Clinical Director, Translational Medicine

Job Description

Our Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific and ethical standards.

We have an exciting opportunity for a Clinical Director in Translational Medicine based in Boston, MA. 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. 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 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 executing clinical studies to evaluate the relevance of potential targets to human disease in order to justify 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 approval of candidates after preclinical development, through Phase 1 studies of safety, tolerability, pharmacokinetics and pharmacodynamics, to Phase 2 studies demonstrating Proof-of-Concept
• Development and execution of clinical pharmacology strategies to support later stages of development through worldwide regulatory applications

Success relies 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 job responsibilities:

• Work 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
• Work with cross-functional teams including discovery scientists, pharmacologists, toxicologists, and other specialists to advance novel therapeutics from preclinical development to clinical development
• As a key member/leader of an early development team, will work 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
• 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

Education:

• MD or international equivalent
• Residency/fellowship training completion

Required Experience and Skills:

• Proven track record in clinical medicine or clinical research, and background in biomedical research
• Demonstrated record of scientific scholarship and achievement. The specific 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
• Prior specific experience in patient care and in basic, translational, and/or clinical research, with experience in scientific writing and publication

Preferred Experience and Skills:

• Clinical Board Certification
• Prior clinical or research experience in Infectious Disease or Immunology

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., Rahway, 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.

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Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

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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:
Regular

Relocation:
Domestic

VISA Sponsorship:
Yes

Travel Requirements:

Flexible Work Arrangements:
Hybrid, On-Site

Shift:
1st - Day

Valid Driving License:

Hazardous Material(s):

Requisition ID:R222096