Fortvita Biologics · 6 hours ago
Sr. Clinical Scientist
Palo Alto, CA
Full-time
Hybrid
Mid, Senior Level
4+ years expFortvita Biologics is seeking a Senior Clinical Scientist to be a key member of their Clinical Development team. The role involves designing, monitoring, and analyzing data from clinical trials while ensuring compliance with regulatory standards and maintaining strong relationships with investigative sites.
Biotechnology
Responsibilities
For clinical trials: design, provide oversight, and support site and subject retention
Ensure successful completion of documents (including clinical trial protocols, investigator brochures, monitoring plans, site training materials, clinical study reports, health authority responses, standard operating procedures, etc.) with cross-functional team members
Participate on study teams and cross-functional teams as appropriate, and as delegated by the Vice President, Clinical Development
Ensure consistent use of language and criteria across multiple endocrine projects
Ensure study integrity, and track accumulating safety and efficacy data
Anticipate obstacles within a clinical trial, and implement solutions
Analyze, evaluate, and support accurate interpretation and reporting of clinical data
Contribute to drafting and reviewing clinical documents, manuscripts, presentations, and regulatory submissions
Maintain up-to-date knowledge of relevant science, medical information, good clinical practices, and regulatory guidance
Collaborate with and serve as a clinical research resource for cross-functional colleagues to optimize product development
Cultivate relationships with investigative sites, clinical consultants, and key opinion leaders to represent the interests of the company
Support corporate strategic and organizational initiatives
Assist with commercial activities as needed
Complete assigned tasks thoroughly, accurately, and on time
Adhere to rigorous ethical standards
Travel up to 20% domestically and internationally for scientific meetings
Qualification
Required
Advanced degree e.g. Ph.D., Pharm.D., MS, or equivalent
Strong track record of scientific and clinical inquiry
Understand statistical concepts and clinical trial design
Understand the connection between nonclinical data and clinical data
Possess excellent communication skills (both written and verbal)
Learn quickly, follow complex directions under pressure
Multi-task while remaining organized and attentive to detail
Work hard, be a trustworthy and collaborative team player
Take initiative and solve problems of moderate complexity
Demonstrate sound judgement in terms of handling complex, confidential, and regulated information
Lead both directly and by example
Preferred
At least 4 years of experience with clinical trial design and execution
At least 4 years of pharmaceutical industry experience
Experience with regulatory submissions and interactions
Company
Fortvita Biologics
Fortvita Biologics is a San Francisco Bay Area–based biopharmaceutical company advancing next-generation biologics with the goal of addressing critical health needs.
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase