I am currently working with a leading global pharmaceutical company seeking two experienced physicians within Phase II and Phase III clinical development. One role will focus on early phase and the other role focused in late stage clinical development of innovative molecules for the treatment of multiple disease areas within immunology, dermatology and rheumatology.
The role is responsible for input and oversight for early / late stage clinical development plans within the immunology, dermatology and rheumatology department, from pre-clinical research, First in Man studies through Phase I / II / III Clinical Trials.
The successful applicant(s) will be responsible for leading the development of key products in these areas. The main purpose of the role will be to oversee a series of immunology, dermatology and rheumatology trials, draft study specific documentation such as NDA / CTA submissions and Investigator Brochures, alongside reviewing study data and providing expert advice to aid in the development of their immunology, dermatology and rheumatology portfolio.
Further Key Responsibilities:
- Directing and overseeing clinical research plans, and providing input to help integrate the Clinical Development Plan with the Drug Development Plan
- Serving as the clinical / medical team expert to provide direction to all project team functions, regularly liaising with KOL's and organizing Advisory Board Meetings
- Implementing strategies to identify, monitor and resolve clinical / program trial issues
- Reviewing / monitoring safety study data and providing clinical expertise and content to regulatory documents
- Proactively and independently find solutions and drive innovation
- Educated to Medical Degree
- Board Certification or Eligibility in immunology, dermatology and rheumatology preferred but not required
- Development experience in lieu of Board Certification
- Demonstrable experience in Phase II/III clinical trial management
- Ability to influence others; self-starter with an inquisitive nature and practical approach to problem solving
- Demonstrated competence as Study Director / Medical Monitor / Research Physician / Medical Advisor and prior experience working with the FDA or EMEA on responses to inquiries for study related information is preferred
If you're interested, get in touch with me ASAP…
Clinical Development and Medical Affairs Consultant
Email: abloomfield (at) barringtonjames.com