The Nuclear Company is the fastest growing startup in the nuclear and energy space creating a never before seen fleet-scale approach to building nuclear reactors. Through its design-once, build-many approach and coalition building across communities, regulators, and financial stakeholders, The Nuclear Company is committed to delivering safe and reliable electricity at the lowest cost, while catalyzing the nuclear industry toward rapid development in America and globally.

About the role

This position is ideal for a highly analytical finance professional who thrives at the intersection of infrastructure, energy, and capital markets. The Senior Associate will collaborate closely with cross-functional teams across the organization (commercial, technical and legal) to facilitate origination, structure contracts, optimize project economics, and execute complicated and multi-party capital financing transactions to support TNC’s execution.

Responsibilities

• Financial Modeling & Analysis
  • Build and maintain detailed project-level and portfolio financial models incorporating capital costs, operating assumptions, and financing terms.
  • Perform scenario and sensitivity analyses to evaluate key drivers of project economics and risk-return profiles.
  • Support valuation of structured financing transactions including sponsor equity, tax equity, project debt, and public-private partnerships.
• Transaction Support
  • Support the execution of complex project finance transactions, including due diligence, documentation review, and coordination with internal and external stakeholders.
  • Prepare investment materials, term sheets, and presentation decks for internal leadership, lenders, and investors.
  • Conduct market and comparable analysis to benchmark financing terms and support negotiation strategy.
• Strategic Collaboration
  • Partner with cross-functional teams (Legal, Development, Engineering, and Government Affairs) to align financing structures with technical, regulatory, and policy objectives.
  • Closely coordinate with FP&A to assess impact of project-level economics in TNC’s corporate financial plan.
  • Support the development of project pipelines and capital deployment strategies aligned with company growth plans.
  • Interface with potential lenders, investors, and advisors to build strong external relationships and represent the company in financing discussions.
• Process & Systems Development
  • Contribute to building internal project finance processes, tools, and templates to support repeatable, scalable deal execution.
  • Help establish key performance metrics and reporting standards for project-level and portfolio-wide financial performance.

Required Experience

Mission-driven, with a passion for accelerating clean energy and infrastructure development.

• Education & Experience
  • Bachelor’s degree in Finance, Economics, Business, Engineering, or related field; MBA or advanced degree preferred.
  • 5+ years of experience in project finance, investment banking, private equity, or corporate finance — ideally within energy, infrastructure, or industrial sectors.
• Skills & Competencies
  • Exceptional analytical and quantitative skills, with advanced proficiency in Excel and financial modeling of levered non-recourse projects.
  • Excellent communication and presentation skills, with the ability to convey complicated concepts to both technical and non-technical audiences.
  • Highly organized, detail-oriented, and comfortable managing multiple priorities in a fast-paced startup environment.

Preferred Qualifications

• Experience with modeling tax equity partnership economics (including full capital account build-ups)
• Familiarity with government-backed financing mechanisms, tax incentives, or DOE/loan guarantee programs is a plus.

Benefits

• Competitive compensation packages
• 401k with company match
• Medical, dental, vision plans
• Generous vacation policy, plus holidays

Estimated Starting Salary Range
The estimated starting salary range for this role is $118,000 - $140,000 annually less applicable withholdings and deductions, paid on a bi-weekly basis. The actual salary offered may vary based on relevant factors as determined in the Company’s discretion, which may include experience, qualifications, tenure, skill set, availability of qualified candidates, geographic location, certifications held, and other criteria deemed pertinent to the particular role. 

EEO Statement
The Nuclear Company is an equal opportunity employer committed to fostering an environment of inclusion in the workplace. We provide equal employment opportunities to all qualified applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other protected characteristic. We prohibit discrimination in all aspects of employment, including hiring, promotion, demotion, transfer, compensation, and termination.

This position is on-site in Seattle, WA.

Join Lumen Bioscience as a Clinical Operations Manager to play a vital role in overseeing and coordinating the clinical operations activities within our growing biopharmaceutical company. In this role, you’ll collaborate with cross-functional teams, and manage CROs and clinical research sites, while ensuring the successful execution of clinical trials, adherence to regulatory guidelines, and the timely delivery of high-quality clinical data.

This position combines hands-on leadership of clinical operations activities with clinical trial oversight, relationship management, clinical sample management, clinical trial supply management, documentation and data management, and process improvement. You’ll oversee the planning, implementation, and execution of clinical trials in collaboration with cross-functional teams, collaborate with CROs and clinical trial sites, and oversee and supervise clinical trial sample management life cycle to maintain chain-of custody in a GxP compliant setting. You’ll assist with forecasting and managing inventory of investigational product, manage relationships with third-party vendors, oversee investigational product shipments domestically and internationally, and oversee the collection, processing, and archival of clinical trial data and documents while identifying opportunities to streamline clinical operations processes, enhance efficiency, and optimize resource allocation. If you have strong leadership skills, in-depth knowledge of clinical research processes, and thrive in a fast-paced environment, we encourage you to apply.

Duties & Responsibilities:

• Clinical Trial Oversight:
  • Oversee the planning, implementation, and execution of clinical trials in collaboration with cross-functional teams, including regulatory affairs, medical writing, production and development, and data management.
  • Ensure compliance with study protocols, Good Clinical Practice (GCP) guidelines, and relevant regulatory requirements.
  • Monitor clinical trial progress, identify potential issues, and proactively develop and implement corrective actions.
• Relationship Management:
  • Collaborate with Contract Research Organizations (CROs) and clinical trial sites to ensure efficient study start-up, enrollment, and conduct.
  • Facilitate effective communication and build strong relationships with external partners, including investigators, site personnel, and vendors.
  • Serve as the main point of contact for clinical trial-related inquiries and issue resolution.
• Clinical Sample Management:
  • Oversee and supervise clinical trial sample management life cycle to maintain chain-of custody in a GxP compliant setting
  • Work closely with CRO, external lab vendors and internal teams to plan and execute sample processing, tracking and shipment of clinical samples
  • Oversee sample receiving procedures and sample testing timelines
• Clinical Trial Supply Management:
  • Assist with forecasting and managing inventory of investigational product needed for upcoming and ongoing clinical trials
  • Establish packaging, labeling and distribution timelines
  • Manage relationships with third-party vendors, e.g., shipping companies and IRT providers.
  • Oversee investigational product shipments domestically and internationally, including coordination of import/export documentation, permits and licenses to ensure timely and compliant delivery of investigational product to drug depots and clinical research sites.
• Documentation and Data Management:
  • Oversee the collection, processing, and archival of clinical trial data and documents, ensuring accuracy, completeness, and traceability.
  • Collaborate with the data management team to implement efficient data capture and reporting processes.
  • Ensure compliance with data protection regulations and maintain data confidentiality.
• Process Improvement:
  • Identify opportunities to streamline clinical operations processes, enhance efficiency, and optimize resource allocation.
  • Contribute to the development and implementation of standardized operating procedures (SOPs) and best practices.
  • Stay up to date with industry trends and regulatory changes to ensure the adoption of current best practices.

Qualifications & Requirements:

• Education and Experience:
  • Bachelor's degree in life sciences or a related field (advanced degree preferred).
  • Minimum of 8 years of experience in clinical operations, with a demonstrated track record of managing clinical trials.
  • Strong knowledge of GCP guidelines, FDA regulations, and other relevant regulatory frameworks.
  • Proven experience in leading and managing teams, with excellent organizational and interpersonal skills.
• Skills and Attributes:
  • Proficiency in clinical trial management systems (CTMS), electronic data capture (EDC) systems, and other relevant software applications.
  • Excellent written and verbal communication skills, with the ability to effectively communicate complex information to diverse stakeholders.
  • Detail-oriented, with strong problem-solving and decision-making abilities.
  • Ability to work effectively in a fast-paced, dynamic environment and manage multiple priorities simultaneously.
  • Demonstrated ability to adapt to changing circumstances and proactively drive process improvements.

Physical Requirements:

• Ability to work on-site in Seattle, WA
• Ability to sit for extended periods of time (2 or more hours)

Benefits at Lumen Bioscience:

• Stock bonus
• Health, Dental, and Vision premiums fully covered by Lumen
• 401k match up to 4%
• Industry-leading PTO policy, paid refresh days, and paid year-end holiday office closure
• Monthly wellness program to support your health and well-being
• Free onsite parking or public transportation subsidies
• Comprehensive parental leave policies
• Life insurance, short & long-term disability, and access to employee assistance programs

At Lumen Bioscience, we foster a workplace built on collaboration, innovation, and professional growth. This role offers a significant opportunity to contribute directly to cutting-edge biotechnology and the advancement of global health solutions.

Join us to shape innovative solutions and drive operational excellence.

Your Impact

You will design and lead the strategy that unlocks scalable procurement and partner-driven growth across our US Public Sector business. By building and optimizing our state and cooperative contract portfolio, activating high-impact commercial partnerships, and proactively clearing procurement hurdles for new products, you will remove friction from the buying process, expand market access and accelerate revenue growth. This role sits at the intersection of Sales, Legal, Product, Finance, and Government Affairs — translating go-to-market priorities into executable contracting and commercialization frameworks that drive measurable growth.

What You’ll Do

Location: This role is based out of our Seattle, WA office and follows a hybrid schedule. We rely on in-person collaboration and ask that team members work onsite Tuesdays through Fridays, with the flexibility to work remotely on Mondays, unless there is an approved workplace accommodation. We believe that connection fuels innovation, and our in-office culture is designed to foster meaningful teamwork, mentorship, and shared success.
Reports to: Senior Director, Strategy & Enablement
Direct Reports: None

State & Cooperative Contract Strategy

• Develop and execute a forward-looking state and cooperative contract strategy aligned to go-to-market priorities; anticipate procurement needs 12–18 months in advance and establish required vehicles ahead of revenue timelines.
• Establish, expand, and renew statewide and cooperative contracts to include new products, services, and pricing models that support growth objectives.
• Lead negotiations for new and expanded contracts, aligning Legal, Sales, Finance, and external stakeholders to secure favorable commercial and operational terms.
• Own strategic relationships with cooperative purchasing organizations and evaluate new vehicles based on revenue potential and market coverage.
• Track contract utilization and performance, identifying opportunities to optimize scope, usability, and adoption across priority markets.

Commercial Partner Strategy & Activation

• Operationalize new commercial partnerships identified by Corporate Development by designing the revenue activation plan and establishing repeatable pathways to secure the first deals on Axon paper.
• Identify priority accounts and use cases where partner products strengthen Axon’s solution; align Sales, Product, Marketing, and the partner on positioning, pricing, and enablement readiness.
• Build scalable procurement and contracting frameworks that allow Axon to compliantly resell partner products within public sector constraints, tracking early performance and refining activation strategy based on results.

New Product Growth Enablement

• Proactively identify and remove procurement, contracting, and regulatory barriers that could delay adoption of new products in state and local markets.
• Ensure state-specific requirements and contract inclusion strategies are understood early and addressed in alignment with launch revenue timelines.
• Translate complex procurement considerations into actionable guidance for Sales and Enablement teams.

What You Bring

• 7+ years of experience in public sector strategy, government contracting, channel/partner strategy, business development, or sales operations within a complex, multi-stakeholder environment.
• Demonstrated success designing and executing strategies that expanded market access and accelerated revenue growth.
• Experience operationalizing commercial partnerships or resell models, translating partnership agreements into executable revenue plans.
• Comfortable balancing legal, financial, and commercial considerations in negotiations.
• Proven ability to influence senior stakeholders and drive cross-functional alignment without direct authority.
• Experience supporting new product launches or commercialization strategies within regulated or procurement-constrained markets.
• Analytical mindset with ability to assess performance metrics, identify friction points, and refine strategy based on data.
• Strategic thinker with a bias for action and a track record of delivering complex, long-horizon initiatives to completion.
• Deep understanding of public sector procurement, including statewide master contracts and cooperative purchasing organizations is a plus.
• Experience in Government Technology, SaaS, or Public Safety Technology preferred.

Benefits that Benefit You

• Competitive salary and 401k with employer match
• Discretionary paid time off
• Paid parental leave for all
• Medical, Dental, Vision plans
• Fitness Programs
• Emotional & Mental Wellness support
• Learning & Development programs
• And yes, we have snacks in our offices

Benefits listed herein may vary depending on the nature of your employment and the location where you work

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

Role Overview 

We are seeking highly skilled, and motivated Director of Combination Product & Device Development, to lead the development, manufacturing, assembly and commercialization of high‑concentration biologic delivery systems, including, prefilled syringes, autoinjectors and other drug–device combination products.

The ideal candidate brings deep expertise in device design control, verification and validation, risk management, combination product regulations, and human factors engineering. This role requires hands‑on technical leadership and extensive experience with regulated devices and combination products (21 CFR 820, ISO 13485), as well as strong knowledge of global device standards (ISO, IEC 62366, ANSI/AAMI HE75) and FDA guidance. A successful track record supporting major regulatory submissions (BLA, MAA, IND/IMPD) and notified body assessments is essential.

Key Responsibilities 

Device Development

• Lead end‑to‑end development and commercialization of prefilled syringes, dual‑chamber cartridges, autoinjectors, and related combination product systems.
• Serve as a hands‑on technical leader and device SME across concept, feasibility, development, qualification, and launch phases.
• Define user needs and product requirements; lead prototyping, test method development, and design verification and validation (DV/V) activities.
• Drive design control documentation, risk assessments, usability studies, and human factors integration.
• Collaborate deeply with internal partners across CMC, drug product development, quality assurance, regulatory affairs, clinical development, supply chain, and commercial functions.
• Build and manage external relationships with CDMOs, device manufacturers, design firms, and suppliers to support development and lifecycle needs.
• Support lifecycle management of commercial combination products, including design history file (DHF) maintenance, change control, validation activities, complaint investigations, and post‑market surveillance.
• Evaluate technical decisions for cross‑functional impact and implement contingency plans as needed.
• Proactively identify and address manufacturing issues; coordinate technical solutions across internal and external teams.
• Lead creation of design control deliverables to ensure compliance with global device and combination product regulations.
• Oversee development of statistically sound verification protocols, reports, and design validation strategies.
• Lead or contribute to investigations of deviations, failures, complaints, and device‑related quality issues.

Design Controls & Human Factors

• Serve as the organizational expert in Human Factors Engineering, ensuring compliance with IEC 62366, ANSI/AAMI HE75, FDA guidance, and related industry standards.
• Integrate usability, human performance considerations, and safety risk mitigations into system requirements and development strategies.
• Ensure all human factors processes, deliverables, and standards are appropriately documented within the Design Control Quality System.
• Lead the cross‑functional design control sub‑team and drive cohesive integration across device design, analytical testing, packaging, manufacturing, clinical, supply chain, commercial, and regulatory functions.
• Manage and prioritize multiple concurrent projects, ensuring alignment to scope, timelines, budgets, and quality standards.

Regulatory Support

• Ensure compliance with global combination product and medical device regulations, including FDA and EU frameworks (e.g., EDDO, MDR).
• Author device‑related sections for regulatory submissions (BLA, MAA, IND/IMPD) and support notified body interactions.
• Represent the combination product function during regulatory audits and inspections.
• Lead proactive risk identification, mitigation planning, and escalation of critical issues.
• Demonstrate strong understanding of FDA’s Office of Combination Products (OCP), including primary mode of action (PMOA) requirements and combination product complaint expectations.

Qualifications 

• Master’s degree (or equivalent) in Mechanical Engineering, Biomedical Engineering, Chemical Engineering, or a related field.
• 15+ years of experience in biologic delivery device development with a proven record of supporting late‑stage development and commercial product launches.

• Experience with design controls, device risk management, medical devices, prefilled syringes, autoinjectors, and related scientific and technical concepts and techniques is required for this position.
• Deep knowledge of subcutaneous delivery systems, systems engineering principles, device materials, and manufacturing technologies; experience with biologics and packaging development preferred.
• Strong understanding of FDA and EU regulations for medical devices and combination products, including relevant quality systems and standards.
• Experience managing external partners, vendors, and contract manufacturers.
• Proven experience with cGMP process development, manufacturing controls, and process risk assessments.
• Excellent communication, leadership, and cross‑functional collaboration skills.
• Ability to thrive in a fast‑paced, agile environment; start‑up experience is highly desirable.

Position Location 

This is a fully remote role with up to 15-20% domestic and/or international travel.

The anticipated salary range for candidates for this role is $210,000 - $235,000. The final salary offered will depend on several factors, which may include, but not limited to, relevant years of experience, educational background, and geography. 

ESA is looking for a Senior Maritime Permitting & Compliance Specialist to join our Pacific Northwest team on a part-time, on-call basis. The selected individual shall be responsible for managing complex federal and state marine permitting, regulatory strategy, and construction compliance for offshore and coastal infrastructure projects. He/she will support offshore wind, subsea linear infrastructure, port development and operations, dredging, and marine construction projects, ensuring compliance with U.S. federal regulations, marine resource protections, and stakeholder engagement requirements. The ideal candidate brings deep expertise in offshore permitting frameworks, vessel compliance, and marine environmental regulations, along with demonstrated success working with fisheries, agencies, and coastal stakeholders. This position will be based out of our Seattle, WA office and be onsite a few days per week. 

Who You Are

• Bachelor’s or Master’s degree in Marine Biology, Oceanography, Maritime Affairs, Environmental Science, Coastal Engineering, or related field
• 10+ years of experience in marine permitting, offshore construction compliance, or maritime environmental management
• Demonstrated experience working with BOEM, NOAA, BSEE, and U.S. Coast Guard regulatory processes
• Strong knowledge of:
  • Marine protected areas, sanctuaries, and reserves
  • ESA, MMPA, NEPA, and CWA frameworks
  • Vessel operations and environmental compliance (including VGP)
• Experience supporting offshore construction projects (e.g., offshore wind, subsea cable, ports, dredging)
• Proven stakeholder engagement experience with fisheries and coastal communities
• Strong communication and stakeholders' management skill
• Ability to operate in fa fast-paced construction environments
• High attention to detail and compliance rigor
• Ability to work in office and in the field traveling to coastal and offshore project sites
• Ability to participate in vessel-based operations and offshore inspections
• Able to collaborate with multidisciplinary teams

Preferred

• Experience supporting offshore wind (OSW) projects and COP/SAP development
• Familiarity with fisheries compensation programs and liaison roles
• Certifications such as:
• Certified Environmental Professional (CEP)
• OSHA HAZWOPER (40-hour)
• Experience with GIS, marine spatial planning, or habitat mapping
• Regulatory strategy and problem-solving in complex, multi-agency environments

What You Will Do

Marine Permitting & Regulatory Strategy

This position will lead and serve as subject matter expert for permitting and compliance efforts under both state and federal frameworks including:

• Outer Continental Shelf (OCS) leasing and approvals (BOEM)
• Essential Fish Habitat (EFH) consultations and Marine Mammal Protection Act (MMPA) compliance (NOAA), Federal and State Endangered Species Act, Federal Clean Water Act (CWA) Section 404/401 (as applicable to marine work), and U.S. Army Corps of Engineers.
• National Marine Sanctuaries Act (NMSA), Marine Protected Areas (MPAs) and marine reserves
• Offshore safety and operational compliance (BSEE)
• Navigation, safety, and Marine Transportation System coordination

The individual will prepare and manage permit applications, technical studies, and regulatory submittals (e.g., COPs, SAPs, NEPA documents)

• Coordinate multi-agency reviews and ensure alignment with federal, state, and local requirements
• Develop and implement mitigation measures and monitoring programs for sensitive marine habitats and species
• Support environmental compliance audits and reporting throughout project lifecycle
• Provide strategic guidance to project managers and clients on permitting risks, schedules, and regulatory pathways

Vessel Compliance & Inspection

The role will oversee vessel compliance with the Vessel General Permit (VGP) and applicable discharge requirements

• Conduct or oversee vessel inspections, audits, and documentation reviews
• Ensure contractor and subcontractor vessel operations meet environmental and safety standards
• Coordinate with marine contractors on best management practices (BMPs) and pollution prevention

Offshore Construction Monitoring & Compliance

• Lead environmental compliance during offshore construction and operations, including:
  • Cable installation and trenching, pile driving and foundation installation, and dredging and port improvements.
  • Implement compliance programs that includes Protected species observers (PSOs), Fisheries liaisons, and Environmental compliance monitoring (ECM).
  • Interface with construction teams to ensure adherence to permit conditions, mitigation measures, and environmental commitments

Stakeholder & Fisheries Engagement

• The position will serve as primary liaison with commercial and recreational fisheries and Tribal governments, and coastal communities as needed.
• The position will lead stakeholder engagement strategies such as fisheries compensation and communication plans and Support public outreach, hearings, and interagency coordination

 Project Management

• Support business development efforts, including proposal writing, scope development, and client presentations

 What’s Special About ESA

Joining ESA means becoming part of a close-knit team of environmental professionals who contribute to outstanding projects, improve environmental stewardship, and advance a more sustainable and resilient future for our communities and wild places.

You are eligible to participate in ESA’s sick leave program. You may be eligible to participate in our employee stock ownership program and tax deferred 401(k) plan if you meet the eligibility requirements for these plans.

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 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.

CORE ACCOUNTABILITIES 

Specific responsibilities include:  

• 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. Demonstrate ability to engage and effectively influence team members across multidisciplinary teams.
• 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. Provide interpretation of regulatory authority feedback, policies, guidelines, and directives.
• 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.

The successful candidate will have:

• 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. Experience in Oncology, Hematology, or related specialty strongly preferred. Successful track record of regulatory submissions and approvals.
• 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.

Physical Requirements:  

• Ability to travel (~20%) for team meetings and/or regulatory interactions as required. Some international travel possible.
• Ability to sit for prolonged periods of time

Senior Director Salary Range: $253,000 - $312,500
Executive Director Salary Range: $272,900 - $337,000