30 days ago
This individual will be responsible for developing and executing the global clinical development program, including the clinical leadership of the trials, medical monitoring and scientific support of clinical trials, input in regulatory interactions and providing strategic direction to the study development team and liaising with the senior clinical development leadership team.
- Contribution to design of scientifically sound, ethically rigorous and operationally feasible clinical studies protocols that reflect the Global Clinical Development Plan;
- Providing medical expertise and contribute to the program and study-related regulatory documents (INDs, Dossiers, Annual Safety and Development Reports) and interactions with regulatory agencies (responses to Health Authorities and Ethics Committees)
- Providing medical and scientific support to cross functional study team (e.g. biostatisticians, data managers, clinical operations, safety, biomarkers specialist etc.) and facilitation of productive cross functional collaboration
- Be a medical expert for clinical study by supporting study execution from the study start up to study completion, including medical oversight of the study, lead review and analyses of clinical study data, contribute to study reports and scientific publications
- Presentation of study updates and results to the study team, Steering Committees and to the senior management
Required professional, educational and personal skills:
- Medical (M.D) or equivalent degree. Specialty training and clinical practice experience in oncology and/or hematology, pediatric oncology and/or working knowledge in these areas are preferred
- Three years or more (5+ years for Senior Medical Director) of clinical development experience and/or drug development in pharmaceutical industry. Relevant academic and industry experience may be considered for this time period.
- Firm knowledge of GCP and ICH regulations, working knowledge of clinical trial design, biostatistics, regulatory and clinical development processes
- Leadership skills and ability to collaborate successfully with multiple functions and external vendors in a cross-functional team environment
- Capability of successful and timely tasks completion and prioritization with high-performance standards and attention to detail
- Excellent communication and presentation skills, agility and ability to learn and succeed in highly dynamic environment that embraces diversity
- High ethics standard and level of integrity. Commitment to work and corporate goals that will ultimately contribute to patient well-being #LI- FJ1