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Senior Specialist - Quantitative Pharmacology and Pharmacometrics - Immune/Oncology (Remote)

at Merck in Dover, Delaware, United States

Job Description

Job Description

Role and Responsibilities:

We are seeking an experienced talented scientist to join the Quantitative Pharmacology and Pharmacometrics - Immune/Oncology (QP2-IO) team in the role of Senior Specialist. QP2-IO team is part of the Global Clinical Development organization and has oversight over drug development aspects related to clinical pharmacology and pharmacometrics of oncology drugs from post-Preclinical Candidate (PCC) to registration. This role is a unique opportunity to accelerate your professional career as a quantitative drug developer taking advantage of our end-to-end pipeline support in one of the world’s most research-intensive biopharmaceutical companies.

Senior Specialists in QP2-I/O will work in collaborative teams with more experienced scientists across disciplines, and are expected to have or develop expertise in one or more areas necessary to perform primary responsibilities including:

+ Applying quantitative approaches to develop and implement translational clinical pharmacokinetics and pharmacodynamics of new chemical entities and biologics

+ Developing and executing pharmacokinetics and pharmacodynamics modelling approaches, such as population pharmacokinetic, exposure-response, quantitative system pharmacology, and other model-based analyses.

+ Perform clinical trial simulations to inform dose selection and go/no-go decisions

+ Being or supporting the QP2-I/O Function Lead on oncology development teams.

+ Data management and analysis.

On the job, working with senior scientists you will develop a comprehensive understanding of global regulatory expectations for small molecules and biologics, including support and authoring for regulatory documents such as Investigational New Drug application, Clinical Study Report, Common Technical Document, and agency interactions. You will also develop leadership skills in areas such as mentoring, managing a program, project, or initiative. In addition to the responsibilities outlined above, Senior Specialists are expected to demonstrate good communication skills, collaborating within QP2-I/O and with other functional areas, as well as with external vendors and partners, creating an aligned, quantitative framework to impact decisions of drug development teams.

The ideal candidate is highly collaborative, eager to learn and not intimidated by tough scientific challenges. Excellent communication skills are required including the ability to clearly present scientific data in group settings.

Minimum education required:

Ph.D. or equivalent degree – OR – a PharmD or equivalent degree with at least 2 years of experience – OR – Masters or equivalent degree with at least 4 years of experience relating to: pharmacometrics, mathematics, statistics/ biostatistics, or chemical/biomedical engineering, where “experience” means having a record of increasing responsibility and independence in a similar role in pharmaceutical drug development or academia.

Required Experience:

+ An educational background in pharmaceutical sciences, pharmacometrics, mathematics, statistics/ biostatistics, computational biology/chemistry, or chemical/biomedical engineering.

+ Proficiency in R, NONMEM, Phoenix, MONOLIX or other similar programing language.

+ Skills in experimental design, mathematical problem solving, critical data analysis/interpretation, and statistics

+ Experience in performing population pharmacokinetics and pharmacodynamics analyses

+ Professional working proficiency in written and verbal communication.

“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.

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.

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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, 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 per

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Job Posting: JC260801685

Posted On: Jun 05, 2024

Updated On: Jul 13, 2024

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