Associate Director, Quantitative Pharmacology and Pharmacometrics, Infectious Diseases and Vaccines
- Represent QP2 on infectious disease and vaccine discovery, early clinical development and late clinical development teams, leveraging quantitative approaches to drive streamlined development of programs within our robust infectious disease and vaccines portfolio.
- Develop model-based strategies ( translational PK/PD strategies, mechanistic, 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 translational strategies, dose selection, clinical trial design, and go/no-go decisions.
- 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 provide input related to analysis and reporting of modeling activities.
- A Ph.D. or equivalent degree with at least 4 years of experience OR a PharmD or equivalent degree with at least 6 years of experience OR an MS or equivalent degree with at least 8 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.
- Experience in performing population PK/PKPD analyses using standard pharmacometrics software (e.g. NONMEM, Monolix, Phoenix, etc.).
- Proficiency in written and verbal communication, interdisciplinary collaboration, and problem scoping and planning.
- Knowledge in infectious disease or vaccine clinical drug development programs
- 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
- An exemplary record of increasing responsibility, independence, and demonstrated impact in driving drug development decisions through application of model-based approaches.
$153,800.00 - $242,200.00 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 . 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 Required Skills:
Clinical Development, Clinical Pharmacology, Data Science, Data Visualization, Drug Development, Modeling Software, Pharmacology, Pharmacometrics, PKPD Modeling, Population Pharmacokinetics Preferred Skills:
Biologics, Infectious Disease, MATLAB, NONMEM, Phoenix WinNonlin, Python (Programming Language), Regulatory Writing, R Programming, Vaccine Development Job Posting End Date:
08/16/2025
*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: R355390
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