Aktuelle Jobs im Zusammenhang mit Head of Global Clinical Programs - Basel, Basel-Stadt - Novartis Farmacéutica

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Head of Global Clinical Programs

vor 1 Woche

Basel, Basel-Stadt, Schweiz Novartis Farmacéutica Vollzeit
Job Description:

The Head of Global Clinical Programs will oversee the development and execution of clinical programs across indications, ensuring compliance with regulatory requirements and market access. This role requires expertise in cardiovascular disease, antithrombotic/anticoagulant drugs, and advanced knowledge of Good Clinical Practice, clinical trial design, statistics, and the regulatory/clinical development process.

About the Job
  • Develops and executes clinical development plans in accordance with company policies and procedures.
  • Coordinates the creation of clinical components of key documents, including Clinical Trial Protocols, Investigator's Brochures, Clinical Study Reports, and regulatory documents.
  • Cultivates strong relationships with external stakeholders, including regulatory authorities, data monitoring committees, advisory boards, and patient advocacy groups.

Responsibilities:

  1. Works closely with cross-functional teams to ensure alignment with business objectives.
  2. Evaluates the drug safety profile, including safety monitoring of clinical studies and signal detection from post-marketing surveillance.
  3. Prepares and presents clinical trial or section program-level data to internal and external stakeholders.