Clinical Project Manager (m|f|d) - Global Early Development

Miltenyi Biomedicine GmbH (Bergisch Gladbach NW, Deutschland) Vor 11 Tagen veröffentlicht

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
  • As a Global Clinical Project Manager you will be responsible for the design and conduct of early clinical trials with medicinal products and / or medical devices. This includes writing and medical review of clinical protocols.
  • In this role you will build up a strong rapport to international medical experts to validate assumptions (e.g. medical need, competition, etc.) and provide expertise for strategic decisions in early clinical development.
  • Your responsibility will include the organization of scientific advisory, data safety and monitoring boards for all early development trials.
  • You will provide expertise for strategy discussion within expert indication teams, including evaluation of early assets as well as early clinical trial planning and set up of early CIT and IIT.

Your profile
  • You hold a Degree in medicine, pharmacy or science. A Ph.D. is a plus.
  • You have at least 3 – 5 years’ experience in the design and conduct of clinical trials.
  • Experience in early clinical trials, conducting trials at the clinical site, drug development in the industry as well as in immunological and cellular treatments is of advantage.
  • You enjoy working in a multidisciplinary team (e.g. R&D, Clinical Development, Regulatory Affairs, Commercial) and dynamic environment.
  • Excellent communication and interpersonal skills as well as independent and efficient working style round off your profile.

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.

Clinical Project Manager (m|f|d) - Global Early Development

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