• Develop and execute AEQ's healthcare go-to-market strategy. • Identify high-value market opportunities across hospitals, health authorities, universities, research institutions, and healthcare organizations. • Build and manage a healthy pipeline of qualified opportunities. • Secure lighthouse customers that establish market credibility. • Develop repeatable sales and market development playbooks. • Lead executive discovery workshops. • Understand customer workflows, operational challenges, and workforce development priorities. • Shape tailored AI and VR solutions with AEQ's product and technical teams. • Develop business cases and ROI models. • Negotiate and close strategic opportunities. • Develop relationships with health authorities, hospitals, academic medical centres, and other stakeholders.

• Conduct 1:1 teleconsultation services across two distinct teams: A parent training program and a neurodiversity at work program • Emphasize the ongoing nature of consultation and strive to ensure regular follow-ups with clients • Log notes, recommendations, referrals, and respond to client messages within 1 business day • Provide guidance and education around behavior analytic tips and strategies • Navigate the school system/IEP process/transition to adulthood programming • Offer referrals to other company-sponsored benefits when appropriate • Report to the Senior Director of Clinical Services and act as the ultimate advocate for parents

Role Description The Senior Director, Regulatory Affairs reports to the Head of Regulatory Affairs and is responsible for content development, compilation, maintenance, and review of the Nonclinical and Clinical Modules for regulatory submissions to support Umoja’s drug products including, DMF, IND and NDA/BLA applications, Health Authority (HA) responses, and briefing packages (including participating in/leading HA meetings). In this role, the Senior Director will be the Regulatory Affairs leader on program teams and will provide expertise to support the development of our in vivo CAR-T therapy programs. This individual will play a critical role in regulatory strategy, study design, execution, and in leading regulatory interactions. The ideal candidate will bring deep experience in cell & gene therapy and a strong track record in oncology or rheumatology drug development. This role will develop and implement regulatory strategies leading to successful registration and life-cycle management of unique and technologically complex products serving patients with cancer and other unmet medical needs. It builds and relies on critical partnerships with key stakeholders to execute the strategies in alignment with business priorities. We will consider candidates at either the Senior Director or Executive Director level based on candidate's qualifications and experience. Qualifications - Senior Director Level: PhD/MS/BS in a relevant scientific field required with a minimum of 12/15/15+ years, respectively, of relevant experience in regulatory affairs. - Executive Director Level: PhD/MS/BS in a relevant scientific field required with a minimum of 15/18/18+ years, respectively, of relevant experience in regulatory affairs. - Experience in Oncology, Hematology, or related specialty strongly preferred. - Successful track record of regulatory submissions and approvals. - Demonstrated expertise in cell & gene therapy, ideally with CAR-T or T-cell engaging modalities preferred; experience in in vivo gene delivery a plus. - Strong knowledge of global regulatory requirements for early- and late-stage development of gene and cell therapies. - Proven ability to interact with regulatory authorities. - Excellent communication, leadership, and cross-functional collaboration skills. - Passion for innovation and commitment to advancing transformative therapies for patients. Requirements - Independently 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, to support program advancement. - Develop registration strategies and plans (e.g., TPP development and assessment) to achieve regulatory approvals and desired product labeling. - Lead global regulatory filings (IND/CTA/BLA/MAA submissions), setting strategy for submissions of product registration documents for health authorities worldwide. - Primary point of contact with global regulatory agencies to support program advancement. - Effectively communicate the regulatory strategy, risks, mitigations and overall plans to Regulatory Affairs, program teams, senior management, and external stakeholders (as relevant). - Identify, communicate, and propose resolutions to both routine and complex issues. - Provide regulatory advice and guidance in the context of available and expected scientific data, regulatory guidance, and precedent to project teams to support decision making and program advancement. - Collaborate closely with translational medicine, preclinical, clinical, CMC Regulatory, and technical teams to align overall strategy with scientific discoveries. - Stay current on emerging trends, competitors, and regulatory guidance in cell & gene therapy and oncology and/or autoimmune therapeutic areas. - Conduct regulatory research to assess the impact of relevant global regulations, guidance, and current regulatory environment. - Work with external program partners collaboratively and effectively to deliver on contractual obligations while moving toward corporate goals and priorities. - Provide organizational support and mentoring as company grows its product development pipeline. Benefits - Competitive Medical, Dental, and Vision plans. - Access to a 401k plan through Fidelity, with a 100% match up to the first 4% deferral. - Generous Paid Time Off policy. - Employee commuter benefits. - Cell phone stipend. Company Description Umoja Biopharma is an industry-leading biotech 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.

• Provides medical oversight of assigned clinical studies in the duty as a medical monitor • Often serves as primary medical contact for customers for assigned clinical studies • Provides medical input and oversight in support of the Drug Safety and Pharmacovigilance department • Responsible for protocol design and development, upon request • Provides input into protocol amendments • Develops and delivers project-specific and therapeutic training to project team members and clinical site staff; provides training to customer staff as needed • Provides oversight to assigned Medical Scientist staff and Medical Director colleagues to review clinical data • Presents identified trends and issues, and mitigation strategies, to customers and project team members to minimize risks to subject safety or integrity of study data • Represents the Company at scientific and industry meetings • Mentors staff to ensure an appropriate level of understanding regarding sound treatment and research principles of specific therapeutic area