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 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.

Responsibilities

• Evaluating pre-clinical and translational work to generate the early clinical development plan and Investigational New Drug applications.
• Providing clinical development support for 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 those strategies.
• Monitoring and managing the conduct of ongoing or new clinical trials for investigational drugs.
• Analyzing and summarizing clinical findings from studies to support decisions regarding safety and efficacy, new drug applications, clinical study reports, or publication.
• Participating 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 senior leadership to ensure appropriate corporate personnel are informed of study progress, competitor data, and expert opinions on scientific questions.
• Maintaining a strong scientific fund of knowledge by:
  • Maintaining awareness of scientific developments in the area of expertise, including new findings and methodologies.
  • Identifying scientifically and operationally strong investigators who can assist in developing the company's investigational drugs in Immunology.
  • Establishing collaborative relationships with external experts in Rheumatology diseases whose research can inform evaluation of the company's investigational drugs.
  • Attending appropriate scientific meetings to maintain competency and awareness of research activities in the area of responsibility.
• Authoring detailed development documents, presentations, budgets, and position papers for