Senior Manager, Government & Industry Affairs Operations

VGW is an interactive entertainment company, harnessing technology and creativity to deliver world-class, free-to-play online social games.

We have an exciting opportunity to join our Government & Industry Affairs team in the United States and are currently looking for a Senior Manager, Government & Industry Affairs Operations to join the team. 

This is a newly created role that will play an important part in helping VGW coordinate and execute its government affairs activity across the US. You will be responsible for bringing structure, discipline, and clear operating rhythm to a complex, multi state lobbying network, ensuring our external partners are well coordinated, accountable, and aligned to business priorities.

You will work closely with Government Affairs, Legal, Marketing, and external lobbying partners to ensure activity is well planned, compliant, and clearly tracked.

We’re open to candidates based anywhere in the US, and this role can be performed remotely. We do not currently have a US office, but occasional in person office attendance may be required if that changes in future.

The salary range  for this role is USD $200,000 - $230,000 per year.

Key responsibilities will include:

• Managing the day to day operations of VGW’s external lobbying contractors, ensuring activity is clearly understood, tracked, and delivered.
• Supporting compliance across VGW’s lobbying activity, including oversight of relevant registrations, disclosures, and state and federal requirements.
• Establishing a single source of truth for legislative tracking, reporting, and key activity across the lobbying network.
• Building dashboards, reporting frameworks, and quarterly operating reviews tied to clear KPIs for lobbying firms.
• Developing detailed execution plans and ensuring strong cross functional alignment across Government Affairs, Legal, Marketing, and other relevant teams.
• Driving accountability with external partners, including performance tracking, budget oversight, resource allocation, and renewal decisions.

What you will bring to the role:

• 8 plus years of experience in government affairs, public policy, lobbying operations, regulatory affairs, or a related field.
• Experience supporting lobbying or government affairs activity in fast moving, high growth, or highly regulated industries.
• Strong multi state coordination skills, with the ability to manage a complex network of external partners, priorities, and deadlines.
• A highly organised and operationally focused approach, with a track record of creating structure where it does not already exist.
• Strong vendor and contract management experience, including the ability to drive accountability and assess performance.
• The ability to read complex regulatory, legislative, or legal materials and translate the practical impact clearly for non technical audiences.
• Experience building tracking, documentation, reporting, or operating systems from scratch and ensuring they are adopted successfully.

About VGW

VGW is an interactive entertainment company, harnessing technology and creativity to deliver world-class, free-to-play online social games.

Our high-quality, acclaimed brands include Chumba Casino, Global Poker and LuckyLand Slots, which are enjoyed by millions of players in North America.

Our games are based on a freemium model, meaning they are available to play at no cost, but include optional in-game purchases to enhance gameplay. We also offer sweepstakes promotions where players can collect free entries for the chance to win real-world prizes.

At VGW, one of our core values is “our players come first”. This means always striving to deliver a safe, responsible and positive player experience.

Why VGW?

At VGW, we’re more than just a team. We’re a diverse and inclusive group of individuals, each playing a vital role in our success.

Our core values are clear and strong; we win together, do what’s right, put our players first and are powered by passion.

We believe in our people and are committed to creating an environment where everyone feels welcome, inspired, and supported. We recognise that life is more than just work - that’s why we’re all about flexibility so you can strike a healthy balance between your personal life and career. We’re also here to champion your growth in your current role and future aspirations, providing opportunities for learning and career advancement. And to top it off, we back this all up with competitive compensation, perks and benefits.  

But it’s not all business. We inject fun into the workplace, celebrate together and create lasting memories, from a mix of in-person and online events, to social gatherings and much more.

It’s our combined skills, ideas and visions that drive us forward. Join us on this exciting journey, and together, we’ll achieve remarkable things. 

If you want to join a team that does things differently, apply today - we look forward to seeing what you can bring to our team.

Find out more at www.vgw.co

#LI-JG1

#LI-Remote

Follows guidance from the senior leader to deliver and implement customer training and support. Performs virtual and onsite visits for imaging site support. Denver, Los Angeles, or Dallas based. 

Responsibilities

• Communicates with imaging partners to increase efficiency and quality of performed scans through education of CCTA best practices for: patient preparation, acquisition, reconstruction, and heart rate control;
• Performs virtual and onsite support events with our imaging partners;
• Organizes and leads training events
• Attends or reviews recording/AI Companion notes for all assigned meetings;
• Reports and documents all related concerns and recommended process improvements to imaging sites and leadership;
• Demonstrates Cleerly software;
• Collaborates with other departments and CT vendors to standardize best practices for image quality and workflow efficiency.
• In person (25% - 50% required travel);
• Travel within the US and International;
• In virtual meetings (50% - 75%);

Required Competencies

• ARRT (CT) required;
• Minimum level of education is an associate degree in radiologic technology or equivalent;
• 2+ years Coronary CTA experience;
• Basic Computer Software Knowledge.

Soft Skills            

• Communication: Clear, concise communication to convey plans and initiatives to team members and stakeholders;
• Critical thinking: evaluate various planning scenarios, anticipate challenges;
• Adaptability: adjust plans in response to unexpected developments;
• Coachability - willingness to Learn;
• Collaboration: cross-functional projects;

The base salary range for this role varies by location and is aligned to market benchmarks.

• Candidates located in higher-cost labor markets, including California, Washington, New York, New Jersey, Connecticut, Massachusetts, and Washington, DC represent the middle to high end of the range, while candidates located in all other U.S. locations represent the low to middle end of the range.
• Final compensation is determined based on location, experience, skills, and internal equity.

This role is eligible for a 10% target annual bonus, resulting in the following base salary and Total Target Compensation (TTC) ranges:

• Base Salary: $103,000 - $108,000
• TTC: $113,300 - $118,800

*Total Target Compensation (TTC): Total Cash Compensation (including base pay, variable pay, commission, bonuses, etc.) Additionally, stock options, paid benefits, and employee perks are part of your total rewards.

About the Opportunity

Cleerly, Inc. is a technology-based healthcare company whose mission is to create digital care pathways to prevent heart attacks. Cleerly, Inc, in Denver, CO is seeking an Engineering Manager, Software to assist with the development of the next generation healthcare diagnosis system, with cutting-edge technologies.  

Job responsibilities and duties include: 

• Lead and support the engineering team throughout the full software development lifecycle for FDA 510(k) regulated medical device software (SaMD). 
• Collaborate with clinicians, regulatory, and quality teams to ensure software development aligns with IEC 62304, ISO 13485, and other relevant standards. 
• Drive decomposition of clinical and regulatory product requirements into actionable technical designs and software features. 
• Manage and mentor engineers, fostering expertise in healthcare software, image processing, and cardiac CT workflows. 
• Collaborate with AI/ML teams to integrate validated algorithms into the clinical product, ensuring regulatory compliance, performance, and usability. 
• Ensure compliance with cybersecurity, HIPAA, and FDA guidance for medical device software. 
• Define and contribute to agile practices tailored to regulated environments, including CI/CD with validated pipelines and automated testing under design controls. 
• Partner closely with product managers, radiologists, and data scientists to ensure clinical accuracy and usability of solutions. 
• Oversee risk management activities, including software hazard analysis and mitigation. 
• Participate in cross-functional design reviews, regulatory audits, and technical file preparation. 
• Recruit and onboard top engineering talent with experience in healthcare and regulated domains.  

Requirements:  

• Bachelor’s degree in Computer Science, Software Engineering, or related discipline (Master’s preferred). 
• 8+ years of software engineering experience, including 2+ years in management/leadership roles. 
• Demonstrated experience in medical device software development or healthcare technology, ideally with FDA 510(k) submissions or CE marking. 
• Strong programming skills in Python, TypeScript/JavaScript, Node.js, React, and SQL/NoSQL databases. 
• Experience developing and securing RESTful and GraphQL APIs. 
• Familiarity with AWS cloud services and infrastructure-as-code (Terraform, CloudFormation). 
• Experience integrating AI/ML algorithms into production healthcare or medical device software, including validation and performance monitoring. 
• Deep understanding of medical imaging (DICOM, PACS, cardiac CT) is a strong plus. 
• Knowledge of IEC 62304, ISO 14971 (risk management), ISO 13485 (QMS) and other regulatory frameworks. 
• Excellent verbal and written communication skills for both technical and clinical audiences. 
• Ability to thrive in a fast-paced, startup-like environment while maintaining regulatory discipline. 
• Passion for mentoring engineers and advancing clinical innovation in cardiovascular care. 

The base salary range for this role varies by location and is aligned to market benchmarks.

• Candidates located in higher-cost labor markets, including California, Washington, New York, New Jersey, Connecticut, Massachusetts, and Washington, DC represent the middle to high end of the range, while candidates located in all other U.S. locations represent the low to middle end of the range.
• Final compensation is determined based on location, experience, skills, and internal equity.

This role is eligible for a 15% target annual bonus, resulting in the following base salary and Total Target Compensation (TTC) ranges:

• Base Salary: $190,000 - $219,000
• TTC: $218,000 - $251,000

*Total Target Compensation (TTC): Total Cash Compensation (including base pay, variable pay, commission, bonuses, etc.) Additionally, stock options, paid benefits, and employee perks are part of your total rewards.

About the Opportunity

We’re looking for our next Senior Technical Program Manager, an experienced scrum master who knows how to shepherd a product portfolio through the full product realization cycle while navigating competing priorities for a regulated product. 

What would I be doing?

You’ll be responsible for driving Cleerly’s product realization process. You’ll help to lead the development team from planning through verification and validation to produce the best possible solution in a compliant, high-quality, and timely manner. You’ll have strong experience in risk management and delivering products in a regulated environment, such as software as a medical device (SaMD). On any given day you could be doing any of the following:

• Communicating and coordinating activities across the product, engineering, AI, regulatory, and quality teams
• Developing and maintaining SOPs, work instructions, and other process documentation for the team and ensuring team alignment and compliance 
• Leading risk analysis activities in accordance with ISO 14971 and IEC 62304
• Tracing requirements to product architecture, system design and verification/validation test cases for compliance and regulatory needs
• Coordinating with AI scientists, engineers, and product managers to develop documentation to support regulatory submissions
• Running agile ceremonies and orchestrating sprint and project milestones in coordination with Product Management
• Ensuring that engineers have all of the information, requirements, acceptance criteria, and designs they need to implement and deliver new features and functionality effectively and efficiently
• Coordinating with engineering managers and product managers on release planning activities, timelines, and documentation
• Leading bug triage and prioritization with the team 

Qualifications

• 5+ years of technical program manager experience, or an equal combination of relevant experience in related disciplines
• Experience working in a highly regulated medical device environment with ISO 13485, ISO 14971, IEC 62304, AAMI TIR 45 standards and regulations
• BS in Engineering preferred or other relevant field with prior experience
• Certified scrum master with demonstrated experience facilitating agile processes 
• Excellent verbal and written communication skills 
• Demonstrated work history maintaining product documentation & versioning within a Quality Management System
• Ability to engage technical and non-technical audiences via strong written, verbal, and visual communication skills
• Proven ability to build relationships, collaborate, and influence internal teams and partners
• Strong analytical and problem solving skills
• Capability to succeed in a fast-paced environment with shifting priorities, and manage projects with competing priorities and timelines

Impress us more

• Previous experience working daily with data scientists, engineers, product managers, regulatory and quality team, and clinicians in a digital health environment
• Previous experience working in a start-up environment with a highly collaborative culture, wearing multiple hats as needed and “pitching in” as necessary

The base salary range for this role varies by location and is aligned to market benchmarks.

• Candidates located in higher-cost labor markets, including California, Washington, New York, New Jersey, Connecticut, Massachusetts, and Washington, DC represent the middle to high end of the range, while candidates located in all other U.S. locations represent the low to middle end of the range.
• Final compensation is determined based on location, experience, skills, and internal equity.

This role is eligible for a 15% target annual bonus, resulting in the following base salary and Total Target Compensation (TTC) ranges:

• Base Salary: $161,000 - $186,000
• TTC: $186,000 - $214,000

*Total Target Compensation (TTC): Total Cash Compensation (including base pay, variable pay, commission, bonuses, etc.) Additionally, stock options, paid benefits, and employee perks are part of your total rewards.

About the Opportunity

We are seeking an experienced Senior Quality Engineer to join our dynamic engineering team.  In this role, you will be responsible for maintaining and confirming the quality of Cleerly’s products and ensuring they conform to and comply with company requirements, international standards, and federal regulations.  You’ll work on a team with developers, developers in test, quality engineers, program managers to identify issues with our software, track resolutions, participate in hazard mitigation and improve our testing methodologies on an ongoing basis.

Key Responsibilities:

• Develop test plans and test cases for product features
• Build complex data sets to be used in test
• Execute end-to-end manual system validation and exploratory testing 
• Test APIs and backend services for compliance to specifications
• Drive defect prioritization and perform impact analysis
• Participate in sprint planning and design meetings to help deliver quality at the earliest possible stage
• Act as a Quality Bar-Raiser for the engineering organization, including contracted QA staff.
• Collaborate with cross-functional teams to understand requirements and translate them into comprehensive test plans
• Continuously evaluate our testing workflow and drive improvements to increase efficiency and product quality
• Stay up-to-date with the latest trends and advancements in QA and share knowledge with the team
• Periodic on-call responsibilities to triage and rapidly escalate issues in our production environment reported by monitoring or customer support

Required Qualifications:

• Bachelor's degree in Computer Science, Information Technology, or related field. Or equivalent work experience.
• 5+ years of experience in software quality engineering 
• Mastery in writing comprehensive test plans.
• Hands-on experience utilizing AWS Cloud Services or an equivalent enterprise cloud service provider.
• Familiarity with manual testing methodologies and test result tracking tools like TestRail.
• Expertise in issue tracking and project management tools like JIRA.
• Strong understanding of the software development life cycle and testing life cycle.
• Excellent problem-solving, analytical, and critical thinking skills.
• Ability to work collaboratively in a remote-first team environment and to communicate effectively with Product Managers, Engineers, and other stakeholders.

Impress Us More…

• Experience working in healthcare or another heavily-regulated industry.
• Experience working in a start-up environment.

Don’t meet 100 percent of the qualifications? Apply anyway and help us diversify our candidate pool and workforce. We value experience, whether gained formally or informally on the job or through other experiences.

If you meet these requirements and are passionate about delivering high-quality software, we encourage you to apply for this exciting opportunity. Together, we can drive innovation and push the boundaries of what's possible.

The base salary range for this role varies by location and is aligned to market benchmarks.

• Candidates located in higher-cost labor markets, including California, Washington, New York, New Jersey, Connecticut, Massachusetts, and Washington, DC represent the middle to high end of the range, while candidates located in all other U.S. locations represent the low to middle end of the range.
• Final compensation is determined based on location, experience, skills, and internal equity.

This role is eligible for a 15% target annual bonus, resulting in the following base salary and Total Target Compensation (TTC) ranges:

• Base Salary: $137,000 - $160,000
• TTC: $157,000 - $184,000

*Total Target Compensation (TTC): Total Cash Compensation (including base pay, variable pay, commission, bonuses, etc.) Additionally, stock options, paid benefits, and employee perks are part of your total rewards.

About the Opportunity

We are seeking a Senior Software Engineer to design, build, deploy, monitor, and optimize production-ready ML services in regulated healthcare. You will work hands-on to package, test, orchestrate, deploy, and maintain ML models, improve workflows, and implement CI/CD and automated testing to ensure reliability, performance, and faster delivery of business value.

Responsibilities

• Design, build, and deploy scalable AI/ML services with clear service boundaries, making pragmatic trade-offs across performance, maintainability, security, and long-term extensibility.

• Own full lifecycle delivery of complex features from architectural planning and API design to implementation and post-release observability.

• Define and enforce robust verification and validation for AI services including unit, integration, and end-to-end testing to ensure reliability of code in production and compliance with our Quality Management System and regulatory standards. 

• Integrate CI/CD and MLOps practices for automated model builds, testing, and deployment.

• Translate product requirements into well-defined technical designs proactively shaping implementation details.

• Contribute to the necessary technical documentation required for regulatory submissions.

• Collaborate cross functionally to reduce knowledge silos and ensure continuity in critical systems through cross-training and documentation. 

Requirements

• Bachelor’s or Master’s degree in Computer Science, Software Engineering, or related field

• 7+ years of software engineering experience, with expertise in AI production systems (Python, PyTorch) and data services (SQL, Postgres, NoSQL, Redis or similar).

• Experience with unit, integration testing for ML models, including data validation, correctness checks, and reproducibility.

• Experience with CI/CD, Orchestration tools (Airflow, MLflow, Kubernetes, Terraform) and ML/data platforms(SageMaker, Databricks, Unity Catalog, Snowflake/Snowpark) to build scalable ML data pipelines and model workflows.

• Strong collaboration skills to work effectively with ML scientists, engineers, and regulatory teams.

• Comfortable operating in ambiguity and driving clarity across product, engineering, and business stakeholders.

This role is eligible for a 15% target annual bonus, resulting in the following base salary and Total Target Compensation (TTC) ranges:

• Base Salary: $153,000 - $179,000
• TTC: $176,000 - $206,000

*Total Target Compensation (TTC): Total Cash Compensation (including base pay, variable pay, commission, bonuses, etc.) Additionally, stock options, paid benefits, and employee perks are part of your total rewards.

About the Opportunity

We are seeking a highly skilled Machine Learning Scientist to drive the development and translation of cutting-edge ML models that have a direct impact on the care pathway for heart disease diagnosis and prognosis. In this role, you will collaborate with ML scientists, data engineers, biostatisticians, regulatory experts, and senior leadership to understand clinical requirements, develop innovative solutions, and support product development and regulatory approvals. You will also engage in high-impact research collaborations with world-renowned academic and medical institutions.

Responsibilities

• Research and develop state-of-the-art machine learning models for coronary CT angiography imaging applications.
• Conduct rigorous analysis and validation of machine learning algorithms and prototypes.
• Explore novel methods for processing and analyzing large, complex medical imaging datasets.
• Collaborate with engineering teams to deploy ML algorithms in clinical practice.
• Present research findings, insights, and recommendations to internal stakeholders and external collaborators.
• Author scientific publications and contribute to patent development.
• Manage collaborative research projects with leading academic partners.

Requirements

• Ph.D. in Computer Science, Data Science, Biomedical Engineering, Biomedical Imaging, or a related technical field; OR an M.S. with 5+ years of relevant experience.
• Strong theoretical and practical expertise in image science, applied mathematics, machine learning, and deep learning.
• Research experience in applying ML and deep learning techniques to medical image processing, including segmentation, registration, classification, reconstruction, and detection.
• Proven track record of publications in top-tier medical imaging or computer vision conferences and journals (e.g., MICCAI, IEEE TMI, CVPR, Medical Image Analysis).
• Proficiency in Python, with experience handling large datasets, implementing ML pipelines, and visualizing analysis results.
• Ability to translate complex clinical requirements into machine learning solutions.
• Strong critical thinking, problem-solving, and project management skills.
• Excellent interpersonal, cross-functional, and cross-cultural collaboration skills.

Preferred Qualifications: 

• 2+ years of postdoctoral research or industry experience.
• Hands-on experience in developing and applying advanced deep learning models, including vision transformers, semi-supervised/self-supervised/unsupervised learning, incremental learning, and continuous learning techniques.
• Strong domain knowledge in CT imaging and its clinical applications.

The base salary range for this role varies by location and is aligned to market benchmarks.

• Candidates located in higher-cost labor markets, including California, Washington, New York, New Jersey, Connecticut, Massachusetts, and Washington, DC represent the middle to high end of the range, while candidates located in all other U.S. locations represent the low to middle end of the range.
• Final compensation is determined based on location, experience, skills, and internal equity.

This role is eligible for a 15% target annual bonus, resulting in the following base salary and Total Target Compensation (TTC) ranges:

• Base Salary: $186,000 - $212,000
• TTC: $214,000 - $245,000

*Total Target Compensation (TTC): Total Cash Compensation (including base pay, variable pay, commission, bonuses, etc.) Additionally, stock options, paid benefits, and employee perks are part of your total rewards.

About the Opportunity

We are seeking a senior machine learning software engineer to design, build, deploy, monitor, and optimize production-ready ML services in regulated healthcare. You will work hands-on to package, test, orchestrate, deploy, and maintain ML models, improve workflows, and implement CI/CD and automated testing to ensure reliability, performance, and faster delivery of business value.

Responsibilities

• Collaborate with AI scientists to package and deploy ML models, ensuring reproducibility, versioning, and compliance.
• Build and maintain model serving infrastructure including monitoring, drift detection, automated retraining, and logging.
• Implement unit, integration, and system-level testing for ML models, covering data validation, model correctness, and deployment workflows.
• Develop and operate end-to-end ML pipelines: ingestion → preprocessing → feature engineering → evaluation → deployment → monitoring.
• Integrate CI/CD and MLOps practices for automated model builds, testing, and deployment.
• Identify and resolve workflow inefficiencies or gaps between research and production.
• Recommend and integrate frameworks, libraries, and infrastructure to improve pipeline efficiency, maintainability, and observability.
• Collaborate cross-functionally to ensure compliance with regulatory requirements (FDA/HIPAA) in production ML workflows.
  
  

Requirements

• 7+ years of experience in software engineering for ML production or ML platform delivery.
• Hands-on experience deploying ML models via APIs, batch pipelines, or streaming inference.
• Proficiency in Python (required), Java, or similar, with software engineering best practices for ML workflows.
• Experience with unit, integration, and pipeline-level testing for ML models, including data validation, correctness checks, and reproducibility.
• Familiarity with cloud platforms (AWS preferred: SageMaker, S3, EC2) and reproducible ML pipelines.
• Experience with CI/CD, Orchestration tools (Airflow, MLflow, Kubernetes, Terraform) and ML/data platforms(SageMaker, Databricks, Unity Catalog, Snowflake/Snowpark) to build scalable ML data pipelines and model workflows.
• Strong collaboration skills to work effectively with AI scientists, software engineers, and regulatory teams.

The base salary range for this role varies by location and is aligned to market benchmarks.

• Candidates located in higher-cost labor markets, including California, Washington, New York, New Jersey, Connecticut, Massachusetts, and Washington, DC represent the middle to high end of the range, while candidates located in all other U.S. locations represent the low to middle end of the range.
• Final compensation is determined based on location, experience, skills, and internal equity.

This role is eligible for a 15% target annual bonus, resulting in the following base salary and Total Target Compensation (TTC) ranges:

• Base Salary: $153,000 - $179,000
• TTC: $176,000 - $206,000

*Total Target Compensation (TTC): Total Cash Compensation (including base pay, variable pay, commission, bonuses, etc.) Additionally, stock options, paid benefits, and employee perks are part of your total rewards.

Role Purpose:

The Product Safety Process & Regulatory Readiness Coordinator supports the Head of Product Safety in preparing Product Safety function for upcoming and evolving regulatory requirements, with a focus on the EU AI Act and Cyber Resilience Act.

The role is responsible for coordinating the development, adoption, and embedding of product safety–related processes, procedures, and governance mechanisms, while actively engaging internal stakeholders across engineering, digital, legal, compliance, cybersecurity, and product management. The position acts as a central integrator, ensuring alignment, traceability, and readiness rather than owning regulatory interpretation or technical implementation.

Responsibilities:

Process & Procedure Enablement

• Support the definition, documentation, and rollout of Product Safety processes and procedures addressing AI‑enabled products, digital components, and cyber resilience requirements.
• Coordinate updates to existing Product Safety frameworks to incorporate regulatory expectations related to AI risk management, secure‑by‑design principles, and lifecycle obligations.
• Ensure consistency and usability of Product Safety documentation across business units and regions.

Regulatory Readiness & Change Support

• Track regulatory developments and internal interpretations related to the EU AI Act and Cyber Resilience Act, in collaboration with Legal, Compliance, and Regulatory Affairs.
• Translate regulatory expectations into practical process impacts for Product Safety without providing legal interpretation.
• Support readiness assessments, gap analyses, and roadmap development for Product Safety–related obligations.

Stakeholder Engagement & Coordination

• Act as a key interface between Product Safety and internal stakeholders including:
• Engineering and R&D
• Digital, Software, and AI teams
• Cybersecurity and IT
• Legal, Compliance, and Risk Management
• Quality, Lifecycle Management, and Product Management
• Plan and facilitate cross‑functional workshops, working groups, and reviews to align on responsibilities, interfaces, and deliverables.
• Drive follow‑up actions and maintain accountability across stakeholders.

Governance, Tracking & Reporting

• Support the establishment of Product Safety governance structures related to AI and cyber topics (e.g., roles, decision forums, escalation paths).
• Maintain structured overviews of initiatives, milestones, dependencies, and risks.
• Prepare concise management‑level updates and materials for the Head of Product Safety and senior stakeholders.

Change Management & Awareness

• Support communication and awareness activities related to Product Safety expectations for AI‑enabled and connected products.
• Contribute to training concepts, guidance materials, and internal communications to promote consistent understanding across the organization.
• Encourage adoption of processes by focusing on clarity, pragmatism, and integration with existing ways of working.

Education and Experience:

• University degree in engineering, computer science, industrial management, or a comparable field.
• Experience in a coordination, program management, product safety, quality, regulatory, or compliance‑related role within an industrial, digital, or regulated environment.
• Familiarity with product lifecycle processes, system engineering, software‑enabled products, and/or cybersecurity concepts.
• Experience working in complex, global, cross‑functional organizations.
• Understanding of (or strong interest in) emerging regulatory topics such as AI governance, product compliance, and cyber resilience.

Qualifications:

• Strong organizational and coordination skills; able to manage multiple workstreams in parallel.
• Excellent stakeholder management and communication capabilities across technical and non‑technical audiences.
• Ability to translate abstract regulatory or governance concepts into structured processes and practical actions.
• Structured, methodical working style with attention to detail and traceability.
• Confident facilitator of workshops and collaborative working sessions.
• Pragmatic, solution‑oriented mindset with the ability to operate in evolving and ambiguous contexts.

What Success Looks Like:

• Clear, usable Product Safety processes in place to support AI Act and Cyber Resilience Act readiness.
• Strong alignment and collaboration between Product Safety and key internal stakeholders.
• Improved transparency of responsibilities, status, and gaps related to AI and cyber product safety topics.
• The Head of Product Safety is effectively supported with structured inputs, coordinated actions, and reliable oversight.

Location: REMOTE (with strong virtual engagement across regions)

Salary Range: $120K-$150K

The actual salary offered is dependent on various factors including, but not limited to, location, the candidate’s combination of job-related knowledge, qualifications, skills, education, training, and experience 

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

About the Opportunity

You will report to a Regional Sales Director and be a part of a regional team that is focused on Hospitals, Providers and Imaging Centers.  As a team, you will work to bring Cleerly to market across outlets throughout your region.  Your focus will be a hybrid of Health Systems and Provider sales, and you must be based in the Denver, CO area.

Responsibilities

• Actively manage a high-value portfolio within a defined regional sales territory
• Prospect and develop new business to drive revenue by identifying opportunities for cross selling and expansions across commercial models / across Cleerly’s business opportunities
• Deliver weekly, monthly, and quarterly reports on sales pipeline, revenue, and other important data.
• Develop and deliver compelling proposals, position complex pricing structures, and negotiate contracts and deal-closing requirements quickly and efficiently.
• Execute key sales strategies to advance the utilization of the Cleerly solution within assigned geographies comprised of diverse customers. This includes collaboration with the Cleerly strategy and customer success teams for conversion of the account
• Meet quarterly and annual sales goals by developing an account strategy and pipeline, maintaining sales reports, developing market and competitor knowledge
• Give presentations and trainings, and travel to customer sites as needed

Requirements

• Actively manage a high-value portfolio within a defined regional sales territory: Colorado, Wyoming, and Montana
• Solid understanding of the Colorado hospital market
• Prospect and develop new business to drive revenue by identifying opportunities for cross selling and expansions across commercial models / across Cleerly’s business opportunities
• Deliver weekly, monthly, and quarterly reports on sales pipeline, revenue, and other important data.
• Develop and deliver compelling proposals, position complex pricing structures, and negotiate contracts and deal-closing requirements quickly and efficiently.
• Execute key sales strategies to advance the utilization of the Cleerly solution within assigned geographies comprised of diverse customers. This includes collaboration with the Cleerly strategy and customer success teams for conversion of the account
• Meet quarterly and annual sales goals by developing an account strategy and pipeline, maintaining sales reports, developing market and competitor knowledge
• Give presentations and trainings, and travel to customer sites as needed

The base salary range for this role is aligned to market benchmarks and determined by experience, skills, and internal equity.

This role is eligible for annual On Target Commission, resulting in the following base salary and Total Target Compensation (TTC) ranges:

• Base Salary: $140,000 - $150,000
• Commission: $150,000
• TTC: $290,000 - $300,000

*Total Target Compensation (TTC): Total Cash Compensation (including base pay, variable pay, commission, bonuses, etc.) Additionally, stock options, paid benefits, and employee perks are part of your total rewards.

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

About the Opportunity

We're seeking a Senior Software Engineer to drive key technical initiatives across our computational imaging pipeline. In this high-impact role, you'll own the complex systems responsible for deploying, scaling, and monitoring our regulated AI algorithms end-to-end. You will influence the architecture of our system, ensuring our solutions meet medical standards for quality and performance, while mentoring other engineers and helping shape our technical culture.

About the Team

You will join our expert Computational Imaging team, where we develop sophisticated algorithms to enhance and improve medical imaging. We are focused on improving the quality and clinical value of medical images, creating powerful, extra software components that correct artifacts, standardize data, and ensure the utmost precision before the final analysis. Our work is essential for elevating the reliability and accuracy of Cleerly’s regulated products.

Responsibilities

• Design, build, and deploy scalable AI services and computational imaging pipelines to production, ensuring robust, high-availability infrastructure for our machine learning algorithms.
• Design extensible system architectures and make pragmatic trade-offs that balance performance, security, and maintainability.
• Own full lifecycle delivery of complex features, from architectural planning and API design to implementation and post-release observability.
• Ensure high availability and observability of our services; improve alerting, logging, and incident response across the stack.
• Set and uphold strong engineering standards via code reviews, technical mentorship, and design documentation.
• Lead technical design reviews and system decomposition efforts across teams.
• Proactively identify risks and gaps in operational or architectural resilience, and drive durable improvements.
• Collaborate closely across AI and engineering to reduce knowledge silos and ensure continuity in critical systems through cross-training and documentation.
• Design and implement robust testing mechanism and validation strategies to ensure compliance with our Quality Management System and regulatory standards 
• Contribute to the necessary technical documentation required for regulatory submissions.

Requirements 

• Bachelor’s or Master’s degree in Computer Science, Software Engineering, or related field (or equivalent experience).
• 8–12 years of software engineering experience, with expertise in AI production systems (Python, PyTorch) and data services (SQL, Postgres, NoSQL, Redis or similar).
• Demonstrable capability in designing, implementing, and securing RESTful web services
• Experience in MLOps orchestration and cloud deployment (Docker, Kubernetes).
• Experience with AWS, GitHub, and continuous integration pipelines
• Proven track record of architecting and delivering scalable systems in production environments.
• Experience mentoring engineers and raising the technical bar through reviews and design feedback.
• Strong systems thinking with the ability to evaluate tradeoffs in scalability, reliability, and maintainability.
• Experience designing for observability and operational excellence (e.g., logs, alerts, dashboards, runbooks).
• Comfortable operating in ambiguity and driving clarity across product, engineering, and business stakeholders.

Preferred:

• Experience designing and optimizing end-to-end medical imaging pipelines in a production environment and familiarity with HIPAA/HITRUST security requirements.
• Hands-on experience with Computer Vision and Deep Learning techniques used for medical image processing.

The base salary range for this role varies by location and is aligned to market benchmarks.

• Candidates located in higher-cost labor markets, including California, Washington, New York, New Jersey, Connecticut, Massachusetts, and Washington, DC represent the middle to high end of the range, while candidates located in all other U.S. locations represent the low to middle end of the range.
• Final compensation is determined based on location, experience, skills, and internal equity.

This role is eligible for a 15% target annual bonus, resulting in the following base salary and Total Target Compensation (TTC) ranges:

• Base Salary: $153,000 - $179,000
• TTC: $176,000 - $206,000

*Total Target Compensation (TTC): Total Cash Compensation (including base pay, variable pay, commission, bonuses, etc.) Additionally, stock options, paid benefits, and employee perks are part of your total rewards.