- The Medical Lead (ML) is the main driver for the clinical development of individual pre-clinical/early clinical assets across various modalities and indications for Oncology. You will provide clinical-scientific leadership ensuring a medically and clinically sound development strategy for one or more global development programs (including due diligences) starting from pre-D1 up to Proof of Concept.
- Depending on seniority and expertise, the Medical Lead can be nominated as a dedicated Expert, acting as a key representative for certain topics (i.e., functional expertise) or parts of the portfolio. In that role, he/she will be asked to both drive the respective topic from an overarching clinical point of view as well as represent it within and outside of the company.
- In addition, the ML is a core member of Oncology (cross-)functional strategic initiatives above the individual program level in support of the overall Oncology strategy.
- Guide the preclinical evaluation and validation of new oncology assets in line with the overarching Oncology strategy focusing on value, differentiation, and unmet medical need.
- Act as the clinical leader and single clinical representative for the global program(s) assigned to him/her and represents them both, internally and externally facing.
- Drive and executes a clinically and medically sound development plan for the assigned assets with a focus on a definitive clinical experiment as well as an "end-to-end" mindset, which enables the collection of all relevant information for further seamless clinical development.
- Be responsible for study medical/safety aspects and risk-benefit assessments supported by Pharmacovigilance and Clinical Trial Scientists.
- Identify new opportunities for collaboration and manages relationships with new and existing internal and external partners within his/her assigned development program or internal/external workstreams.
- Have sole responsibility for the development project, autonomously drive and execute a clinically and medically sound strategy with limited support needed from other peers; can be asked to support other MLs with clinical development expertise as well to mentor or deputize for those colleagues.
- Push the boundaries of early drug development to accelerate and improve decision making, while continuously implementing the patient's perspective and ensuring patient's safety and benefit at all times.
- Provide comprehensive knowledge of scientific, development, and regulatory landscape as well as clinical development methodology to enable state-of-the-art early precision drug development. Contribute deep disease specific knowledge within Oncology and can be asked to act as an expert representing an indication.
- Contributes to Oncology-wide strategic initiatives
Qualifications (Education, skills, experiences, and personal characteristics necessary for success in this position):
- Medical excellence: M.D., M.D./PhD or equivalent degree and 5+ years in direct patient care; board certification within oncology/hematology or associated subspecialties is a plus
- Solid experience in clinical drug development (Senior Medical Lead: 4+ years) as an academic investigator or within a pharmaceutical/biotech environment
- Understanding of the scientific methods and tools used in early clinical development studies: biomarkers, translational modelling, biostats
- Good understanding of Oncology medical needs and the clinical trial landscape
- Understanding of basic science relevant to clinical oncology (biochemistry, immunology, molecular biology and/or genetics)
- Experience with global health authority interactions. Participated and led a drug development program to registration or IND filling preferred
- High energy with focus and vision; self-motivated with a high sense of ownership, urgency, proactive and solution-oriented, flexible entrepreneurial and open-minded approach to new and creative ideas