Principal Scientist, Clinical Research - Immunology/Dermatology

Merck • Boston, MA

12d • $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. 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. They will provide 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 is key. Monitoring and managing the conduct of ongoing or new clinical trials for investigational drugs, and 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 are also core responsibilities. Participation in internal and joint internal/external research project teams relevant to the development of new compounds is expected. The Clinical Director may supervise the activities of Clinical Scientists in the execution of clinical studies and work closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects. They will 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, and 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 is also crucial. 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, and 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, as well as the ability to work collaboratively in a cross-functional team environment.
• Allergy and Immunology
• Clinical Development
• Clinical Immunology
• Clinical Research
• Clinical Trials
• Dermatology
• Drug Investigation
• Immunology
• Statistics
• Strategic Planning

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 determination of appropriate disease indications to pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication.
• 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.
• Participation in internal and joint internal/external research project teams relevant to the development of new compounds.
• Supervising the activities of Clinical Scientists in the execution of clinical studies.
• Working closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects.
• Assisting 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.
• 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.
• Authoring detailed development documents, presentations, budgets, and position papers for internal and external audiences.
• Facilitating collaborations with external researchers around the world.
• Traveling 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
• annual bonus
• long-term incentive

What This Job Offers

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