Job Description

Directors in Quantitative Pharmacology and Pharmacometrics (QP2) apply quantitative approaches to characterize clinical pharmacokinetics and pharmacodynamics of new chemical entities and biologics, inform dose selection and go/no-go decisions, and shape, present and defend regulatory strategies to support global regulatory submissions and post-approval expansions in indications. Directors perform job duties independently with minimal supervision, lead QP2 efforts on drug development programs, and author strategic documents. Directors are expected to have or be developing expertise in several areas, including:

• Serving as an expert representative for QP2 on teams developing infectious disease or vaccine assets

• Framing critical drug development questions for optimizing model-based development

• Developing and executing translational PK/PD models, population pharmacokinetic models, exposure-response and, stratification biomarker models, quantitative system pharmacology (QSP) and disease progression models, clinical trial design via outcome/enrollment modeling and simulation, comparator modeling, absorption/biopharmaceutical modeling, clinical utility index modeling, and other model-based analyses

• Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics, authoring regulatory documents (INDs, CSRs, CTDs), and representing QP2 at regulatory meetings

• In partnership with key cross-functional area experts, strategically frame and progress issues related to clinical pharmacology and biopharmaceutics

• Mentoring and/or supervising junior colleagues to perform the above duties and to develop the above capabilities

The Director is a skilled quantitative drug and vaccine developer, with a strong, integrated understanding of the strategic elements of drug discovery and development. They develop strategies for quantitative analyses (and commensurate experiments/trials) within and across development programs and/or functions. In addition to the responsibilities described above, Directors demonstrate outstanding leadership and communication skills. They collaborate with other functional areas, as well as with external vendors and partners, creating an aligned, quantitative and model-informed regulatory framework to impact strategies and decisions of drug development teams.

This role will be focused on efforts in the infectious disease and vaccines therapeutic area.

Required:

• a Ph.D. or equivalent degree with at least seven years of experience OR (a PharmD or equivalent degree with at least nine years of experience where “experience” means having a record of increasing responsibility and independence in a similar role in pharmaceutical drug development or academia

• Educational background in biopharmaceutics, pharmaceutical sciences, pharmacometrics, mathematics, statistics/biostatistics, computational biology/chemistry, chemical/biomedical engineering, or a related field.

• Experience with modeling programing language(s) (e.g. R, NONMEM, Matlab, SAS, or other similar)

• Direct experience in regulatory interactions and filings for small molecule and/or biologic drug development

Preferred:

• Prior experience working in infectious diseases, including respiratory viruses

• An exemplary record of increasing responsibility, independence, and demonstrated impact in driving drug development decisions through application of model-based approaches in the pharmaceutical industry

• Ability to influence regulatory strategies including independently formulating and defending registration packages to support global filings

• A strong understanding of clinical pharmacology studies to support intrinsic/extrinsic factor evaluation

• Experience in performing population PK, PKPD, or viral dynamic analyses using standard pharmacometric software (e.g. NONMEM, Monolix, Phoenix, etc.)

• Expert skills in experimental design, mathematical problem solving, critical data analysis/interpretation, and statistics

• Scientific understanding of biopharmaceutical and ADME properties of small molecules and/or biologics

• Proficiency in written and verbal communication, interdisciplinary collaboration, and problem scoping and planning

• Demonstrated ability to participate in and to lead an interdisciplinary team, and to oversee the work of other scientists

Required Skills:

Clinical Pharmacology, Clinical Study Design, Clinical Trials, Computational Biology, Data Modeling, Data Science, Data Visualization, Drug Development, Interdisciplinary Collaboration, Pharmaceutical Development, Pharmaceutical Sciences, Pharmacodynamics, Pharmacokinetics, PKPD Modeling, Population Pharmacokinetics, Stakeholder Relationship Management

Preferred Skills:

Infectious Disease, Machine Learning (ML), Vaccine Development

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.

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

$190,800.00 - $300,300.00

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

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:

04/11/2026

*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.