Senior Principal Scientist, Clinical Research, Neuroscience

MSD•North Wales, PA

1d•Hybrid

About The Position

Our Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific and ethical standards. The Senior Director (Senior Principal Scientist) has primary responsibility for the planning and directing clinical research activities involving new or marketed Neuroscience Medicines. Our company's Neuroscience Medicines span all phases of clinical development (pre-clinical to post-licensure). With a focus on late-stage development, the Senior Director will manage the entire cycle of clinical development, including study design, initiation, execution, monitoring, analysis, regulatory reporting, publication, and presentation at national and international meeting. They will provide internal scientific leadership for cross-functional areas supporting clinical trials and will interact externally with key opinion leaders. Specifically, the Senior 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 clinical development strategies for investigational or marketed Neuroscience drugs that incorporate the latest scientific developments, regulatory requirements, the competitive landscape, and commercial considerations; 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 Neuroscience 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; and Support of business development assessments of external opportunities. Provide support for other therapeutic areas regarding clinical issues related to Neuroscience. The Senior 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 Vice President in ensuring that appropriate Corporate personnel is informed of the progress of studies of our company and competitors' drugs and internal and external expert opinion on scientific questions relevant to his/her areas of responsibility. The Senior 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 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's 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 Senior 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.

Requirements

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 3 -5 years 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.
Required Skills: Alzheimer's Disease, Alzheimer's Disease, Clinical Development, Clinical Judgment, Clinical Medicine, Clinical Research, Clinical Research Management, Clinical Studies, Clinical Testing, Clinical Trials, Data Analysis, Decision Making, Drug Development, Ethical Standards, Intellectual Curiosity, Interdisciplinary Problem Solving, Neuropathic Pain, Neuroscience, Neuroscience Research, Pain Management, Pharmaceutical Development, Regulatory Affairs Compliance, Regulatory Compliance, Scientific Leadership, Scientific Publications + 1 more

Nice To Haves

Board Certified or Eligible in Neurology or Psychiatry
Prior specific experience in clinical research and prior publication

Responsibilities

Evaluating pre-clinical and translational work for the purpose of generating early clinical development plan and Investigational New Drug applications
Developing clinical development strategies for investigational or marketed Neuroscience drugs that incorporate the latest scientific developments, regulatory requirements, the competitive landscape, and commercial considerations
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 Neuroscience 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
Support of business development assessments of external opportunities
Provide support for other therapeutic areas regarding clinical issues related to Neuroscience
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 Vice President in ensuring that appropriate Corporate personnel is informed of the progress of studies of our company 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's 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.