Full-Time

Director – Quantitative Pharmacology and Pharmacometrics

Posted on 2/3/2025

Merck

Merck

10,001+ employees

Develops medicines and vaccines for health issues

Biotechnology
Healthcare

Compensation Overview

$181.6k - $285.8kAnnually

+ Bonus + Long Term Incentive

Senior, Expert

H1B Sponsorship Available

Remote in USA

This remote position is only applicable for those that are not within commutable distance to primary sites noted in posting. Standard commute is less than 50 miles.

Category
Physicians & Surgeons
Medical, Clinical & Veterinary

You match the following Merck's candidate preferences

Employers are more likely to interview you if you match these preferences:

Degree
Experience
Requirements
  • (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) OR (an MS or equivalent degree with at least 11 years of experience), where “experience” means having a record of increasing responsibility and independence in a similar role in pharmaceutical drug development, regulatory agency, or academia.
  • Educational background in biopharmaceutics, pharmaceutical sciences, pharmacometrics, chemical/biomedical engineering, or a related field.
  • 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.
  • Direct experience in regulatory interactions.
  • 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.
  • Knowledge in modeling of complex therapeutics.
  • Flexibility to react rapidly to changing situations/environment.
  • Knowledge in ophthalmology and/or cardiometabolic clinical drug development programs.
  • Knowledge in modeling of complex ophthalmology therapeutics.
Responsibilities
  • Develop model-based strategies (translational PK/PD strategies, mechanistic model, POPPK/PD, clinical trial simulations, etc.) for quantitative analyses, within and across development programs and/or departments, to inform and optimize drug discovery and all phases of drug development including, but not limited to dose selection, clinical trial design, and go/no-go decisions.
  • Represent QP2 on ophthalmology discovery, early clinical development and late clinical development teams, leveraging quantitative approaches to drive streamlined development of programs within our growing ophthalmology portfolio.
  • 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 discovery and development teams.
  • Collaborate with other functional areas, as well as with external vendors and partners, on activities related to study design, protocol development, study execution, reporting and interpretation of data.
  • Maintain a comprehensive understanding of global regulatory expectations and shape, present and defend regulatory documents and submissions.
  • Work closely with pharmacometrics team members and provides input related to analysis and reporting of modeling activities.
  • Mentor or supervise early career scientists to grow their skill sets to perform project related duties.
Desired Qualifications
  • Ability to influence regulatory strategies including independently formulating registration packages to support global filings, a strong understanding of clinical pharmacology studies to support intrinsic/extrinsic factors, ability to independently author, defend regulatory filings.
  • Experience in performing population PK/PKPD analyses using standard pharmacometrics 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.
  • Experience with modeling programing language(s) (e.g. R, NONMEM, R, Phoenix, or other similar packages)

Merck develops medicines and vaccines to address significant health challenges such as cardiovascular disease, diabetes, and cancer. The company conducts extensive research and development to create new treatments, focusing on the pharmaceutical and biotechnology sectors. Merck's products include prescription medicines, vaccines, and animal health products, which are sold to patients, healthcare professionals, and institutions around the world. A key aspect of Merck's approach is its commitment to patient assistance programs that provide free medicines and vaccines to those in need. Unlike many competitors, Merck also offers professional resources through platforms like Merck Connect and Merck Manuals, enhancing support for healthcare providers.

Company Stage

IPO

Total Funding

$347.4M

Headquarters

Kenilworth, Illinois

Founded

1891

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Simplify's Take

What believers are saying

  • Collaboration with Atropos Health enhances Merck's data analytics capabilities.
  • Acquisition of WuXi Vaccines' facility expands Merck's vaccine production capacity.
  • Partnership with Purdue and Eli Lilly may innovate drug manufacturing processes.

What critics are saying

  • Increased competition from U.K. biotech firms challenges Merck's market share.
  • Acquisition of WuXi facility may pose operational integration risks.
  • Collaboration with Atropos Health may face data privacy and compliance challenges.

What makes Merck unique

  • Merck focuses on innovative medicines and vaccines for major health issues.
  • The company invests heavily in R&D to create new treatments and therapies.
  • Merck offers patient assistance programs and professional resources globally.

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Benefits

Health Insurance

Dental Insurance

Vision Insurance

401(k) Retirement Plan

401(k) Company Match

Paid Holidays

Paid Vacation

Paid Sick Leave

Hybrid Work Options

Flexible Work Hours