Umoja Biopharma · 20 hours ago
Associate Director, Clinical Scientist
Seattle, WA
Full-time
Hybrid
Senior Level, Lead/Staff, Director/Executive
$153K/yr - $189K/yr
5+ years expUmoja Biopharma is an industry-leading biotech focused on transforming the treatment of cancer with a novel integrated immunotherapy platform. They are seeking a highly experienced Clinical Scientist to lead clinical trial start-up and execution, ensuring compliance with regulatory standards and fostering collaboration among team members and vendors.
BiopharmaBiotechnology
Responsibilities
Successfully plan and execute early phase clinical trials from study outline/protocol through CSR completion according to internal SOPs, regulatory standards, and GCP/ICH guidelines
Lead the clinical trial study team by fostering a team approach and ensure study deliverables and milestones are met within agreed upon timelines
Manage and partner with selected CRO and other study vendors to ensure appropriate study conduct and accuracy of study operations and that budgets are within the agreed variance
Key contributor to the development, review, and approval of study documents including but not limited to protocol, informed consent forms (ICF), investigator’s brochure (IB), study plans, eCRFs, pharmacy and lab manuals, regulatory documents, and clinical study reports
Involved in every aspect of trial management including site management, patient enrollment and recruitment, study start up, maintenance and close out activities, regulatory submissions, site and vendor contracts, TMF maintenance, audit preparation, inspections, site monitoring activities, training, investigator meetings, etc. in conjunction with clinical trial operational support provided either through a vendor or internal hire
Prepare and present timely status updates and performance metrics to leadership, project teams, and main stakeholders
Ensure quality and compliance of clinical trials with local regulatory requirements; overall data integrity; and human subject protection
Effectively communicate and interface between numerous functional groups, investigator sites, and vendors to ensure apt communication and strong relationships
Proactively identify, negotiate, and broker solutions to clinical study risks and issues that may arise
Aid in developing clinical operations standard operating procedures (SOPs)
Qualification
Required
Bachelor's degree or higher in life sciences, healthcare, or nursing required
Minimum of 5-8 years of clinical research and/or pharmaceutical experience combined for Senior Manager Level
Minimum of 3 years leading and accountable for planning and execution of clinical trials for Senior Manager Level
Minimum of 8+ years of clinical research and/or pharmaceutical experience combined for Associate Director Level
Minimum of 5 years leading and accountable for planning and execution of clinical trials for Associate Director Level
Expertise in managing early phase clinical trials (phase 1-2)
Working knowledge of clinical trial design, data acquisition, and reporting
Prior experience in IND/BLA/NDA/MAA submissions is required
Expert knowledge of FDA regulations, ICH guidelines, Good Clinical Practices (GCP) and the drug development process
Experience managing CROs and other study vendors such as central labs, IRT, and database systems
Experience posting and maintaining clinicaltrials.gov data
Expert abilities in Microsoft Word, Excel, and PowerPoint
Preferred
Background in oncology drug development is strongly preferred
Background in cell or gene therapy drug development is strongly preferred
Excellent written and verbal communication skills
Ability to influence and reach compromises cross functionally
Good understanding of other cross-functional departments/disciplines and how they contribute to the drug development process
Flexible with the ability to learn new medical/clinical therapeutic areas and/or indications quickly
The ability to independently coordinate and prioritize multiple projects in a fast-paced environment
Benefits
Competitive Medical, Dental, and Vision plans
401k plan through Fidelity, with a 100% match up to their first 4% deferral
Generous Paid Time Off policy
Employee commuter benefits
Cell phone stipend
Company
Umoja Biopharma
Umoja Biopharma is a biopharmaceutical company developing next-generation immunotherapies intended to combat cancer.
51-200 employees
H1B Sponsorship
Umoja Biopharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2022 (2)
Funding
Current Stage
Growth StageTotal Funding
$363MKey Investors
DCVC Bio
2025-01-14Series C· $100M
2021-06-15Series B· $210M
2020-11-18Series A· $53M
Leadership Team
Ryan Crisman
Co-Founder and Chief Technology Officer
Recent News
BioWorld Financial Watch
2025-12-29
2025-12-08
Company data provided by crunchbase