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Director of Clinical Programs
vor 2 Monaten
Immunic Therapeutics is an innovative biotechnology firm focused on developing selective, orally administered therapies aimed at treating chronic inflammatory and autoimmune disorders. Our pipeline includes three small molecule candidates currently advancing through various clinical phases.
This pivotal role is essential to our organization, and the responsibilities will reflect its significance. As the Program Head for IMU-838, you will oversee and direct all development and pre-registration activities across multiple departments for Vidofludimus Calcium, our leading candidate in Phase 3 trials for Relapsing MS and Phase 2 trials for Progressive MS. Your extensive expertise in drug development and pre-registration processes will be instrumental in propelling the program towards success.
Your profound knowledge of the R&D landscape, coupled with a commercially astute perspective, will be vital in addressing clinical, CMC, regulatory, and pre-clinical hurdles. This position requires a leader who excels in a dynamic, entrepreneurial setting and has the capability to influence and guide cross-functional teams without direct authority.
- Lead the IMU-838 program through various clinical development phases, ensuring alignment with strategic goals and adherence to regulatory requirements.
- Collaborate with various leaders and functions within the organization, acting as a liaison to Immunic's management.
- Coordinate cross-functional teams, promoting collaboration and ensuring seamless integration of clinical development, regulatory affairs, compliance, GxP, and vendor management.
- Oversee program budget and manage financial implications with external suppliers and vendors.
- Provide comprehensive leadership for NDA preparations in the coming years, focusing on regulatory affairs, CMC, and Quality Management, as well as readiness for pre-approval FDA inspections (GCP).
- Drive the program with a proactive, entrepreneurial mindset, fostering innovative problem-solving and challenging conventional approaches.
- Present program updates and strategies to senior management, effectively communicating timelines, development progress, and proposing solutions for emerging challenges.
Qualifications:
- Advanced degree in a relevant field (PhD or MD preferred).
- Significant leadership experience in program or project management across diverse therapeutic areas.
- Proven ability to navigate the commercial aspects of drug development and guide programs through pivotal studies.
- Strong background in managing external suppliers and virtual teams, ideally in a small, entrepreneurial context.
- Exceptional communication and leadership abilities, capable of influencing without direct authority and fostering team cohesion.
- High energy, motivated, and integrative personality with a problem-solving orientation.
- Strategic thinker with excellent business acumen, able to operate effectively in a start-up environment.
- A strong cultural fit with Immunic AG's values, complemented by cross-cultural experience.
- Fluency in both German and English.
Be part of a company where your contributions directly enhance our mission of advancing patient care through pioneering research. Immunic AG offers a stimulating work environment that values innovation and collaboration, alongside competitive compensation and comprehensive benefits.