POSITION SUMMARY

The Associate Director, Statistical Programming will be responsible for strategic planning, executing and quality checking of data programming and statistical analysis deliverables to support clinical trial conduction and prepare submission readiness package. This role provides technical and operational leadership to ensure compliant, high-quality analysis datasets, tables, listings, and figures (TLFs) in accordance with CDISC standards and FDA guidance. This role will operate as an individual contributor and is responsible for enhancing the statistical programming infrastructure of the Biometric department, building and leading a highly efficient data and matrixed statistical programming team (contractors, vendors, CROs, FTEs) over time.

This role will partner closely with Biostatistics, Clinical Data Management, Clinical Operations, and Regulatory Affairs to support submission readiness and successful regulatory interactions.

This role will ideally be based out of our Seattle, WA location and work onsite at least 2 days/week. We are open to remote within the US for the right candidate.

CORE ACCOUNTABILITIES

Specific responsibilities include:  

• Lead statistical programming activities for clinical trials and ensure the timely delivery of high-quality outputs throughout the full study life cycle.
• Review clinical trial protocols, SAP, CRF designs, and EDC deployments, and provide input for EDC edit checks to enhance clinical trial data quality.
• Guide and review outputs from CROs, which may encompass submission datasets, programs, and outputs to ensure the submission package (SDTM and ADaM specifications, SDTM and ADaM programs and datasets, Tables, Listings, and Figures (TLFs) outputs, define.xml, and reviewer guides, etc.)  adheres to regulatory requirements and is compliant with CDISC standards.
• Lead and support statistical programming activities for regulatory submissions including INDs, NDAs, and/or BLAs.
• Review data management plans, data transfer plans, and test EDC deployment to ensure readiness for downstream programming.
• Provide hands-on SAS programming support for key safety and efficacy analyses of clinical trials, as well as ad hoc exploratory and publication analyses as required.
• Mentor and provide technical oversight to statistical and data programmers and contractors.
• Collaborate closely with biostatisticians, study physicians, data management, clinical operations, and safety review teams to review data or programming issues and improve the overall quality of clinical trial data.
• Support internal and external audits, inspections, and regulatory inquiries related to statistical programming deliverables.
• Assist the department head in building the infrastructure of the biometrics department, which may include creating macros and programs, TLF shells, departmental SOPs, and best practices for statistical programming and data traceability.

The successful candidate will have:

• MS in biostatistics, statistics, computer science, or a closely related field, coupled with extensive quantitative analysis methodologies and statistical programming proficiency with a minimum of 10 years of experience in pharmaceutical companies or CROs is required.
• At least 5 years of demonstrated leadership experience in projects and managing, mentoring, and developing teams.
• A solid comprehension of statistical programming principles, advanced SAS programming expertise, extensive experience in the preparation of regulatory submission packages, and substantial knowledge of CDISC standards.
• Exceptional attention to detail and a strong risk-mitigation mindset, a self-driven learner to continuous learning and updating programming skills and therapeutic area (TA) knowledge.
• Excellent verbal, written, and interpersonal communication skills are mandatory for clear and efficient communication and collaboration with cross-functional teams, which may include clinical operations, data management, study physicians, statisticians, and medical writers.
• A sound working knowledge of ICH, FDA, and GCP regulations and guidelines.

Preferred Qualifications:  

• Prior experience with NDA/ BLA submission and interaction with regulatory agencies is highly desirable, as is leading early and late-phase clinical trials.
• Experience in immunology, hematology, or oncology clinical trials is preferred
• Experience with using R in clinical analysis

Physical Requirements:  

• Ability to sit for prolonged periods of time
• Ability to read, interpret, and review detailed technical documents, datasets, tables, listings, figures, and on‑screen material
• This role will ideally be based out of our Seattle, WA office and will be onsite 2 days/week
• If this role is remote, the ability to travel up to 20% as needed

Salary Range: $185,100 - $228,700

POSITION SUMMARY

The Senior Clinical Trial Manager is primarily responsible for the operational management and oversight of Umoja’s clinical studies. This individual will work closely with Clinical Operations leadership, Medical Director(s), other cross-functional team members, and designated CROs to ensure the successful completion of all clinical study activities and project deliverables within specified quality, time, and cost parameters.

The ideal candidate brings clinical operations expertise in biotech and the ability to thrive in a fast-paced, entrepreneurial environment.

This role is ideally based out of our Seattle, WA location and is onsite at least 2 days/week. We are open to remote work within the US for the right candidate.

CORE ACCOUNTABILITIES

Specific responsibilities include:  

• Ensures studies are carried out according to the study protocol, SOPs, and ICH/GCP guidelines/regulations and study specific manuals and procedures
• Independently develop study timelines, key deliverables, and risk/mitigation strategies
• Lead selection and performance management of CROs and other ancillary vendors during study start-up, conduct, and close-out
• Plan and lead study team meetings
• Lead the development of study materials (e.g., study plans, monitoring guidelines, site initiation visit materials, site tools and worksheets)
• Contribute to the content and review of study documents (e.g., protocol, informed consent forms, case report forms (CRF), CRF completion guidelines, product administration guidelines)
• Track and ensure optimization of site startup activities and activation, subject enrollment, data collection, and trial closeout
• Ensure accurate and timely execution of site visit monitoring reports
• Identify, select, and monitor performance of sites
• Negotiate and manage the budgets and payments for sites
• Develop and maintain strong working relationships with study investigators and site staff
• Manage investigational product release packages and investigational product accountability
• Coordinate with Clinical Supply Chain Operations regarding investigational product shipment to sites
• Oversee the Trial Master File according to ICH- GCP and SOPs
• May assist in clinical data review and query generation
• Collaborates closely with Clinical Operations, Clinical Development, Biometrics, Clinical Data Management, Regulatory Affairs, Translational Medicine, Clinical Supply Chain, Pharmacovigilance, and Clinical Quality Assurance
• Actively participate in and contribute to the development of department initiatives aimed at improving efficiency and best practices

The successful candidate will have:

• Manager Level: Bachelor’s degree or equivalent in Life Sciences with at least 6 years of clinical operations experience in the pharmaceutical industry with at least 1 year experience managing industry-sponsored pharmaceutical clinical studies as a sponsor employee
• Senior Manager Level: Bachelor’s degree or equivalent in Life Sciences with at least 8 years of clinical operations experience in the pharmaceutical industry with 3+ years’ experience managing industry sponsored pharmaceutical clinical trials as a sponsor employee
• Significant knowledge of GCP/ICH guidelines and the clinical development process
• Ability to plan, organize and conduct clinical studies with minimum oversight
• Significant experience managing CROs and other vendors and assessing performance
• Experience leading, managing, or mentoring clinical operational staff and cross-functional teams
• Strong organizational skills and the ability to balance changing priorities
• Strong interpersonal and communication (written and verbal) skills
• Demonstrated ability to work independently and as part of a multi-functional team
• Able to solve problems under pressure
• Self-motivated and able to work effectively in a matrix/team environment

Preferred Qualifications:  

• Experience supporting Phase 1 and 2 clinical trials is preferred
• Oncology experience is highly preferred

Physical Requirements:  

• Ability to travel as needed (approximately 20%)
• Ability to work onsite 2 days/week at our Seattle, WA office
• Ability to sit for prolonged periods of time

Manager Level Salary Range: $125,000 - $150,000
Senior Manager Level Salary Range: $150,000 - $175,000

POSITION SUMMARY

The Associate Clinical Trial Manager is primarily responsible for supporting the operational management and oversight of Umoja’s clinical studies. This individual will work closely with Clinical Operations leadership, Medical Director(s), other cross-functional team members, and designated CROs to ensure the successful completion of assigned clinical study activities and project deliverables within specified quality, time, and cost parameters.

The ideal candidate brings clinical operations expertise in biotech and the ability to thrive in a fast-paced, entrepreneurial environment.

This role is ideally based out of our Seattle, WA location and is onsite at least 2 days/week. We are open to remote work within the US for the right candidate.

CORE ACCOUNTABILITIES

Specific responsibilities include:  

• Ensures studies are carried out according to the study protocol, SOPs, and ICH/GCP guidelines/regulations and study specific manuals and procedures
• Leads specific aspects of assigned clinical trial(s) and demonstrates a high level of knowledge of Clinical Operations’ methodologies, organizational, project management and leadership capabilities
• Supports selection and performance management of CROs and other ancillary vendors during study start-up, conduct, and close-out
• May act as a country lead for large global studies, working under the guidance of the Clinical Trial Manager/Clinical Operations Leadership
• Tracks and ensures optimization of site startup activities and activation, subject enrollment, data collection, and study closeout
• Contributes to the content and review of trial materials (e.g., protocol, informed consent forms, case report forms (CRF), CRF completion guidelines, monitoring guidelines, site initiation visit materials, site tools and worksheets, product administration guidelines)
• Coordinates, files and tracks the distribution of study documents and creates and updates study reports
• Assists in the set up and oversight of the Trial Master File according to ICH- GCP and company SOPs
• Ensures all trial documentation is in a state of audit readiness
• Identifies, selects, and monitors performance of investigational sites
• Ensures accurate and timely site visit monitoring reports
• Develops and maintains strong working relationships with trial investigators and staff
• Assists in management of budgets and payments for investigative sites
• Coordinates with Clinical Supply Chain Operations regarding investigational product shipment to sites
• Manages investigational product release packages and investigational product accountability
• May assist in clinical data review and query generation
• Actively participates in and contributes to the development of department initiatives aimed at improving efficiency and best practices
• Collaborates closely with Clinical Operations, Clinical Development, Biometrics, Clinical Data Management, Regulatory Affairs, Translational Medicine, Clinical Supply Chain, Pharmacovigilance, and Clinical Quality Assurance
• Performs administrative tasks to support Clinical Operations and other team members, as needed

The successful candidate will have:

• Bachelor’s degree or equivalent in Life Sciences with at least 3-5 years of clinical operations experience in the pharmaceutical industry with significant knowledge of GCP/ICH guidelines and the clinical development process
• Strong organizational skills and the ability to balance changing priorities
• Strong interpersonal and communication (written and verbal) skills
• Demonstrated ability to work independently and as part of a multi-functional study team
• Able to solve problems under pressure
• Self-motivated and able to work effectively in a matrix/team environment

Preferred Qualifications:  

• Experience supporting Phase 1 and 2 clinical trials is preferred
• Oncology experience is preferred

Physical Requirements:  

• Ability to travel as needed (approximately 20%)
• Ability to work onsite 2 days/week at our Seattle, WA office
• Ability to sit for prolonged periods of time

Salary Range: $110,000 - $130,000

POSITION SUMMARY

The Senior Director, Clinical Data Management will provide strategic and operational leadership for all clinical data management activities across Umoja’s clinical development programs. This role sits within the Clinical organization and is accountable for ensuring the integrity, quality, and regulatory compliance of clinical trial data from protocol development through database lock and regulatory submission.

This individual will lead the planning, execution, and oversight of data management activities, clinical systems, and external vendors, while building scalable processes and capabilities to support a growing clinical pipeline. The role partners closely with Clinical Development, Clinical Operations, Biostatistics, Translational Medicine, Regulatory Affairs, and external partners like CROs to ensure timely delivery of high quality, decision-read‑y‑ clinical data.

This role will be an Individual Contributor and will lead a matrixed team of vendors (CROs) and contractors to start. This person will be responsible for building out a future team.

This role will ideally be based in Seattle, WA or Louisville, CO but can be remote within the US. If remote, travel to Umoja Headquarters will be required at least once per quarter.

CORE ACCOUNTABILITIES

Specific Responsibilities include:
Hands‑On Clinical Data Management Execution (as needed while building CDM team)

• Serve as the primary clinical data management lead for assigned clinical trials, with direct accountability for data quality, timeliness, and inspection readiness from protocol development through database lock.
• Perform detailed protocol review with a focus on data flow, endpoints, data collection strategy, and facilitation of downstream analysis requirements.
• Lead hands-on CRF design and review, ensuring alignment with protocol objectives‑, statistical analysis plans, and regulatory expectations.
• Develop, review, and approve data management plans (DMPs), database specifications, edit check specifications, data transfer agreements, and data review plans.
• Actively participate in EDC system configuration and validation activities, including review of database builds, user acceptance testing (UAT), and system change control.
• Perform ongoing hands-on data review, query trend analysis, and proactive data cleaning to ensure high-quality, analysis ready‑ datasets.

Technical Oversight & Data Quality

• Partner with Clinical Operations and other groups to define and implement data quality standards, reconciliation strategies, and risk based‑monitoring approaches for clinical data.
• Lead hands-on‑oversight of external CROs and vendors delivering data management services, including detailed review of deliverables, issue resolution, and escalation management.
• Directly review and contribute to data listings, data exports, and interim analysis datasets in partnership with Biostatistics and Statistical Programming.
• Ensure clinical trial data is compliant with applicable regulatory requirements, including GCP, ICH, and CDISC standards.
• Support inspection readiness activities by authoring, reviewing, and maintaining data management documentation and responding directly to audit and inspection findings.

Cross Functional Collaboration

• Partner closely with Clinical Operations to align data management activities with study execution, site operations, monitoring strategies, and operational reporting needs.
• Collaborate with Biostatistics and Statistical Programming to ensure smooth handoff of clean, well documented- datasets for analysis and reporting.
• Provide technical data management expertise to Regulatory Affairs in support of clinical study reports, INDs, BLAs, and other regulatory submissions.
• Serve as the clinical data management subject matter‑ expert on study teams, governance forums, and internal reviews.

Process & Systems Ownership

• Own and continuously improve clinical data management processes, tools, and SOPs to support efficient execution in a growing organization.
• Evaluate, implement, and optimize clinical data systems and technologies (e.g., EDC, IRT, eCOA) to enhance data quality, traceability, and scalability.
• Contribute hands‑on to vendor selection, scope definition, and budgeting for data management services and systems.

The successful candidate will have:

• Bachelor’s degree or higher in life sciences, health informatics, computer science, or a related discipline with a minimum of 15 years of experience. Equivalent combinations of education and experience will be considered.
• Significant experience in clinical data management within the biotechnology or pharmaceutical industry, including 8+ years of leadership of data management functions for clinical trials.
• Demonstrated experience overseeing CROs and external vendors delivering clinical data management services.
• Strong working knowledge of clinical trial processes, EDC systems, data standards, and regulatory expectations for clinical data.
• Proven ability to lead teams, manage complex programs, and collaborate effectively in a fast‑paced, matrixed environment.
• Excellent written and verbal communication skills.

Preferred Qualifications:

• Experience supporting oncology and/or cell or gene therapy clinical development programs.
• Experience building or scaling clinical data management capabilities in a growing biotech organization.
• Prior involvement in regulatory submissions and inspection readiness activities.

Physical Requirements

• Preference to work onsite at least 2 days/week in our Seattle, WA or Louisville, CO location. If remote, the ability to travel to Seattle, WA at least once per quarter.
• Ability to sit for prolonged periods of time.

Salary Range: $247,400 - $305,600

POSITION SUMMARY

The Medical Director will serve as a clinical leader, providing medical and scientific expertise to support the development of our in vivo CAR-T therapy programs. This individual will play a critical role in clinical strategy, study design, execution, and regulatory interactions while partnering cross-functionally with R&D, Clinical Operations, Regulatory, and Program Leadership teams. The ideal candidate will bring deep experience in cell & gene therapy and a strong track record in oncology or rheumatology clinical development.

We will consider candidates at either the Director or Senior Director level based on candidate's qualifications and experiences.

CORE ACCOUNTABILITIES

Specific responsibilities include:  

• Provide medical leadership and clinical oversight for ongoing and planned in vivo CAR-T therapy programs.
• Contribute to the clinical development strategy, including indication selection, trial design, and endpoints.
• Serve as medical monitor for clinical studies, ensuring patient safety, data integrity, and compliance with GCP and regulatory requirements.
• Lead preparation of clinical protocols, investigator brochures, clinical sections of regulatory filings (IND, CTA, BLA), and other medical documents.
• Partner with Clinical Operations on trial execution, including site and investigator engagement, medical monitoring, and data review.
• Engage with global regulatory agencies to support program advancement.
• Provide scientific and clinical expertise to business development, investor relations, and partnership discussions as needed.
• Collaborate closely with translational medicine, preclinical, and regulatory teams to align clinical strategy with scientific discoveries.
• Stay current on emerging trends, competitors, and regulatory guidance in cell & gene therapy and oncology.
• Work with external program partners collaboratively and effectively to deliver on contractual obligations while moving toward corporate goals and priorities.

 The successful candidate will have:

• Director Level: MD, MD/PhD, or equivalent medical degree. Board certification in Oncology, Hematology, or related specialty strongly preferred. 2-5 years of clinical development experience, including at least 2 years in the biotechnology or pharmaceutical industry.
• Senior Director Level: MD, MD/PhD, or equivalent medical degree. Board certification in Oncology, Hematology, or related specialty strongly preferred. Minimum of 5 years of clinical development experience, including at least 4 years in the biotechnology or pharmaceutical industry.
• Demonstrated expertise in cell & gene therapy, ideally with CAR-T or T-cell engaging modalities; experience in in vivo gene delivery a plus.
• Direct experience in oncology clinical trial design, execution, and medical monitoring.
• Strong knowledge of global regulatory requirements for early- and late-stage development of gene and cell therapies.
• Proven ability to interact with investigators, KOLs, and regulatory authorities.
• Excellent communication, leadership, and cross-functional collaboration skills.
• Passion for innovation and commitment to advancing transformative therapies for patients.

Physical Requirements:  

• Ability to travel at least 6x per year to site initiation visits, domestic and international conferences, ad boards, etc
• Ability to work onsite at least 2 days/week

Director Salary Range: $250,000 - $313,000
Senior Director Salary Range: $270,000 - $333,000