Sr. Clinical Scientist

Galvanize

6d•$145,000 - $165,000

About The Position

The Sr. Clinical Scientist provides scientific and writing support for clinical strategy, clinical trial development, data analysis and visualization, and dissemination of clinical data through presentations and publications. The role critically reviews internal and external documents and interacts with internal and external stakeholders, including regulatory and commercial teams, KOLs, physicians, and clinical staff. The position contributes to evidence development and clinical research strategies, supports study design and endpoint selection, and partners with Clinical Affairs on trial planning and implementation. It also contributes to clinical sections of Clinical Evaluation Reports, literature reviews, publications, data visualizations, scientific meeting submissions, KOL and advisory board interactions, and investigational investigator-initiated trial (IIT) design.

Requirements

Bachelor’s degree in Life Sciences, engineering, statistics, or a related field.
At least 12 years of experience in clinical research focused on managing clinical science or research activities.
Medical device industry experience.
Experience authoring and reviewing clinical documents.
Working knowledge of GCP, ICH, and FDA guidance and regulations for clinical trials.
Ability to analyze data and prepare audience-appropriate summaries, such as reports and presentations, for various stakeholders.
Excellent interpersonal and organizational skills.
Strong analytical skills, including the ability to understand and interpret scientific research and literature.
Sufficient technical and disease-area knowledge to interact confidently with internal and external partners.
Excellent writing and presentation skills, with the ability to listen and communicate with a cross-functional team.
Ability to manage multiple projects simultaneously and demonstrate organizational, prioritization, and time-management proficiency.
Ability to complete tasks independently and efficiently, with attention to detail and timeliness.

Nice To Haves

Advanced degree (MS, PhD, or MD).
Oncology clinical trial experience.
Proficiency with one or more standard statistical software packages, such as SAS, R, SPSS, or MiniTab.

Responsibilities

Contribute to evidence development and clinical research strategies in collaboration with the clinical science team, internal and external stakeholders, and external advisory groups.
Develop study design options and clinical endpoints to facilitate decision-making.
Use relevant literature and other information sources to support endpoint selection, performance goals, and endpoint data collection methods.
Collaborate with Clinical Affairs to assess budget and timeline impacts of clinical trial options.
Partner with Clinical Affairs to support successful clinical trial implementation, including reviewing trial materials and providing ad hoc scientific support.
Independently contribute significantly to clinical sections of Clinical Evaluation Reports.
Conduct literature searches and maintain a relevant literature library with the Clinical Science team for clinical documents and regulatory responses or submissions.
Write, format, and submit publications.
Create data visualizations, such as charts, posters, and presentations, for internal communication and submission, including conference abstracts.
Coordinate submissions to scientific meetings and other appropriate venues or groups.
Participate in and support KOL interactions, advisory board meetings, company presence at major medical meetings, and other events.
Maintain scientific and clinical knowledge in relevant therapeutic areas.
Participate in IIT design.