Associate Principal Scientist, Quantitative Pharmacology and Pharmacometrics

Job Description

New hires based in the US & Puerto Rico will be required to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption or accommodation to this vaccination requirement, subject to applicable law.

The Quantitative Pharmacology and Pharmacometrics (QP2) department within Pharmacokinetics, Pharmacodynamics, and Drug Metabolism (PPDM) drives model-informed drug discovery and development (MIDD). This Associate Principal Scientist position in the Pharmacometrics group within QP2 offers an opportunity to be an integral part of a team of pharmacometricians focused on implementing state-of-the art pharmacometric capabilities across multiple therapeutic areas and modalities to drive pipeline impact.

Associate Principal Scientists in the Pharmacometrics group apply quantitative approaches to develop and implement translational PK/PD strategies, characterize clinical pharmacokinetics and pharmacodynamics of new chemical entities and biologics, and inform dose selection and go/no-go decisions.

Associate Principal Scientists perform job duties independently with minimal supervision, support or lead QP2 efforts on drug/vaccine development programs, and author or co-author strategic documents. Associate Principal Scientists are expected to have or be developing expertise in several areas, including:

• Serving as an expert pharmacometric/QP2 representative for QP2 on drug/vaccine development teams
• Mentoring junior colleagues
• Framing critical drug development questions for optimizing model-based development
• Developing and executing translational PK/PD models, population pharmacokinetic models, exposure-response models, quantitative system pharmacology (QSP) and disease progression models, clinical trial design via modeling and simulation, comparator modeling, absorption/biopharmaceutical modeling, and other model-based 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

Associate Principal Scientists in the Pharmacometrics group are skilled pharmacometricians, with a strong, integrated understanding of the strategic elements of drug discovery and development and lead the combined efforts of QP2 and the wider PPDM department. In addition to the responsibilities described above, Associate Principal Scientists demonstrate excellent leadership and communication skills. They collaborate within QP2 and with other functional areas, as well as with external vendors and partners, creating a quantitative framework to impact strategies and decisions of drug development teams.

Required:

• (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 biopharmaceutics, pharmaceutical sciences, pharmacometrics, mathematics, statistics/biostatistics, computational biology/chemistry, chemical/biomedical engineering, or a related field.
• Proficiency in NONMEM, R or other similar programing language

Preferred:

• Proficiency in performing population PK / PKPD and non-compartmental analyses using standard pharmacometric software (e.g. Monolix, Phoenix, Matlab, SAS, etc.)
• Strong skills in experimental design, mathematical problem solving, critical data analysis/interpretation, and statistics
• Scientific understanding of biopharmaceutical and ADME properties
• Proficiency in written and verbal communication, interdisciplinary collaboration, and problem scoping and planning
• Experience leading a team.

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

Who we are …

We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for …

In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization.

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.

Residents of Colorado

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#EligibleForERP

For positions located in the United States and Puerto Rico – Subject to applicable law, all new hires (including internal transfers) must demonstrate that they are fully vaccinated against COVID-19 or that they qualify for a medical or religious exemption to this vaccination requirement. New hires (including internal transfers) to a position that, as determined by the Company, requires routine collaboration with external stakeholders (such as roles in health services or customer-facing commercial or research-based roles) (“Customer-Facing Role”) who are not vaccinated must qualify for a medical or religious exemption and be in a position that the Company determines can accommodate unvaccinated employees without causing an undue burden to business operations. If, following dialog with the candidate as appropriate, it is determined that the candidate either a) does not qualify for a religious or medical exemption or, b) for candidates applying for Customer-Facing roles, it is determined that allowing the candidate to work without vaccination would cause an undue burden to the Company, the candidate will be ineligible for hire or transfer, or any offer of employment or transfer (if applicable) will be revoked. Please note that notwithstanding the approval of any reasonable accommodation, the Company reserves the right to monitor, modify, or revoke any such accommodation if it is determined, following dialog with the employee, that the accommodation is no longer effective or results in an undue burden to the Company.

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US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

For more information about personal rights under Equal Employment Opportunity, visit:

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We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Under New York City law, the Company is required to provide a reasonable estimate of the salary range for this job. 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 salary range:

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

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Hazardous Material(s):

Number of Openings:

Requisition ID:R162174