Senior Clinical Project Manager
Umoja Biopharma is a game-changing biotech start-up with locations in Seattle, WA and Louisville, CO, focused on transforming the treatment of cancer with a novel integrated immunotherapy platform. Our vision is to develop off-the-shelf therapies capable of treating any tumor, any time. We are a diverse and growing team working in brand-new facilities in downtown Seattle, Washington, and Louisville, Colorado, and we are looking for innovative thinkers who are excited by groundbreaking science and technology, and passionate about squaring up to the challenges inherent to cutting edge drug development. We are committed to the principles of Diversity Equity and Inclusion and strongly invite applications from enthusiastic individuals who share our commitment and help position Umoja as a leader in this front.
We at Umoja believe in the importance of stories; we are looking for great people to join our team to help us create more stories for ourselves, for you, and most importantly for patients and their families.
Umoja Biopharma – Your Body. Your Hope. Your Cure.
Umoja is looking for an experienced Senior Clinical Project Manager who supports planning and execution of clinical trials with the primary focus on facilitating cross-functional Study Team activities, establishing and maintaining project milestones, timelines, forecasts, and managing/overseeing Clinical Research Organization (CRO) for early phase trial activities.
The candidate will ideally have a background in biologics and/or cellular/genetic therapies. Experienced, independent clinical operations lead 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.
Specific responsibilities include:
- Drives all aspects of the project management process from clinical trial planning, execution, control, and closure.
- Establish and maintain comprehensive cross-functional study timelines and collaborates with the cross functional clinical trial study team and CRO(s) for trial operational delivery to ensure timelines are met.
- Develop comprehensive clinical study budgets in partnership with the cross -functional study team members and provides oversite to ensure clinical studies remain within established budgets.
- Develops enrollment projection, and drug supply needs as part of the budget.
- Initiate and facilitate Requests for Proposal and Requests for Information Procure.
- Manage, and oversee CROs, Central Laboratories and other vendors.
- Ensure quality and compliance of clinical trials with local regulatory requirements; overall data integrity; and human subject protection.
- Contributes to the development and implementation of study design, IB, protocols and various cross-functional study plans and materials including but not limited to CRO oversight plans, vendor oversight plans, communication plans, data management plans, safety management plans, and IND safety report distribution.
- Identify potential risks to successful clinical trial execution and develop and institutes mitigation plans.
- Prepare and present timely status updates and performance metrics to leadership, project teams, and main stakeholders.
- Effectively communicate and interface between numerous internal functional groups, the CRO and vendors to ensure apt communication and strong relationships.
- Aid in developing clinical operations standard operating procedures (SOPs).
- Manages/reviews/approves vendor invoices, accruals, and SOW changes.
The successful candidate will have:
- Bachelor’s degree or higher in a scientific or healthcare discipline preferred with a minimum of 6 years of prior clinical work experience and a minimum of 2 years project management experience. Note: an equivalent combination of education and experience will be considered.
- Knowledge and experience using project management methodologies and tools.
- Experience developing comprehensive study/project timelines.
- Experience forecasting and managing project budgets.
- Experience managing CROs and other study vendors such as central labs, IRT, and database systems.
- 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.
- Expert knowledge of FDA regulations, ICH guidelines, Good Clinical Practices (GCP) and the drug development process.
- Must have the ability to independently coordinate and prioritize multiple projects in a fast-paced environment.
- Background in oncology drug development is strongly preferred.
- Background in cell or gene therapy drug development is strongly preferred.
- Project management training certification preferred.
- Highly effective written/verbal communication skills Proficiency with MS Word, Excel, Outlook, PowerPoint, SharePoint, OneNote Demonstrated Proficiency with SmartSheet and/or MS project preferred.
- Ability to travel as needed. Approximately 10% travel.
Salary Range: $133,450 - $172,700
Umoja Biopharma offers its employees competitive Medical, Dental, and Vision plans through Premera Blue Cross, Delta Dental, and VSP. Additionally, we offer Umojians access to a 401k plan through Fidelity, with a 100% match up to their first 6% deferral. Umoja also provides a competitive, unlimited Paid Time Off policy, employee commuter benefits, and childcare reimbursement. For a full breakdown of our benefits offerings, please see the Benefits section of our website.