FirmaTimshel Sp. z o. o.
An opportunity for an experienced Medical Director in oncology field has opened within a newly formed Biotechnology Company. As a Medical Director you will provide medical expertise to the clinical trials for the timely preparation and execution of the clinical development program. Our Client develops novel small molecule therapies across oncology with current focus in hematological and oncological indications
We are looking for oncologist or hematooncologist who will become a part of Clinical Team and who will contribute to development of current studies and future ones.
- Contribute scientific and strategic input to the development and execution of the clinical development plan (CDP)
- Preparation of clinical trial protocol summaries and protocols, reports and publications
- Provide clinical development expertise to support other departments and line functions
- Build relationships among the clinical/scientific community and with other external experts
- Contribute medical /scientific expertise to clinical strategy and program documents (investigator brochure, IND annual report, Health/Competent Authority briefing books and submissions)
- Participate as clinical representative in Project Teams
- Contribute medical expertise to the execution of clinical trials (including selection of investigators/study sites)
- Review clinical trial reports and summaries
- Maintain oversight of product safety, and safety monitoring in clinical trials
- Review and approval of study documents throughout the clinical trial course: feasibility questionnaires, pre-study/initiation/monitoring/close-out visit reports, statistical analysis plans, AE reconciliation reports, etc.
- Write and review abstracts/manuscripts, etc. for presentation/publication at internal/external meetings
- Prepare training materials for internal and external use as required
- MD degree and state-of-the-art medical knowledge within oncology
- Familiar with all aspects of the clinical development process within oncology solid tumors, especially early phases knowledge required
- Experience in hematooncology clinical trials is a plus
- Knowledge in clinical trial design, intermediate statistics and pharmacokinetics
- Proven ability to interpret efficacy and safety data
- Medical-Scientific writing skills
- Knowledge of GCP and world-wide regulatory requirements
- Collaborative and supportive work culture
- Possibility to work from home
- Training program enabling scientific development: Peer to Peer Academy, scientific lectures, participation in conferences
- Participation in challenging and ambitious projects and opportunity for rapid career development
- Package of benefits: private medical healthcare, sports activities support and many others
- Work in a dynamic Company with a high perspective of growth and operating in the innovative business sector
- Long-term cooperation based on stable employment conditions
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