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Project manager/Director pre-clinical & clinical development [f/m]

 Thermosome GmbH  Planegg-Martinsried (bei München)
Thermosome is an entrepreneurial biopharmaceutical company located in Martinsried near Munich that strives to develop proprietary drug candidates in the field of oncology. Core of our development is our unique, proprietary and patent-protected drug delivery technology using a thermo-sensitive nanocarrier for local high-concentrated delivery of active pharmaceutical ingredients (APIs). Our nanocarrier encapsulates APIs safely at normal body temperature, but instantly releases the APIs once entering mildly heated tissue (achieved through approved medical devices). Our lead drug candidate has shown pre-clinical proof-of-concept in several species, is within CMC and will shortly move into formal toxicological testing.
We are a young, very dynamic and highly committed team that is extremely eager to move our technology and derived drug candidate into the next development phase. Most importantly, we are working on our long-term vision to help patients with severe oncological problems to receive better treatment options and increase quality of life. In addition, it is crucial for us to have fun as a team. We closed our first Venture Capital financing round end of 2015 and are now further building up a core team to handle the key areas of the pharmaceutical development process. As part of our company building, we are currently looking for a:
Project manager/Director pre-clinical & clinical development [f/m]
Your responsibilities:
  • Taking over full ownership for project management of the toxicological and clinical development program of our lead drug candidate in one oncological focus indication in collaboration with our team, Principal Investigator (PI) and external service providers (e.g., regulatory, medical writing)
  • Setting-up our first-in-human oncological trial with a limited number of centers in one country, including evaluation and selection of an experienced oncological CRO
  • Preparing and/or coordinating preparation and submission of necessary regulatory documents to initiate a first-in-human study (e.g., IB, IMPD, ethical committee)
  • Potentially drive project management of further pre-clinical and clinical activities
Your profile:
  • In-depth / first-hand experience in the setup and management of pre-clinical and/or clinical studies – preferably in oncology. Your experience will have included close coordination with CROs and other relevant service providers in all phases of the project, including feasibility assessments, site initiation, trainings and regular follow-up visits as well handling of all relevant internal and external documentation and process management items
  • Prior work experience at a contract research organization (CRO), in the pre-clinical and clinical development at a biopharmaceutical firm or equivalent – preferably in oncology
  • University education with a Master’s or PhD degree in natural science
  • Fluent English written and spoken – German is a plus, but not a necessity
  • Strong motivation to take over full ownership of your own work and to work independently with a self-starter attitude
  • Ability to work in a team comprising complementary educational and work experiences
  • Willingness to learn new skills and to go the extra mile to achieve even better results
  • Humor and having fun while working on a meaningful drug development project that has the potential to improve healthcare
Your opportunity:
  • Being responsible for a high-impact preclinical and clinical project developed in a high unmet need orphan disease in oncology
  • Working in a multinational and interdisciplinary small team without hierarchy
  • Personal and professional development through responsibilities across a broad range of subjects
  • Pleasant and flexible working environment in a young, dynamic team including international partners from several countries
  • Opportunity to work either half-time or full-time in a flexible manner (if applicable)

How to apply:
Please send your CV and references including the desired salary to careers@thermosome.com.
Kontakt für Bewerbungen
Thermosome GmbH
Am Klopferspitz 19
82152 Planegg/Martinsried
Tel.: +49 89 7167760-31
Email: careers@thermosome.com

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