Job Summary - Can be permanent or part-time (no agencies)
- TranScrip Senior Partner and medical leadership role in the immunology therapeutic area team.
- The position will be home based.
Duties and Responsibilities
- Will lead teams on immunology therapeutic area projects in auto-immune and allergic diseases, Pain, CNS, etc. for a wide base of clients (>100), ranging from top-ten pharma to biotechs at various stages of development and/or peri-launch and post-launch support
- Tasks will vary from strategic development advice to medical safety monitoring of complex disease and will involve creation/oversight of documentation for regulatory authorities for internal client decision-making (including due diligence of acquisitions).
Key Attributes and Competencies
- 'Board certified' in Immunology or related therapeutic area (rheumatology, respiratory, allergology, etc.) and/or with >10 years’ in immunology drug development and/or life cycle management experience as a pharmaceutical physician
- Experience of leading teams in clinical development/registration of drugs in USA, Europe and/or Japan or hands-on experience of launching immunology-based products, regionally or globally
- Experience of dealing with major Health Authorities (FDA, EMA, PMDA and other national authorities) for Scientific Advice, Pre–IND, End of Phase 2, Pre-NDA meetings and Advisory Committees.
- Post qualification degree in a scientific element of drug development or disease understanding preferred but not absolutely necessary
- Some direct clinical experience of immunology therapeutics
- Some other therapeutic area experience would be useful
- Should have a visible profile in the immunology space, such as membership of working parties, company board membership.