Program Head
vor 4 Wochen
This is a key and critical role within our organization and this should be reflected in the responsibilities for this position. As the Program Head for IMU-838, you will coordinate and steer all of the development and pre-registration activities throughout all of the different departments for Vidofludimus Calcium, our most advanced development candidate in Phase 3 trials for Relapsing MS and in Phase 2 trials for Progressive MS. You will leverage your extensive experience in drug development and pre-registration activities to drive the program forward towards success. Your deep understanding of the R&D process, along with a commercially savvy mindset, will be crucial in navigating clinical, CMC, regulatory, and pre-clinical challenges. This role demands a leader who thrives in a fast-paced, entrepreneurial environment and possesses the ability to influence and lead multifunctional teams without direct authority.
- Lead the IMU-838 program through various stages of clinical development, ensuring alignment with strategic objectives and compliance with regulatory standards.
- Work with various leaders and functions in the company and function as 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.
- Manage program budget and oversee budget impact with external suppliers and vendors.
- Provide overarching leadership for the NDA preparations over the next years in the areas regulatory affairs, CMC and Quality Management, as well as preparations to 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.
- 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.
- Strong experience in managing external suppliers and virtual teams, preferably in a small, entrepreneurial setting.
- Exceptional communication and leadership skills, capable of influencing without direct authority and fostering team spirit.
- High energy, motivated and integrative personality with a questioning and problem-solving mindset.
- Strategic thinker with excellent business acumen and the ability to operate effectively in a start-up environment.
- A very good cultural fit with Immunic AG's team and values, along with cross-cultural experience.
- Excellent proficiency in both German and English.
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.
CRWL1_DE
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Gräfelfing, Deutschland Immunic AG VollzeitImmunic 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: . This is a key and critical...
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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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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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Gräfelfing, Bayern, Deutschland Immunic AG VollzeitJob DescriptionProgram HeadImmunic AG is a dynamic biotechnology company with a pipeline of selective, orally available immunology therapies for the treatment of chronic inflammatory and autoimmune diseases. Our company is committed to improving patient care through groundbreaking research.Key Responsibilities:Lead the IMU-838 program through various stages...
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