Vice President Operational Risk Jobs in Seattle, WA

POSITION SUMMARY

The Vice President, Clinical Development is a strategic and operational leader responsible for advancing the company's clinical-stage pipeline through all phases of clinical development. This role provides leadership and oversight for the Clinical Development organization, including Medical Directors and Clinical Scientists. The VP will lead the development and execution of integrated clinical development strategies, ensuring high-quality, compliant, and efficient clinical programs that support regulatory approvals and commercialization objectives.

As a key member of the Clinical Development Leadership Team, this role collaborates closely with Regulatory Affairs, Translational Medicine, Research, CMC, Quality, Commercial, and Executive Leadership to drive clinical and corporate objectives.

This role will ideally be based out of our Seattle, WA location and work onsite at least 2 days/week. We are open to remote on the West Coast for the right candidate with the expectation to be in Seattle 5 business days per month. 

CORE ACCOUNTABILITIES:
Specific responsibilities include:  

• Lead the overall clinical development strategy for the company's portfolio, ensuring alignment with corporate and regulatory objectives.
• Partner with the CMO and Executive Leadership team to define development pathways, clinical endpoints, and regulatory strategies.
• Build and develop a high-performing, scalable clinical organization of Medical Directors and Clinical Scientists. Establish clear goals, metrics and development plans for team members and leaders in alignment with Umoja's values and principles. 
• In collaboration with the CMO, communicate the clinical vision and emerging data to the Board, investors and potential partners, helping articulate the value, differentiation and development potential of Umoja's pipeline.
• Shape the long-term clinical development strategy translating emerging clinical, translational and competitive insights into indication selection, sequencing and investment recommendations.
• Define the clinical path for establishing in vivo CAR-T as a new therapeutic modality, including evidence generation that differentiates Umoja from conventional autologous, allogeneic, and other in vivo cell-therapy approaches.
• Evaluate emerging clinical data, competitive intelligence, and scientific developments to inform development plans.
• Serve as a key contributor to portfolio prioritization, resource planning, and investment decisions.
• Drive accountability, operational excellence, and cross-functional collaboration.
• Ensure appropriate staffing, vendor management, and resource allocation across programs.
• Ensure clinical studies are conducted on time, within budget, and in compliance with regulatory requirements.
• Lead clinical governance processes, risk management, and portfolio prioritization.
• Oversee safety monitoring, data quality, and clinical study reporting.
• Ensure inspection readiness and compliance with GCP, ICH, FDA, and global regulations.
• Provide scientific and clinical expertise to business development, investor relations, and partnership discussions as needed.
• Partner with Regulatory Affairs in preparing global regulatory submissions and agency interactions.
• Participate in meetings with health authorities, including FDA, EMA, and other international agencies.
• Support preparation of briefing documents, submission packages, and responses to regulatory inquiries.
• Build and lead a network of external scientific and clinical advisors, establishing Umoja as a preferred partner for investigators, thought leaders, vendors, partners, and scientific organizations in hematologic oncology, cell therapy and autoimmune field.

The successful candidate will have:

• Significant experience within biotechnology, pharmaceutical, or related life sciences organizations.
• Prior experience leading clinical development functions and multidisciplinary teams is highly preferred.
• Demonstrated success leading clinical programs through multiple stages of development, including late-stage and registration-enabling studies.
• Experience supporting regulatory interactions and submissions.
• Cell and gene therapy or advanced modality experience preferred.
• Hematology/oncology, immunology, rheumatology, or advanced therapeutic experience strongly preferred.
• Strategic thinker with strong scientific and business acumen.
• Proven ability to lead and scale high-performing teams.
• Excellent communication, influence, and stakeholder management skills.
• Demonstrated ability to operate effectively in a dynamic, fast-paced biotech environment.

Physical Requirements:  

• The ideal candidate will be able to work onsite based out of our Seattle, WA office at least 2 days/week. There may be the ability to work remotely on the west coast and travel to Seattle, WA at least 5 days/month. 
• Ability to travel domestically and, if applicable, internationally (typically up to 30-50%, depending on role), including air travel and extended periods away from home.
• Ability to attend and actively participate in external meetings, some of which may require travel.
• Ability to sit for prolonged periods of time.

Salary Range: $320,000 - $400,000