Principal Scientist, Clinical Research - Immunology/Dermatology

MSD • Boston, MA

13d • $255,800 - $402,700 • Hybrid

About The Position

The Clinical Director (Principal Scientist) has primary responsibility for the strategic planning and directing clinical research activities involving investigational compounds in Immunology. With a focus on late-stage development, the Clinical Director will manage the entire cycle of clinical development, including determination of appropriate disease indications to pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication. Specifically, The Clinical Director May Be Responsible For: Evaluating pre-clinical and translational work for the purpose of generating the early clinical development plan and Investigational New Drug applications. Providing clinical development support of business development assessments of external opportunities to grow the Immunology Pipeline Developing clinical development strategies for investigational drugs and 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 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 The Clinical 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 Assist the Senior Director, Associate Vice-President/Vice-President and Product Development Team Lead 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 their areas of responsibility. The Clinical 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 drugs in Immunology Establishing collaborative relationships with external experts in Rheumatology diseases, particularly those whose research focus and expertise can inform and assist the evaluation of the company's investigational 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 Clinical 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., D.O., M.D./PhD, or D.O./PhD
• Minimum of 5 years of clinical and/or development experience (academia, clinical medicine, and/or corporate clinical development).
• Demonstrated record of scientific scholarship and achievement.
• Strong interpersonal skills.
• Ability to work collaboratively in a cross-functional team environment.

Nice To Haves

• Prior experience in design and execution of phase 2 or 3 clinical trials in rheumatologic diseases is preferred.

Responsibilities

• Strategic planning and directing clinical research activities involving investigational compounds in Immunology.
• Managing the entire cycle of clinical development, including disease indication determination, study design, initiation, execution, monitoring, analysis, regulatory filing, and publication.
• Evaluating pre-clinical and translational work for early clinical development plans and Investigational New Drug applications.
• Providing clinical development support for business development assessments of external opportunities.
• Developing clinical development strategies for investigational drugs and planning clinical trials.
• Monitoring and managing the conduct of ongoing or new clinical trials.
• Analyzing and summarizing clinical findings to support decisions regarding safety and efficacy, new drug applications, clinical study reports, or publications.
• Participating in internal and joint internal/external research project teams.
• Supervising the activities of Clinical Scientists in the execution of clinical studies.
• Working closely with cross-functional experts in commercialization, regulatory affairs, statistics, and manufacturing.
• Assisting senior leadership in informing corporate personnel about study progress and expert opinions.
• Maintaining awareness of scientific developments and research methodologies in their area of expertise.
• Identifying scientifically and operationally strong investigators.
• Establishing collaborative relationships with external experts in Rheumatology diseases.
• Attending scientific meetings to maintain competency and awareness of research activities.
• Authoring detailed development documents, presentations, budgets, and position papers.
• Facilitating collaborations with external researchers.
• Traveling on company business about twenty (20) percent of the time.

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: Principal
• Education Level: Ph.D. or professional degree