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About the Role

We have an exciting opportunity for a physician-scientist to join our group as a Principal Scientist (Clinical Director) in Translational Medicine/Early Clinical Development in the Infectious Diseases Therapeutic Area. Translational Medicine at our Research Division is responsible for early clinical development of novel therapeutics, working in close collaboration with our discovery scientists and late-stage clinical researchers. The Infectious Diseases Therapeutic Area specifically focuses on translational and clinical development of anti-infectives, both for treatment and for prophylaxis indications. We are seeking a highly qualified individual for a position in our group. Candidates must have a strong background in basic and/or clinical translational research and a desire to work collaboratively with functional area partners across therapeutic areas and stages of development.

Responsibilities

Contribute to the identification of novel targets by partnering with Discovery Sciences to bring a clinical perspective into the earliest stages of target identification and validation.
Execute clinical studies to evaluate the relevance of potential targets to human disease in order to justify full development.
Lead the early clinical development strategy for novel therapeutic programs from the preclinical stage through Phase 1 studies of safety, tolerability, pharmacokinetics and pharmacodynamics, to Phase 2 studies demonstrating Proof-of-Concept and enabling Phase 3 clinical trials.
Develop biomarker strategies through cross-functional teams that advance therapeutics from First-in-Human studies through clinical Proof-of-Concept, including experimental medicine studies to establish and/or validate biomarker platforms.
Develop and execute clinical pharmacology strategies to support later stages of development, from Phase 3 through to worldwide regulatory applications.
Work with basic science teams on specific diseases and therapeutic areas, providing clinical expertise for identification and validation of novel targets.
Design preclinical and clinical experiments to validate targets and/or pathways, and leverage this work for development of novel therapeutics.
Work with cross-functional teams including discovery scientists, pharmacologists, toxicologists, and other specialists to advance novel therapeutics from preclinical development into clinical development.
As a key member/leader of an early development team, work in close collaboration with internal and external staff and scientists for the design and execution of early clinical development strategy.
Take a lead role in developing and executing clinical pharmacology studies for programs in all phases (I – IV) of development, including formulation or device changes, drug-drug interaction studies, and studies in special populations.
Provide early phase/clinical pharmacology support for programs through the regulatory filing process including preparation of supportive documents and presentations.
Develop and execute studies to validate established and novel clinical biomarkers, including blood/tissue sampling, imaging, electrophysiological, wearable devices, and behavioral responses to study biological activity in humans.
Provide clinical and scientific expertise to assess internal and external opportunities for partnership.
Engage with the broader internal and external scientific community in disease or therapeutic areas of interest, including via consultations with scientific/academic thought leaders, preparation of posters and publications, and attendance/presentation at conferences.
Work broadly with key functions across the company at research sites around the world.

Requirements

MD or MD/PhD

Skills

Clinical Research
Early Clinical Development
Infectious Disease
Translational Medicine

Location

Rahway, NJ, USA

Work Type

Hybrid
Regular

Experience Level

Principal Scientist

Education Level

MD
MD/PhD

Salary/Compensations

$260,300.00 - $409,700.00

Benefits

Medical
Dental
Vision healthcare
Other insurance benefits (for employee and family)
Retirement benefits, including 401(k)
Paid holidays
Vacation
Compassionate and sick days

About the Company

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA.
We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds.
The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment.
We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Equal Opportunity

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.
As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.
For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights
EEOC GINA Supplement
Learn more about your rights, including under California, Colorado and other US State Acts
San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance