Associate Principal Scientist, Quantitative Pharmacology and Pharmacometrics - Immune/Oncology ( MERCUSR116879ENUS)
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.
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.
New hires in office-based roles in the US & Puerto Rico will be required, subject to applicable law, to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption to this vaccination requirement that can be accommodated without an undue burden to the operation. However, subject to applicable law, employees working in roles that the Company determines require routine collaboration with external stakeholders, such as employees in health services, customer facing commercial, or research based roles, will be required to be fully vaccinated as a condition of employment.
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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.
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Flexible Work Arrangements:Remote Work
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Number of Openings:2