Senior Principal Scientist, Clinical Research, Breast Cancer

MSD • North Wales, PA

10d • $282,200 - $444,200 • Remote

About The Position

The Senior Director (Sr. Principal Scientist) has primary responsibility for the planning and directing clinical research activities involving new or marketed Oncology medicines. Our Company'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. 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, establishing communications with prominent clinical investigators, and attending appropriate scientific meetings. To accomplish these goals, the Director may author detailed development documents, presentations, budgets, and position papers for internal and external audiences, facilitate 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.

Requirements

• M.D or M.D./Ph.D. Required
• 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
• Breast Cancer
• Clinical Development
• Clinical Medicine
• Clinical Research Management
• Clinical Trials
• Data Analysis
• Decision Making
• Drug Development
• Ethical Standards
• Oncology Research
• Oncology Trials
• Scientific Publications
• Strategic Planning

Nice To Haves

• Board Certified or Eligible in Oncology (and/or Hematology)
• Prior specific experience in clinical research
• Prior publication

Responsibilities

• 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
• 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
• 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 our Company'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 our 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
• 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

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree