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Clinical Director, Translational Medicine

Job Description

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.

We have an exciting opportunity for a Principal Scientist (Director) in Translational Medicine based in the US (Rahway, NJ; West Point, PA; Boston, MA; or South San Francisco, CA).

Translational Medicine 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 Medicine 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 Medicine, 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 Medicine Operations, Translational Medicine-EU, Drug Metabolism/Modeling & Simulation, Regulatory Affairs, and late-stage Clinical Research throughout research sites around the world.

Education:

  • MD/PhD or MD

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.

  • Clinical Board Certification preferred

  • Prior specific experience in clinical research and prior publication preferably with experience in the area of basic or 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” 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.

Current Employees apply HERE

Current Contingent Workers apply HERE

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:

EEOC Poster

EEOC GINA Supplement​

OFCCP EEO Supplement

Pay Transparency Nondiscrimination

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., 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:

Regular

Relocation:

Domestic

VISA Sponsorship:

No

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

Requisition ID:R177759

Clinical Director, Translational Medicine

West Point, PA
Full Time

Published on 06/23/2022

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