Senior Clinical Scientist: Clinical Strategy & Data

Galvanize; United States; On-site; USD 145,000 - 165,000; Full time

Benefits offered by this job

Medical, dental, and vision coverage

Life insurance

Short- and long-term disability

401(k)

Paid time off

Job summary

Galvanize Therapeutics, a biomedical platform company, seeks a Sr. Clinical Scientist to lead clinical strategy, trial development, data analysis, and dissemination through publications and presentations.

You will review scientific documents, interact with regulatory and commercial teams, KOLs, and clinical staff, and manage multiple projects with strong writing and presentation skills.

Qualifications

• Bachelor’s degree in Life Sciences, engineering, statistics, or related field required.
• Advanced degree (MS, PhD, MD) preferred.
• Minimum of 12 years’ experience in clinical research focused on managing clinical science/research activities.

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

Skills

Scientific writing

Stakeholder management

Cross-functional collaboration

Independent work

Multitasking

Education

Bachelor’s degree in Life Sciences, engineering, statistics, or related field

Advanced degree (MS, PhD, MD) preferred

Tools

SAS

R

SPSS

MiniTab

Job description

Galvanize Therapeutics, a biomedical platform company, seeks a Sr. Clinical Scientist to lead clinical strategy, trial development, data analysis, and dissemination through publications and presentations.

You will review scientific documents, interact with regulatory and commercial teams, KOLs, and clinical staff, and manage multiple projects with strong writing and presentation skills.