Senior Medical Director

Role Summary

The Senior Medical Director reports to the VP of Clinical Development and will lead the planning and implementation of the clinical strategy for RPT904, an extended half-life anti-IgE monoclonal antibody, in chronic spontaneous urticaria. This physician-scientist will serve as the subject-matter expert and medical lead in this therapeutic area to provide clinical and drug development expertise to the cross functional team. The role includes serving as the medical lead responsible for the execution and reporting of Phase II/III clinical studies, as well as supporting the regulatory and commercial/medical affairs strategies in alignment with the overall development strategy.

Responsibilities

• Provide strategic and design input for clinical trials and clinical development plans
• Participate in/and or lead preparation, design, and/or review of clinical documents, e.g. protocols, investigator‚Äôs brochures, DSUR
• Contribute to clinical sections of relevant regulatory filings (IND, study reports, NDA, PIP, briefing packages, etc.)
• Represent the company at scientific meetings and presentations
• Develop and maintain collaborative relationships with key opinion leaders for clinical programs
• Contribute to the medical affairs strategy through the development of the publication plan, including authoring and / or reviewing abstracts, presentations and manuscripts for medical accuracy and content
• Represent RAPT and provide medical support during investigator and consultant meetings (e.g., investigator meetings, clinical advisory boards)
• Oversee internal clinical development team members and be responsible for clinical trials (e.g. Sponsor medical monitors, clinical scientists) to ensure patient safety and data integrity

Education

• M.D. or M.D./Ph.D., with board certification in Allergy and Immunology or Dermatology or related field required

Experience

• Minimum of 8 years mid-to-late stage (Phase II/III/IV) global clinical trial experience in pharmaceutical or biotech industries preferred, or equivalent academic and clinical experience
• Clinical development or clinical practice experience in the field of Allergy/Immunology or Dermatology preferred
• Experience with successful Health Authority (eg FDA, EMA, PMDA) interactions (eg NDA, EOP2, Scientific Advice)
• Minimum of 2 years experience managing a team
• Be well connected within the medical and scientific community and have a proven successful track record
• Hands-on experience with clinical trial strategy, methods and designs
• Ability to work proactively and effectively, with exceptional creative problem-solving skills
• Excellent strategic planning, organizational and communication skills
• Up to 20% travel