Job title: SENIOR SCIENTIST– NON-CLINICAL PROJECT LEAD (F/M/D)
Company: Myelo Therapeutics GmbH
Job description: Myelo Therapeutics GmbH develops an innovative clinical stage therapy, that mitigates Chemotherapy- and Radiation-induced Myelosuppression, a common and serious side effect of anticancer therapy. In addition, Myelo Therapeutics develops this therapy for the treatment of Acute Radiation Syndrome in close collaboration with the US National Institutes of Health. Our international team works in a bright, spacious loft office in the heart of Berlin-Mitte.
Myelo Therapeutics offers an attractive position in a challenging work environment and a lean, non-hierarchical organization. We give our employees a large degree of freedom to drive our scientific and commercial progress and to grow professionally.
The position will report directly to the Managing Director/Chief Science and Medical Officer.
This role combines leadership of a network of collaborators, research strategy with hands-on in-depth scientific and regulatory work. You will play a key role in developing a treatment for some of the most relevant medical challenges of our time.
- Developing and aligning our non-clinical program with a regulatory strategy
- Crafting strategic non-clinical program development plans.
- Independently designing, planning, monitoring and reporting non-clinical in vivo and in vitro studies in accordance with the development plans and with the latest scientific methods available.
- Selecting and supervising contract research organizations, universities, and subject matter experts.
- Preparing presentations and reports and presenting results in internal groups and interdisciplinary meetings.
- Working in compliance with GLP and GCP guidelines.
- Evaluation of new methods and models (e.g. animal models) to support non-clinical development.
- Conducting systematic literature research.
- Writing publications.
- Writing of scientific documents for regulatory submissions in support of market authorization approval.
- Developing and reviewing SOP’s, guidelines, and work instructions.
- Building a deep understanding of pharmacodynamic and pharmacokinetic research specific for us
- Doctorate in health, biologic or regulatory sciences with a sound knowledge of the specialist aspects and methods involved in biochemistry, organic chemistry or pharmaceutics and/or comparable level of training by experience.
- Minimum of 5 years‘ experience with the conduct of non-clinical in vivo and in vitro studies in an advanced academic or preferably pharmaceutical industry.
- Expertise in the field of radiation- and chemotherapy, oncology, immunology, or hematology is advantageous.
- Strong knowledge of regulatory policies and guidance documents on non-clinical pharmaceutical studies and their application to experimental planning and design.
- Writing regulatory documentation and regulatory interaction has been part of your job.
- Writing grants and publications is part of your repertoire of skills.
- Proficient in the conduct of in vitro and in vivo studies and analysis of data derived from such studies.
- Good knowledge of and familiarity with the application of GLP
- Ability to conduct multiple projects delivering agreed milestones and adhering to timelines.
- Interdisciplinary thinking, willingness to embrace new subject areas, and eagerness to learn new things.
- Good team player with excellent and proactive communication skills. Project leadership skills.
- Ability to think out of the box and across functional boundaries.
- Highly independent working style.
- The desire to work in an entrepreneurial environment. We retained the culture of a start-up and are not big pharma.
- Excellent written and spoken English.
- Permanent or secondary place of residence is or will be Berlin.
If necessary, we may support you in obtaining a German work permit.
We offer a dynamic and ambitious start-up environment with broad opportunities to learn and grow. Incentives include a flexible home office / remote work policy, and perks such as gym, child care, or public transport co-pay. The position advertised is a permanent position. Starting date: August 2021.
Please send your CV along with your expected salary and earliest date of availability in an Email.
We look forward to getting to know you!
Myelo Therapeutics GmbH
Att: Dirk Pleimes
Managing Director, Chief Scientific & Medical Officer
Subject: SENIOR LEAD
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