Senior Clinical Scientist
Ikena Oncology (NASDAQ: IKNA) is a targeted oncology company focused on developing cancer therapies targeting key signaling pathways that drive the formation and spread of cancer. Ikena is advancing five programs that include four product candidates in either clinical development or IND-enabling studies and has a global strategic collaboration with Bristol Myers Squibb.
The Senior Clinical Scientist is a key member of our clinical development team and is a major contributor to the development and execution of the clinical strategy for our Targeted Oncology programs, providing clinical research support for programs as assigned. The successful candidate will interface with our management team on significant matters, often requiring the coordination of activity across organizational functions, physicians, and external CROs and medical writers.
- Working with the Chief Medical Officer and the medical team, create key strategic documents including clinical development plans, protocol concepts and full protocols for product(s) in early development along with contributing to activities for product(s) in later stages of development, including NDA filings
- Contribute to the development of clinical sections of regulatory documents such as Investigators’ Brochures, briefing books, safety updates, IND/NDA submission documents, responses to Health Authorities questions
- Perform clinical data review during study execution to ensure integrity of accruing study data and appropriate safety follow-up
- Set up and coordination of investigator initiated clinical and/or pre-clinical trials
- Develop effective working relationship with key investigators and KOL in assigned programs to optimize scientific quality/innovation of clinical study design, execution, reporting and publication
- Contribute and co-lead program and trial-related advisory boards
- Co-lead investigators meetings and protocol training meetings
- Analyze and interpret study data from an individual study and translating study level clinical data across the program of studies for a particular drug, ensuring that all studies are conducted with the highest level of ethical and safety standards and follow GCP and all regulatory policies
- Support Clinical Operations team in the preparation and run dose escalation meetings with investigators (phase 1)
- Coordinate the real time availability of quality clinical trial data including safety, efficacy, pharmacokinetic and biomarker data, to provide consolidated information for dose escalation meetings and Phase II data reviews with investigators
- Support Clinical Operations team in forecasting trial resource needs and assist in developing clinical outsourcing specifications to facilitate bid templates and selection of CROs and other 3rd parties
- Serve as a scientific resource to cross-functional internal teams to facilitate quality of study execution and problem resolution. Provide relevant clinical scientist expertise to internal teams, including clinical operations, medical writing, data management, pharmacovigilance to ensure quality processes and deliverables
- Ph.D. in a related life-sciences discipline and 5+ years of clinical research and/or preclinical research and drug development within the pharmaceutical industry, a CRO or similar organization. Master’s degree in the life sciences considered if extensive relevant work experience as a clinical scientist
- Prior drug development experience in Oncology is required
- Proficient knowledge of GCP/ICH, study design, statistics and clinical operations is required
- Proven experience in developing effective relationships with key investigators and KOL
- Experience writing, editing and reviewing protocols, informed consent templates, study manuals, conference presentations, journal publications
- Team oriented, goal-driven, organized, highly collaborative
- Excellent written and oral communication skills and the ability to clearly articulate the scientific rationale and clinical development plan and represent the team to internal and external stakeholders
Personal attributes: team oriented, goal-driven, organized, highly collaborative, open-minded, data-driven, creative, persistent in the face of obstacles and uncertainty, flexible, self-aware of strengths and weaknesses, objective in the evaluation of data and strongly optimistic about overcoming obstacles.