Senior Program Director

Vor 7 Tagen

Gräfelfing, Bayern, Deutschland Immunic AG Vollzeit

Job Summary:

As a Senior Program Director at Immunic AG, you will lead the IMU-838 program through various stages of clinical development, ensuring alignment with strategic objectives and compliance with regulatory standards.

Key Responsibilities:

  • Work with various leaders and functions in the company and function as a link to Immunic's management.
  • Coordinate cross-functional teams, fostering collaboration and ensuring seamless integration of clinical development, regulatory affairs, compliance, GxP, and vendor management.
  • Provide overarching leadership for the NDA preparations over the next years in the areas of regulatory affairs, CMC, and Quality Management, as well as preparations for a pre-approval FDA inspection (GCP).
  • Drive the program with a hands-on, entrepreneurial approach, encouraging innovative thinking for problem-solving and challenging the status quo.
  • Present program updates and strategies to senior management, effectively communicating program timelines, development progress, and propose solutions for emerging challenges.

Requirements:

  • Advanced university degree in a relevant discipline (PhD or MD preferred).
  • Substantial leadership experience in program or project management across multiple therapeutic areas.
  • Demonstrated ability to navigate the commercial aspects of drug development and lead programs into and through pivotal studies.
  • Strategic thinker with excellent business acumen and the ability to operate effectively in a start-up environment.
  • Excellent proficiency in both German and English.

About Immunic AG:

Immunic AG offers a stimulating work environment where innovation and collaboration are valued. We provide competitive compensation, comprehensive benefits, and opportunities for professional growth.

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