Immunic AG
Senior Medical Director(m/w/x)
Full-timeOn-siteSenior
Gräfelfing
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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.
Requirements
- 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
Tasks
- 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
Work Experience
- 3 - 5 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Native
Benefits
Career Advancement
- Professional growth opportunities
Startup Environment
- Dynamic, flexible, and innovative working environment
Competitive Pay
- Stock option program participation
Healthcare & Fitness
- Wellpass
Mental Health Support
- OpenUp
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Immunic AG and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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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.
Requirements
- 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
Tasks
- 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
Work Experience
- 3 - 5 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Native
Benefits
Career Advancement
- Professional growth opportunities
Startup Environment
- Dynamic, flexible, and innovative working environment
Competitive Pay
- Stock option program participation
Healthcare & Fitness
- Wellpass
Mental Health Support
- OpenUp
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Immunic AG and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
About the Company
Immunic AG
Industry
Pharmaceuticals
Description
Immunic Therapeutics is a biotechnology company developing immunology therapies for chronic inflammatory and autoimmune diseases.
Not a perfect match?
- Immunic AG
Senior Medical Director(m/w/x)
Full-timeOn-siteSeniorGräfelfing - Alexion
Medical Science Liaison Manager, Neurology(m/w/x)
Full-timeOn-siteSeniorMünchen - Scholar Rock
Country Medical Director(m/w/x)
Full-timeOn-siteSeniorFrankfurt am Main, München - BioNTech SE
(Senior-) Director Clinical Development(m/w/x)
Full-timeOn-siteSeniorMainz, München - Regeneron GmbH
Country Medical Director(m/w/x)
Full-timeOn-siteManagementMünchen