Senior Principal Scientist, Clinical Research, Immunology

Merck & Co. • Rahway, NJ

96d

About The Position

The Senior Director (Sr. 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 Senior 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.

Requirements

• M.D., D.O., M.D./PhD, or D.O./PhD.
• Experience in the design and/or execution of phase 2 or 3 clinical trials specifically in Immunology (Rheumatology, Gastroenterology or Dermatology).
• Minimum of 3 years of clinical medicine experience.
• Minimum of 5 years of industry experience in drug 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.

Nice To Haves

• Clinical Development
• Clinical Medicine
• Clinical Research Management
• Clinical Studies
• Clinical Trial Development
• Clinical Trials
• Dermatology
• Drug Development
• Gastroenterology
• Inflammatory Bowel Diseases
• Pharmaceutical Industry
• Regulatory Compliance
• Rheumatology

Responsibilities

• 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.
• 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 Executive Director in ensuring that appropriate corporate personnel are informed of the progress of studies of the company and competitors' drugs and internal and external expert opinion on scientific questions relevant to his/her areas of responsibility.
• Maintain a strong scientific fund of knowledge by maintaining awareness of scientific developments within his/her area of expertise.
• Identify scientifically and operationally strong investigators who can assist in the development of the company's investigational drugs in Immunology.
• Establish collaborative relationships with external experts in Rheumatology, Gastroenterology, Dermatology, and pulmonary disease.
• Attend appropriate scientific meetings to maintain competency and awareness of research activities in his/her 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.

What This Job Offers

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