Director, Clinical Research, Immunology

Job Description

The Clinical Director (Principal Scientist) has primary responsibility for 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 study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication.

Specifically, the position may be responsible for:

• Evaluating pre-clinical and translational work for the purpose of generating clinical development plans 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

The Clinical Director may:

• Work closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects; and assist the Senior/Executive Clinical Director/Vice-President 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 one’s areas of responsibility.

The Clinical Director is responsible for maintaining a strong scientific fund of knowledge by:

• Maintaining awareness of scientific developments within one’s 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 related disease areas, 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 one’s competency and to maintain awareness of research activities in one’s area of responsibility.

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

• Travel on company business about twenty (20) percent of the time to manage future or ongoing clinical research projects.

Qualifications / Education:

• M.D., D.O., M.D./Ph.D, or D.O./PhD.

Required:

• Minimum of 5 years of clinical and/or development experience (academia, clinical …