Senior Director, Clinical Operations
Umoja Biopharma
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.
POSITION SUMMARY
The Sr. Director of Clinical Operations will build and lead the Clinical Operations function at Umoja Biopharma, providing strategic oversight and operational leadership for all clinical development activities. This individual will be accountable for the design, planning, execution, and reporting of clinical trials across the portfolio, while establishing the infrastructure, processes, and team needed to scale clinical development as the company grows. The ideal candidate brings deep clinical operations expertise in biotech, proven leadership in building high-performing teams, and the agility to thrive in a fast-paced, entrepreneurial environment.
CORE ACCOUNTABILITIES
Specific responsibilities include:
- Build and lead the Clinical Operations organization, including hiring, mentoring, and developing a high-performing team.
- Provide strategic and operational leadership for the planning and execution of early- and late-phase clinical trials, ensuring adherence to timelines, budgets, and quality standards.
- Oversee selection, management, and performance of CROs, vendors, and clinical trial sites.
- Partner closely with Clinical Development, Regulatory, Biometrics, CMC, Medical Affairs, and other cross-functional leaders to advance programs.
- Develop and implement clinical operations policies, SOPs, and best practices to ensure compliance with GCP, ICH, and global regulatory requirements.
- Anticipate and mitigate risks to clinical program execution; provide proactive solutions to keep programs on track.
- Contribute to long-range clinical strategy and portfolio planning, providing operational insight and recommendations.
- Represent Clinical Operations at internal governance forums, with external partners, and (as appropriate) with investigators, regulators, and key stakeholders.
- Foster a culture of accountability, collaboration, and patient focus within the Clinical Operations function.
The successful candidate will have:
- Senior Director Level: Bachelor’s degree in life sciences or related field required; advanced degree preferred with 12+ years of experience in clinical research/clinical operations within biotechnology or pharmaceutical companies, with at least 5 years in a senior leadership role.
- Executive Director Level: Bachelor’s degree in life sciences or related field required; advanced degree preferred with 15+ years of experience in clinical research/clinical operations within biotechnology or pharmaceutical companies, with at least 7 years in a senior leadership role.
- Proven track record of building and leading Clinical Operations teams, ideally within an emerging or growing biotech.
- Demonstrated experience successfully managing all aspects of global clinical trials from Phase 1 through Phase 3.
- Strong understanding of GCP, ICH guidelines, and global regulatory requirements.
- Experience in vendor selection and oversight, including CROs and central labs.
- Exceptional leadership, communication, and collaboration skills.
- Strategic thinker with a hands-on, roll-up-the-sleeves approach suitable for an entrepreneurial environment.
- Passion for improving patient lives through innovative therapies.
Physical Requirements:
- Ability to travel up to 2 days/month
- Ability to work onsite at least 2 days/week
Senior Director Level Salary Range: $223,635 - $276,255
Executive Director Level Salary Range: $245,565 - $303,345
Benefits Offerings
Umoja Biopharma offers its employees competitive Medical, Dental, and Vision plans. Additionally, we offer Umojians access to a 401k plan through Fidelity, with a 100% match up to their first 4% deferral. Umoja also provides a generous Paid Time Off policy, employee commuter benefits, and cell phone stipend. For a full breakdown of our benefits offerings, please see the Benefits section of our website.