Job Description

R5 - 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 Director to drive pipeline impact and mentor/coach a talented group of pharmacometricians.

The Director-Pharamcometrics will work with scientists within QP2 by proactively evaluating and incorporating one or more of the following pharmacometrics capabilities into programs and thereby strengthening our pharmacometric capabilities on a continuous basis in decision making and driving pipeline impact: population pharmacokinetics (PK) and pharmacodynamics (PD) analysis, model-based meta analysis (MBMA), clinical trial simulations (CTS), disease progression modeling and Artificial Intelligence /Machine Learning. In addition, the individual will be accountable for coaching/mentoring talented pharmacometricians with diverse backgrounds to drive portfolio impact.

Directors (Pharamcometrics) are expected to provide expertise in one or more of the pharmacometrics capabilities through the following responsibilities.

• Responsible for achieving results on major program deliverables by identifying, driving the development and 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

• Serve as a subject matter expert and foster collaboration within QP2 and across functions to plan and execute novel analyses for informed decision making on programs

• Mentor and/or supervise junior colleagues to perform the above duties and to develop the above capabilities

• Leverage significant pharmacometric and subject matter expertise in a broad range of therapeutic areas, modalities and stages of drug discovery/development to independently provide day-to-day coaching/guidance to individual contributors

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

Required Experience:

• Ph.D. or equivalent degree with at least 7 years of experience OR a PharmD or equivalent degree with at least 9 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 or academia

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

• Extensive experience in performing population PK and PK/PD analyses using standard pharmacometric software (e.g. NONMEM, R, Monolix, etc.)

• Deep expertise in pharmacometrics with ability to understand how (MIDD can drive portfolio and regulatory decisions

• Deep knowledge of drug development, pharmacokinetics and pharmacology and basic science skills required

Preferred Experience:

• Expertise in advanced PK/PD modeling and Pharmacometrics

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

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

• Excellent communication Skills including ability to effectively present complex data, development plans and strategies to various audiences in both verbal and written form, steer and influence interpretations (including impact) and conclusions for reports and regulatory documents that are clear and concise

• Demonstrated external visibility in the field of pharmacometrics, through publications, presentations, and involvement in professional organizations

• Experience in developing quantitative strategies impacting pipeline decisions

• Ability to participate in and to steer an interdisciplinary team, and to oversee the work of other scientists

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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 listed here.

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

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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.

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Requisition ID:R323398