Merck Director, Clinical Research in North Wales, Pennsylvania
The Director reports to a Senior or Executive Director in the Infectious Disease Clinical Research Group.
Under the guidance of a supervisor, the Director has primary responsibility for protocol development and medical/scientific oversight of clinical research studies involving new or marketed drugs in the infectious diseases (Clinical Research) group. The individual would participate in all phases of clinical trial process (mainly Phase II-V) including study design, medical monitoring, and medical/scientific interpretation of study analyses, regulatory reporting, and publication. 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. He/she 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; and
Participation in internal and joint internal/external research project teams relevant to the development of new compounds, and the further study of marketed compounds.
In executing these duties, the Director may:
Supervise the activities of Clinical Scientists in the execution of clinical studies
Work closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects; and
Assist the Senior/Executive Director in ensuring that appropriate Corporate personnel are informed of the progress of studies of our company's and competitors' drugs and internal and external expert opinion on scientific questions relevant to his/her areas of responsibility.
The Director is responsible for maintaining a strong scientific fund of knowledge by:
Maintaining awareness of scientific developments within his/her area of expertise, including new scientific findings and research methodologies
Establishing connections with prominent clinical investigators in his/her particular field of interest, particularly those who will be willing and able to assist in the evaluation of company drugs
Attending appropriate scientific meetings to maintain his or her competency and to maintain awareness of research activities in his/her area of responsibility.
To accomplish these goals, the Director may:
Author detailed development documents and presentations for internal and external audiences
Author scientific publications
Facilitate collaborations with external researchers around the world
Travel on company business about fifteen (15) percent of the time to manage future or ongoing clinical research projects.
- M.D or M.D./Ph.D who is Board Certified or Eligible in Infectious Disease
Demonstrated record of scientific scholarship and achievement
Experience in clinical medicine and background in biomedical research are essential
Prior specific experience in clinical research is desirable but not necessary
Strong interpersonal skills, as well as the ability to function in a team environment, are essential.
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.
Merck & Co., Inc., Kenilworth, New Jersey, USA is known as “Merck” in the United States, Canada & Puerto Rico. We are known as “MSD” in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.
We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development.
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.
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.
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We are an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.
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Flexible Work Arrangements:
Valid Driving License:
Number of Openings:
Requisition ID: R74286
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