MSD Associate Director- Pharmacometrics 

United States, New Jersey, Rahway 

724513141

Job Description

This Associate Director will work with scientists within QP2 by applying one or more of the following pharmacometrics capabilities such as population pharmacokinetics (popPK), PK/PD models, exposure response (ER) models, model-based meta-analysis (MBMA), clinical trial simulations (CTS) and disease progression modeling into programs and thereby strengthening our pharmacometric capabilities on a continuous basis in decision making and driving pipeline impact. The Associate Director will perform job duties independently with minimal supervision and/or lead QP2 efforts on drug/vaccine development programs, and author or co-author strategic documents. Please note, this position is open to remote work. To comply with applicable law, candidates based in Sweden and Switzerland are required to work on a hybrid schedule, spending 2-3 days in the office and cannot work fully remotely.

Associate Directors are expected to have or be developing expertise in several areas, including:

• Responsible for achieving results on major program drivers by implementation of one or more novel quantitative approaches that seek to improve cycle time, cost/size, number of trials, clinical trial design and Go/No Go decisions

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

• Responsible for developing and executing population pharmacokinetic models, PK/PD models, ER models, MBMA, CTS, disease progression models, and other pharmacometric analyses

• Developing and 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

Required Experience:

• (a Ph.D. or equivalent degree with a minimum 3 years of experience) OR (a PharmD or equivalent degree with at least 5 years of experience) OR (an MS or equivalent degree with at least 7 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 pharmacometrics, biopharmaceutics, pharmaceutical sciences, mathematics, statistics/biostatistics, computational biology/chemistry, chemical/biomedical engineering, or a related field.

• Proficiency in performing pharmacometrics analyses such as population PK, PKPD, ER, MBMA, CTS, etc

• Knowledge of drug development, pharmacokinetics and pharmacology principles required

Preferred Experience:

• Proficiency in performing MBMA, CTS in standard pharmacometric software (e.g. R, NONMEM, Monolix, Matlab, etc.)

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

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

• Good interpersonal skills that ensure teamwork and productive interactions among diverse personalities/areas of expertise

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

Current Contingent Workers apply

US and Puerto Rico Residents Only:

if you need an accommodation during the application or hiring process.

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, generally Tuesday, Wednesday and either Monday or 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 aagreement (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”.

Expected salary range:

$149,400.00 - $235,100.00

1st - Day

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.

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.