• 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

Role Description The Virtual ARNP provides psychiatric evaluation and medication management services to PHP/IOP clients via telehealth, working 2 to 3 days per week on a contract basis. This role partners closely with the clinical team to support each client's treatment plan and is well suited to a provider seeking a flexible, part-time telehealth schedule. - Conduct psychiatric evaluations and medication management appointments for PHP/IOP clients via telehealth. - Develop, adjust, and monitor medication regimens in collaboration with the clinical team and primary counselor. - Document evaluations, prescriptions, and follow-up plans in the EMR in a timely manner. - Coordinate with clinical staff on treatment planning, level-of-care recommendations, and clinical staffing as needed. - Respond to urgent clinical questions from the program's clinical or administrative team during scheduled clinic days. - Maintain compliance with Wisconsin telehealth, prescribing, and documentation requirements. Qualifications - Active, unrestricted Advanced Practice Registered Nurse (APRN/ARNP) license in Wisconsin, or eligibility for Wisconsin licensure. - Psychiatric Mental Health Nurse Practitioner (PMHNP) certification or equivalent psychiatric prescribing credential. - Active DEA registration and prescriptive authority in Wisconsin. - Comfort delivering care entirely via telehealth, with reliable technology and a private, HIPAA-compliant workspace. - Working knowledge of HIPAA and 42 CFR Part 2 confidentiality requirements. - Availability of 2 to 3 days per week for scheduled telehealth appointments. Requirements - Prior experience providing psychiatric care in a PHP, IOP, or other behavioral health treatment setting. - Experience with co-occurring substance use and mental health diagnoses. - Familiarity with the EMR platform used by the program (to be confirmed during onboarding). Benefits - This role is structured as a 1099 contract position at $100.00 per hour, 2 to 3 days per week. - This is a contract opportunity with Wisconsin Behavioral Health. Atlantic Health Strategies is recruiting on their behalf.