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.
Karrierestufe
Management
Beschäftigungsverhältnis
Zeitarbeit
Tätigkeitsbereich
Unternehmensberatung, Projektmanagement und Wissenschaft
Branchen
Arzneimittelherstellung und Biotechnologieforschung
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