POSITION SUMMARY

Umoja is looking for a highly experienced Clinical Scientist who can work closely with members of the Clinical Development and Operations team as the primary point of contact for all matters related to clinical trial start-up and site initiation, including leading clinical trial document writing (protocol, IB, etc.), site selection/initiation, provide critical feedback on trial design/endpoints (both clinical and translational), and overall trial execution. The candidate should demonstrate a high-level knowledge of clinical scientific and operational methodologies and retain organizational, project management, teamwork, and leadership qualities.

The candidate will ideally have a background in biologics and/or cellular/genetic therapies. Experienced, independent Clinical Scientists who have worked with cross- functional program teams in the past and are looking for an exciting challenge with a novel therapeutic platform at a growing company and be a part of the next generation of cancer therapies should apply. 

The applicant could be local to the Seattle area or elsewhere in the US

CORE ACCOUNTABILITIES

Specific responsibilities include:  

• 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
• Oversee 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)

The successful candidate will have:

• Bachelor’s degree or higher in a scientific or healthcare discipline preferred
• Minimum of 15 years of clinical research experience, 6 of which are in a leading role accountable for the planning and execution of clinical trials
• Expertise in managing early phase clinical trials and working knowledge of clinical trial design, data acquisition, and reporting 
• 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
• 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
• Flexible with the ability to learn new medical/clinical therapeutic areas and/or indications quickly

Preferred Qualifications:  

• 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
• The ability to independently coordinate and prioritize multiple projects in a fast-paced environment

Physical Requirements:  

• Ability to work from home and travel to/between Umoja locations quarterly or as needed

Salary Range: $207,000 - $253,000