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Merck Principal Scientist, Quantitative Pharmacology and Pharmacometrics in Rahway, New Jersey

Job Description

Our Quantitative Sciences team uses big data to analyze the safety and efficacy claims of our potential medical breakthroughs. We review the quality and reliability of clinical studies using deep scientific knowledge, statistical analysis and high-quality data to support decision making in clinical trials.

Principal Scientists in Quantitative Pharmacology and Pharmacometrics (QP2) apply quantitative approaches to develop and implement translational Pharmacokinetics (PK)/ Pharmacodynamics (PD) strategies, characterize clinical pharmacokinetics and pharmacodynamics of new chemical entities and biologics, and inform dose selection and go/no-go decisions. Principal Scientists perform job duties independently with minimal supervision, and mentor others to develop similar capabilities. They 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:

Primary Responsibilities:

  • 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 (investigational new drugs/INDs, clinical supplies requestor (CSRs), clinical trial applications (CTDs), and representing QP2 at regulatory meetings.

  • Overseeing a group of scientists (in a scientific and/or supervisory role).

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

The Principal Scientist is a skilled modeler and a quantitative drug/vaccine developer, with a strong, integrated understanding of the strategic elements of drug discovery and development, and leads the combined efforts of QP2 and the wider Department of Pharmacokinetics, Pharmacodynamics and Drug Metabolism (PPDM). 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 within QP2 and with other functional areas, as well as with external vendors and partners, creating an aligned, quantitative framework to impact strategies and decisions of drug development teams. This role will be focused on efforts in infectious disease areas.

Education Minimum Requirements:

  • Ph.D., PharmD, or equivalent degree with at least seven years of experience

  • 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.

Required Experience and Skills:

  • Educational background in biopharmaceutics, pharmaceutical sciences, pharmacometrics, mathematics, statistics/biostatistics, computational biology/chemistry, chemical/biomedical engineering, or a related field.

  • Proficiency in R, NONMEM, MATLAB, SAS, or other similar programming language.

Preferred Experience and Skills:

  • 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.

  • Direct experience in regulatory interactions and filings, and drug development of biologics.

  • 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.

  • 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” and that great medicines can make a significant impact to our world. And 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 …

Merck & Co., Inc., Kenilworth, New Jersey, USA is known as “Merck” in the United States, Canada & Puerto Rico. We are known as “MSD” in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.

We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development.

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. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.

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.

US and Puerto Rico Residents Only:

If you need an accommodation for the application process please email us at [email protected]

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

EEOC Poster at https://www.dol.gov/sites/dolgov/files/ofccp/regs/compliance/posters/pdf/eeopost.pdf

EEOC GINA Supplement​ at https://www.eeoc.gov/sites/default/files/migratedfiles/employers/eeocgina_supplement.pdf

OFCCP EEO Supplement at https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdf

OFCCP Pay Transparency Rule at https://www.dol.gov/ofccp/pdf/pay-transp%20EnglishformattedESQA508c.pdf

We are an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.

Search Firm Representatives Please Read Carefully

Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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:

Regular

Relocation:

Domestic/International

VISA Sponsorship:

Yes

Travel Requirements:

10%

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

Requisition ID: R67200

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