Executive Clinical Director, Immunology, IBD Lead

Job Description

The Executive Clinical Director (Distinguished 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 Executive 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.

Specifically, the Executive Director may be responsible for:

• 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

The Executive Director may:

• Oversee the Clinical Directors and 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 Associate Vice resident/ Vice President and product development team lead 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 their areas of responsibility.

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

• Maintaining awareness of scientific developments within their 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 in Rheumatology, Gastroenterology, Dermatology, and Pulmonary disease, 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 their competency and to maintain awareness of research activities in their area of responsibility.

To accomplish these goals, the Executive 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.

Education Requirements:

• M.D., D.O., M.D./Ph.D, or D.O./PhD

Required Experience and Skills:

• Must have experience in the design and/or execution of phase 2 or 3 clinical trials in immunology therapeutic areas.

• Experience in late stage IBD trials and regulatory filing is preferred.

• 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

• Prior experience in working with business development to assess external assets preferred

• Strong interpersonal skills, as well as the ability to work collaboratively in a cross-functional team environment

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in curr