Position Overview

The Senior Clinical Data Manager (Sr. CDM) is responsible for leading end-to-end data management activities across one or more complex clinical trials. This role ensures high-quality, reliable clinical data that meets regulatory standards and supports timely clinical development decisions. The ideal candidate is a proactive problem solver with experience in data standards, EDC systems, and cross-functional collaboration. 

Responsibilities

Study Planning & Start-Up 

• Serve as the data management lead for assigned clinical studies, providing strategic input into protocol design and data collection strategy. 

• Develop and manage Data Management Plans (DMPs), CRF/ eCRF specifications, edit check specifications, and data validation plans. 

• Lead EDC system set-up, UAT, and deployment; coordinate with external vendors and internal biometrics teams. 

Execution & Oversight 

• Oversee all data review activities, including query management, data cleaning, discrepancy resolution, and ongoing data quality monitoring. 

• Ensure adherence to CDISC/CDASH/SDTM standards where appropriate, as well as applicable regulatory requirements (ICH-GCP, FDA, EMA). 

• Track study metrics, identifying risks and implementing mitigation strategies to maintain high-quality and timely deliverables. 

• Manage interactions with CROs, central labs, imaging vendors, and other data contributors. 

Close-Out & Reporting 

• Lead database lock activities, ensuring audit readiness and complete documentation. 

• Support statistical programming and medical writing teams in delivering data for interim analyses, CSR outputs, and regulatory filings. 

• Contribute to process improvements and knowledge sharing within the data management function. 

Qualifications

• Bachelor’s degree in relevant field 

• A minimum of 5 years of Clinical Data Management experience in the biotech/pharma industry. Oncology experience is strongly preferred.  

Knowledge and Skills

• Demonstrated expertise with EDC systems (e.g., Medidata Rave, Oracle InForm, Veeva CDMS). 

• Understanding of clinical trial methodology, regulations, and data standards. 

• Experience leading data management activities for Phase I–III global clinical trials. 

• Vendor oversight experience and ability to drive cross-functional alignment. 

• Knowledge of FDA, ICH-GCP, and 21 CFR Part 11 compliance. 

• Excellent communication, documentation, and project management skills. 

Position Overview

The Senior EDC (Electronic Data Capture) Programmer (Sr. EDCP) is responsible for leading the design, development, and maintenance of clinical trial databases in an EDC system. This role will work closely with Clinical Data Management, Biostatistics, Clinical Operations, and external vendors to ensure high-quality, compliant data collection systems that support efficient trial execution. 

Responsibilities

• Lead the design, build, validation, and deployment of a study build within an EDC system. 

• Develop and maintain edit checks, custom functions, derivations, and integrations. 

• Review study protocols and provide input on CRF design and database structure. 

• Collaborate with Data Management to ensure alignment with data standards (CDISC, SDTM where applicable). 

• Perform User Acceptance Testing (UAT) and support database releases and migrations. 

• Ensure EDC systems comply with regulatory requirements (FDA, ICH-GCP, 21 CFR Part 11). 

• Troubleshoot and resolve database issues in a timely manner. 

• Oversee and/or mentor junior programmers or external vendors. 

• Contribute to SOP development and process improvements. 

• Support data integrations with external systems (IRT, ePRO, labs, etc.). 

• Maintain documentation including specifications, validation records, and audit trails. 

Qualifications

• Bachelor’s degree in relevant field. 

• A minimum of 5 years of EDC programming experience in the biotech/pharma industry. Oncology experience is preferred.  

Knowledge and Skills

• Strong hands-on experience with at least one major EDC platform (Medidata Rave preferred). 

• Solid understanding of clinical trial processes and data flow. 

• Experience with CDISC standards (SDTM, CDASH) is preferred. 

• Familiarity with regulatory requirements (ICH-GCP, 21 CFR Part 11). 

• Strong problem-solving skills and attention to detail. 

• Ability to manage multiple studies and priorities. 

Legend Biotech is seeking a Sr. Medical Science Liaison as part of the Medical Affairs team based Remotely in the Mid Atlantic Territory.

Role Overview

The Senior Medical Science Liaison (MSL) is a field‑based scientific expert within U.S. Medical Affairs, responsible for fostering credible, compliant, and non‑promotional scientific exchange with healthcare professionals (HCPs), investigators, and other external stakeholders in hematology/oncology.

This role serves as a key scientific partner across academic and community settings, supporting Legend Biotech’s marketed and pipeline assets through evidence‑based dialogue, clinical trial support, medical education, and generation of actionable medical insights. The Senior MSL operates with a high degree of autonomy, contributes to territory and national medical strategy execution, and may mentor or support the development of junior MSL colleagues.

Key Responsibilities

Scientific Engagement & External Partnerships

• Develop and maintain long‑term, peer‑to‑peer scientific relationships with key opinion leaders (KOLs), investigators, and other relevant healthcare stakeholders within the assigned territory.
• Deliver fair‑balanced, scientifically rigorous medical information in response to unsolicited requests, consistent with PhRMA Code, FDA regulations, and company SOPs.
• Serve as a trusted scientific resource on disease state, mechanism of action, clinical data, and emerging evidence related to Legend Biotech and relevant competitive landscapes.

Clinical Research & Development Support

• Act as the primary field‑based medical contact for investigators and research staff involved in company‑sponsored and investigator‑initiated studies.
• Support clinical trial feasibility, site identification, site initiation, and enrollment discussions in collaboration with Clinical Development and Clinical Operations.
• Provide education and support related to protocol concepts, safety reporting, and adverse event (AE) management, as appropriate and compliant.

Medical Strategy Execution & Insights

• Execute Medical Affairs strategies and tactics at the territory level in alignment with national medical plans.
• Collect, synthesize, and communicate high‑quality medical insights related to clinical practice, unmet needs, treatment paradigms, and competitive intelligence.
• Translate field insights into actionable recommendations for internal stakeholders to inform medical, clinical, and research strategies.

Scientific Exchange & Medical Education

• Support and participate in scientific congresses, symposia, advisory boards, and investigator meetings.
• Interpret scientific data presented at meetings and communicate key findings, trends, and implications to cross‑functional partners.
• Contribute to the development and continuous improvement of medical resources, training materials, and scientific content.

Cross‑Functional Collaboration & Leadership

• Collaborate effectively with internal partners including Medical Affairs, Clinical Development, Commercial (as appropriate), Regulatory, and strategic alliance teams while maintaining appropriate medical independence.
• Collaborate with alliance partners on field-based strategies and tactics
• Mentor and provide informal leadership support to newly hired or less experienced MSLs, as needed.
• Demonstrate strong judgment, adaptability, and professionalism in complex and evolving environments.

Compliance & Operational Excellence

• Adhere to all company policies, SOPs, and external regulations, including PhRMA Code, FDA guidance, and internal compliance standards.
• Maintain accurate and timely documentation of field activities, insights, and metrics using approved systems and tools.
• Manage territory operations effectively, including planning, prioritization, and travel logistics.

Requirements

• Advanced terminal degree (PharmD, PhD, MD, DO) or other advanced clinical degree (e.g., NP, PA) with relevant clinical experience.
• Minimum of 3-5 years of Medical Science Liaison experience in a therapeutic area aligned with hematology/oncology, immunology or CAR-T therapy; or 3-5 years of hematology/oncology clinical experience.
• Strong foundational knowledge of clinical research, trial design, and drug development processes.
• Demonstrated ability to engage in high‑level scientific exchange with expert clinicians and researchers.
• Excellent verbal, written, and presentation skills, with the ability to communicate complex scientific concepts clearly.
• Proven ability to work independently while collaborating effectively in a matrix organization.
• Valid U.S. driver’s license and ability to travel extensively, including overnight and occasional weekend travel.
• Residence within the assigned territory or within reasonable commuting distance.
• Core Competencies:
  • Scientific and Clinical Acumen
  • Strategic Thinking and Problem Solving
  • Insight Generation and Communication
  • Stakeholder Relationship Management
  • Emotional Intelligence and Professional Presence
  • Adaptability and Change Management
  • Compliance Mindset and Ethical Judgment
  • Digital and Technical Proficiency

#Li-JK1

#Li-Remote

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

Science 37’s Nursing Solutions Group brings together expert nurses who share a passion for organizing, planning and implementing mobile clinical nurse services to participants in clinical trials. Science 37’s extraordinary work environment allows continuous collaboration between clinicians, clinical researchers, patient recruitment specialists, data managers and technology developers. The Nursing Solutions Group is involved throughout the trial life cycle, from protocol development and feasibility analysis to clinical trial implementation and closeout.

The Per Diem Mobile Research Nurse is a Registered Nurse who will work per diem and has experience across multiple therapeutic areas with the ability to work independently and integrate well with the Nursing Solutions Group. With interest/expertise in Science 37’s decentralized model of care delivery, the Mobile Research Nurse will perform delivery of care to participants as well as collaborate with brick and mortar sites, if indicated, for shared clinical trial implementation. The Mobile Research Nurse ensures the professional delivery of patient care in compliance with all federal and state regulations, Good Clinical Practice, and Standard Operating Procedures. 

*This is a travel role that requires on-site visits to participants homes.

Duties for this position include but are not limited to:

1. Participate and provide research nurse services to qualified study participants at home
2. Apply clinical research and nursing practices to develop solutions to complex problems
3. Collaborate with Lead and Per Diem Mobile Research Nurses on solutioning, education, and resource support
4. Participate in activities that will further the operational development of Science 37 nursing service delivery
5. Develop relationships with study team members and serve as the subject matter expert (SME) on all nursing processes
6. Other duties as assigned as the needs of Science 37 evolve and change

This position has the following qualifications:

1. BSN degree preferred
2. Full Covid Vaccination strongly preferred. Science 37 follows CDC guidelines for vaccination recommendations and such guidelines are subject to change.
3. Active RN licensure in home state as well as eligibility for Compact Licensure required
4. Minimum 2+ years clinical/research experience preferred
5. Basic Life Support (BLS) Certification
6. Maintain a positive reflection of the company by representation in participant’s homes or in clinic settings
7. Travel and availability qualifications are as follows:
   1. 1-2 days minimum a week dedicated to support Science 37's study visits
      1. Weekday/night availability required
   2. Must be willing to travel to a participants homes 
   3. Active Driver’s License

Science 37 is looking for people with the following skills and competencies:

1. BSN degree preferred
2. Active RN licensure in home state as well as eligibility for Compact Licensure required
3. Minimum 2+ years clinical/research experience preferred
4. Basic Life Support (BLS) Certification
5. Active Driver’s License
6. Weekday/night availability required
7. Maintain a positive reflection of the company by representation in participant’s homes or in clinic settings
8. Up to 100% travel, as needed, for study participant visits, project team meetings, and other professional meetings/conferences as needed
9. Occasional Travel to NYC may be required for visits
10. Ability to obtain nursing license in multiple states based on study needs
11. Physical ability to perform nursing tasks and lift equipment up to 15 kg in weight
12. Access to a reliable vehicle to perform study participant visits and transport equipment
13. Ability to drive to local and/or remote locations to perform study participant visits
14. Ability to use technology effectively and appropriately for study participant assessments and documentation including but not limited to study participant care equipment, laptop computers, communication devices and tablets
15. Ability to communicate in English (both verbal and written)

There is minimal supervision for this position, with individuals reporting to the Manager, Nursing Solutions Group.

Compensation varies based on location and work being performed. The starting pay range for a candidate selected for this position is generally within the range of $50-55 per hour. Employees may be eligible for additional discretionary bonuses and commissions. The successful candidate’s actual pay will also be based on qualifications and experience, so the actual starting pay may be above or below this range.

Science 37 is an equal opportunity employer.  

We are committed to creating a diverse environment and is an equal opportunity employer. All qualified applicants receive consideration for employment without regard to age, race, ethnicity (including but not limited to hair texture and protected hairstyles), ancestry, color, sex, national origin, sexual orientation, gender, gender identity, gender expression, transgender status, religious creed, physical or mental disability (including actual or perceived disability), medical condition (including HIV/AIDS), pregnancy, perceived pregnancy and pregnancy related conditions, genetic information, marital status, political affiliation or activities, status as a victim of domestic violence, assault, or stalking, veteran status or participation in the uniformed military services of the United States, including the National Guard, or any other basis prohibited by applicable law.

Science 37 values the well-being of its employees and aims to provide team members with everything they need to succeed. 

Submit your resume to apply!

POSITION SUMMARY

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

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

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

CORE ACCOUNTABILITIES

Specific responsibilities include:  

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

The successful candidate will have:

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

Preferred Qualifications:  

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

Physical Requirements:  

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

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

POSITION SUMMARY

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

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

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

CORE ACCOUNTABILITIES

Specific responsibilities include:  

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

The successful candidate will have:

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

Preferred Qualifications:  

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

Physical Requirements:  

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

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

Position Overview

The Director, Supply Operations will lead and develop Immunome’s Supply Operations function.  This role is accountable for ensuring efficient, compliant, and uninterrupted supply of clinical and commercial packaged products.  This is a highly visible role that will help shape Product Supply infrastructure, external partner networks, operational and business processes critical to Immunome’s growing pipeline and commercial success. 

Responsibilities

• Develop and oversee a high-performing team of supply operations professionals. Maintain a positive and inclusive environment where staff are motivated, empowered, and challenged.        

• Accountable for the successful planning and execution of clinical and commercial labeling and packaging operations.   

• Own business relationship with relevant external suppliers. Develop and implement metrics and KPIs to measure performance. Ensure supplier performance is routinely reviewed via formal business review meetings and periodic executive steering committee meetings.   

• Actively engage with Planning, Commercial, Clinical Development, and Regulatory to understand evolving commercial supply and clinical study plans.   

• Monitor drug inventory levels across distribution depots and trial sites, working closely with the Planning team to ensure supply plans are appropriately adjusted as needed.   

• Advise cross-functional teams on optimal supply strategy, associated timelines, and risks.  Ensure plans are communicated and integrated into program timelines.  

• Design, develop, and implement business processes and cGMP procedures encompassing but not limited to labeling and packaging operations, comparator and co-medication sourcing, returns and reconciliation.  

• Support department leadership and Finance team to develop budgets and performance targets, ensure spending is accurately tracked and variances are communicated proactively.  

• Support the development and implementation of supply management tools for use in day-to-day operations. Support the design and implementation of systems including ERP, Serialization, IRT, etc.  

• With a continuous-improvement mindset, seek opportunities to evolve processes and systems to increase compliance and efficiency.    

• Partner with Quality to ensure efficient documentation reviews pre- and post-production and support QP release requirements where required.   

• Manage Quality systems work, including training, change controls, investigations, corrective and preventive actions.   

Qualifications

• Bachelor’s or advanced degree in Supply Chain Management, Biotechnology, or related field.  

• APICS or ISM certification is preferred.    

• Minimum of 12 years of biopharmaceutical industry experience in supply chain roles, supporting both clinical and commercial product supply.  

• Minimum of 8 years of supervisory experience.  

• Position will require domestic and international travel (up to 20%) and occasional evening and/or weekend commitment.  

Knowledge and Skills

• Excellent cross-functional collaboration, communication, and influencing skills.  

• Strong business acumen, including budgeting, forecasting, and contract negotiation.  

• Demonstrated ability to lead through ambiguity and scale operations in a dynamic environment.  

• Experience with both sterile injectables and oral dosage forms is desired.  

• Strong understanding of clinical and commercial supply and distribution models and frameworks.    

• Demonstrated experience supporting commercial product launches.  

• Thorough understanding of regulations applying to supply chain activities, including cGMP, GCP, GDP, and computer systems/Part11 compliance.     

• Thorough understanding of clinical and commercial labeling and packaging requirements, planning, and execution.   

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

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 Overview

Immunome is seeking a highly organized, proactive, and detail-oriented Contracts Manager to join its legal team. This role is ideal for a legal professional who excels at managing contract lifecycles while also being able to provide broader support across corporate, transactional, and compliance functions. The ideal candidate will have experience in the biotech or pharmaceutical industries and be comfortable supporting cross-functional teams in a fast-paced, dynamic environment.

Responsibilities 

Contracts Management

• Serve as the primary administrator for the company’s contract lifecycle management (CLM) system (e.g., Ironclad), including contract intake, routing, tracking, and archiving.
• Draft, review, and coordinate the execution of standard agreements, including NDAs, consulting agreements, SOWs, CTAs, MTAs, and vendor agreements.
• Identify and assess legal and business risks and escalate as necessary. 
• Ensure all contractual activities comply with internal policies, applicable laws and regulations, and industry best practices. 
• Maintain accurate records of contract status, key terms, and renewal/termination dates.
• Collaborate with internal stakeholders (R&D, Finance, Clinical) to ensure timely and compliant contract processing, including renewal or cancellation of existing contracts.
• Assist with improving and maintaining contract templates, playbooks, and process workflows.

Qualifications

• Bachelor’s degree required. Paralegal certificate or JD, strongly preferred.
• A minimum of 5 years of contracts management experience, biotechnology or life sciences industry experience is required.

Knowledge and Skills

• Deep understanding of contract structures, terms, and risk assessment.
• Proficiency with contract lifecycle management tools (e.g., Ironclad, ContractWorks).
• Exceptional organizational and time management skills.
• Ability to manage multiple priorities and deadlines.
• Strong interpersonal, communication, and client service skills; capable of working collaboratively across departments.
• Commitment to integrity and ethical conduct and ability to protect confidential information.
• Familiarity with software tools like DocuSign, Microsoft Office Suite, and Adobe Acrobat.
• Experience supporting clinical trial or research-related contracts, preferred.

Position Overview

Immunome is seeking a highly experienced and strategic Senior Director, Global Market Access, to lead the development and execution of global market access strategies across our oncology portfolio. The individual will play a critical role in ensuring launch readiness globally, with particular emphasis on Europe, by aligning regulatory, pricing, and reimbursement pathways to support successful launch of varegacestat in countries outside of the US.

This role will also be responsible for proactively integrating payer and HTA requirements into clinical development, evidence generation, and lifecycle planning for Immunome’s pipeline assets, to enable timely patient access and reimbursement across key markets.

The successful candidate will bring deep expertise in global pricing and reimbursement, HTA engagement, and value dossier development, with a proven track record of successfully navigating HTA submissions and delivering reimbursement outcomes. This includes demonstrated experience leading market access strategy and execution for global launches, particularly across major EU markets (e.g., Germany, France, Italy, Spain, and the UK), including AMNOG processes, joint clinical assessments under the evolving EU HTA Regulation, and national pricing and negotiation frameworks.

The role requires close collaboration with Regulatory, Clinical, Commercial, and regional affiliates to ensure evidence packages, value narratives, and pricing strategies are optimized for diverse global payer environments. This position offers a highly visible leadership opportunity to shape Immunome’s access strategy from early development through launch and beyond.

Responsibilities

Strategic Leadership

• Develop and lead global market access, pricing, and reimbursement strategy across major markets for Immunome’s oncology portfolio, aligned with the target product profile (TPP) and commercial objectives.
• Build and continuously refine the global payer value proposition, value messaging, and evidence needs (clinical, economic, and patient-relevant outcomes) to support reimbursement and uptake.
• Provide strategic guidance on access risks, opportunities, and competitor dynamics; translate evolving HTA and payer expectations into actionable development and lifecycle recommendations.

Program Oversight and Execution

• Lead global access evidence planning and value dossier development, ensuring a consistent value story across regions and readiness for launch.
• Obtain early scientific advice from HTA bodies and payers across geographies (e.g., NICE, G-BA, HAS, CADTH, PBAC and other key agencies) and advocate for incorporation of feedback into clinical development and evidence generation plans.
• Partner with HEOR, Clinical Development, Biostatistics, Regulatory, Medical Affairs, and Commercial teams to drive integrated plans for endpoints, comparators, PROs, real-world evidence, and economic modeling.

Vendor and Partner Management

• Identify, qualify, and manage global market access vendors and consultants (e.g., HEOR modelers, dossier writers, policy advisors) to deliver high-quality outputs on time and within budget.
• Maintain oversight of external partners supporting payer research, advisory boards, and submission execution, ensuring adherence to Immunome’s standards and regional requirements.

Regulatory and Documentation Support

• Lead development, review, and submission of global and regional HTA dossiers (e.g., NICE, SMC, G-BA/AMNOG, HAS, AIFA, CADTH, PBAC, ICER) and manage responses to HTA questions through appraisal and negotiation.
• Drive strategy and content alignment for European joint assessments under the EU HTA framework, including participation in Joint Clinical Assessment (JCA) and Joint Scientific Consultation (JSC) activities where applicable (preferred; nice to have).
• Ensure access deliverables are consistent with the regulatory label, clinical data package, and publication strategy; collaborate with Regulatory and Medical Writing on relevant evidence summaries and modules.

Leadership and Collaboration

• Serve as the market access lead on cross-functional program and asset teams, influencing decisions from early development through launch.
• Communicate payer/HTA requirements and recommendations clearly to senior leadership and stakeholders; build alignment and accountability around access-critical activities.
• Mentor and develop team members and foster a culture of collaboration, scientific rigor, and patient-centered decision making.

Qualifications

• Advanced degree (PharmD, PhD, MD, MSc, MPH, MBA) in life sciences, health economics, public health, pharmacy, or a related field; bachelor’s degree with equivalent experience considered.
• 12+ years experience in global market access, pricing, HTA, and reimbursement within biotech/pharma, including oncology or rare disease launch experience.
• Demonstrated track record leading successful HTA submissions and achieving favorable reimbursement outcomes across multiple geographies (e.g., EU5/UK, Canada, Australia, etc.).
• Proven experience obtaining and leveraging early scientific advice from global HTA bodies and payers to shape clinical development and evidence generation strategies.
• Strong understanding of HEOR principles, cost-effectiveness and budget impact modeling, value communication, and evidence synthesis.
• Experience leading cross-functional teams (Clinical Development, HEOR, Regulatory, Medical Affairs, Commercial, Finance) and managing multiple programs in a fast-paced environment.
• Experience with EU HTA Joint Clinical Assessment (JCA) and/or Joint Scientific Consultation (JSC) processes preferred (nice to have).
• 30% travel.

Knowledge and Skills

• Deep knowledge of global pricing and reimbursement landscapes and HTA requirements (e.g., NICE, G-BA/AMNOG, HAS, AIFA, SMC, CADTH, PBAC).
• Ability to translate payer and HTA insights into actionable development strategy recommendations for endpoints, comparators, trial design, and evidence generation.
• Expertise in global value story and value dossier development, including local adaptation; strong writing and content review capabilities.
• Strong strategic thinking and program/project management skills, with the ability to prioritize across competing timelines and stakeholders.
• Excellent communication and influencing skills, including experience presenting to executive leadership and facilitating decision making.
• Proven vendor management and budgeting skills; ability to drive high-quality deliverables through external partners.
• High learning agility and comfort operating across early-stage and late-stage development in a dynamic biotech environment.
• Strong collaborative mindset and commitment to patient-centered access and compliant, ethical conduct.

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

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

-Building Together-

Fleishman Hillard and Porter Novelli are coming together as one integrated agency under the Fleishman Hillard banner, bringing together two industry-leading teams to create something even stronger.

Our combination provides more of what clients need right now: teams with deeper sector expertise, faster access to solutions, and the precision to handle complex, mission-critical assignments. Together, we are one of the industry’s leading communications consultancies, with pronounced strength in health & life sciences, technology, financial services, social impact, and public sector, among others.

The Role 

The VP Healthcare will join a dynamic Healthcare & Pharmaceutical team. This particular position will lead large pharmaceutical communications programs with pre-approval, approval and post approval HCP and consumer outreach and strong understanding of data. This role requires expertise across corporate healthcare and data/product communications, with a strong background in pre‑approval strategy, clinical trial recruitment, and communications spanning early‑phase clinical development.

As a VP on our team, you will be provided with a clearly articulated and well-supported path for career growth. Growth may include working with our other leading pharma clients across a variety of therapeutic categories as well as more health policy.  The work is an interesting blend of product, corporate, advocacy and issues management.  

What you will be doing:

• Developing strong client relationships by providing strategic counsel, building and leading solid account teams, mentoring, motivating, growing and retaining employees and managing accounts to consistently achieve business objectives. 
• Demonstrating independence and autonomy with respect to their responsibilities and must exhibit a deep understanding of the clients, their industry, the account and the agency. 
• Participating in new business development, company-wide initiatives, and managing finances and resources profitably.  

The Experience that will contribute to your success:

• Complete comfort and facility understanding data, the regulatory process, the barriers to success 
• Well-developed knowledge of the healthcare marketplace and business practices 
• Current knowledge of the challenges facing the pharma industry in general 
• A passion for ideas and moving pharma clients forward into new avenues of thinking 
• Know-how to develop and execute integrated communications strategies and programs including digital and social 
• Leadership and management of relationships with multiple internal and external clients 
• Direct responsibility for organic account growth, and participated in pitching and securing new business 
• Relevant level of expertise in general business acumen, budget management, communications, leadership and mentoring skills 
• About 10 years public relations experience with relevant healthcare agency experience or equivalent 
• Preferred experience in science related health care public relations accounts including pharmaceutical and direct-to-consumer product marketing, advocacy, program development and execution, social marketing and media relations 

The anticipated salary range for this position is $140,000 - $180,000. Salary is based on a range of factors that include relevant experience, knowledge, skills, other job-related qualifications, and geography. Benefits at Porter Novelli include a range of medical, dental, vision, 401(k) with company match and generous paid time off benefits are also available.  Employees from diverse or underrepresented backgrounds are encouraged to apply.

As an Omnicom company, Porter Novelli offers a robust suite of benefits for our employees:

• Medical & Prescription
• Dental
• Vision
• Flexible Spending Accounts
• 401k (with discretionary employer match)
• Employee Stock Purchase Plan
• Short-Term Disability, Long-Term Disability & Life Insurance
• Vacation, Sick & Personal Days
• 14.5 Paid Company Holidays 
• Parental Leave
• Family Forming Benefits
• Wellness Benefit
• Hybrid Working Environment (2 days remote, 3 days in office)

Porter Novelli is an equal opportunity employer. We do not discriminate in any aspect of employment against any person on account of race, creed, color, religion, national origin, ancestry, sex, sexual orientation, gender identity and expression, disability, disabled veteran, veteran of the Vietnam era or other eligible veteran, age, marital status, veteran status, or physical or mental handicap unrelated in nature and extent to an individual's ability to perform a job or any other characteristic protected by the employment discrimination laws in any state or political subdivision in which Porter Novelli does business. 

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. 

#LI-Remote

Position summary:  

We are seeking an accomplished Senior Director, Clinical Development to join our passionate and collaborative team and drive the advancement of our pipeline of targeted cancer therapies. In this high-impact role, you will lead clinical strategy and execution within our innovative portfolio of ADC and radioligand therapies across all stages of development. 

Key Responsibilities:  

• Lead and execute the clinical development strategy for novel oncology therapies.  

• Collaborate with internal and external stakeholders to design and implement a clinical development plan across indications.  

• Author/lead key clinical trial documents and clinical sections of regulatory filings such as pre-INDs and INDs.  

• Serve as the primary Medical Monitor for assigned programs, including overseeing internal and external teams and providing medical guidance to CRO partners and clinical sites.  

• Support safety monitoring and pharmacovigilance activities.  

• Collaborate cross-functionally with clinical operations, regulatory, project management, manufacturing, and business development to define timelines, manage risks, and ensure milestone delivery. 

• Work closely with translational sciences to integrate key biomarker and pharmacodynamic endpoints into clinical study designs 

• Establish and maintain strong relationships with PIs, KOLs and other external stakeholders.  

• Review, assess, interpret, and communicate clinical trial data to internal stakeholders and external partners. 

• Lead clinical trial data publication efforts.  

• Facilitate key meetings such as advisory boards, safety review committees, investigator meetings.  

Qualifications:  

• M.D., D.O. or equivalent. Board certification in medical oncology or hematology preferred.   

• A minimum of 2-4+ years of experience leading Clinical Development and Phase 1 – 3 oncology clinical trials in a biotech or pharmaceutical setting.   

Knowledge and Skills 

• Proven experience advancing therapeutic programs from IND-enabling studies through early and late-stage clinical development 

• Understanding of FDA and EMA regulatory requirements and successful track record in regulatory interactions 

• Demonstrated leadership and ability to effectively manage cross-functional teams 

Position Overview

We are seeking a highly motivated and experienced Clinical Scientist to join our team. The Principal/Senior, Clinical Scientist will play a critical role in the design, execution, and interpretation of multiple clinical trials for our oncology drug candidates. This individual will work closely with cross-functional teams, including clinical operations, regulatory affairs, and research and development, to ensure the successful progression of multiple clinical programs.

Responsibilities

• Oversee the execution of clinical trials and ensure scientific and regulatory rigor.
• Design and develop multiple clinical trial protocols, informed consent forms, and other study-related documents.
• Collaborate with principal investigators, key opinion leaders, and clinical trial sites to ensure robust study design and execution. Serve as Lead Clinical Scientist for multiple trials.
• Conduct activities related to data generation and validation, including CRF design and clinical data review/query resolution.
• Contribute to the preparation of clinical study reports, regulatory submissions, and publications.
• Review development of site and CRA training materials and presentation at SIV and Investigator meetings and support on Study committee (e.g., DMC) activities.
• Perform site-facing activities such as training and responding to clinical questions.
• Participate in the strategic development of clinical development plans and timelines.
• Present clinical trial data and findings to internal and external stakeholders, including scientific advisory boards and regulatory agencies.
• Mentor and develop junior team members with potential to manage direct reports.
• Travel may be required.

Qualifications

• PhD, MD, PharmD, MS, or equivalent degree in life sciences.
• A minimum of 2 years of experience in clinical science, clinical research, or equivalent; clinical development experience is required, biopharmaceutical/biotechnology industry and oncology experience preferred.
• Strong leadership, project management, and communication skills.

Knowledge and Skills

• Extensive experience in drug development process, study design, clinical operations.
• Extensive experience in clinical trial data analysis software and tools.
• Strong knowledge and skills to support program specific data review, trend identification, and data interpretation.
• Strong understanding of regulatory requirements and guidelines for clinical trials (e.g., GCP, ICH, FDA).
• Excellent analytical, organizational, and communication skills.
• Ability to work effectively in a fast-paced, collaborative environment.
• Strong problem-solving skills and attention to detail.

E/E/O

Immunome, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

WA State Range: Principal Scientist, Clinical Science - $169,883 - $225,742

WA State Range: Senior Scientist, Clinical Science - $145,823 - $182,019