Associate Director of Pharmacometrics, Quantitative Pharmacology & Pharmacometri

Job Description

Associate Director – Pharmacometrics, Quantitative Pharmacology and Pharmacometrics

The Quantitative Pharmacology and Pharmacometrics (QP2) department drives model-informed drug discovery and development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced leadership team, deep modeling expertise and state-of-the-art modeling approaches across multiple therapeutic areas and modalities to drive portfolio impact from discovery through life-cycle management. The team is externally visible and continues to be at the leading edge of building innovative state of the art tools. With MIDD as an essential component of decision-making at our company, this position offers an opportunity for the Associate Director to drive pipeline impact across therapy areas.

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.

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 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

This (remote) position is only applicable for those that are not within commutable distance to primary sites noted in posting. If commutable, please see requisition "#R326823”. Please note that standard commute is (less than) <50 miles.

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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 Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.

Expected US salary range:

Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listedhere.

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: