Immunic AG
Senior Medical Director(m/w/x)
Vollzeitnur vor OrtSenior
Gräfelfing
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
IMImmunic AG
Medical Director(m/w/x)
Gräfelfing
VollzeitVor OrtBerufserfahren
Nejo KI-Zusammenfassung
Medical leadership for Phase 3 trial unblinding and data readout in immunology therapies. MD with 3-5+ years late-stage biotech/pharma experience and Phase 3 trial involvement required. Stock option program participation, Wellpass, OpenUp.
Anforderungen
- Medical Degree (MD), ideally with neurology training/clinical background, or advanced science/related degree
- 3-5+ years experience in biotech/pharma or academic clinical research (late-stage trials)
- Previous involvement in Phase 3 clinical trials
- Expertise in Multiple Sclerosis, advantageous scientific understanding of disease mechanisms/clinical development pathways
- Solid knowledge of GCP and international regulatory requirements (FDA, EMA)
- Experience in assessing risks/opportunities/implications in late-stage drug development
- Ability to lead and collaborate in cross-functional/matrix teams
- Excellent communication skills and strategic mindset
- Native-level English proficiency
Aufgaben
- Lead unblinding, data review, and readout of Phase 3 trials
- Analyze and interpret comprehensive trial data
- Provide medical leadership for Clinical Study Reports
- Support pre-NDA regulatory activities (FDA, EMA)
- Communicate clinical outcomes and study rationale clearly
- Collaborate with medical advisory board and key investigators
- Represent the program at scientific and medical conferences
- Collaborate with NDA preparation team
- Shape key messages, clinical summaries, and data presentations for NDA
- Evaluate high-level Phase 3 results
- Support global registration and reimbursement strategies
- Support scientific publications
- Provide hands-on medical monitoring for Phase 3 trials
- Review activities during data cleaning
- Partner with Pharmacovigilance on medical assessment of safety cases
- Review and prepare narratives for serious adverse events (SAEs)
- Lead interactions with regulatory authorities
- Ensure alignment on clinical evidence and program strategy
Berufserfahrung
- 3 - 5 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – fließend
Benefits
Karriere- und Weiterentwicklung
- Professional growth opportunities
Startup-Atmosphäre
- Dynamic, flexible, and innovative working environment
Attraktive Vergütung
- Stock option program participation
Gesundheits- & Fitnessangebote
- Wellpass
Mentale Gesundheitsförderung
- OpenUp
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Immunic AG erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
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IMImmunic AG
Medical Director(m/w/x)
Gräfelfing
VollzeitVor OrtBerufserfahren
Nejo KI-Zusammenfassung
Medical leadership for Phase 3 trial unblinding and data readout in immunology therapies. MD with 3-5+ years late-stage biotech/pharma experience and Phase 3 trial involvement required. Stock option program participation, Wellpass, OpenUp.
Anforderungen
- Medical Degree (MD), ideally with neurology training/clinical background, or advanced science/related degree
- 3-5+ years experience in biotech/pharma or academic clinical research (late-stage trials)
- Previous involvement in Phase 3 clinical trials
- Expertise in Multiple Sclerosis, advantageous scientific understanding of disease mechanisms/clinical development pathways
- Solid knowledge of GCP and international regulatory requirements (FDA, EMA)
- Experience in assessing risks/opportunities/implications in late-stage drug development
- Ability to lead and collaborate in cross-functional/matrix teams
- Excellent communication skills and strategic mindset
- Native-level English proficiency
Aufgaben
- Lead unblinding, data review, and readout of Phase 3 trials
- Analyze and interpret comprehensive trial data
- Provide medical leadership for Clinical Study Reports
- Support pre-NDA regulatory activities (FDA, EMA)
- Communicate clinical outcomes and study rationale clearly
- Collaborate with medical advisory board and key investigators
- Represent the program at scientific and medical conferences
- Collaborate with NDA preparation team
- Shape key messages, clinical summaries, and data presentations for NDA
- Evaluate high-level Phase 3 results
- Support global registration and reimbursement strategies
- Support scientific publications
- Provide hands-on medical monitoring for Phase 3 trials
- Review activities during data cleaning
- Partner with Pharmacovigilance on medical assessment of safety cases
- Review and prepare narratives for serious adverse events (SAEs)
- Lead interactions with regulatory authorities
- Ensure alignment on clinical evidence and program strategy
Berufserfahrung
- 3 - 5 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – fließend
Benefits
Karriere- und Weiterentwicklung
- Professional growth opportunities
Startup-Atmosphäre
- Dynamic, flexible, and innovative working environment
Attraktive Vergütung
- Stock option program participation
Gesundheits- & Fitnessangebote
- Wellpass
Mentale Gesundheitsförderung
- OpenUp
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Immunic AG erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Über das Unternehmen
Immunic AG
Branche
Pharmaceuticals
Beschreibung
Immunic Therapeutics is a biotechnology company developing immunology therapies for chronic inflammatory and autoimmune diseases.
Noch nicht perfekt?
- Immunic AG
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Vollzeitnur vor OrtSeniorMünchen - Scholar Rock
Country Medical Director(m/w/x)
Vollzeitnur vor OrtSeniorFrankfurt am Main, München - BioNTech SE
(Senior-) Director Clinical Development(m/w/x)
Vollzeitnur vor OrtSeniorMainz, München - Regeneron GmbH
Country Medical Director(m/w/x)
Vollzeitnur vor OrtManagementMünchen