Merck Director, Clinical Research, HIV & HCV in North Wales, Pennsylvania
Our Clinical Research team addresses global challenges in infectious disease through research and innovation. Through clinical trials, we ensure the safety and efficacy of our existing products and advance the pipeline to produce safe, effective, innovative medicines.
The Clinical Director has primary responsibility for protocol development and medical/scientific oversight of clinical research studies involving new or marketed drugs in the Infectious Disease Clinical Research group. The individual would participate in all phases of clinical trial process including study design, oversight and medical monitoring of Phase II-IV studies, and medical/scientific interpretation of study analyses, regulatory reporting, and publications. The individual would apply an in-depth understanding of the disease under study and drug/vaccine pharmacology to the Infectious Disease franchise’s clinical development strategy and the implementation of short and long-term research objectives. They would provide internal scientific leadership for cross-functional areas supporting clinical development and external leadership through interaction with key scientific leaders.
Specifically, the Director may be responsible for:
Evaluating pre-clinical and translational work for the purpose of generating early clinical development plan and Investigational New Drug applications
Developing of clinical development strategies for investigational or marketed Infectious Disease drugs
Planning clinical trials (design, operational plans, settings) based on these clinical development strategies
Monitoring and managing the conduct of ongoing or new clinical trials for investigational or marketed Infectious Disease drugs
Analyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publication
Participation in internal and joint internal/external research project teams relevant to the development of new compounds, and the further study of marketed compounds.
- This position can be 100% remote.
Education Minimum Requirement:
MD or equivalent graduate education, preferably with demonstrated expertise in Infectious Diseases subspecialty.
Eligibility for medical licensure and board certification desirable.
Required Experience and Skills:
M.D. or D.O. with a clear grasp of infectious diseases. A person with postgraduate program in Infectious Diseases sciences yielding a Pharm D. or Ph.D. degree and demonstrated expertise in a field of medicine or clinical research may also be considered for appointment to the position.
Evidence of strong scientific productivity such as authorship on published manuscripts
Excellent communication (verbal and written) skills
Strong analytic skills
Strong interpersonal skills, as well as the ability to function effecitively in a team environment
Preferred Experience and Skills:
- Research background in design and implementation of clinical studies, familiarity with biostatistics, and/or regulatory review process is desirable but not necessary
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 …
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth .
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Flexible Work Arrangements:
Valid Driving License:
Number of Openings:
Requisition ID: R79280
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