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

Job Description

Our Quantitative Sciences team use 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 the Pharmacometrics group at the department of Quantitative Pharmacology and Pharmacometrics apply quantitative approaches to develop and implement translational PK/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:

  • Serving as an expert pharmacometric/QP2 representative on drug/vaccine development teams

  • Framing critical drug development questions and develop modeling and simulation strategies for optimizing model-based drug development

  • Developing and executing on translational PK/PD models, population pharmacokinetic models, exposure-response and, stratification biomarker models, quantitative system pharmacology and disease progression models, clinical trial design via outcome/enrollment modeling and simulation, comparator modeling, absorption/bio-pharmaceutical 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, Clinical Supplies Requestor, Common Technical Documents), 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

Education Requirements:

  • Ph.D. or equivalent degree with 7 years of experience) OR (a PharmD or equivalent degree with 9 years of experience) OR (an MS or equivalent degree with 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 pharmacometrics, pharmaceutical sciences, mathematics, statistics/bio-statistics, computational biology/chemistry, chemical/biomedical engineering, or a related field.

  • Proficiency in NONMEM, Monolix, R, Matlab, Statistical Analysis System, or other similar programming language

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.

  • Experience in performing population PK / PKPD and state-of-the-art analyses using standard pharmacometric software

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

  • Scientific understanding of biopharmaceutical and Absorption, Distribution, Metabolism and Excretion 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

VISA Sponsorship:

Yes

Travel Requirements:

10%

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

Requisition ID: R53333

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