Director, Clinical Research, Translational Pharmacology-MD
Location:
, Pennsylvania
Posted:
October 29, 2016
Reference:
CLI005384
Two (2) positions open

Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us.

Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

Translational Pharmacology at Merck Research Labs is responsible for early clinical development of novel therapeutics, working in close collaboration with Discovery Sciences and late stage Clinical Research. We are seeking highly qualified individuals with expertise in Cardiovascular Disease, Thrombosis, Diabetes, Metabolism, Kidney Disease, Infectious Disease, Vaccines, Immunology or Neuroscience.

Translational Pharmacology is specifically responsible for:
  • Development and execution of the early clinical development strategy for novel therapy programs from Preclinical Candidate approval through clinical Proof-of-Concept (Phase 2a)
  • Development of biomarker strategies through cross-functional teams that provide line-of-sight from First-in-Human studies through clinical Proof-of-Concept
  • Development and execution of clinical pharmacology strategies for late stage development programs from Proof-of-Concept (Phase 2a) through worldwide marketing application
  • 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 that can be bridged into full development
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.
Individuals will report directly to one of the Translational Pharmacology Area Leads.

Primary responsibilities will include the following:
  • Key member of early development teams, 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 1 through 4 of development. This may include studies to validate clinical platforms utilizing established and novel biomarkers to demonstrate biological activity in humans
  • 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.
  • Provide clinical expertise for new targets in the Target Identification, Target Validation and Lead Identification space including participation in the selection of targets, and the design of preclinical pharmacology experiments to validate specific targets and/or pathways
  • 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, Drug Metabolism/Modeling & Simulation, Regulatory Affairs, late stage Clinical Research



Qualifications:
Education:
  • MD or MD/PhD; Board Certification or Eligibility preferred


Required:
  • Proven track record in clinical medicine or clinical research, and background in biomedical research.
  • Demonstrated record of scientific scholarship and achievement in cardiovascular, thrombosis, diabetes, metabolism, kidney, bacteriology, virology, immunology or neuroscience research, translational medicine and/or early drug development.
  • Strong interpersonal, writing and presentation skills, as well as the ability to function in a team environment are essential.


Preferred:
  • Prior specific experience in clinical research and prior publication is desirable but not necessary; preferably with experience in the area of basic, translational research and/or early clinical development


Our employees are the key to our company's success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company's benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at staffingaadar@merck.com.

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