Associate Principal Scientist, Quantitative Pharmacology and Pharmacometrics - Immune/Oncology

Job Description

Subject to applicable law, all prospective hires will be required to demonstrate that they have been fully vaccinated for COVID-19 or intend to be vaccinated for COVID-19 by November 1, 2021, or qualify for a medical or religious accommodation to this vaccination requirement. Hired candidates who are not vaccinated by November 1, 2021, and who have not been approved for a legally-required medical or religious accommodation will be subject to disciplinary action up to and including termination of employment, subject to applicable law.

We are seeking talented scientists to join the Global Clinical Development Quantitative Pharmacology and Pharmacometrics Immune/Oncology team in the role of Associate Principal Scientist. In this role, you will apply quantitative approaches to develop and implement translational clinical pharmacokinetics and pharmacodynamics of new chemical entities and biologics, and perform clinical trial simulations to inform dose selection and go/no-go decisions. You 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 performing primary responsibilities including:

• Being or supporting the lead representative for Quantitative Pharmacology & Pharmacometrics on oncology discovery and development teams.

• Framing critical drug development questions and using quantitative methods for optimizing drug development.

• Developing and executing pharmacokinetics and pharmacodynamics approaches, population pharmacokinetic models, exposure-response models, quantitative system pharmacology, and other model-based analyses.

• Data management and analysis.

On the job, you will develop a comprehensive understanding of global regulatory expectations for small molecules, biologics and/or vaccines, including support for regulatory documents 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 Scientists are expected to demonstrate good communication skills, collaborating within Quantitative Pharmacology Pharmacometrics 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.

Education Minimum Requirements:

• Ph.D. or equivalent degree with 3 years of experience - OR- a PharmD or equivalent degree with 5 years of experience / educational background relating to: PKPD, pharmacometrics, mathematics, statistics/ biostatistics, computational biology/chemistry, or chemical/biomedical engineering OR

• Masters or equivalent degree with 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.

Required Experience and Skills:

• Proficiency in R, Matlab or other similar programming language.

• Professional working proficiency in written and verbal communication.

Preferred Experience and Skills:

• Experience in pharmacokinetics and pharmacodynamics of large molecules, e.g., mAb Physiological Based Pharmacokinetics (PBPK) modeling.

• Experience in performing population pharmacokinetics and pharmacodynamics analyses.

• Experience with standard pharmacometric software (e.g., NONMEM, Monolix, Phoenix, etc.).

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

#DATA2020

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 …

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

Invent. Impact. Inspire.

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.

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.

Current Employees apply HERE

Current Contingent Workers apply HERE

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:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID:R116879