Clinical Development Director

vor 4 Wochen


Zug, Zug, Schweiz ITech Consult AG Vollzeit
Clinical Development Leader

We are seeking a highly qualified Clinical Development Leader to join our team at ITech Consult AG. As a Clinical Development Leader, you will be responsible for planning and implementing clinical development activities for assigned products.

Key Responsibilities:
  • Designing scientifically sound clinical studies in cross-functional teams, including clinical study design and execution, critical review of study results, protocol and report generation to support new product development.
  • Conducting comprehensive literature reviews, collating relevant clinical and scientific information from different sources, and creating new scientific content with minimal guidance/direction.
  • Providing medical/scientific input and assisting with the preparation of regulatory submissions, as well as responses to reviewers from regulatory agencies.
  • Maintaining clinical, regulatory, and scientific expertise as it relates to In-Vitro-Diagnostic (IVD) product development and regulatory documentation.
  • Building and maintaining close relationships with external thought leaders, supporting the preparation of advisory boards within the assigned indication area.
  • Building and maintaining relationships with international opinion leaders, investigators, and key customers, bringing external know-how in-house for the development of new products and innovative study designs.
  • Building and maintaining strong, collaborative relationships with cross-functional leaders, key internal and external stakeholders, and other alliance partners, in meeting business goals and ensuring operational excellence.
  • Supporting competitive differentiation, innovation, and early pipeline activities, and development of intellectual property strategy.
  • Supporting the management of external development partnerships (industry & academia).
  • Navigating complex situations by applying a diverse skill set.
  • Communicating difficult concepts and negotiating with others, influencing them to adopt a different point of view.
  • Driving patient and customer-centricity (mindset, behaviors, and actions) by always putting the needs of patients and customers first.
  • Supporting colleagues with less experience and helping them develop skills/expertise.
  • Permanently optimizing processes to increase quality and efficiency standards.
Requirements:
  • Medical degree (Medical Director) or advanced degree in Life Science (PhD), preferably with relevant expertise in the Healthcare Industry and/or academic institutions (experience in Neurology/Neuroscience preferred).
  • 3 years (if Neurologist) or 5+ years (if PhD) academic, diagnostics, or pharma industry experience, preferably with IVD or Medical Device related projects.
  • Experience in regulatory submissions (IVDR/FDA).
  • Good understanding of clinical development, including clinical study design and scientific writing experience, as well as leading matrixed teams.
  • Detailed understanding of the healthcare industry or equivalent academic experience.
  • Excellent communication and presentation skills in English.
  • Ability to travel required up to 25% (can vary per project phase and position).

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