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.

This position is on-site in Seattle, WA.

Join Lumen Bioscience as a Senior Clinical Operations Manager to plan, execute and continuously improve clinical operations across multiple clinical studies. In this strategic, cross-functional role, you’ll lead operational strategy and execution for one or more clinical development programs, oversee CRO and vendor selection and performance, manage study budgets and timelines, ensure regulatory readiness and inspection response, and support the career development of the operations team while being accountable for delivering high-quality data on time and on budget.

This position combines program ownership and strategy, team leadership, CRO and vendor management, budget and resource ownership, quality and compliance, clinical trial execution, data and documentation, process improvement and SOPs, and cross-functional leadership. You’ll create program timelines, resourcing plans, and run-rate forecasts; manage vendor KPIs and SLAs and drive performance improvements; own program budgets and control spend; ensure inspection readiness and lead remediation after audits; oversee site selection and activation, enrollment performance, monitoring strategy, and vendor deliverables; ensure eTMF completeness and adherence to GCP/ICH and applicable regulations; and drive continuous improvement and implementation of SOPs and automation to increase efficiency and quality while presenting program status to leadership and the executive team.

If you bring deep clinical operations experience, strong leadership, communication, negotiation and problem-solving skills, and a passion for advancing clinical development programs, we encourage you to apply.

Duties & Responsibilities:

• Program Strategy & Execution: 
  • Lead operational strategy and execution for one or more clinical development programs (Phase I–III or platform trials).
  • Create program timelines, resourcing plans, and run-rate forecasts.
  • Oversee site selection/activation strategy, enrollment performance, monitoring strategy (RBM), SIVs, close-out, and vendor deliverables.
  • Escalate and resolve issues that threaten timelines or data quality.
• Team & Vendor Leadership: 
  • Mentor Clinical Ops Managers/CRAs; recruit, mentor, and develop talent; run performance reviews and succession plans.
  • Manage vendor KPIs/SLAs, run vendor governance, and drive performance improvements.
  • Hold CROs accountable for timelines, data quality, monitoring, and TMF completeness.
• Budget & Resource Management: 
  • Own program budgets; provide accurate forecasting and control spend.
  • Approve study-level operational expenses within delegated authority.
• Quality, Compliance & Documentation: 
  • Ensure inspection readiness and lead remediation after internal or external audits.
  • Accountable for issues escalation and coordination of inspection/agency responses.
  • Ensure eTMF completeness, timely monitoring visit documentation, query resolution, and adherence to GCP/ICH and applicable regulations (FDA, EMA, local).
  • Work closely with Data Management and Safety to ensure integrated delivery.
• Process Improvement & Cross-Functional Leadership: 
  • Drive continuous improvement; implement SOPs and automation (CTMS/EDC/eTMF optimizations) to increase efficiency and quality.
  • Present program status to leadership and the executive team.

Qualifications & Requirements:

• Education and Experience:
  • MS/PharmD/PhD preferred; BS with robust experience considered
  • Minimum of 12 years of clinical operations experience, including program/CRO oversight and people management
  • Demonstrated ownership of Phase I–III trials and experience supporting IND/CTA filings
  • Experience in biologics or oral/edible drug delivery modalities
  • Prior inspection response ownership or regulatory submission leadership
• Skills and Attributes:
  • Strong working knowledge of CTMS, eTMF, EDC platforms
  • Proficiency in clinical trial management systems (CTMS), electronic data capture (EDC) systems, and other relevant software applications
  • Deep familiarity with ICH-GCP, FDA/EMA regulations and inspection processes
  • Strong leadership, communication, negotiation and problem-solving skills
  • ACRP or SOCRA certification

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.

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

Real World Data Analyst

Truveta is the world’s first health provider led data platform with a vision of Saving Lives with Data. Our mission is to enable researchers to find cures faster, empower every clinician to be an expert, and help families make the most informed decisions about their care. Achieving Truveta’ s ambitious vision requires an incredible team of talented and inspired people with a special combination of health, software and big data experience who share our company values.

Truveta was born in the Pacific Northwest, but we have employees who live across the country.  Our team enjoys the flexibility of a hybrid model and working from anywhere.  In person attendance is required at least once per year for an onsite meeting. 

For overall team productivity, we optimize meeting hours in the pacific time zone. We avoid scheduling recurring meetings that start after 3pm PT, however, ad hoc meetings occur between 8am-6pm Pacific time. #LI-remote

Who We Need 

Truveta is rapidly building a talented and diverse team to tackle complex health and technical challenges. Beyond core capabilities, we are seeking problem solvers, passionate and collaborative teammates, and those willing to roll up their sleeves while making a difference. If you are interested in the opportunity to pursue purposeful work, join a mission-driven team, and build a rewarding career while having fun, Truveta may be the perfect fit for you. 

This Opportunity 

The Real World Data Analyst role is a high-impact, intellectually challenging position that requires a diverse set of analytical and technical skills. It offers a unique opportunity for professional growth through access to an unprecedented volume of high-quality, real-world Electronic Health Record (EHR) data. In this role, you will tackle meaningful healthcare challenges using an EHR database encompassing more than 125 million patients—and growing—helping drive insights that can ultimately improve patient care. This position reports to the Senior Director of Research Services.

As a Real World Data Analyst, you will collaborate strategically with some of our largest life sciences partners. This role provides the opportunity to dive deeply into complex research questions related to human health and generate data-driven insights that support impactful scientific decisions. 

Responsibilities

• Translate study protocols and statistical analysis plans (SAPs) into reproducible analytical code, executing end-to-end research studies from data extraction and wrangling through statistical analysis and results generation using SQL, R, or Python within agreed timelines.
• Review and interpret study protocols and SAPs, ensuring analytical approaches are implemented accurately and consistently with study objectives.
• Develop robust data pipelines for cohort building, data cleaning, feature engineering, and preparation of analytical datasets using large-scale real-world data sources.
• Conduct rigorous quality control (QC) of code, datasets, and statistical outputs, including verification of model assumptions, reproducibility of results, and validation of analytical approaches.
• Proactively identify and communicate potential data issues, methodological concerns, or deviations from study protocols early in the research process, recommending solutions and mitigation strategies.
• Collaborate closely with biostatisticians and researchers to support the development, refinement, and review of statistical analysis plans and analytical methods.
• Interpret analytical results and contribute to the synthesis of findings, ensuring outputs are scientifically sound and aligned with study objectives.
• Partner with life sciences customers and internal teams to execute high-quality analyses that support peer-reviewed publications, regulatory submissions, and scientific research.
• Provide clear, proactive communication on study progress, analytical challenges, and timelines, ensuring stakeholders remain informed and aligned.
• Work closely with cross-functional teams across Truveta to investigate data sources, validate data integrity, and support scientific credibility of research outputs.
• Deliver feedback to internal teams based on research experiences and customer needs to help inform improvements to Truveta’s data platform and research capabilities.

Required Skills

• Undergraduate or graduate degree in biostatistics, epidemiology, clinical research, data science, clinical informatics, or a related field.
• 3+ years of experience conducting analyses using large healthcare datasets (e.g., electronic health records or other real-world data sources).
• Strong proficiency in SQL and at least one statistical programming language (R or Python) for data wrangling, analysis, and reproducible research workflows.
• Experience translating research protocols or statistical analysis plans into executable analytical code.
• Experience performing rigorous quality control of analytical datasets, code, and statistical outputs.
• Demonstrated experience working with complex healthcare data involving millions of patient records.
• Experience collaborating with research teams or customers to deliver high-quality scientific analyses.
• Strong problem-solving skills and the ability to identify data or methodological issues early and communicate them effectively.
• Excellent written and verbal communication skills, including the ability to clearly explain analytical approaches and findings to technical and non-technical stakeholders.
• Ability to learn quickly and adapt in a dynamic, fast-paced environment.
• Willingness to learn new analytical tools, programming languages, and proprietary platforms used to analyze real-world data.

Preferred Qualifications

These qualifications are preferred but not required, please do not let them stop you from applying for this role. You will likely get the opportunity to learn how to do these more advanced analyses if you don’t already have experience with them.   

• Experience applying causal inference methods to observational healthcare data, including approaches such as propensity score matching/weighting, inverse probability weighting, marginal structural models, or instrumental variable analysis.
• Familiarity with study designs used to estimate causal effects in real-world data, such as target trial emulation, difference-in-differences, regression discontinuity, or interrupted time series.
• Experience evaluating confounding, selection bias, and other threats to causal validity in observational studies.

Why Truveta?   

Be a part of building something special. Now is the perfect time to join Truveta. We have strong, established leadership with decades of success. We are well-funded. We are building a culture that prioritizes people and their passions across personal, professional and everything in between. Join us as we build an amazing company together.  

We Offer:

• Interesting and meaningful work for every career stage
• Great benefits package
• Comprehensive benefits with strong medical, dental and vision insurance plans
• 401K plan
• Professional development & training opportunities for continuous learning
• Work/life autonomy via flexible work hours and flexible paid time off
• Generous parental leave
• Regular team activities (virtual and in-person)
• The base pay for this position is $94,000 to $145,000. The pay range reflects the minimum and maximum target. Pay is based on several factors including location and may vary depending on job-related knowledge, skills, and experience. Certain roles are eligible for additional compensation such as incentive pay and stock options.

If you are based in California, we encourage you to read this important information for California residents linked here.

Truveta is committed to creating a diverse, inclusive, and empowering workplace. We believe that having employees, interns, and contractors with diverse backgrounds enables Truveta to better meet our mission and serve patients and health communities around the world. We recognize that opportunities in technology historically excluded and continue to disproportionately exclude Black and Indigenous people, people of color, people from working class backgrounds, people with disabilities, and LGBTQIA+ people. We strongly encourage individuals with these identities to apply even if you don’t meet all of the requirements.

Please note that all applicants must be authorized to work in the United States for any employer as we are unable to sponsor work visas or permits (e.g. F-1 OPT, H1-B) at this time. We appreciate your interest in the position and encourage you to explore future opportunities with us.

Senior Clinical Data Scientist - Applied Intelligence Solutions

Truveta is the world’s first health provider led data platform with a vision of Saving Lives with Data. Our mission is to enable researchers to find cures faster, empower every clinician to be an expert, and help families make the most informed decisions about their care. Achieving Truveta’ s ambitious vision requires an incredible team of talented and inspired people with a special combination of health, software and big data experience who share our company values.

Truveta was born in the Pacific Northwest, but we have employees who live across the country.  Our team enjoys the flexibility of a hybrid model and working from anywhere.  In person attendance is required at least once per year for an onsite meeting. 

For overall team productivity, we optimize meeting hours in the pacific time zone. We avoid scheduling recurring meetings that start after 3pm PT, however, ad hoc meetings occur between 8am-6pm Pacific time. #LI-remote

Who We Need 

Truveta is rapidly building a talented and diverse team to tackle complex health and technical challenges. Beyond core capabilities, we are seeking problem solvers, passionate and collaborative teammates, and those willing to roll up their sleeves while making a difference. If you are interested in the opportunity to pursue purposeful work, join a mission-driven team, and build a rewarding career while having fun, Truveta may be the perfect fit for you. 

This Opportunity 

We are seeking a Senior Clinical Data Scientist to join the Catalysts team, focused on applied intelligence solutions for Truveta.

This role focuses on building the concrete intelligence assets that intelligence uses to solve defined healthcare problems correctly and safely. You will work on concrete problem types such as safety monitoring, cohort feasibility, HEOR analyses, clinical trial workflows, and operational oversight, and be responsible for directly creating the knowledge assets, examples, and guardrails that intelligence uses to support these problems effectively and safely. 

A core part of the role is creating and maintaining practical intelligence assets that intelligence directly uses to support specific, repeatable solutions. These assets are contributed into a shared knowledge base maintained by the broader Catalysts team. 

You will also influence how intelligence consumes and applies knowledge by producing clear, reusable assets that translate complex technical and domain concepts into forms usable by both intelligence systems and non technical stakeholders. 

Out of scope: This role is not focused on model training, infrastructure, or large scale implementation. You are expected to be technically fluent and able to prototype, while deeper execution is handled collaboratively with peers who specialize in speed and scale. 

Responsibilities

• Intelligence solution construction: Independently build small scale, concrete intelligence solutions for specific healthcare problems by creating the required knowledge assets, examples, reference analyses, and guardrails that allow intelligence to answer the right questions and respect clear boundaries, within current platform capabilities.
• Domain problem breakdown: Break down healthcare problems in areas such as clinical research, HEOR, and clinical trials into the concrete assumptions, decision points, and data considerations that intelligence needs to handle correctly.
• Knowledge and guidance definition: Create and maintain the domain knowledge, guidelines, templates, and decision logic that intelligence systems need in order to perform effectively in each problem domain.
• Agent and workflow shaping: Shape how intelligence agents operate at a practical level by defining task breakdowns, decision logic, and required knowledge, working within current platform constraints.
• Knowledge extraction and transformation: Work with domain experts and users to extract assumptions, heuristics, and expertise, and convert them into structured inputs that intelligence systems can reliably consume.
• Generative AI reasoning: Apply an understanding of how generative AI systems retrieve and reason over knowledge to improve correctness, safety, and consistency of intelligence outputs, using concrete examples and test questions.
• Validation and guardrails: Define and validate constraints, exclusions, and limitations to ensure intelligence outputs are appropriate, trustworthy, and aligned with real world healthcare use.
• Collaboration and facilitation: Work closely with colleagues across the Catalysts team, contributing domain expertise, intelligence design, and reusable assets into a shared knowledge base, and collaborating as peers on intelligence solutions rather than owning a separate execution pipeline. 

Required Skills

• Education: Bachelor’s degree or equivalent experience in a quantitative or technical field such as computer science, data science, statistics, engineering, or a related discipline.
• Applied intelligence and LLM expertise: Strong understanding of how large language models consume, retrieve, and reason over knowledge, and how to structure information so it can be used efficiently and reliably by intelligence systems.
• Healthcare domain knowledge: Solid understanding of healthcare problem spaces such as clinical research, HEOR, clinical trials, and healthcare operations, and the types of questions and decisions users need support with.
• Generative AI fluency: Hands on experience using generative AI tools to synthesize, generate, and refine knowledge assets including guidance, templates, prompts, and structured explanations.
• Applied solution design: Ability to design and prototype applied intelligence solutions for specific problem types by combining domain knowledge, templates, prompts, guardrails, and workflows.
• Technical fluency: Comfortable writing and reviewing production quality analysis code (e.g., SQL, Python, or R) to prototype analyses, validate logic, and create reusable examples that intelligence and teammates can reuse. Deep engineering expertise is not required, but hands on technical fluency is expected.
• Knowledge creation and translation: Create clear, reusable intelligence assets by synthesizing expert input or authoring directly, translate technical and domain specific concepts into guidance that is understandable and actionable for a wide range of audiences, and explicitly define exclusions and limitations where intelligence should not provide answers. 

Preferred Qualifications

• Healthcare and EHR exposure: Experience working with healthcare or EHR data, including awareness of common data quality issues, biases, and clinical context.
• Decision support systems: Experience designing, evaluating, or contributing to decision support systems, recommendations, or intelligent assistants.
• Applied research background: Background in product analytics, applied research, or applied machine learning in support of real world decision making.
• Advanced technical depth: Experience building more complex analytical workflows, reusable code libraries, or data products that others rely on, even if this is not the primary focus of the role.
• Knowledge formalization: Experience translating expert knowledge into structured guidance, documentation, schemas, or training materials.
• Teaching and enablement: Teaching, mentoring, or enablement experience with analysts, researchers, or cross functional teams. 

Why Truveta?   

Be a part of building something special. Now is the perfect time to join Truveta. We have strong, established leadership with decades of success. We are well-funded. We are building a culture that prioritizes people and their passions across personal, professional and everything in between. Join us as we build an amazing company together.  

We Offer:

• Interesting and meaningful work for every career stage
• Great benefits package
• Comprehensive benefits with strong medical, dental and vision insurance plans
• 401K plan
• Professional development & training opportunities for continuous learning
• Work/life autonomy via flexible work hours and flexible paid time off
• Generous parental leave
• Regular team activities (virtual and in-person)
• The base pay for this position is $155,000 to $170,000. The pay range reflects the minimum and maximum target. Pay is based on several factors including location and may vary depending on job-related knowledge, skills, and experience. Certain roles are eligible for additional compensation such as incentive pay and stock options.

If you are based in California, we encourage you to read this important information for California residents linked here.

Truveta is committed to creating a diverse, inclusive, and empowering workplace. We believe that having employees, interns, and contractors with diverse backgrounds enables Truveta to better meet our mission and serve patients and health communities around the world. We recognize that opportunities in technology historically excluded and continue to disproportionately exclude Black and Indigenous people, people of color, people from working class backgrounds, people with disabilities, and LGBTQIA+ people. We strongly encourage individuals with these identities to apply even if you don’t meet all of the requirements.

Please note that all applicants must be authorized to work in the United States for any employer as we are unable to sponsor work visas or permits (e.g. F-1 OPT, H1-B) at this time. We appreciate your interest in the position and encourage you to explore future opportunities with us.

Partner Data Analyst

Truveta is the world’s first health provider led data platform with a vision of Saving Lives with Data. Our mission is to enable researchers to find cures faster, empower every clinician to be an expert, and help families make the most informed decisions about their care. Achieving Truveta’ s ambitious vision requires an incredible team of talented and inspired people with a special combination of health, software and big data experience who share our company values.

Truveta was born in the Pacific Northwest, but we have employees who live across the country. Our team enjoys the flexibility of a hybrid model and working from anywhere. In person attendance is required at least once per year for an onsite meeting. 

For overall team productivity, we optimize meeting hours in the pacific time zone. We avoid scheduling recurring meetings that start after 3pm PT, however, ad hoc meetings occur between 8am-6pm Pacific time. #LI-remote

Who We Need 

Truveta is rapidly building a talented and diverse team to tackle complex health and technical challenges. Beyond core capabilities, we are seeking problem solvers, passionate and collaborative teammates, and those willing to roll up their sleeves while making a difference. If you are interested in the opportunity to pursue purposeful work, join a mission-driven team, and build a rewarding career while having fun, Truveta may be the perfect fit for you.

This Opportunity

The analytics Rapid Response Team (RRT) sits within Truveta’s broader Partner Insights and Enablement team and plays a critical role in coordinating with internal teams and supporting customers to get fast, high-quality answers from Truveta data. As a Partner Data Analyst on the RRT team, you will help ensure customers find value in the data, supports issue investigation, and build confidence in the platform through efficient, responsive analytics. You will support data quality efforts, conduct analyses, answer customer questions, and support new data releases. You will be solving consequential problems in healthcare using an EHR database of ~100 million patients (and growing!) and make an impact on patient care. As a Partner Data Analyst, you will work at the intersection of EHR data knowledge and efficient data delivery. You’ll support feasibility analyses, quickly summarize patient populations, and assist in identifying and tracking data issues. This position is ideal for someone with hands-on experience working with EHR or healthcare data, strong data wrangling skills, and a passion for translating data into actionable insights.

Responsibilities

• Proven experience wrangling large healthcare datasets and translating clinical concepts into structured queries.
• Proficiency in SQL and at least one programming language (e.g., Python or R) for data analysis and pipeline development.
• Ability to work cross-functionally in a fast-paced, collaborative team environment.
• Comfort summarizing populations or generating feasibility numbers from clinical data quickly and accurately.
• Use technical skills to scope out customer analyses requests, produce studies and results using SQL, R and Python within an agreed upon deadline.
• Collaborate with life science, academic research organizations, and health system partners to conduct analyses.
• Collaborate with success managers and support team to ensure that Truveta partners can be successful with the platform.
• Required to excel in providing technical analytics support as well as directly working with customers on calls to troubleshooting code and platform questions.
• Work with customers to achieve their goals, teaching them how to wrangle and analyze data using SQL, R and Python on RWD to address their empirical questions.
• Collaborate closely with other Truveta teams to conduct investigations of data sources to demonstrate veracity to current customers.
• Deliver feedback to internal teams based on customer requests to inform Truveta’s product roadmap.

Required Skills

• Undergraduate or graduate level educational in clinical research, data analysis, clinical informatics or related field.
• Experience working with large relational database consisting of millions of patients' data.
• 2+ years of experience wrangling and analyzing Electronic Health Record data or other Real World Data sources in life science companies, CROs, other EHR data companies or healthcare using SQL, R and Python.
• Knowledge of clinical terminologies such as ICD, SNOMED, LOINC, NDC or RxNorm.
• Willingness to learn new coding languages including internal proprietary coding language to analyze data and build cohorts.
• Experience working with customers delivering high quality research analyses.
• Ability to learn and adapt quickly in a dynamic start-up environment.

Preferred Qualifications

These qualifications are preferred but not required, please do not let them stop you from applying for this role. You will likely get the opportunity to learn how to do these more advanced analyses if you don’t already have experience with them.  

• Experience working with unstructured clinical data or natural language processing outputs
• Spark/PySpark experience
• Regex query writing experience
• Experience building cohort definitions or eligibility criteria for research studies or trial design

Why Truveta?   

Be a part of building something special. Now is the perfect time to join Truveta. We have strong, established leadership with decades of success. We are well-funded. We are building a culture that prioritizes people and their passions across personal, professional and everything in between. Join us as we build an amazing company together.  

We Offer:

• Interesting and meaningful work for every career stage
• Great benefits package
• Comprehensive benefits with strong medical, dental and vision insurance plans
• 401K plan
• Professional development & training opportunities for continuous learning
• Work/life autonomy via flexible work hours and flexible paid time off
• Generous parental leave
• Regular team activities (virtual and in-person as soon as we are able)
• The base pay for this position is $94,000 to $120,000. The pay range reflects the minimum and maximum target. Pay is based on several factors including location and may vary depending on job-related knowledge, skills, and experience. Certain roles are eligible for additional compensation such as incentive pay and stock options.

If you are based in California, we encourage you to read this important information for California residents linked here.

Truveta is committed to creating a diverse, inclusive, and empowering workplace. We believe that having employees, interns, and contractors with diverse backgrounds enables Truveta to better meet our mission and serve patients and health communities around the world. We recognize that opportunities in technology historically excluded and continue to disproportionately exclude Black and Indigenous people, people of color, people from working class backgrounds, people with disabilities, and LGBTQIA+ people. We strongly encourage individuals with these identities to apply even if you don’t meet all of the requirements.

Please note that all applicants must be authorized to work in the United States for any employer as we are unable to sponsor work visas or permits (e.g. F-1 OPT, H1-B) at this time. We appreciate your interest in the position and encourage you to explore future opportunities with us.

The Clinical Trial Manager (CTM) is responsible for the oversight and management of all clinical operational activities at the trial and site level. The CTM will interact well with the Heartflow Clinical Research staff and collaborate effectively with Heartflow onsite and field staff, clinical research coordinators, principal investigators, and vendors to aid in ensuring clinical studies meet or exceed timelines and maintain high quality standards. The CTM will have demonstrated experience with clinical research study execution, exceptional organizational skills, excellent attention to detail, and will be comfortable working in a fast- paced start-up culture.

Job Responsibilities:

• Participates in clinical research activities including management of clinical study sites, management of study documentation, vendor management, and completion of project management tasks
• Develops clinical trial timelines, enrollment projections, and instructional materials in support of trial execution, including project, communication, monitoring, recruitment, risk mitigation, and contingency plans
• Participates in and leads process improvement activities within the department and cross functionally, including SOP development
• Conducts study start-up activities including the development of protocols, informed consent forms, source document worksheets, training presentations, etc.
• Reviews site regulatory documents (informed consents, IRB approvals, research agreements) to ensure compliance with study requirements and GCPs
• Maintains effective working relationships with investigators/investigational site research coordinators, and vendors including core labs and data management
• Perform other duties as required for successfully completing studies, as necessary

Skills Needed:

• Ability to work in a smaller team environment with a willing, all hands on deck attitude
• Ability to manage multiple tasks and be comfortable working in an environment with shifting priorities
• High attention to detail, accuracy, and quality and able to effectively prioritize multiple projects
• Knowledge of ICH Guidelines, US FDA, and European clinical trial requirements and regulations
• Excellent written and oral English communication skills required
• Proficiency in computer programs and specifically in Microsoft office tools including Word, Excel and PowerPoint

Educational Requirements & Work Experience:

• Bachelor’s degree in science or health related field
• Demonstrated 5 years minimum relevant experience required
• Experience in cardiovascular medical device clinical research a plus

Travel required: up to 25%

A reasonable estimate of the base salary compensation range is $110,000 to $150,000 (for San Francisco Bay Area) or $95,000 to $125,000 (for all other areas) and cash bonus. #LI-IB1

Role Overview 

The Senior Director, Clinical Operations is responsible for directing the strategy, management, and oversight of clinical program(s) and functional activities as assigned.  

Key Responsibilities 

• Acts as Clinical Operations program lead for assigned program(s) 
• Represent Clinical Operations at the Clinical Development Team and/or Global Program Team
• Develops and executes program operational strategy 
• Partners closely and effectively with other functions and functional heads to drive program forward 
• Provides strategic and technical recommendations to senior leadership 
• Directs the selection of CROs and other vendors (IxRS, Central Lab, ancillary/tech vendors) 
• Acts as an escalation point for CRO/vendor issues 
• Directs development of vendor Scopes of Work (SOW), scope changes, budgets, and vendor payments 
• Partners with CRO and other vendors to deliver on study execution 
• Creates and tracks clinical program budgets 
• Directs risk mitigation, escalation, and resolution activities both internally as well as with sites and vendors 
• Directs technical and strategic input into the development of clinical documents (protocols, monitoring plans, informed consent forms, investigator brochures, clinical study reports, etc.)  
• Builds relationships with clinical sites, vendors, and key stakeholders  
• Maintains understanding of external landscape and adjusts plans accordingly 
• Represents Clinical Operations in cross-functional activities as assigned 
• Plays a key role in the development and management of the Clinical Operations function; may act as a deputy for the Head of Clinical Operations as assigned 
• Hires, manages, coaches, and mentors staff 
• Contributes to building the organization 

Qualifications 

• Bachelor's degree in a related field required, an advanced degree is a plus 
• 17+ years of clinical research experience, including 10+ years of trial and/or program-level management within a biopharmaceutical company, and 3+ years of line management experience 
• Exceptional clinical trial & program management skills with a focus on strategic oversight of program execution on time and on budget 
• Extensive experience selecting and managing vendors, including CROs, labs, IxRS, EDC, and ancillary technology/applications (e.g. eDiaries, eConsent, apps, etc) 
• Thorough knowledge and understanding of FDA and ICH Guidelines, GCP, medical terminology, and clinical trials 
• Detailed understanding of all aspects of clinical protocol design, implementation, IND/BLA/NDA submissions, and overall drug development  
• Experience managing, coaching, and mentoring personnel 
• Excellent communication, organizational, negotiation, and interpersonal skills with a strong reputation for collaboration 
• Able to drive decisions forward in times of ambiguity or with incomplete information 
• Effective in promoting and maintaining productive internal and external relationships 
• Proven leadership and team building skills, along with success in proactive risk mitigation and problem solving 
• Flexible and creative to meet the needs and challenges of a growing, dynamic company 
• Demonstrated problem solving abilities 
• Proven ability to influence up, down, and across the organization 
• Strong financial acumen with outstanding track record of building budgets and managing expenses to budget 
• Study coordinator and/or site monitoring experience a plus 
• Thrives in a small company environment, where day-to-day duties go above and beyond this job description 
• May contribute to corporate activities, e.g. preparation for Board of Director meetings 

Position Location 

This is a remote role; periodic travel to team and company events is required. 

The anticipated salary range for candidates for this role is $255,000 – $280,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. 

As part of the I-9 verification of authorization to work in the United States, Jade Bioscience participates in E-Verify. To learn more about E-Verify please review this poster. 

Jade Biosciences is proud to be an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. 

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. 

Role Overview 

We are seeking a Director of Clinical Supply Chain to lead end-to-end clinical supply execution for a global late-stage clinical trial. This role will have full ownership of clinical supply strategy and execution, from demand forecasting through distribution, for programs involving prefilled syringes (PFS) and autoinjectors. The successful candidate will be comfortable operating within a fast-paced environment and partnering closely with Clinical Operations, Quality, CMC, and external vendors to ensure uninterrupted drug supply for our studies. This is a great opportunity to own a critical late-stage program with real patient impact and to have the ability to shape clinical supply strategy during a pivotal stage of the company’s evolution.

Key Responsibilities 

Clinical Supply Strategy & Execution

• Own the global clinical supply strategy for late-stage programs, including demand forecasting, inventory management, and risk mitigation.
• Develop and maintain integrated supply plans aligned with enrollment forecasts, dosing schedules, and protocol amendments.
• Ensure seamless transition and continuity of drug supply.

Drug Product Development

• Lead clinical supply activities for vials, prefilled syringes (PFS), and autoinjectors, including:
• Device assembly and packaging considerations
• Cold-chain (2–8°C) requirements
• Labeling, blinding, and re-supply strategies
• Partner with CMC and device vendors to support lifecycle changes, comparability, and scale-up impacts to clinical supply.

Vendor & Depot Management

• Manage external partners including:
• Packaging and labeling vendors
• Global depots and regional distribution hubs
• Couriers and specialty logistics providers, as appropriate
• Lead vendor selection, SOWs, budgets, timelines, and performance oversight.
• Ensure qualified shippers, temperature monitoring, excursion management, and deviation handling are done in a compliant manner.

Distribution & Regulatory Compliance

• Oversee global distribution across multiple regions, ensuring:
• Country-specific import/export requirements
• QP release and EU clinical supply compliance where applicable
• Ensure inspection-ready documentation and robust supply chain traceability.

Cross-Functional Leadership

• Serve as the clinical supply chain lead on cross-functional study teams.
• Partner closely with:
• Clinical Operations on enrollment and site strategy
• Quality on GMP/GDP compliance and deviations
• Regulatory and CMC on changes impacting supply
• Communicate risks, mitigations, and trade-offs clearly to senior leadership.

Qualifications 

• Bachelor’s degree and 15 years of experience or a master’s degree with 12+ years of experience
• 10+ years of experience in clinical supply chain / clinical supply operations.
• Direct experience managing Phase 3 clinical trials, including global distribution.
• Hands-on experience with prefilled syringes (PFS) and/or autoinjectors in a clinical trial setting.
• Demonstrated ownership of:
• Forecasting and supply planning
• Packaging, labeling, and distribution
• Vendor and depot management
• Strong understanding of GMP/GDP, ICH-GCP, and global clinical supply requirements.
• Cold-chain biologics experience (2–8°C).
• Experience transitioning programs toward commercial readiness.
• Demonstrated ability to balance strategy and execution.
• An ownership mindset, ability to anticipate risk and solve problems proactively.
• Clear communication skills and the ability to translate supply complexity into actionable decisions.

Position Location 

This is a remote role; periodic travel to team and company events is required. 

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. 

Role Overview 

The Associate Director, Quality Control will lead critical Quality Control functions to support Jade’s product pipeline across various stages of development. The Associate Director will manage analytical method life cycle including method development, qualification, transfer and validation as phase appropriate. This individual will work very closely with internal stakeholders and external CDMO partners and will be responsible for developing and executing product release testing, stability study and product shelf-life management strategy whileensuring full quality compliance with regulatory requirements and internal quality systems.

Key Responsibilities 

• Work with both internal (Manufacturing, Quality Assurance, Regulatory and other key stakeholders) and external CDMO partners to develop and implement QC strategies appropriate for different phases of development programs
• Oversee analytical method development, qualification, transfer and validation activities at and cross CDMOs

• Develop product specifications and oversee product in-process, release, and stability testing strategy and execution in compliance with both cGMP and ICH guidance and internal quality standard
• Work with Quality Assurance to create and manage QC documentation including SOPs, protocols, and technical reports
• Collaborate cross-functionally with Manufacturing, QA, Regulatory, and R&D to support tech transfers and lifecycle management, regulatory filing and interactions etc.
• Manage CDMO relationships to ensure compliance with quality standards, timely deliverables, and effective communication
• Review and approve CDMO generated data, investigations, and documentation
• Ensure timely investigation and resolution of OOS results, deviations, and CAPAs
• Serve as QC subject matter expert during regulatory inspections and audits

Qualifications 

• Master’s or advanced degree in Chemistry, Biology, Biochemistry, or related field with 10+ years of related experience (7+ years of experience with PhD)

• 8+ years of experience in Quality Control management within the biotech or pharmaceutical industry
• A strong quality compliance and collaborative mindset, and ability to thrive in a fast-paced working environment
• Strong knowledge of cGMP, FDA, EMA, and ICH regulations
• Strong experience in analytical method life cycle management including phase appropriate method qualification, transfer and validations from early to late phase development including BLA filing
• Experience with common analytical techniques such as HPLC/UPLC, CE-SDS, ELISA, and cell-based assays for biologics development
• Proven leadership in managing internal QC operations or external CDMOs  
• Excellent communication, organizational, and problem-solving skills

Position Location 

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

The anticipated salary range for candidates for this role is $170,000 - $190,000. The final salary offered will depend on several factors, which may include, but not limited to, relevant years of experience, educational background, and geography. 

Role Overview 

The Associate Director, Clinical Site Budgets & Payments will architect and lead the company’s global approach to clinical trial site budgeting, investigator grant strategy, transparency compliance, and site/vendor payment governance across our clinical trial portfolio. This leader will define Jade’s global investigator grant philosophy, including structured opening offer and negotiation parameters that ensure speed, fairness, and alignment with global FMV benchmarks.  They will establish standards for invoiceables, conditional procedures, pass‑through costs, and country‑specific budgeting norms that apply across all Jade clinical studies.

This role oversees a full‑service CRO partner responsible for operational execution of budgets, payments, reconciliation, and study financial controls. It also builds and maintains global site budget forecasts, ensures just‑in‑time CRO funding, and supports accruals, reconciliation, and inspection‑readiness.

The successful candidate must be equally fluent in clinical trial protocols and financial statements, highly skilled in influencing cross‑functional and vendor partners, and able to uphold strict compliance with FMV and Sunshine/Open Payments regulations. This is a high‑visibility, individual‑contributor role reporting directly to the Executive Director, Development Outsourcing and operating globally across all Jade studies. The position is remote, with domestic travel up to four times per year.

Key Responsibilities 

Global Payment Philosophy, Compliance & Governance

• Define Jade’s global investigator grant strategy, including opening‑offer tiers, decision and negotiation parameters, aligned with international FMV standards.
• Establish and maintain policies for invoiceables, pass‑throughs, conditional procedures, screen‑fail handling, and complex visit structures; ensure global consistency.
• Develop and maintain SOPs/WIs governing budgeting, payments, documentation, and global transparency requirements (e.g., U.S. Sunshine/Open Payments and ex‑US equivalents).
• Define FMV justification expectations and ensure audit‑ready documentation across all investigator/HCP engagements.

Study‑Level Budget Design & Financial Oversight

• Translate clinical protocols into country‑specific and site‑level cost models that accurately reflect procedures, visit schedules, and conditional events.
• Build and maintain global study budget forecasts, partnering closely with Clinical Operations and Finance to ensure alignment with development plans.
• Implement and monitor just‑in‑time CRO funding, minimizing idle cash at CROs while ensuring on‑time site payments.
• Oversee accruals, spend tracking, payment reconciliation, and close‑out documentation for accuracy and inspection readiness.

CRO Governance & Issue Escalation

• Serve as Jade’s primary owner of CRO performance for site budgets and payments, including contract expectations, KPIs, and service delivery standards.
• Lead the payment‑related components of CRO governance forums, including issue resolution, aging analysis, cycle‑time performance reviews, and payment forecasting.
• Resolve escalated site payment issues, driving sustainable root‑cause solutions and process improvements.

HCP/KOL Payment Operations (“White‑Glove” Model)

• Implement a high‑touch service model for KOL/HCP payments (consulting, advisory boards, speaking engagements), ensuring accuracy, speed, and FMV alignment.
• Streamline administrative burden for external experts by simplifying processes, documentation, and support.

Cross‑Functional Leadership & Decision Support

• Partner closely with Clinical Operations, Development Outsourcing, Legal, Compliance, and Finance to ensure budgets and payments reflect protocol intent, operational realities, and compliance needs.
• Provide executive‑level visibility into performance metrics such as payment timeliness, disputes, forecast accuracy, and CRO funding utilization.
• Serve as Jade’s internal subject‑matter expert for investigator/HCP budgeting and payment strategy across a global two‑program portfolio in Autoimmune disease.

Qualifications 

• Bachelor’s degree in finance, life sciences, business, or related field with 13+ years of experience or an advanced degree (MBA, MS, MPH) with 10+ years of experience.
• 10+ years of relevant experience in biotech/pharma or CRO roles with direct responsibility for site budgeting and payment oversight
• Demonstrated ability to interpret clinical protocols and convert them into robust, compliant global site budgets
• Strong understanding of global FMV frameworks and Sunshine/Open Payments transparency requirements.
• Proven experience governing a full service CRO, including KPI management, escalation handling, and process improvement.
• Ability to analyze financial statements, accruals, and cash flow impacts.
• Excellent communication, negotiation, and cross functional influence.
• Experience supporting Autoimmune or immune mediated diseases preferred.
• Experience managing global payment models across diverse regulatory environments preferred.
• Exposure to KOL/HCP engagement processes with FMV and transparency considerations preferred.

Position Location 

This is a remote role; periodic travel to team and company events is required. 

The anticipated salary range for candidates for this role is $170,000 - $190,000. The final salary offered will depend on several factors, which may include, but not limited to, relevant years of experience, educational background, and geography. 

POSITION SUMMARY

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

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

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

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

CORE ACCOUNTABILITIES

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

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

Technical Oversight & Data Quality

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

Cross Functional Collaboration

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

Process & Systems Ownership

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

The successful candidate will have:

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

Preferred Qualifications:

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

Physical Requirements

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

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

POSITION SUMMARY

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

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

CORE ACCOUNTABILITIES

Specific responsibilities include:  

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

 The successful candidate will have:

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

Physical Requirements:  

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

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

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

Role Overview 

The Executive Director, Clinical Quality Assurance (CQA) will be responsible for all aspects of Quality Assurance focused on Good Clinical Practice (GCP), Good Pharmacovigilance Practices (GPvP) and Good Laboratory Practices (GLP) activities to ensure quality assurance and compliance of Jade sponsored clinical trials with applicable regulations, ICH guidelines, OECD Principles of GLP, Jade procedures and policies, and current industry standards and practices.

The Executive Director, Clinical Quality Assurance will perform day-to-day clinical quality operations and compliance activities to support the success of our clinical programs in addition to being a strategic partner to Clinical Development and Operations. This role will maintain and ensure effectiveness of quality programs and documentation to assure compliance and inspection readiness with all applicable quality requirements and regulatory standards. The ideal candidate brings hands-on expertise in GCP, GPvP and GLP QA operations, a proactive approach to problem-solving, and the ability to guide and influence cross-functional teams while upholding the highest standards of quality and compliance.

Key Responsibilities

• Provide hands on clinical QA oversight and review of protocols, Informed Consent Forms (ICFs), Clinical Study Reports (CSRs), and other clinical trial specific documents.
• Provide coaching, Quality decisions and be Quality approver to study teams on protocol deviations, vendor oversight, CAPAs, and issue management.
• Act as the primary GCP/GPvP/GLP QA subject matter expert and point of contact for all related matters and issues.
• Represent Quality on project teams, service providers and CROs operational meetings, and QA to QA meetings.
• Oversee ongoing clinical programs to ensure they are risk‑based, fit‑for‑purpose and in compliance with applicable regulations and guidelines across all phases of development.
• Review and approve (as appropriate) procedures, service provider quality agreements, qualification and onboarding forms and regulatory filings.
• Develop, implement and execute a risk-based audit strategy and detailed plans for clinical and non-clinical studies.
• Establish and maintain GCP/GPvP/GLP QA programs, policies and procedures.
• Work collaboratively with the internal Clinical Operations Team and Development Teams to provide leadership and guidance to support study execution, data integrity, and regulatory compliance.
• Identify and assess compliance risk and develop and implement risk mitigation measures.Lead the identification, investigation (root cause analysis), and resolution of quality issues through a robust investigation and CAPA process.
• Contribute to building a strong quality culture within the organization.
• Ensure the timely and effective follow up of all identified or assigned quality issues.
• Direct and/or deliver yearly training for internal staff as needed.
• Work closely with Development, Clinical Operations, and other functions/departments to drive inspection readiness and support regulatory interactions.
• Champion continuous improvement and simplification across clinical quality systems.
• Prepare KPIs, metrics and analysis and present status updates as needed.
• Provide leadership in inspection preparedness to clinical sites and service providers for regulatory government agencies.
• Stay current on global regulations, industry trends, and best practices to ensure continuous improvement and innovation within the QA function.
• Apply risk‑based thinking to identify the quality activities that meaningfully influence study outcomes, rather than defaulting to checklists or bureaucracy.
• Understand when to escalate, when to intervene, and when to let teams move forward without over engineering processes.
• Provide clear, concise guidance that helps teams stay focused, aligned, and inspection ready.

Qualifications 

• Bachelors + 17 or Masters + 15 or PhD + 10 years of related experience Extensive expertise in GCP, GPvP, GLP and ICH clinical requirements, clinical development and methodologies of clinical studies.
• Successful track record of translation and implementation of clinical requirements into operational execution.
• Extensive knowledge of FDA regulations and practices, ICH guidance, and strong knowledge of global health authority regulations and practices.
• A successful track record of working with service providers and CROs.
• Ability to make timely and sound quality decisions when faced with complex clinical, compliance, technical and regulatory considerations. Highly skilled in the ability to work with ambiguity and complexity.
• Ability to tactically and strategically execute the day-to-day operations to support clinical trials and clinical and non-clinical development activities. 
• Knowledge of Quality Management Systems; experience in building, implementing and managing quality systems in the pharmaceutical industry.
• Expertise in reviewing, revising, and writing Standard Operating Procedures (SOPs).
• Effective communication skills (verbal and written) for interactions across functional areas and for interactions with key regulatory agencies.
• Strong organizational skills and the ability to participate effectively cross-functionally.
• A self-starter and a team player who thrives in a fast-paced dynamic team environment.
• Ability to work with minimal supervision, to set priorities to meet timelines, and to motivate and influence others. Prior management experience is required.
• Previous experience in successfully leading assigned activities within cross-functional teams.
• Proficiency in using SharePoint, Veeva and Microsoft Office applications required (MS Outlook, MS Word, MS Excel, MS PowerPoint).

Position Location 

This is a remote role; periodic travel to team and company events is required. 

The anticipated salary range for candidates for this role is $265,000 - $300,000. The final salary offered will depend on several factors, which may include, but not limited to, relevant years of experience, educational background, and geography. 

About the role: We are hiring frontline sales professionals to be part of a diverse and elite biopharma sales team dedicated to helping patients in need. With a laser focus on the eye care customer, the Territory Leader will be responsible for territory disease state education along with the launch and ongoing growth of XDEMVY. They will deliver high standards for the ongoing launch and beyond and will champion a culture of outstanding performance, compliance and full ownership of all activity and results. The Territory Leader will be experts in account management, business ownership, sales execution, resource utilization, and they will build and foster relationships with key eye care customers. The Territory Leader will relentlessly pursue excellence to maximize sales in their territory while learning to adapt to changes and needs of the business. In doing so, they will have the unique opportunity to meaningfully contribute to the growth and performance of Tarsus. This critical sales role will be ideal for someone who thinks strategically, operates with tactical precision and strives for excellence.

Geography: Candidates must live in Seattle, Tacoma, or Alaska.

Let’s talk about some of the key responsibilities of the role:

Account Management & Eye Care Experts

• Experts in eye care clinical information: anatomy, disease state, products, XDEMVY and office treatment patterns
• Experts in selling skills and account development including building relationships with all key stakeholders
• Experts in pull through tactics with a full understanding of managed care hurdles
• Understand all functions within an ophthalmology/optometry practice and how their roles impact product prescribing and pull through
• Maximize managed care opportunities within the territory and have an understanding of how it impacts the District, Region and Nation and share important feedback
• Understand key opinion leaders within respective geographies and foster engagement with Tarsus leadership
• As eye care experts, champion compliant promotion in alignment with our corporate values

Business Acumen & Sales Execution

• Drive top tier execution by exceeding sales performance goals and key productivity metrics across the territory
• Use expert analytical skills to guide highly productive activity – prioritize key customer engagements, drive reach and frequency to extend depth and breadth of product trial and utilization
• Drive a successful launch and ongoing performance by monitoring all key performance metrics weekly, monthly, quarterly, and annually – ability to adjust approach as needed based on data
• Ensure actionable business plans are set - align all selling activities to drive impact
• Share ongoing insights with leadership and internal stakeholders to ensure feedback is captured
• Personal accountability for driving the highest standards of ethics and compliance

Business Owners & Culture Champions

• Drive our culture of commitment, empowerment and teamwork which includes extreme ownership, high accountability, continuous improvement and relentless pursuit of excellence
• Achieve success and be prepared to adapt in a complex selling environment partnering with many stakeholders: district leaders, marketing, market access, medical affairs, sales ops, inside sales, training, and other important stakeholders
• Provide frontline feedback and intel to sales leadership and the broader organization
• Ensure PDMA compliance and adhere to all company & industry compliance guidelines
• Share ongoing best practices among peers and leadership to elevate national performance
• Maximize all key resources that lead to territory success

Factors for Success:

• Bachelor’s degree in business, science, or related field or commensurate experience
• 2+ years pharmaceutical sales / relevant healthcare sales experience or a proven track record of business to business sales - required
  • Proven track record of pharmaceutical launch experience - strongly preferred
  • Eye Care experience- preferred
• Established track record with evidence of excellent problem solving and collaboration
• Highly adaptable to change, able to quickly pivot and respond given new market information in a fast-paced environment
• Strong communication and change management skills
• Proven ability to escalate difficult issues and make tough decisions
• Established track record in the following job competencies:
  • Selling skills
  • High performance
  • Impact & influence
  • Customer focus & account management
  • Maximizing resources
  • Analytical skills
  • Relationship building
  • Decision making & judgment
  • Teamwork & collaboration
  • Adaptability & GRIT

A Few Other Details Worth Mentioning:

• This is a field-based position reporting to the District Sales Leader
• Geography: Candidates must live in Seattle, Tacoma, or Alaska.
• Travel will be required within the selling geography and beyond to sales meetings, possibly across various customer conventions and occasional travel to HQ in Irvine CA
• 40% - 50% travel required in some larger geographies
• Territory Leader Salary Range;

• • Associate Territory Leader – 2+ years proven B2B selling - $110,000
  • Territory Leader – 1-2 years pharma selling - $123,000
  • Territory Leader – 2-5 years pharma selling - $139,000
  • Sr. Territory Leader – 5-8 years pharma selling - $145,000
  • Sr. Territory Leader – 8+ years pharma selling - $161,000

At Tarsus, we understand the importance of attracting and retaining top talent. In addition to a competitive base pay, we offer an incentive bonus, stock equity, and comprehensive benefits. The base pay range reflects the target range for this position, but individual pay will be determined by additional factors such as job-related skills, experience and relevant education or training. Our benefits include health, dental and vision insurance benefits to ensure your well-being. We believe in work-life balance and offer generous paid time off, including vacation, holidays, and personal days. For more details regarding Tarsus benefits, please visit: https://eb.alliant.com/26tarsusbenefitssnapshot. 

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