Job Description

Job Description

Principal Scientist, Quantitative Pharmacology and Pharmacometrics

Our Company is on a quest for cures and is committed to being the worlds premier most research-intensive biopharmaceutical company. Today, were doubling down on this goal. Our Research Laboratories is a true scientific research facility of tomorrow and will take our company's leading discovery capabilities and world-class small molecule and biologics Research & Development (R&D) expertise to create breakthrough science that radically changes the way we approach serious diseases.

Role and Responsibilities:

We are seeking talented scientists to join the Quantitative Pharmacology and Pharmacometrics (QP2) Immune-Oncology team in the role of Principal Scientist. The Principal Scientist is a skilled modeler and a quantitative drug 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. 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. Principal Scientists are expected to have or be developing expertise in several areas necessary to performing primary responsibilities including:

Primary Responsibilities:

* Serving as an expert representative for QP2 on Oncology development teams

* Framing critical drug development questions for optimizing model-based developments

* Developing and executing translational PK/PD approaches, population pharmacokinetic models, exposure-response models, clinical trial design simulation, comparator modeling and other model-based analyses

* Strategizing and executing modeling of tumor size and survival endpoints including proportional hazards models

* Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics in the Oncology area, authoring regulatory documents (investigational new drugs/INDs, clinical study reports (CSRs), clinical trial applications (CTDs)), and representing QP2 at regulatory meetings

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

Education & Experience Requirements:

* Ph.D., PharmD or equivalent degree with at least seven years of experience / educational background relating to: PKPD, pharmacometrics, mathematics, statistics/ biostatistics, or chemical/biomedical engineering.

* Master or equivalent degree with at least eleven years of experience, where experience means having a record of increasing responsibility and independence in a similar role in pharmaceutical drug development or academia.

* Demonstrated impactful experience with applications of pharmacometrics method in the Oncology area

* Experience in IND, NDA, and other submissions to global regulatory agencies in the Oncology area

* Skills in experimental design, mathematical problem solving, critical data analysis/interpretation, and statistics

* Proficiency in R, NONMEM or other similar programing language

* Professional working proficiency in written and verbal communication

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

VISA Sponsorship:

Yes

Travel Requirements:

10%

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1
Requisition ID:R89892