(Senior) Medical Director - Gastroenterology (m/f/x)

Empresa: Immunic AG
Tipo de empleo: Otros
About usImmunic Therapeutics is a dynamic biotechnology company with a pipeline of selective, orally available immunology therapies for the treatment of chronic inflammatory and autoimmune diseases. Currently, three small molecule product candidates are in various stages of clinical development. For more information, please visit: .Your mission

At Immunic AG, a pioneer in biopharmaceutical innovation focused on developing novel therapies, we are seeking an experienced (Senior) Medical Director to lead our gastroenterology program. This role is crucial for guiding clinical drug development activities, coordinating clinical trials, and supporting regulatory submissions.

  • Provide medical leadership for a gastroenterology development candidate.
  • Lead, perform, and coordinate clinical drug development activities.
  • Engage closely with medical advisory board members and key medical experts in gastroenterology.
  • Plan clinical trials in collaboration with key physicians, integrating their feedback to enhance project planning and execution.
  • Select medical indications and conduct in-depth analysis of medical needs, clinical endpoints, and the competitive landscape.
  • Continuously review study data, making strategic recommendations to meet project goals.
  • Develop and refine clinical protocols, overseeing medical monitoring and ongoing medical data review, including protocol exemptions, violations, and eligibility issues.
  • Manage pharmacovigilance for assigned projects and oversee ongoing safety reviews, including monitoring adverse events and lab abnormalities.
  • Maintain and enhance medical advisor activities.
  • Collaborate on regulatory submissions, providing essential input for regulatory documents.
  • Supervise a Clinical Project Assistant for designated activities.
Your profile
  • Medical degree (MD) or an advanced degree in science or medicine with significant experience in medical monitoring roles.
  • Extensive experience in clinical trials within CROs, sponsors, or clinical sites, preferably in gastroenterology.
  • Proven experience in protocol development and engagement with key opinion leaders.
  • Demonstrated leadership in managing projects.
  • Ability to work self-directed, drive processes, and excel in project management. Comfortable in a flat hierarchy and able to multitask.
  • Experience in collaborating with service providers and consultants.
  • A strong cultural fit with the Immunic team and its values.
  • Excellent English communication skills.
Why us?

Join us and be part of a company where your work directly contributes to our mission of improving patient care through groundbreaking research. Immunic AG offers a stimulating work environment where innovation and collaboration are valued. We provide competitive compensation, comprehensive benefits, and opportunities for professional growth.