Oncology Clinical Director (Early 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. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Merck’s Oncology organization is dedicated to delivering breakthrough innovations that extend and improve the lives of cancer patients worldwide. Our team of dauntless, forward-thinking individuals achieves this through an unwavering commitment to supporting accessibility to medicine, providing new therapeutic procedures, and collaborating with governments and payers to ensure that people who need medicines have access to them. At Merck, our focus is on innovation and launch execution excellence; we translate breakthrough science into innovative medicines that help people with cancer across the globe.
The Director reports to a Senior or Executive Director in the Oncology Clinical Research Group.
Under the guidance of a supervisor, the Director has primary responsibility for the planning and directing of 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
- Participation in internal and joint internal/external research project teams relevant to the development of new compounds, and the further study of marketed compounds.
- 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
- Attend appropriate scientific meetings to maintain his or her competency and to maintain awareness of research activities in his/her area of responsibility.
- Author detailed development documents, presentations, budgets, and position papers for internal and external audiences;
- Facilitating collaborations with external researchers around the world; and
- Travel on company business about twenty (20) percent of the time to manage future or ongoing clinical research projects.
- Board Certified or Eligible in Oncology (and/or Hematology)
- Prior specific experience in clinical research and prior publication
Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.
If you need an accommodation for the application process please email us at firstname.lastname@example.org.
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Job: Clinical Research (M.D.)
Employee Status: Regular
Travel: Yes, 25 % of the Time
Number of Openings:
Shift (if applicable):
Company Trade Name: Merck