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Principal Scientist, Quantitative Pharmacology and Pharmacom

at Merck in Dover, Delaware, United States

Job Description

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.

Principal Scientists in Quantitative Pharmacology and Pharmacometrics (QP2) apply quantitative approaches to characterize clinical pharmacokinetics and pharmacodynamics of new chemical entities and biologics, inform dose selection and go/no-go decisions, and shape, present and defend regulatory strategies to support global regulatory submissions and post-approval expansions in indications. Principal Scientists perform job duties independently with minimal supervision, lead QP2 efforts on drug development programs, and author strategic documents. Principal Scientists are expected to have or be developing expertise in several areas, including:

+ Serving as an expert representative for QP2 on drug/vaccine development teams

+ Framing critical drug development questions for optimizing model-based development

+ Developing and executing translational PK/PD models, population pharmacokinetic models, exposure-response and, stratification biomarker models, quantitative system pharmacology (QSP) and disease progression models, clinical trial design via outcome/enrollment modeling and simulation, comparator modeling, absorption/biopharmaceutical modeling, clinical utility index modeling, and other model-based analyses

+ 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

+ Mentoring and/or supervising junior colleagues to perform the above duties and to develop the above capabilities

The Principal Scientist is a skilled quantitative drug/vaccine developer, with a strong, integrated understanding of the strategic elements of drug discovery and development. They develop strategies for quantitative analyses (and commensurate experiments/trials) within and across development programs and/or functions. In addition to the responsibilities described above, Principal Scientists demonstrate outstanding leadership and communication skills. They collaborate with other functional areas, as well as with external vendors and partners, creating an aligned, quantitative and model-informed regulatory framework to impact strategies and decisions of drug development teams.

This role will be focused on efforts in the infectious disease therapeutic area.

Required:

+ (a Ph.D. or equivalent degree with at least seven years of experience) OR (a PharmD or equivalent degree with at least nine 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 biopharmaceutics, pharmaceutical sciences, pharmacometrics, mathematics, statistics/biostatistics, computational biology/chemistry, chemical/biomedical engineering, or a related field.

+ Experience with modeling programing language(s) (e.g. R, NONMEM, Matlab, SAS, or other similar )

+ Direct experience in regulatory interactions and filings for small molecule and/or biologic drug development

Preferred:

+ An exemplary record of increasing responsibility, independence, and demonstrated impact in driving drug development decisions through application of model-based approaches in the pharmaceutical industry.

+ Ability to influence regulatory strategies including independently formulating registration packages to support global filings, a strong understanding of clinical pharmacology studies to support intrinsic/extrinsic factors, ability to independently author, defend regulatory filings.

+ Experience in performing population PK/PKPD analyses using standard pharmacometric software (e.g. NONMEM, Monolix, Phoenix, etc.)

+ Expert skills in experimental design, mathematical problem solving, critical data analysis/interpretation, and statistics.

+ Scientific understanding of biopharmaceutical and ADME properties of small molecules and/or biologics

+ Proficiency in written and verbal communication, interdisciplinary collaboration, and problem scoping and planning.

+ Demonstrated ability to participate in and to lead an interdisciplinary team, and to oversee the work of other scientists

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., Kenilworth, 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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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 (https://survey.sogosurvey.com/r/aCdfqL) 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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Pay Transparency Nondiscrimination

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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Job Posting: JC197526657

Posted On: Nov 13, 2021

Updated On: Jan 17, 2022