Job Details
Clinical Project Physician
4854
Posted: 23/07/2024
- £Competitive
- basel, Switzerland
- Contract
Clinical Project Physician - 12 month contract - On site, Basel, Switzerland
We are seeking a Clinical Project Physician for a major Pharmaceutical client based in Basel, Switzerland, to provide medical oversight on clinical development projects, from concept generation to design. This role is a 12 month contract.
Responsibilities:
- Contribute to the medical oversight of clinical trials within the assigned project.
- Address medical/scientific questions from Ethics Committees (ECs) and Health Authorities regarding trials.
- Ensure trials receive adequate supported to meet goals and timelines from a medical perspective.
- Serve as the company's clinical expert at key regulatory interfaces, investigator meetings, and partner meetings (where applicable).
- Actively contribute to the medical/scientific information required in clinical documents.
- Provide medical leadership for all assigned project and trial activities (e.g., Lifecycle Team, Regulatory & Safety aspects) through a comprehensive understanding of the science, medicine, product environment, and competitive landscape related to a disease area.
- Deliver the medical aspects of the Clinical Project Development Plan related to the indication and oversee its implementation.
- Provide medical leadership externally based on thorough scientific review of relevant product data and consultation with internal and external experts.
- Develop and maintain medical interactions with key external experts and trial investigators.
- Organize and lead medical aspects of clinical advisory boards and study-specific committees (steering committees, data monitoring committees, safety event committees).
- Contribute to the clinical/scientific content for interactions (briefing book, submission dossier) with regulatory agencies and IRBs/ethics boards.
- Provide medical input to the project/trial-related communication/publication plan.
Requirements:
- MD, with a background as a cardiologist/nephrologist preferred.
- 10+ years experience (post qualification) in clinical research within a Pharmaceutical or Biotech company.
- Extensive knowledge of both drug development and clinical trials.
- Excellent knowledge of regulatory requirements and GCP/ICH guidelines.
- Experience leading late-stage development and, preferably, the submission process of a drug.
- Prior experience overseeing several clinical trials from a medical perspective, including data review.
- Experience in direct interactions with Health Authorities.
- Excellent written and spoken communication skills in English.
If this role interest you, apply below or get in touch at conor@warmanobrien.com.
Conor Burke
Consultant in Clinical Research