Clinical Project Physician

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.