Principal Scientist (Director) in Translational Pharmacology

Job Description

Our company, is a global health care leader with a diverse portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where our company has codified its legacy for over a century. Our company's success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

We are on a quest for cures and committed to being the world's premier, most research-intensive biopharmaceutical company. Our Research Division will take our company's leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach diseases.

We have an exciting opportunity for aPrincipal Scientist (Director) in Translational Pharmacologyto be based in the US (Greater Philadelphia area).

Translational Pharmacology at our Research Division is responsible for early clinical development of novel therapeutics, working in close collaboration with Discovery Sciences and late stage Clinical Research. We work with all therapeutic areas within our Research Division. 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 across different therapeutic areas.

Translational Pharmacology is specifically responsible for:
  • Contributing to the identification of novel targets by partnering with discovery research teams to bring a clinical perspective into the earliest stages of target identification and validation, and executing clinical studies to evaluate the relevance of potential targets to human disease in order to justify investment in full development, that can be bridged into full development
  • Development of biomarker strategies through cross-functional teams that provide line-of-sight from First-in-Human studies through clinical Proof-of-Concept. This includes Experimental Medicine studies to establish and/or validate biomarker platforms.
  • Leadership of the early clinical development strategy for novel therapy programs from Preclinical Candidate approval through Clinical Pharmacology testing (Phase 1), and clinical Proof-of-Concept (Phase 2).
  • Development and execution of clinical pharmacology strategies to support later stages of development from Proof-of-Concept (Phase 2) through worldwide marketing application.


Success depends on the integrity, knowledge, imagination, creativity, skill, diversity and teamwork of the people in the group. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of the global team, you will collaborate with talented and dedicated colleagues in Translational Pharmacology, as well as Discovery Sciences and late stage Clinical Research while developing and expanding your career.

Primary responsibilities for the Principal Scientist include the following:
  • Key member of an early development team, providing leadership in designing and executing early clinical development strategy
  • Development and execution of early clinical strategy for novel therapeutics including authoring initial clinical and biomarker plans for Lead Optimization programs, early clinical development plans for Preclinical Candidate molecules, and clinical pharmacology studies for programs in Phases I through IV of development.
  • Development and execution of studies to validate clinical platforms utilizing established and novel biomarkers, including imaging, electrophysiological and behavioral responses to interrogate biological activity in humans.
  • Provide clinical expertise for identification and validation of novel targets, including the design of preclinical and/or clinical pharmacology experiments to validate targets and/or pathways
  • Safe and timely execution of Phase I studies; close collaboration with internal and external clinical study support staff and scientists (including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs, and global clinical trials operations)
  • Provide clinical pharmacology support for programs through the worldwide marketing application filing including supportive registration documents and presentations
  • Provide clear, timely communication and interpretation of study results to therapeutic area governance, functional area experts and development review committees.
  • Contribute to assessment of internal and external opportunities identified by Business Development and Licensing
  • Interface broadly with key functions including Discovery Sciences, Preclinical Pharmacology, Pharmaceutical Sciences, Toxicology, Translational Biomarkers, Translational Pharmacology Operations, Translational Pharmacology-EU, Drug Metabolism/Modeling & Simulation, Regulatory Affairs, and late stage Clinical Research throughout sites in the USA, UK and Belgium.


Education:
  • MD or MD/PhD; or
  • PhD/PharmD; at least10years of drug development experience to include preclinical pharmacology, biomarker validation and development, and team management


Required:
  • Proven track record in clinical medicine or clinical research, and background in biomedical research.
  • Demonstrated record of scientific scholarship and achievement. The particular clinical or scientific background is less important than having a track record of excellence and a willingness to work collaboratively across different therapeutic areas.
  • Strong interpersonal, writing and presentation skills, as well as the ability to function in a team environment are essential.
  • Board Certification or Eligibility (MD and MD/PhD) preferred
  • Prior specific experience in clinical research and prior publication preferably with experience in the area of basic, translational research and experience with early clinical development and patient care.


We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we "follow the science" and that great medicines can make a significant impact to our world. And 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.

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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.

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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:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:
1

Requisition ID:R110651