- Be an integral member of the clinical development team and the clinical study team and drive execution of the clinical study in partnership with other functions
- With appropriate supervision, manage the design and implementation of study protocols for a clinical development program in support of the overall Clinical Development Plan
- Work closely with Pharmacovigilance, Clinical Operations, Regulatory Affairs, Biostatisticians and Business functions to ensure appropriate site selection, efficient execution of study protocols and overall timelines for key deliverables
- Be responsible for oversight of clinical studies, monitoring overall study integrity and review, interpretation and communication of accumulating study data pertaining to safety and efficacy of the compound internally, and where appropriate to forums externally
- Contribute to analysis, interpretation and reporting of scientific content of clinical study protocols, investigator brochures, clinical study reports, regulatory submissions and responses and other program documents
- Provide insights to the development and study team with regards to current medical practice and identify unmet need.
- May contribute to the generation of the Clinical Development Plan and Target Product Profile as the clinical representative for the protocols for which the incumbent has responsibility, when applicable
- Participate in Key Opinion Leader interactions related to clinical study and its disease area(s).
- Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. May contribute to regulatory responses and discussions.
- Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.
- Medical Doctor with adequate clinical experience in oncology; This may include Oncology drug development experience from academia, looking to move into their first industry role, or pharmaceutical drug development of at least 2 years
- Clinical or pharmaceutical experience in oncology (solid tumours) is desirable
- Evidence of keeping up to date with the recent development in clinical practice and scientific progress
- Open-mindedness, flexible and willing to learn with a high level of scientific / medical curiosity and strategic mindset
- Being able to deal with uncertainty, manage risks and drive a proper decision making
- Excellent written and verbal communication skills
- Leadership and ability to collaborate in a team within an matrix organization, while remaining autonomous and having an Innovative mind-set
- Knowledge of GCP, clinical trial design, statistical analysis methodology, and of ensuring compliance with GCP, SOPs, and regulatory requirements
|Job Category||CLINICAL DEVELOPMENT|