Job Description

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-Pharmacometrics will work with scientists within QP2 by proactively evaluating and incorporating advanced pharmacometrics capabilities like comparator modeling, model-based meta-analysis (MBMA) and clinical trial simulations (CTS) into programs and thereby strengthening our pharmacometric capabilities on a continuous basis in decision making and driving pipeline impact.The Director will have the ability to independently develop and deploy comparator models across different therapeutic areas. In addition, the individual will be accountable for coaching/mentoring talented pharmacometricians with diverse backgrounds to drive portfolio impact.

Directors (Pharmacometrics) 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 such as MBMA 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

Required Experience:

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

• Extensive experience in performing pharmacometrics analyses such as MBMA and CTS 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 principles required

Preferred Experience:

• Experience in performing pharmacometric analyses such as population pharmacokinetics (PopPK), pharmacokinetic/pharmacodynamic models, exposure-response models using NONMEM, R, Monolix, etc.

• 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

#EBRG

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

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

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US and Puerto Rico Residents Only:

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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:

$181,600.00 - $285,800.00

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 (https://www.benefitsatmerck.com/) .

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/International

VISA Sponsorship:

Yes

Travel Requirements:

10%

Flexible Work Arrangements:

Remote

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

N/A

Required Skills:

Business Intelligence (BI), Database Design, Data Engineering, Data Modeling, Data Science, Data Visualization, Machine Learning, Software Development, Stakeholder Relationship Management, Waterfall Project Management

Preferred Skills:

Job Posting End Date:

11/30/2024

*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: R301521