*****Only screening candidates with recent clinical science experience*****
RESPONSIBLITIES:
· Contribute to the design, implementation (study start-up, execution, analysis), review, and communication of clinical protocols and study reports for scientific and operational accuracy
· Responsible for analyzing data and timely delivery of high-quality clinical study data analysis for publications and scientific presentations; present clinical study results to the cross functional team and external stakeholders
· Work with the Medical Director to review clinical data and develop clinical development strategy with KOLs
· Collaborate with the Medical Director and Clinical Operations to expedite execution of clinical trials
· Interpret and communicate clinical information including literature reviews, competitive intelligence, and changing treatment paradigms to apply knowledge and support a robust clinical development strategy
· Identify, qualify, manage, and maintain relations with clinical trial sites, including collaborating with Principal Investigators, CRO and field team to develop robust study protocols, drive site selection, and patient recruitment programs that deliver enrollment
REQUIREMENTS:
· Masters/PhD degree in health science field, PharmD, MD (non-US MD acceptable), MSN, or other relevant advanced degree in a health science field.
· 5 years of clinical research experience in oncology clinical trials, including a minimum of 8-10 years industry experience. Experience with kinase inhibitors and/or pediatric drug development experience highly desirable.
· Excellent time management skills
· Excellent working knowledge of ICH GCP guidelines, CFR, EMA, and HIPAA regulations
· Able to work independently and make appropriate strategic decisions to operationalize and move clinical trials forward, in collaboration with the Medical Monitor
· Excellent written and oral communication skills
· Excellent presentation skills
· The ability to manage multiple priorities
· Experience operating effectively within a matrixed work from home environment, specifically in a healthcare biotech/pharmaceutical start-up setting
· Excellent computer skills (Microsoft Office Suite, Project, Word, Excel, PowerPoint, Outlook, and IXRS/EDC platforms)
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