Senior Director, Clinical Operations

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