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Director Clinical Sciences* (m/w/d)
Immatics Biotechnologies GmbH
München, Bayern | Tübingen, Baden-Württemberg
Home Office (optional)
Klinische Prüfung
GCP
klinische Entwicklung
Krebstherapien
Design der klinischen Prüfung
Dokumentation der klinischen Prüfung
Director Clinical Sciences*
Permanent employee, Full-time · Tuebingen, Munich or remote (Germany)Overview
We are currently seeking a Director Clinical Sciences* to join our dynamic team. This role will be responsible for overseeing key aspects of clinical trial design and documentation, collaborating closely with interdisciplinary teams to ensure the successful clinical development of investigational medicinal products (IMPs). The position is based in Tübingen, Munich or home-based (within Germany) and reports directly to the Vice President of Clinical Sciences.
Your mission
Your main responsibilities will include but are not limited to the following tasks:
- Drive the clinical development (phase 1 to 3) of cancer immunotherapies in various solid tumor indications currently focused on two bi-specific molecules targeting two different tumor targets.
- Lead and oversee (Senior) Managers Clinical Sciences (direct reports).
- Provide strategic input into advisory boards and KOL interactions, ensuring stakeholder alignment on clinical aspects including target medicine profile, tumor indication and trial design.
- Lead cross-functional teams for preparation of regulatory (IND and CTA) submissions and subsequent submissions of amendments, addressing clinical/ scientific and procedural topics and integrating preclinical data, biomarkers, and competitive intelligence into trial designs.
- Author and manage the development of clinical trial synopsis/ protocols (CTPs) and related amendments, clinical trial reports (CTRs), patient information sheets and informed consent forms (PIS-ICFs), and other patient-facing materials in alignment with cross-functional teams.
- Prepare and review clinical sections of briefing books for US (FDA) and Europe (e.g., PEI in Germany). Ensure prompt responses on clinical aspects to regulatory and ethical review bodies.
- Prepare and review clinical sections of, e.g., investigator brochures (IB), and development and safety update reports (DSURs).
- Conduct trainings (e.g., CTP) to clinical sites, internal teams, and external partners, ensuring CTP accuracy.
- Establish functional plans and oversee the development, maintenance, and compliance of controlled documents (e.g., SOPs and Working Instructions) within Clinical Sciences.
- Manage internal and external stakeholders, organize data review meetings to analyze clinical trial data.
- Provide technical or subject matter expertise in clinical research programs.
Your profile
- Master's degree or PhD in Biology, Clinical Sciences, or Life Sciences.
- A Minimum of 7 years of experience in clinical trial conduct, with in-depth knowledge of Good Clinical Practice (GCP) and a solid understanding of clinical development processes.
- Demonstrated ability to lead cross-functional teams and manage good clinical documentation in a regulated environment.
- Experience with the development of cancer therapies is an advantage.
- Excellent communication skills, both in English and German.
- Ability to work independently as well as collaboratively in a multidisciplinary setting.
- Ability to apply technical expertise and make sound decisions.
- Flexibility and adaptability in a changing environment.
Why us?
We are a committed and inspired team and cherish the collegial, highly motivated and family-friendly atmosphere within Immatics. Our culture allows for a high level of originality, independent thinking and initiative. We believe in supporting our employees’ professional and social skills: We enable them to join conferences and trainings as well as to enjoy our Immatics benefits - e.g. job bike, job ticket, Health Programs, childcare benefits, relocation allowance, Company summer and winter events.
Notice*
We value diversity and inclusion. Immatics N.V. and all Immatics subsidiaries are equal opportunity employers that evaluate qualified applicants without regard to color, national origin, religion, age, marital status, disability, veteran status, romantic orientation, gender identity, or other characteristics protected by law.About us
Immatics combines the discovery of true targets for cancer immunotherapies with the development of the right T cell receptors with the goal of enabling a robust and specific T cell response against these targets. This deep know-how is the foundation for our pipeline of Adoptive Cell Therapies and TCR Bispecifics as well as our partnerships with global leaders in the pharmaceutical industry. Operating from Tuebingen, Munich and Houston, we are committed to delivering the power of T cells and to unlocking new avenues for patients in their fight against cancer. For more detailed information, visit www.immatics.com.
Vollzeit
, Festanstellung
Fachkraft
Aktualisiert am
06.11.2024
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Arbeitsort
Standort der Stelle
Machtlfinger Str. 11
81379 München
Bayern
Deutschland
Paul-Ehrlich-Str. 15
72076 Tübingen
Baden-Württemberg
Deutschland
Home Office (optional)
Gut zu erreichen aus...
- Stuttgart
- Reutlingen
- Esslingen am Neckar
- Ludwigsburg
- Sindelfingen
- Landshut
Gehalt
Der angegebene Wert ist das geschätzte durchschnittliche Bruttojahresgehalt für vergleichbare Vollzeitpositionen.
€ 63.690
Über Immatics Biotechnologies GmbH
Immatics kombiniert die Identifizierung hochspezifischer Zielstrukturen für Krebsimmuntherapien mit der Entwicklung von geeigneten T-Zell-Rezeptoren (TCRs), um eine starke und spezifische T-Zell-Antwort gegen Tumor-Zielstrukturen hervorzurufen. Diese fundamentale Expertise bildet die Basis für unsere Pipeline adoptiver Zelltherapien und bispezifischer TCR-Moleküle sowie für...
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