Director of Clinical Programs
vor 4 Wochen
Company 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 IMU-838 is pivotal within our organization. This position entails overseeing and directing all development and pre-registration initiatives 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 background in drug development and pre-registration will be instrumental in propelling the program towards successful outcomes.
Key Responsibilities:
- Lead the IMU-838 program through its clinical development phases, ensuring alignment with strategic goals and adherence to regulatory requirements.
- Collaborate with various leaders and departments within the organization, acting as a liaison to Immunic's management.
- Coordinate cross-functional teams, promoting collaboration and ensuring the smooth integration of clinical development, regulatory affairs, compliance, GxP, and vendor management.
- Oversee program budgets and manage financial impacts associated with external suppliers and vendors.
- Provide comprehensive leadership for NDA preparations in the areas of 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.
- Deliver program updates and strategic insights to senior management, effectively communicating timelines, development progress, and 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 dimensions 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 capabilities, with a talent for influencing without direct authority and fostering team cohesion.
- Dynamic, motivated, and integrative personality with a strong problem-solving orientation.
- Strategic thinker with excellent business acumen, capable of thriving in a start-up environment.
- A strong cultural fit with Immunic AG's values and team dynamics, complemented by cross-cultural experience.
- Fluency in both German and English.
Why Immunic AG? We offer a stimulating work environment where your contributions directly impact our mission to enhance patient care through pioneering research. Our organization values innovation and collaboration, providing competitive compensation, comprehensive benefits, and opportunities for professional development.
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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...
-
Director of Clinical Programs
vor 4 Wochen
Gräfelfing, Bayern, Deutschland Immunic AG VollzeitCompany 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...
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Senior Program Director
Vor 4 Tagen
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
vor 6 Stunden
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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Program Director
Vor 4 Tagen
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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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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Program Director
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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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