Senior Director, Quantitative Pharmacology and Pharmacometrics-Immunology

Job Description

This Team Leader (Senior Director) role provides strategic leadership and scientific oversight to part of the immunology therapeutic area portfolio that has been a strategic growth area for our Company during the last years. The Immunology Team Leader is responsible for application of cutting-edge quantitative and translational clinical pharmacology and pharmacometrics strategies to propel the internal portfolio forward leveraging the full strength of the QP2 department. The Immunology Team Leader will be tasked with overseeing a team of QP2 scientists, providing guidance in personnel management, scientific strategy, and operational execution, in addition to serving as QP2 lead on assigned projects. Reporting directly to the QP2 Immunology Executive Director 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. 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. Senior Directors are recognized as scientific thought leaders that develop and implement translational PK/PD strategies, characterize clinical pharmacokinetics and pharmacodynamics, and shape regulatory strategy, dose selection, and go/no-go decisions.

Responsibilities:

• Leading a team of approximately 4 QP2 scientists including people management, scientific and operational oversight, under the direction of the Executive Director of Immunology
• Leveraging end-to-end drug discovery/development and disease area expertise to independently provide day-to-day scientific oversight to individual contributors
• Setting priorities for direct reports and driving performance management, hiring and retention, staff development and training, and input into calibration and talent management processes
• Serving as an expert representative for QP2 on drug development and discovery teams and engaging in cross-functional and governance discussions, including business development and licensing evaluations
• Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics, contributing to cross-functional regulatory strategy, authoring regulatory documents (INDs, CSRs, CTDs)
• Developing and applying mechanistic, disease progression and comparator modeling platforms to help drive insights portfolio decisions and inform biomarker strategies
• In partnership with Executive Director of Immunology, identify resource needs and contribute to resource allocation internally
• Serve as QP2 lead on assigned projects

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Required:--

• Ph.D./PharmD or equivalent degree with at least 10 years of experience where "experience" means having a record of increasing responsibility and independence in a similar role in pharmaceutical drug development or regulatory
• Educational background in-biopharmaceutics, pharmaceutical sciences, pharmacometrics, chemical/biomedical engineering, mathematics, computational biology, or a related field
• Immunology therapeutic area or disease knowledge
• Extensive experience in developing quantitative strategies for impacting pipeline decisions, and drug development expertise
• Demonstrated ability to lead an interdisciplinary team or taskforce, and/or to oversee 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-
• Relevant regulatory and quantitative pharmacology experience--
• Proficiency in written and verbal communication, interdisciplinary collaboration, and problem scoping and planning-

Preferred:-

• Expert skills in performing population PK/PKPD analyses using standard pharmacometrics software (e.g., NONMEM, R, Monolix, Phoenix, etc.)
• Knowledge of quantitative strategies for complex modalities
• Scientific understanding of biopharmaceutical and ADME properties across modalities-
• Record of applying mechanistic models to inform decisions-
• Ability to influence regulatory strategies including prior experience independently authoring and defending regulatory filings for marketing authorization (NDA/MAA)-
• 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:
Biomarkers, Biopharmaceutics, Clinical Pharmacology, Data Modeling, Data Science, Data Visualization, Drug Development, Drug Discovery Research, Immunology, Interdisciplinary Collaboration, Machine Learning (ML), Organizational Performance Management, Pharmacokinetics, Product Approvals, Regulatory Experience, Stakeholder Relationship Management, Translational Medicine

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:

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

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".

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 .

You can apply for this role through (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

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

Relocation:
Domestic

VISA Sponsorship:
Yes

Travel Requirements:
10%

Flexible Work Arrangements:
Hybrid

Shift:
Not Indicated

Valid Driving License:
No

Hazardous Material(s):
n/a

Job Posting End Date:
02/25/2026
*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: R384285