Senior Principal Scientist, Quantitative Pharmacology and Pharmacometrics (Remote)

Job Description

This Senior Principal Scientist role is intended to provide leadership for the immunology therapeutic area and drive the integration of immunology-driven targets across the broader suite of therapeutic areas. 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 a portfolio of projects and leading QP2 efforts on drug development programs. Senior Principal Scientists are expected to have or be developing expertise in several areas, including:

• Overseeing a portfolio of programs (including both program strategy and execution) across the immunology portfolio

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

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

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

• Influencing clinical trial design via trial simulations and comparator modeling

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

• Mentoring and/or supervising junior 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 elements of drug discovery and development that can represent the combined efforts of QP2 and the wider Department of Pharmacokinetics, Pharmacodynamics and Drug Metabolism (PPDM). She/he develops strategies for quantitative analyses (and commensurate experiments/trials) within and across development programs and/or functions. In addition to the responsibilities described above, Senior Principal Scientists demonstrate outstanding leadership and communication skills, collaborating across PPDM 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 immunology therapeutic area, including a record of both internal and external impact in driving model-informed drug development strategies within immunology programs

• 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.

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.

• 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.

Residents of Colorado

[Register to View] to request this role’s pay range.

NOTICE FOR INTERNAL APPLICANTS

In accordance with [Register to View] 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.

DATA2020

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.

Current Employees apply [Register to View]

Current Contingent Workers apply [Register to View]

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 [Register to View] if you need an accommodation during the application or hiring process.

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

[Register to View]

[Register to View]

[Register to View]

[Register to View]

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.

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID:R119650