Umoja Biopharma

Program Manager

• Manage / lead cross functional teams to drive programs into and through clinical trials.
• Partner with project teams and functional leadership to create development strategies with options, define goals and milestones, track and report program progress, identify and escalate gaps and challenges, and execute asset development plans.
• Within PPAS team, establish program management infrastructure buildout and process development within Umoja.
• Work closely with leadership and key stakeholders to establish standards, policies, and practices across organization.
• Partner with functional leadership to drive operational excellence across the organization.
• Enable efficient drug development by driving highly effective, inclusive and collaborative program/alliance teams and ensuring inclusive and robust discussions leading to optimized operational plans.
• Support product and Governance decisions with best meeting practices to ensure robust, durable decision making and operational implementation follow-up.
• Ensure clear and consistent program communications across the organization including systematic reporting to ensure transparency across the organization (e.g., monthly reports, milestone tracking).
• Partner with Finance, Business operations and other functional stakeholders to support corporate program planning, including cross-functional resource planning and financial assessments.
• Support initiatives and special projects as needed.

Associate Director – Program Management

Medical Director

• Provide regulatory leadership and oversight for ongoing and planned in vivo CAR-T therapy programs.
• Develop and execute global regulatory strategies to support indication selection, trial design, and endpoints.
• Develop registration strategies and plans to achieve regulatory approvals.
• Lead global regulatory filings (IND/CTA/BLA/MAA submissions).
• Primary point of contact with global regulatory agencies.
• Communicate the regulatory strategy, risks, mitigations, and overall plans to various stakeholders.
• Identify, communicate, and propose resolutions to routine and complex issues.
• Provide regulatory advice and guidance to project teams.
• Collaborate closely with various teams to align overall strategy with scientific discoveries.
• Stay current on emerging trends, competitors, and regulatory guidance in applicable areas.
• Work with external program partners collaboratively and effectively.

Senior Director, Clinical Regulatory Affairs

• Establish and lead Umoja Biopharma’s Medical Affairs function.
• Build the function from the ground up—developing medical strategy, external engagement models, evidence generation plans, and field medical capabilities.
• Ensure the organization is positioned to effectively communicate scientific and clinical value to healthcare professionals, investigators, and key stakeholders.
• Define the vision, infrastructure, and roadmap for Medical Affairs to support Umoja’s transition into clinical development and beyond.
• Serve as the internal subject matter expert and strategic thought partner on scientific communication and external engagement.
• Develop and lead a KOL engagement strategy, building trusted relationships with external experts, investigators, and key institutions.

Executive Director, Medical Affairs

Director

• Oversee case processing activities, including intake, triage, medical review support, and expedited reporting
• Ensure compliance with global safety reporting requirements (FDA, EMA, ICH guidelines)
• Manage relationships with PV vendors/CROs, ensuring service quality, timeliness, and data integrity
• Support maintenance of safety databases and related systems
• Lead preparation of DSURs, PSURs/PBRERs, and IND safety reports
• Support safety sections of regulatory submissions and responses to health authority queries
• Contribute to development and maintenance of SOPs and Pharmacovigilance System Master File (PSMF)

Associate Director – Program Management

Senior Director, Clinical Regulatory Affairs

Executive Director, Medical Affairs

Director, Pharmacovigilance