Medical Director
vor 2 Monaten
Work Your Magic with us
Ready to explore, break barriers, and discover more? We know you've got big plans '“ so do we Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.
**Your role**:
- Act as a Global Project Team (GPT) clinical representative and ensure medical responsibility for the dedicated projects / programs.
- Design early and late clinical development strategies.
- May act as functional supervisor of Clinical Research Scientists (CRS) as assigned.
- Provide medical and scientific expertise / input to business development activities, to discovery and non-clinical development, to stratified medicine, medical communications, quality assurance, clinical operations, biostatistics, regulatory affairs and patient safety.
- Drive and support the development and preparation of early and late clinical development plans, study concept sheets, and study protocols in collaboration with clinical and project team members.
- Provide medical / scientific input and drive the creation of relevant clinical documents to ensure high quality of e.g. study concept sheets, clinical study protocols and clinical study reports, Investigator Brochures, submission / registration documents, publications, etc.
- In particular, review and sign off all clinical documents related to First-in-Man (FIM) and PoC studies (e.g. study protocols and study reports), supervise and conduct the review, analysis and interpretation of study data. Support communication of study results as assigned.
- Responsible for the medical supervision of assigned projects/programs.
- Drive execution of early clinical development strategies for assigned projects / programs in order to establish a clear path to FiM and PoC studies and related Go / No Go criteria. Potential to drive execution of late stage clinical studies.
- Support / Contribute to annual budget and resource planning.
- Increase scientific knowledge in the Clinical Oncology organization by attending international congresses and related workshops. Assist in organizing scientific development activities within Clinical Oncology, such as internal courses and inviting external speakers
- Participate in cross-functional development project team activities to provide medical / scientific input into e.g. business plan, project strategy, in
- / out licensing activities, etc. as assigned.
- Provide functional supervision of Clinical Research Scientists (CRS). Provide functional clinical guidance to cross-functional development project team activities and members
**Who you are**:
- Medical Doctor (MD) specialized in the therapeutic area Oncology
- In-depth knowledge of ICH-GCP and other applicable regulatory guidelines / practices
- Expert in clinical drug development with sound knowledge in early development, knowledge in pharmacogenomics and pharmacokinetics is desireable
- A minimum of 4 years of experience in clinical R&D as investigator and / or within the pharmaceutical and / or biotech industry at an international level
- Experiences in interaction with Health Authorities in Europe, US and possibly Japan and / or China.
- Experience in immuno-oncology clinical development preferred
- Working experience with relevant R&D interface partners such as Clinical Pharmacology, DMPK, Toxicology, Clinical Safety, Clinical Development & Operations and Regulatory Affairs
- Understanding the needs of R&D as well as non-R&D (e.g. marketing, portfolio management, HR) interface partners, external academic, biotech and pharmaceutical collaborators as well as regulatory agencies
- Very strong communication skills (face-to-face, presentations, reports, etc.)
- Excellent influencing and presentation skills and Project management capabilities
- Very strong analytical skills and solid strategic orientation
- Excellent initiative and driven by a strong sense of urgency.
- Entrepreneurial spirit and action/results driven
- Multitasking capability Ability to work in a constantly changing and challenging environment
**What we offer**:We are curious minds that come from a broad range of backgrounds, perspectives, and life experien
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