Medical Director, Clinical Sciences, Allergy & Immunology

Role Summary

The 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 some 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 for immunology indications

Responsibilities

• Defines clinical trial-related Clinical Development Program (CDP) goals and objectives
• Responsible for the relevance and accuracy of medical science underpinning of clinical study concepts (CSC) based on thorough scientific review and consultation with internal and external experts
• Leads and supervises the work of Clinical Team to produce high quality program deliverables on schedule
• Organizes clinical advisory boards, steering committees and data safety monitoring boards as required
• Researches literature for relevant program-related material and informs clinical team of findings
• Responsible for the analysis of clinical data, including safety monitoring
• Responsible for all activities and procedures that ensure patient safety
• Ensures Clinical Team compliance with FDA, EMEA, ICH and GCP guidelines
• Is the primary clinical contact for communications with regulatory agencies and IRBs/ethics boards

Qualifications

• Required: MD, or equivalent with at least 1-2 years pharmaceutical industry experience. Extensive clinical trial experience in the academic setting can be considered. Allergy, Immunology, Dermatology, Pulmonology training (board certified/eligible) is strongly preferred.
• 4 days a week on-site presence for this role
• Desire to impact patient populations through innovative drug development
• Rigorous work ethics with focus on details and high-quality results
• Works effectively under pressure
• Ability to work in matrix environment
• Superior written and oral communication skills
• Ability to develop original ideas

Skills

• Strong scientific and clinical expertise in immunology indications
• Regulatory and compliance awareness in the pharmaceutical industry
• Clinical data analysis and safety monitoring
• Medical communications with regulatory agencies and ethics boards

Education

• MD or equivalent medical degree required

Additional Requirements

• On-site presence required: 4 days per week