Job Details

JOB Summary

The Scientific Director (SD) will provide scientific and clinical input to early and late-stage oncology clinical development programs with an emphasis on protocol-specific and medical data review activities. This includes collaborating on the design, implementation and execution of study protocols. They will be responsible for the review of data from assigned clinical trials, as well as assist with data interpretation and communication to both internal and external stakeholders. The SD may also assist in health authority and ethics committee communications, as appropriate.

primary responsibilities

• Partner on study teams of internal experts (e.g. medical, safety, clinical operations, statistics, precision medicine, clinical pharmacology, regulatory) to execute clinical studies
• Collaborate with the Medical Director to strategize and build innovative, robust clinical development plans and trial designs
• Develop and maintain clinical trial protocols, related manuals/documents, and study reports
• Review informed consent, lab manuals, CRF designs, clinical query design, deviations, etc.
• Review materials to support SIVs, Investigator Meetings, and Safety Review Committees
• Review clinical database on a routine basis
• Identify clinical trends in datasets and escalate as appropriate
• Review and validate clinical study reports and clinical portions of other regulatory documents (e.g. IB, DSUR, responses to health authorities)
• Provide scientific expertise and support for regulatory filings and interactions, including responses to health authorities

• Author internal clinical documents,  abstracts, posters, and presentations for scientific and clinical conferences
• Provide asset development updates to management as appropriate

QUALIFICATIONS

• Advanced Clinical/Science Degree is required (e.g. MD, Pharm.D., Ph.D., MSN) 
• A Master’s degree may be considered with supporting industry experience.
• A minimum of 5 years experience in clinical science, clinical research, clinical development or equivalent in oncology
• Proficient knowledge of oncology, analysis and interpretation of clinical data (safety and efficacy), GCP/ICH, study design, statistics, biomarkers, pharmacokinetics, clinical operations, and regulatory requirement for clinical studies
• Able to communicate (written and oral) clinical and scientific data to a broad range of audiences
• High level of organizational and project management skills
• Operate with a high degree of autonomy and professionalism