy for selected immunology assets, and ensuring high quality regulatory documents (INDs, CSRs, CTDs)
  • Applies immunology knowledge and strategic thinking to identify, prioritize and develop enabling modeling platforms (disease, mechanistic, comparator models) at scale to create a differentiated immunology portfolio in an end-to-end manner in partnership with key internal/external collaborators
  • Implements quantitative clinical pharmacology, pharmacometrics and translational modeling efforts to streamline drug discovery and development strategies and integrating knowledge to inform key decisions
  • Engaging as an expert representative for QP2in cross-functional and governance discussions, including business development and licensing evaluations
  • Setting priorities for direct reports and driving performance management, hiring and retention, staff development and training, and input into calibration and talent management processes
  • In partnership with the Therapeutic Area Head of Immunology, identify resource needs and contribute to resource allocation internally
  • Fostering a culture of collaborative and high-performing teaming


Education:
  • Ph.D./PharmD or equivalent degree with at least 12 years of experience where "experience" means having a record of increasing responsibility and independence in a similar role in pharmaceutical drug development or regulatory


Required Experience and Skills:
  • Educational background in biopharmaceutics, pharmaceutical sciences, pharmacometrics, chemical/biomedical engineering, computational biology, or a related field
  • Immunology therapeutic area and translational science knowledge
  • Demonstrated experience in regulatory strategies in Immunology including prior experience independently authoring and defending regulatory filings for marketing authorization (NDA/MAA)
  • Extensive experience in developing quantitative strategies for impacting pipeline decisions across different phases, and including complex modalities
  • Strong understanding of functional deliverables in drug R&D, with an ability to connect QP2 contributions to broader activities and needs
  • Demonstrated ability to lead interdisciplinary teams or taskforces, and to oversee and drive results through the work of others
  • 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
  • Proficiency in written and verbal communication, interdisciplinary collaboration, and problem scoping and planning


Preferred Experience and Skills:
  • Expert skills in performing mechanistic modeling and/or population PK/PKPD analyses using standard software (e.g., Mathlab, NONMEM, R, Monolix, Phoenix, etc.)
  • Scientific understanding of biopharmaceutical and ADME properties across modalities
  • Record of applying mechanistic models to inform decisions
  • Recognized leader in the field of quantitative pharmacology with a track record of sustained external visibility through publications, presentations and/or involvement in professional organizations


Required Skills:
Clinical Pharmacology, Immunology, Informed Decision Making, People Management, Pharmacometrics, Regulatory Submissions, Stakeholder Relationship Management, Strategic Planning

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

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:
07/1/2026
*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.

About Merck & Co, Inc

Schering-Plough Corporation is a major U.S.-based manufacturer of pharmaceuticals. It operates in three segments: Prescription Pharmaceuticals, Animal Health, and Consumer Health Care. Schering-Plough develops products targeting on allergy, cancer, hepatitis, cardiovascular, central nervous system, respiratory system, and more.  It was founded in 1851 by Ernst Christian Friedrich Schering as Schering AG in Germany. Schering-Plough manufactured several pharmaceutical drugs, the most well-known of which were the allergy drugs Claritin and Clarinex, an anti-cholesterol drug Vytorin, and a brain tumor drug Temodar. It also developed drugs targeting on central nervous system and the respiratory system. Schering Plough also owned and operated the major foot care brand name Dr. Scholl's and the skin care line Coppertone. These also became a part of the new company. Schering-Plough was a full member of the European Federation of Pharmaceutical Industries and Associations (EFPIA), a membership which is also maintained by the new Merck.

Merck & Co, Inc Careers

Join the visionary team at Merck & Co, Inc, a global leader in healthcare dedicated to advancing the world of medicine. As part of our professional community, you'll find dynamic job opportunities that foster innovation and leadership across various fields. Merck & Co, Inc is not just a company; it's a place where you can make a difference.

Work You’ll Do

At Merck & Co, Inc, we are committed to improving global health through groundbreaking research and innovative healthcare solutions. Our team is at the forefront of developing new therapies and vaccines that significantly impact public health worldwide. By joining us, you will collaborate with some of the brightest minds in the industry, using your skills to contribute to projects that save and improve lives around the globe.

Explore Career Paths

Whether you're seeking an internship, a graduate opportunity, or a professional position, Merck & Co, Inc offers a range of career paths in environments that promote rapid professional growth and development. Explore job opportunities in research, digital transformation, manufacturing, and more, all while benefiting from a culture that supports diversity and inclusion.

Innovate and Lead

Merck & Co, Inc is an ideal environment for those who lead with curiosity and the drive to innovate. Our leadership is committed to fostering a culture where inventive thinking and collaboration are encouraged, making it a perfect place for professionals who seek to make an impact through their work.

Develop Your Skills

With Merck & Co, Inc, you are not just getting a job; you're gaining access to unparalleled career development opportunities. Enhance your skills through diverse training programs, workshops, and continuous learning courses designed to help you grow at every stage of your career.

Benefits and Culture

We understand that our employees are our greatest asset, which is why we offer competitive benefits designed to support the health and well-being of you and your family. From comprehensive health care coverage and retirement plans to flexible working conditions and wellness programs, our benefits package is designed to meet the diverse needs of our team members.

Join Our Team

Ready to advance your career at Merck & Co, Inc? Search open positions that match your skills and interests. We are continuously hiring and looking for passionate, creative, and solution-driven team players. Prepare your resume, sharpen your interview skills, and become part of a company that's dedicated to making a difference.

Stay Connected

Keep up to date with career tips, insider perspectives, and industry-leading insights you can put to use today—all from the people who work here. Engage with us through our careers blog and by participating in networking events and employment fairs. Subscribe to receive personalized job alerts and the latest news tailored to your preferences. Discover the exciting and rewarding opportunities that await at Merck & Co, Inc. Join us in our mission to improve health and wellness around the world.
Learn more about Merck & Co, Inc
Size
68,000 employees
Market Cap
$282.6 billion
Industry
Pharmaceuticals & Biotech
Net Income
$7 billion
Founded
1668
5 Year Trend
+4.1%
Revenue
$47.9 billion
NASDAQ
MRK
* Ladders Estimates

Similar Jobs

Ad banner background

Get Ready For Your
Next Interview

More Jobs at Merck & Co, Inc

More Pharmaceuticals & Biotech Jobs

Find similar Executive Director, Quantitative Pharmacology and Pharmacometrics jobs:

NationwideRahway, NJ