Oncology Clinical Director (Late Stage Clinical Development)
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.
The Director (Sr. Principal Scientist) has primary responsibility for the planning and directing clinical research activities involving new or marketed Oncology medicines. Merck's Oncology medicines span all phases of clinical development (pre-clinical to post-licensure). The Director will manage the entire cycle of clinical development, including: study design, placement, monitoring, analysis, regulatory reporting, and publication.
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 Oncology 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 Oncology 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 Merck'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, in terms of new scientific findings, research methodologies
- Identification of scientifically and operationally strong investigators who can assist in the development of Merck's investigational and marketed drugs
- Establishing communications 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 Merck 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, presentations, budgets, and position papers for internal and external audiences
- Facilitating collaborations with external researchers around the world
- Travel on company business about twenty (20) percent of the time to manage future or ongoing clinical research projects.
- M.D or M.D./Ph.D
- Must have experience in industry or senior faculty in academia
- Minimum of 3 years of clinical medicine experience
- Minimum of 1 year of industry experience in drug development or biomedical research experience in academia
- Demonstrated record of scientific scholarship and achievement
- A proven track record in clinical medicine and background in biomedical research is essential
- Strong interpersonal skills, as well as the ability to function in a team environment are essential.
- Board Certified or Eligible in Oncology (and/or Hematology)
- Prior specific experience in clinical research and prior publication
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