Clinical Scientist

Position Summary

The Clinical Scientist will be a key member of the Clinical Development team with responsibilities to provide scientific support for clinical development activities. This role will collaborate closely with R&D, program management, clinical operations, biostatistics, and data management. Additionally, the Clinical Scientist will support the development of key scientific external relationships with key opinion leaders and provide clinical input into safety and regulatory interactions. A working knowledge of drug development process, GCP, ICH guidelines and FDA regulations is highly desirable.

Key Duties and Responsibilities

• Contribute to the clinical strategy and creation of the clinical development plans for various oncology indications, working as part of an integrated drug development team
• Provide scientific input to the preclinical pharmacology team for translational studies of interest
• Provide scientific input to protocol development and definition of efficacy and safety endpoints for Phase II and III clinical trials
• Collaborate with the clinical development team on the review, analysis, and interpretation of study results, including exploratory endpoints and assure appropriate data review and accurate data reporting
• Prepare data and contribute to scientific publications including posters, abstracts and manuscripts
• Support the clinical team with the development of program documents, including the clinical sections of various regulatory documents and submissions to support product approvals
• Develop and cultivate relationships with external partners such as clinical investigators, clinicians, scientists, and vendors
• Provide support to advisory boards, consultant meetings and investigator meetings, including preparation and delivery of presentations
• Understand competitive landscape and provide insights on strategic development pathways
• Proactively seek out and recommend process improvements
• Anticipate potential study problems and prepare contingency plans as needed
• Participate in Development Planning for assigned compounds
• Rakuten Medical is a dynamic environment and each employee may be asked to assist in work areas outside of their usual duties.
• Other duties as assigned

Desired Education, Skills and Experience

• Advanced degree in life sciences (Pharm D, MS, PhD or equivalent)
• Minimum 5 years' experience in design, planning, executing, reporting and publishing clinical studies
• Strong scientific background, preferably with clinical and/or research experience in medical, surgical, or radiation oncology
• Strong experience of clinical study design, including scientifically, medically and statistically appropriate endpoints
• Understanding and ability to apply principles of PK, correlative studies and other studies integrate into clinical research protocols
• Comprehensive understanding of the drug development process in all phases of testing with emphasis on Phase 2 and 3 clinical studies
• Experience with pharma/biotech clinical operations and conduct of research collaborations, with a thorough understanding of ICH, GCP, and relevant regulatory requirements
• Strong analytical and strategic thinking skills
• Experience with interacting with clinical investigators and medical experts
• Excellent verbal, written, and interpersonal communication skills (fluency in written and spoken English is required)
• Ability and willingness to travel as needed

The expected salary range for this position based in California is $19,000 to $220,000 annually. Actual pay will be determined based on experience, qualification, geographic location, and other job-related factors.