TITLE: Director, Clinical Research-Inflammation - Princeton, NJ

Job Description
Develop, implement and monitor clinical studies (predominantly registration trials in Phases II and III) in therapies for chronic immune-mediated inflammatory diseases, working in a team setting, where effective interaction with highly skilled colleagues, and with internal and external stakeholders, is critical. Provide medical and scientific support in other aspects of company activities in the assigned therapeutic area. Become the internal and external medical leader in, and contact person for, disease- and/or molecule-defined projects.

RELATIONSHIPS:

Reports to the Vice President, Medical & Science- Inflammation, with whom a close working relationship is an important component of success. Internal relationships include working with Headquarters, Clinical Trial Operations, Statistics, Regulatory Affairs and Marketing and Sales organization. External relationships will evolve with the program's development and will include expert advisory board members, investigators, other consultants, and key customer groups.

ESSENTIAL FUNCTIONS:

CLINICAL STUDY MANAGEMENT
· Provide medical input, and act as the medical expert, in the global clinical development plan, acting as the driving factor in the cross-organisational implementation of clinical strategies.
· Obtain expert medical community input at appropriate stages of development
· Develop protocols, and cooperate in the development of other necessary documents, for clinical studies, providing expert medical input throughout.
· Assist in identification and recruitment of investigators for clinical studies.
· Assure timely initiation of studies; act as liaison with Regulatory, project teams, and investigators.
· Manage all required protocol amendments/deviations.
· Maintain a close collaboration with Clinical Trials Operations personnel involved in studies in the active monitoring of clinical studies and be prepared to take the lead in dealing with all medically related issues, especially adversities.
· Provide high-quality input at meetings and interactions with health authorities and in response to questions posed by health authorities worldwide.

PROJECT MANAGEMENT LIAISON
· Chair the cross-functional scientific team of internal and, if required, external researchers involved in the different phases of drug development
· Through the project development team, assure timely initiation and completion of studies of qualified patients.
· Assist in developing clinical program time lines, budgets, and strategies.

REGULATORY LIAISON
· Write and/or review clinical sections of clinical/statistical reports, including investigator's brochures, INDs and NDAs.
· Provide medical input to the design and implementation of NDA database structures.
· Assist in providing medical representation at Regulatory meetings.
· Assist in the interpretation of regulatory guidelines and directives to judge risk and causality

MEDICAL AND SCIENTIFIC SUPPORT FOR OTHER COMPANY ACTIVITIES:
· Medical liaison with the Marketing/Business Developments. Support ongoing sales and marketing objectives by making presentations, as appropriate, to external groups, e.g. academic and community medical departments (grand rounds), professional associations, and P&T committees.
· Review medical content of company education of sales staff and promotional materials and be part of their educational program.
· Oversee company interactions with the expert community.
· Stay abreast of regulatory requirements and guidelines and current trends and medical practice in the fields of immunology, gastroenterology, and rheumatology, including reports and intelligence on key and critical new technologies or treatment advances.
· Represent NN medical department in regulatory interactions, investigators' and expert advisory board meetings, external professional societies, seminars, and conventions
· Must maintain necessary credentials and remain in good standing with the medical community and medical ethics boards.

KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
· M.D. or Ph.D. required
· 4-6 years experience required - pharmaceutical experience preferred, especially with strategy and planning of trials involving monoclonal antibodies or other large proteins.
· Prior clinical research or related experience, e.g. monitoring the conduct of clinical studies and knowledge of Phases I through III.
· Documented clinical expertise in the field of auto-immunity is a definite advantage, especially in inflammatory bowel disease. Prior experience in SLE or rheumatoid arthritis is also very relevant.
· Excellent communication skills.
· High energy, excellent coordination and planning skills, considerable flexibility and a keen sense of quality and purpose.
· Ability to actively and effectively manage upward and downward in a "matrixed" organization.