Senior Medical Director, Clinical Development, Immunology & Inflammation

Role Summary

The Senior Medical Director, Clinical sciences is responsible for facilitating assigned studies, providing investigator support of Regeneron driven studies, and may serve as a resource to anticipate and/or resolve study clinical and conduct issues. This role reports into the Clinical Program Lead, Clinical Sciences and is expected to have proficient knowledge of the drug development process, good clinical practice, study design and research methodology as well as understand Regulatory and compliance landscape in the pharmaceutical industry. This role utilizes scientific and clinical expertise to initiate, propose, design and execute research and development programs for early and/or late stage assets. This role may be suitable for an Allergist, Immunologist, Pulmonologist, or Dermatologist. Industry experience preferred.

Responsibilities

• Provides clinical leadership and responsible for all clinical deliverables within the assigned section of a clinical program. Clinical deliverables may include individual protocols; clinical components of regulatory documents/registration dossier and brand related medical information, clinical communication and publications
• Demonstrated ability to influence team and may influence across function
• Ability to lead activities within a matrix environment
• Exhibits confidence and professional diplomacy, while effectively relating to people at all levels internally and externally
• Advanced analytical and influencing skills
• Ability to communicate concise and clear messages
• Seeks to understand different perspectives and cultures and values differing points of view
• Can identify critical risks and mitigation
• Proficient medical writing skills and advanced presentation skills

Qualifications

• MD or equivalent required
• Specialized clinical fellowship training in Allergy, Immunology, Pulmonology, or Dermatology strongly preferred
• A minimum of 4 years of industry experience in clinical development required

Skills

• Clinical leadership
• Medical writing
• Regulatory documentation
• Communication and presentation
• Risk identification and mitigation
• Matrix leadership

Education

• Medical Doctor (MD) or equivalent