Senior Principal Scientist, Quantitative Pharmacology and Pharmacometrics

Job Description

New hires in Non-Field based roles in the U.S. & Puerto Rico will be required, subject to applicable law, to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption to this vaccination requirement that can be accommodated without an undue burden to the operation. However, non-office based roles who routinely collaborate with external stakeholders such as employees in customer facing commercial or research based roles will be required, subject to applicable law, to be fully vaccinated as a condition of employment.

This Senior Principal Scientist (Senior Director equivalent) role is intended to provide scientific leadership for the clinical development of assets in the cardiometabolic therapeutic area, and at the discretion of the Executive Director may include direct reports.

Senior Principal Scientists in Quantitative Pharmacology and Pharmacometrics (QP2) oversee and directly 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.

Senior Principal Scientists provide strategic leadership and oversight, both supervising the work of other scientists and leading QP2 efforts on drug development programs and on business development efforts. Senior Principal Scientists are expected to have or be developing expertise in several areas, including:

• Overseeing a suite of programs (including both program strategy and execution) across the cardiometabolic portfolios

• Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics, contributing to cross-functional regulatory strategy, authoring regulatory documents (INDs, CSRs, CTDs), and representing QP2 at regulatory meetings

• Serving as an expert representative for QP2 on drug development teams and in cross-functional and governance discussions, including business development and licensing evaluations

• Framing critical drug development questions for optimizing model-based development population pharmacokinetic, exposure-response, quantitative system pharmacology (QSP) and disease progression models

• Driving the development of mechanistic, disease progression and comparator modeling platforms to help drive portfolio decisions

• Influencing clinical trial design via trial simulations and comparator modeling

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

The Senior Principal Scientist is a skilled quantitative drug developer, with a strong, integrated understanding of the strategic and regulatory elements of drug development. She/he develops strategies for quantitative analyses (and commensurate experiments/trials) within and across development programs. In addition to the responsibilities described above, Senior Principal Scientists demonstrate outstanding leadership and communication skills, collaborating across QP2 and with other functional areas, as well as with external vendors and partners to create a quantitative model-informed approach to impact program strategies and decision making on drug development teams.

Required:

• (a Ph.D. or equivalent degree with at least 10 years of experience) OR (a PharmD or equivalent degree with at least 12 years of experience) OR (an MS or equivalent degree with at least 14 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.

• Drug development expertise within the cardiometabolic therapeutic area, including a record of both internal and external impact in driving model-informed drug development strategies

• Ability to influence regulatory strategies including prior experience independently authoring and defending regulatory filings for marketing authorization (NDA/MAA)

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

Preferred:

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

• Scientific understanding of biopharmaceutical and ADME properties of both small molecules and biologics

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

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 …

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

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.

New hires in office-based roles in the US & Puerto Rico will be required, subject to applicable law, to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption to this vaccination requirement that can be accommodated without an undue burden to the operation. However, subject to applicable law, employees working in roles that the Company determines require routine collaboration with external stakeholders, such as employees in health services, customer facing commercial, or research based roles, will be required to be fully vaccinated as a condition of employment.

Current Employees apply HERE

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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 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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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.

Residents of Colorado:

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Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, 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.

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Relocation:

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Requisition ID:R165706