Principal Scientist, Clinical Research, Immunology

Primary responsibility for the strategic planning and directing of clinical research activities involving investigational compounds in Immunology, with a focus on late-stage development. Manage the entire cycle of clinical development, including determination of appropriate disease indications, study design, initiation, execution, monitoring, analysis, regulatory filing, and publication.

Responsibilities

• Evaluate pre-clinical and translational work to generate early clinical development plans and Investigational New Drug applications.
• Provide clinical development support for business development assessments of external opportunities to grow the Immunology Pipeline.
• Develop clinical development strategies for investigational drugs and plan clinical trials (design, operational plans, settings).
• Monitor and manage the conduct of ongoing or new clinical trials for investigational drugs.
• Analyze and summarize clinical findings to support decisions regarding safety, efficacy, new drug applications, clinical study reports, or publication.
• Participate 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 cross-functional experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects.
• Assist leadership in ensuring appropriate corporate personnel are informed of study progress, competitor drugs, and expert opinions on scientific questions.
• Maintain a strong scientific fund of knowledge by staying aware of new scientific findings, research methodologies, and identifying scientifically strong investigators.
• Establish collaborative relationships with external experts in Inflammatory Bowel Disease.
• Attend scientific meetings to maintain competency and awareness of research activities.
• Author detailed development documents, presentations, budgets, and position papers for internal and external audiences.
• Facilitate collaborations with external researchers globally.
• Travel on company business approximately 20% of the time to manage 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 and ability to work collaboratively in a cross-functional team environment.

Preferred Experience

• Prior experience in design and execution of phase 2 or 3 clinical trials in Inflammatory Bowel Disease.

Skills

• Clinical Development
• Clinical Research
• Clinical Trial Planning
• Clinical Trials Monitoring
• Drug Development
• Gastroenterology
• Inflammatory Bowel Diseases

Preferred Skills

• Inflammatory Bowel Disease Treatment

Pay

The salary range for this role is $255,800.00 - $402,700.00. An employee’s position within the salary range will be based on factors including, but not limited to, relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

Benefits

• Medical, dental, vision healthcare, and other insurance benefits (for employee and family).
• Retirement benefits, including 401(k).
• Paid holidays, vacation, and compassionate and sick days.

More information about benefits is available at Merck Compensation and Benefits.

Schedule

• Travel requirements: 25%
• Flexible work arrangements: Hybrid