Job Description

Job Description

Principal Scientists in Quantitative Pharmacology and Pharmacometrics (QP2) apply quantitative approaches to characterize clinical pharmacokinetics and pharmacodynamics of new chemical entities and biologics, and 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

* Cross therapeutic area experience

* Developing and executing population pharmacokinetic models, exposure-response analyses, clinical trial design and simulation, comparator modeling, absorption/biopharmaceutical modeling, and other model-based analyses

* Shaping complex and evolving regulatory interactions beyond initial filings, including those encompassing pediatric strategies, post-approval requirements/studies, biopharmaceutics considerations and special populations/drug-drug interactions. Global regulatory and drug development experience capable of identifying, influencing and executing strategies

* Incorporate pragmatic modeling and simulation strategies for mature products, meeting the rigor of regulatory expectations and requirements

* Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics, including biopharmaceutic and life-cycle management strategies.

* Authoring regulatory documents (INDs, CSRs, CTDs), informing drug labeling, representing QP2 at regulatory meetings, and ability to develop and influence regulatory strategies

The Principal Scientist is a skilled 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 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:

* Ph.D., PharmD or equivalent degree with a minimum of 7 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.

* 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. 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 staffingaadar@msd.com
For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster

EEOC GINA Supplement

OFCCP EEO Supplement

OFCCP Pay Transparency Rule

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:R89237