Principal Scientist (Director), Clinical Research, Immunology

About the role

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 role manages the entire cycle of clinical development, including determining 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 IND 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) based on those strategies.
• Monitor and manage the conduct of ongoing or new clinical trials for investigational drugs.
• Analyze and summarize clinical findings to support decisions on safety, efficacy, new drug applications, clinical study reports, or publications.
• Participate in internal and joint internal/external research project teams relevant to new compound development.
• Supervise 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 senior leadership in ensuring appropriate corporate personnel are informed of study progress and competitor information.
• Maintain a strong scientific knowledge base by staying current with new findings, identifying strong investigators, establishing collaborations with external experts in Rheumatology, and attending scientific meetings.
• Author detailed development documents, presentations, budgets, and position papers for internal and external audiences.
• Facilitate collaborations with external researchers worldwide.
• Travel on company business approximately 20% of the time to manage future or ongoing clinical research projects.

Qualifications

• Education: M.D., D.O., M.D./Ph.D, or D.O./Ph.D.
• Minimum of 5 years of clinical and/or development experience (academia, clinical medicine, or corporate clinical development).
• Demonstrated record of scientific scholarship and achievement.
• Prior experience in design and execution of Phase 2 or Phase 3 clinical trials in rheumatologic diseases is preferred.
• Strong interpersonal skills and ability to work collaboratively in a cross‑functional team environment.

Skills

• Required: Clinical Development, Clinical Research, Clinical Trial Planning, Cross‑Functional Teamwork, Immunology, Rheumatology.

Benefits

• Comprehensive benefits package including medical, dental, vision, and other healthcare insurance (employee and family).
• Retirement benefits, including 401(k).
• Paid holidays, vacation, compassionate and sick days.
• Additional information available at https://jobs.merck.com/us/en/compensation-and-benefits.

Pay

The salary range for this role is $255,800.00 –