Clinical Trial Physician (m|f|d)

Miltenyi Biomedicine is a newly established international biopharmaceutical company that develops innovative cell and gene therapies. We are focused on bringing cancer treatments and regenerative therapies to patients. Our initial focus is on difficult to treat hematological cancers using CAR-T technology whilst exploring treatments for solid tumors.  We are currently in discussion with the FDA, EMA and Japanese health authorities regarding initiating pivotal Phase II trials. We strongly believe that despite promising developments, there is significant room to improve on current cancer therapies.

Your Role

  • The overall goal of this newly created function is to develop a strategy to perform the clinical trials. You will be responsible for the design and coordination of clinical trials for company sponsored trials and the respective clinical trial documents complying with GCP and regulations in Europe, USA and APAC.
  • As a medical expert and member of the core trial team you provide clinical and scientific input into the setup of the clinical trials and needed documentation. This includes protocols, regulatory documents, Investigator brochures.
  • You will design and write,  develop and review the study related documents, especially the protocol, but also informed consent, study report etc.
  • You will execute  & guide the trial execution throughout the whole process and establish with R&D a target production profile.
  • Your tasks will not only include to give and ensure scientific and medical advice relevant to the clinical development program but also be the first point of contact for medical /scientific inquiries from health authorities.
  • In addition you will set up investigators meetings and discuss with clinical experts.

Your profile

  • You hold an university degree as a medical doctor (MD), ideally with PhD. Medical expertise in oncology is an advantage.
  • You gained clinical or research expertise in a pharma-/biotech company and/or CRO.
  • Your understanding of several clinical trial design methods, statistical requirements, regulatory requirements as well as all regulations and guidance including ICH/GCP is excellent.
  • You have demonstrable experience in clinical trial management as well as prior experience working with the FDA or EMEA.
  • Very good skills in data review and data analysis as well as the ability to influence others and to adapt to other areas are part of your profile.
  • Your inquisitive nature, your collaborative and communicative personality and your practical approach to solve problems helps you to set up strong networks.

What we offer

  • A modern workplace and exciting opportunities in the development of technologies with a secure future
  • Cross-border intercultural cooperation and short communication channels
  • A collegial corporate culture and flexible working hours enable time management on your own terms
  • Personalized employee development program: specialist and personal training courses provided by our own training academy
  • Diverse corporate benefits with regard to employee health, sport, and staff events

 

Contact us

If you have the skills and qualifications for this position, please use the link to send us your details (application letter, curriculum vitae, references and certificates). Please give us some idea of when you can start and the kind of salary you are looking for.

Your contact

Stefanie Eicks
Tel.: +49 2204 8306 3033

Apply now

Miltenyi Biomedicine GmbH
Human Resources
Friedrich-Ebert-Strasse 68
51429 Bergisch Gladbach Germany
www.miltenyibiotec.com/jobs