The focus of the Sr. Clinical Scientist will be to provide scientific and writing support for clinical strategy, clinical trial development, data analysis and visualization, and clinical data dissemination via presentations and publications. The Sr. Clinical Scientist will be responsible for critical reviews of internally and externally facing documents, and for interaction with internal and external stakeholders including, regulatory and commercial teams, and KOLs, physicians, and clinical staff.
QualificationsEducationandTraining:- Bachelor's degree in Life Sciences, engineering, statistics, or related field required. Advanced degree (MS, PhD, MD) preferred.
- A minimum of 12 years' experience in clinical research focused on managing clinical science/research activities.
Skills and Experience:- Experience in the medical device industry required; oncology clinical trials is preferred.
- Experience in authoring and reviewing clinical documents
- Working knowledge of the GCP, ICH and FDA guidance and regulations for clinical trials
- Comfortable analyzing data and preparing audience-appropriate summaries (e.g. reports, presentations, etc.) for various stakeholders.
- Proficiency with one or more standard statistical software packages (e.g. SAS, R, SPSS, MiniTab, etc.) preferred
- Highly curious, and self-motivated to use existing data to drive future clinical and medical development
- Excellent interpersonal and organizational skills
- Strong analytical skills, especially in understanding and interpreting scientific research and literature
- Sufficient technical and disease area knowledge to be able to interact with confidence with internal and external partners
- A combination of excellent writing and presentation skills and the ability to listen and communicate to a cross-functional team
- Must be able to work on multiple projects simultaneously and demonstrate organizational, prioritization, and time management proficiencies
- Able to complete tasks independently and efficiently with attention to detail and in a timely manner
Key Responsibilities- Key contributor to evidence development and clinical research strategies in collaboration with clinical science team, internal and external stakeholders, and external advisory groups.
- Facilitate decision-making by developing a range of study design options and clinical endpoints.
- Use and have command of relevant literature and other information sources to defend clinical endpoint selection, performance goals, endpoint data collection methods, etc.
- Collaborate with Clinical Affairs to assess budgetary/timeline impacts of clinical trial options
- Partner with Clinical Affairs for the successful implementation of clinical trials, including review of relevant trial materials and ad hoc scientific support
- Contributes significantly and independently to clinical sections of Clinical Evaluation Reports
- Conduct literature searches and, in coordination with the Clinical Science team, maintains a library of relevant literature for efficient use in clinical documents and regulatory responses/submissions
- Publication writing, formatting, and submission
- Create data visualizations (e.g. charts, posters, presentations, etc.) for internal communication and for submission (e.g. conference abstracts)
- Coordinates submissions to scientific meetings and/or other appropriate venues or groups
- Participates in and supports KOL interactions, advisory board meetings, company presence at major medical meetings and other events
- Maintains scientific and clinical knowledge in the relevant therapeutic area(s)
- Independent contributor, with strong writing and critical thinking skills
- Participates in IIT design
This role pays between $145,000 and $165,000 per year, and your actual base pay will depend on your location, skills, qualifications, and experience.
Galvanize offers a robust benefits package to full-time employees, including medical, dental, and vision coverage, life insurance, short- and long-term disability protection, 401(k), and flexible paid time off.
