Senior Principal Scientist (Senior Director), Clinical Research, GI Oncology

MSD•Rahway, NJ

4d•Hybrid

About The Position

The Senior Director (Sr. Principal Scientist) has primary responsibility for the planning and directing of 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 Senior Director will manage the entire cycle of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication. Specifically, the Senior Director may be responsible for: Evaluating pre-clinical and translational work for the purpose of generating early clinical development plans and Investigational New Drug applications Development 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 publications 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 Senior Director will: Lead a cross-functional team including Clinical Scientists in endeavors ranging from drafting clinical study protocols to overseeing protocol adherence to assessing patient-level data, ensuring data completeness and integrity, and ultimately interpreting and contextualizing aggregate data to assess safety and efficacy Work closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects Assist the Executive Director in ensuring that appropriate corporate personnel are informed of the progress of studies of our Company's and competitors' drugs and engage with internal and external experts on scientific questions relevant to their areas of responsibility. The Senior Director is responsible for maintaining a strong scientific fund of knowledge by: Maintaining awareness of scientific developments within their 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 their 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 their competency and to maintain awareness of research activities in their 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 Facilitate 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.
Minimum 3 years of clinical medicine experience in adult or pediatric oncology and/or hematology
Minimum 1 year of drug-development/pharmaceutical industry experience or biomedical research experience in academia/fellowship
Demonstrated record of scientific scholarship and achievement
Strong interpersonal and communication skills, as well as the ability to function in a large cross-functional team environment are essential.
Clinical Development
Clinical Judgment
Clinical Medicine
Clinical Reporting
Clinical Studies
Clinical Trial Development
Clinical Trials
Drug Development
Gastrointestinal Oncology
Medical Monitoring
Medical Research
Oncology
Oncology Trials
Regulatory Affairs Compliance
Research Methodologies

Nice To Haves

Successful completion of an ACGME-medical oncology, combined medical oncology/hematology or pediatric hematology fellowship
Board Certified in adult or pediatric oncology (and/or hematology)
A proven track record in clinical academic medicine with a focus on adult GI medical oncology, proficient in the GI oncology treatment landscape with academic publication experience

Responsibilities

Evaluating pre-clinical and translational work for the purpose of generating early clinical development plans and Investigational New Drug applications
Development 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 publications
Participation in internal and joint internal/external research project teams relevant to the development of new compounds, and the further study of marketed compounds
Lead a cross-functional team including Clinical Scientists in endeavors ranging from drafting clinical study protocols to overseeing protocol adherence to assessing patient-level data, ensuring data completeness and integrity, and ultimately interpreting and contextualizing aggregate data to assess safety and efficacy
Work closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects
Assist the Executive Director in ensuring that appropriate corporate personnel are informed of the progress of studies of our Company's and competitors' drugs and engage with internal and external experts on scientific questions relevant to their areas of responsibility
Maintaining awareness of scientific developments within their 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 their 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 their competency and to maintain awareness of research activities in their area of responsibility
Author detailed development documents, presentations, budgets, and position papers for internal and external audiences
Facilitate 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.