Senior Medical Director, Clinical Development (Rheumatology)

Role Summary

Senior Medical Director, Clinical Development (Rheumatology) responsible for facilitating assigned studies, providing investigator support of Regeneron driven studies, and serving as a resource to anticipate and resolve study clinical and conduct issues. Requires proficient knowledge of the drug development process, good clinical practice, study design and research methodology, and understanding of regulatory and compliance landscape. Utilizes scientific and clinical expertise to initiate, propose, design and execute R&D programs for rheumatology/autoimmunity indications. Suitable for a physician with industry experience in Rheumatology, Allergy, Immunology, Pulmonology, or Dermatology.

Responsibilities

• Provides clinical leadership and is responsible for all clinical deliverables within the assigned section of a clinical program, including protocols, clinical components of regulatory documents/registration dossiers, brand-related medical information, clinical communication and publications
• Demonstrates ability to influence team and across functions
• Leads activities within a matrix environment
• Exhibits confidence and professional diplomacy, relating effectively to people at all levels internally and externally
• Demonstrates advanced analytical and influencing skills
• Communicates concise and clear messages
• Understands different perspectives and cultures, values differing points of view
• Identifies critical risks and mitigations
• Demonstrates proficient medical writing and advanced presentation skills

Qualifications

• MD or equivalent required
• Specialized clinical fellowship in Rheumatology, Allergy, Immunology, Pulmonology, or Dermatology strongly preferred
• Minimum of 4 years of industry experience in clinical development required
• Clinical research experience in academic/clinical settings may be considered at the Medical Director level

Skills

• Clinical leadership
• Regulatory and compliance understanding
• Medical writing and presentation
• Matrix leadership and cross-functional collaboration
• Risk identification and mitigation

Education

• MD or equivalent required