Clinical Scientist - Manager/Senior Manager (m/f/d)

vor 1 Monat

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Tubulis GmbH

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Biotechnology • Pharmaceuticals

Die Tubulis GmbH ist ein Biotechnologieunternehmen, das sich auf das Design und die Entwicklung von Antikörper-Wirkstoff-Konjugaten (ADCs) der nächsten Generation zur Krebsbehandlung spezialisiert hat. Das Unternehmen nutzt proprietäre Plattformtechnologien, um einzigartig angepasste ADCs mit verbesserten biophysikalischen Eigenschaften, dauerhaftem On-Tumor-Transport und starker präklinischer Antitumoraktivität zu erzeugen. Die führenden klinischen Programme, TUB-040 (anti-NaPi2b) und TUB-030 (anti-5T4), zielen auf Indikationen mit hohem Bedarf an soliden Tumoren ab, und Tubulis treibt sowohl seine proprietäre Pipeline als auch Partnerschaftsprogramme voran, um das therapeutische Potenzial von ADCs für Patienten und Partner zu erweitern.

51 - 200 Mitarbeiter

🧬 Biotechnologie

💊 Pharmazie

Beschreibung

• Support the Medical Director in the oversight of clinical studies including review and interpretation of clinical trial data • Take a lead role in writing protocol amendments, informed consents, and other protocol-related documents for the operational execution of clinical studies • Participate in the start-up of global clinical studies, working with Clinical Operations to ensure on schedule site activation and subject enrollment • Actively identify areas of emerging risk for the execution of clinical studies and proposing solutions to minimize and mitigate risk • Play a key role in the review of study data to ensure timely and high-quality data entry • Participate in investigator meetings, investigator engagement, including assisting in the preparation of Advisory Board meetings

🎯 Anforderungen

• BS or BSN is minimally required • An advanced degree in a scientific discipline (i.e. MS, PharmD, PhD, MD) is preferred • A minimum of 1 year of clinical development research in oncology or related clinical research experience within the industry (pharmaceutical, biotech, CRO) is required • Strong knowledge in clinical development in Oncology development is required • Significant experience with clinical evaluation projects including development of protocols, case report forms, informed consent and study initiation and monitoring • Significant experience with data integrity, exploration, analysis and presentation • High-performing and energetic individual who demonstrates outstanding scientific knowledge applicable to early disease clinical research and the highest personal and ethical standards • Self-organized, self-motivated, and able to work independently

🏖️ Vorteile

• Professional development opportunities • Flexible working hours