- Primary medical responsibility for clinical study(ies)
- Oversees clinical studies and reviews clinical protocols and clinical study reports for scientific and medical accuracy.
- Develops and demonstrates expertise in data review and interpretation to deliver meaningful efficacy and safety conclusions.
- Demonstrates the ability to interpret conclusions in context of product profiles and medical practice to create key messages, in collaboration with key stakeholders.
- Collaborates with Therapeutic Area leadership (TA Head, Development Team Leads and Clinical Development Leads), Clinical Operations and Medical Affairs to support all development activities for the therapeutic area
- Provides expert Medical advice to assist the project teams for the development of Phase I-IV clinical programs.
- Provides medical and scientific advice within Shire R&D and other functions (e.g. Business Unit Strategy Teams, Commercial Brand Teams) leveraging scientific expertise and providing guidance in support of product launches.
- Interacts as needed with Clinical Development partners such as Clinical Operations, Regulatory, Commercial, Compliance, and Business Unit management teams.
- Leads and/or participates in clinical/medical advisory panels, steering committees and investigator meetings.
- Participates in safety review committees and risk management activities as appropriate.
- Assists in providing medical information support for marketed and developmental projects.
- Participates in drug safety surveillance for Development projects.
- Provides credible company representation in the academic Medical/Scientific Community to facilitate the constructive exchange of positions and ideas.
- Supports Therapy Area Business Unit and Commercial Teams in crafting target product profiles.
- Provides input to global publication strategy for the projects/products assuring the highest standards of science, within product strategic needs and Compliance requirements. May work with academic investigators to present and publish clinical trial results at scientific meetings and in peer reviewed medical journals.
- Remains up-to-date with current information on pharmaceutical regulations, guidelines, and practices and therapeutic area knowledge and ensures consistent best practice across all activities.
Education & Experience Requirements
- M.D. degree (required), at least 1-3yearexperience in Clinical Research in the pharmaceutical/biotech industry (required), experience in Internal Medicine and/or Pediatrics in combination with knowledge of Immunology or related fields (required), specialty training and certification in Allergy/Immunology (preferred),
- Pharmaceutical Industry experiencepreferred such as submissions of IND/CTX/NDA/MAA and interactions with Regulatory authorities, designing and conducting Phase II-III clinical trials
- Availability to travel approximately 20% of time.
- Availability to participate in early or late meetings/teleconferences if required.
Req ID: R0016101