Als mittelständisches Unternehmen mit Sitz in Ladenburg bei Heidelberg legen wir großen Wert auf eine offene und kollegiale Arbeitsatmosphäre. Wir duzen uns, arbeiten gerne im Team und übernehmen Verantwortung für unseren Arbeitsbereich.
Gemeinsam arbeiten wir an einem neuen Behandlungsansatz in der Onkologie. Auf der Basis unserer ADC-Technologien entwickeln wir neuartige Arzneimittel für die gezielte und hochwirksame Krebsbehandlung. ADCs sind Antikörper-Wirkstoff-Konjugate (Antibody Drug Conjugates), die die Spezifität von Antikörpern mit der Wirksamkeit von Toxinen kombinieren, um gezielt Krebszellen zu bekämpfen. Wir verwenden mehrere Beladungswirkstoffe und haben eine ADC-Toolbox aufgebaut, die über vielfältige Wege Tumorresistenzen überwindet und über verschiedene Antikörper unterschiedliche Krebsarten adressiert. Unser Ziel ist die Entwicklung von zielgerichteten und hochwirksamen ADCs zur Behandlung einer Vielzahl von bösartigen hämatologischen und soliden Tumoren. Wir bieten abwechslungsreiche Positionen in Forschung, Entwicklung und Verwaltung. Wir begleiten dich auf deinem persönlichem Karriereweg und bieten dir vielfältige Möglichkeiten, dich weiterzuentwickeln.
(Senior) Clinical Trial Manager (f/m/d)
To strengthen our Clinical Operations team at the Ladenburg site, we are looking for a full-time and permanent position at the earliest possible start date.
What awaits you:
- You plan, execute and monitor Phase 1 (FIH) clinical trials in cooperation with other scientific departments as well as the responsible CRO (Clinical Research Organization).
- You participate in the preparation of study protocols as well as associated documents, such as CRFs, Monitoring Plan, and other documents.
- In addition, you are responsible for compliance with quality standards, timelines, and study budget.
- In your role as Clinical Trial Manager, you are in charge of the supply chain activities for IMPs of national and international clinical trials.
- You create and maintain accurate clinical supply demand for assigned studies.
- You also define and develop appropriate supply strategies for clinical trial supplies, e.g. labelling requirements, packaging design/layout, depot structure and distribution setup for global clinical trials, together with the relevant multiple internal (e.g. CMC) and external interfaces.
- You manage and monitor external vendors
What we look for in you:
- You have a degree in health care, life sciences, nursing or other medical professions or equivalent professional experience.
- 5-10 years (Clinical Trial Manager), 10+ years (Senior Clinical Trial Manager) of professional experience in the field of clinical research with a CRO, pharmaceutical or biotech company is required for this position.
- You have experiences in Phase 1 oncology clinical trials; FIH would be an asset
- You are a highly motivated problem solver and have a proactive personality with the ability to work in a multi-cultural team as well as self-dependent.
- It is self-evident for you to treat information and data confidentially.
What we offer:
- Flexible working hours with compensation options and the opportunity to work remotely so that your job fits in with your life
- Mentoring program: In addition to comprehensive onboarding, you will receive a buddy who will show you everything so that you feel at home quickly
- Prospects for your personal and professional development: Benefit from our training program so that you can take your qualifications to a new level
- We support you and your family through our “FamPlus” Employee Assistance Program, e.g. in organizing childcare or caring for relatives
- We offer you a wide range of social benefits: Company pension scheme with employer subsidy, pension benefits as part of company health insurance and job bike
- Would you like to improve your fitness? No problem, then join our weekly sports meeting
- You can use our free charging stations for your electric car
- Happy coffee break, weekly fruit day and regular great company events await you