Director of Clinical Programs
vor 4 Wochen
Company Overview: Immunic Therapeutics is an innovative biotechnology firm dedicated to developing selective, orally available therapies targeting chronic inflammatory and autoimmune conditions. Our pipeline includes three small molecule candidates currently undergoing various phases of clinical evaluation.
Position Summary: We are seeking a Program Head for IMU-838, a pivotal role that will oversee and guide all development and pre-registration initiatives for Vidofludimus Calcium, our leading candidate in Phase 3 trials for Relapsing MS and Phase 2 trials for Progressive MS. This position requires a seasoned professional with a robust background in drug development to propel the program towards successful outcomes.
Key Responsibilities:
- Steer the IMU-838 program through clinical development stages, ensuring alignment with strategic goals and adherence to regulatory requirements.
- Act as a liaison between various leaders and departments within the organization, facilitating communication and collaboration.
- Coordinate cross-functional teams to ensure integration of clinical development, regulatory affairs, compliance, GxP, and vendor management.
- Oversee program budget and assess financial implications with external partners and suppliers.
- Provide leadership for NDA preparations, focusing on regulatory affairs, CMC, and Quality Management, including readiness for pre-approval FDA inspections.
- Adopt a hands-on, entrepreneurial approach to drive the program, fostering innovative solutions and challenging conventional practices.
- Deliver program updates and strategic insights to senior management, clearly communicating timelines, progress, and potential solutions to 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 dimensions of drug development and lead programs through critical studies.
- Extensive experience managing external suppliers and virtual teams, ideally in a dynamic, entrepreneurial environment.
- Exceptional communication and leadership capabilities, with a talent for influencing without direct authority and fostering teamwork.
- High-energy, motivated individual with a proactive, problem-solving mindset.
- Strategic thinker with strong business acumen, capable of thriving in a start-up atmosphere.
- Cultural fit with Immunic AG's values and cross-cultural experience is highly valued.
- Fluency in both German and English is essential.
Work Environment: At Immunic AG, we value innovation and collaboration, providing a stimulating workplace where your contributions directly impact our mission to enhance patient care through pioneering research. We offer competitive compensation, comprehensive benefits, and opportunities for professional advancement.
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Director of Clinical Programs
vor 4 Wochen
Gräfelfing, Bayern, Deutschland Immunic AG VollzeitImmunic 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...
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Director of Clinical Programs
vor 4 Wochen
Gräfelfing, Bayern, Deutschland Immunic AG VollzeitCompany Overview: 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 undergoing various phases of clinical trials.Position Overview: The role of Program Head for...
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Gräfelfing, Bayern, Deutschland Immunic AG VollzeitJob 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...
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Senior Program Director
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Gräfelfing, Bayern, Deutschland Immunic AG VollzeitJob 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...
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Gräfelfing, Bayern, Deutschland Immunic AG VollzeitJob Description**Program Head for IMU-838**We are seeking a highly experienced and skilled Program Head to lead our IMU-838 program through various stages of clinical development. As a key member of our team, you will be responsible for ensuring alignment with strategic objectives and compliance with regulatory standards.Key Responsibilities**Lead the...
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