Job Description

We have an exciting opportunity for a physician-scientist to join our group as aPrincipal 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.

Translational Medicine is specifically responsible for:

• Contributing 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, and to execute clinical studies to evaluate the relevance of potential targets to human disease in order to justify full development.
• Leadership of 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.
• Development of biomarker strategies through cross-functional teams that advance therapeutics from First-in-Human studies through clinical Proof-of-Concept. This includes experimental medicine studies to establish and/or validate biomarker platforms.
• Development and execution of clinical pharmacology strategies to support later stages of development, from Phase 3 through to worldwide regulatory applications.
• Success depends on the integrity, knowledge, imagination, creativity, skill, versatility and teamwork of the people in the group. To this end, we strive to create an environment of mutual respect, encouragement, and teamwork.

Education Requirements:

• MD or MD/PhD

Primary responsibilities for the Principal Scientist include the following:

• Working with basic science teams on specific diseases and therapeutic areas, providing clinical expertise for identification and validation of novel targets, including the design of preclinical and clinical experiments to validate targets and/or pathways, and leveraging this work for development of novel therapeutics
• Working 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, working in close collaboration with internal and external staff and scientists (including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs, and global clinical trials operations) for the design and execution of early clinical development strategy
• Taking a lead role in developing and executing clinical pharmacology studies for programs in all phases (I 6 IV) of development, including formulation or device changes, drug-drug interaction studies, and studies in special populations
• Providing early phase/clinical pharmacology support for programs through the regulatory filing process including preparation of supportive documents and presentations
• Developing and executing 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
• Providing clinical and scientific expertise to assess internal and external opportunities for partnership
• Engaging 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
• Working broadly with key functions across the company at research sites around the world.

Required Skills:

Preferred Skills:

Current Employees apply

Current Contingent Workers apply

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 if you need an accommodation during the application or hiring process.

The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee019s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at .

You can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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 Angeles019 Fair Chance Initiative for Hiring Ordinance

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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.

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

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