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. 

Position Overview 

The Senior Director, Medical Strategy & Communications will establish a strategy to support generation and communication of scientific information. This individual will drive planning and execution of publications aligned with strategic priorities. They will lead the development and training of scientific communication materials for effective medical affairs operations, oversee establishment and growth of the medical information function, and manage medical evidence generation/ISR strategies to support external research. The position will report to the SVP, Medical Affairs and will be an integral part of the leadership team. They will be empowered to make decisions and drive results, which will require deep scientific subject matter expertise, strong business acumen, effective communication, and coaching/development skills.   

Responsibilities 

• Foster partnerships with senior leaders and cross functional teams to shape data, communication and engagement strategy.  
• Drive planning and execution of publications.  
• Lead development of scientific communication materials and training.  
• Support advisory board and congress planning.  
• Contribute to the Medical, Legal, and Regulatory (MLR) process. 
• Manage medical information function.  
• Plan and operationalize medical evidence generation activities (ISRs, etc.). 

Qualifications 

• A minimum of 6 years' experience in biotech/pharmaceutical industry medical affairs required; 8+ years preferred. 
• Oncology Medical Affairs experience is required.  
• Deep expertise in medical communications and regulatory considerations. 
• Strong interpersonal skills for effective communication. 
• Up to 10% travel required. 

Knowledge and Skills 

• Demonstrated success in driving peer reviewed publications.  
• Deep expertise in the evolving landscape of publications, medical communications, and medical information.  
• Proven ability to develop new teams and deliver on compressed timelines.  
• Strong understanding of investigator sponsored research.  
• Proven ability to independently manage complex projects and communicate effectively with a wide range of internal and external stakeholders. 

Position Overview 

The Pharmacovigilance (PV) Operations Manager at Immunome is responsible for managing day-to-day global safety operations across Immunome’s clinical stage oncology programs as well as commercial product(s). This role oversees case management activities conducted by external safety vendors, supports clinical study teams on safety matters, and ensures timely and compliant safety reporting in alignment with global regulatory requirements and Immunome’s internal standards.  

As a growing biotechnology organization, Immunome requires an adaptable and highly organized PV Operations Manager who can support cross functional communication, maintain inspection ready safety systems, and drive operational excellence across all PV workflows.  

Responsibilities

Safety Case Management Oversight  

• Oversee safety case processing activities performed by Immunome’s PV vendors, including AE/SAE intake, assessment, follow up, MedDRA coding, and regulatory submissions.  

• Ensure cases are processed within required timelines and maintain compliance with FDA, EMA, ICH, CIOMS, and other applicable regulations.  

• Validate case narratives, source documentation, and sponsor queries submitted by external partners.  

Vendor & CRO Management  

• Serve as Immunome’s point of contact for PV operations with contracted partners.  

• Monitor vendor performance through periodic metrics review, and compliance dashboards.  

• Coordinate operational clarifications and ensure prompt resolution of sponsor queries.  

Compliance, Quality, & Inspection Readiness 

• Maintain continuous inspection readiness across all safety operations, ensuring complete, accurate, and audit ready documentation.  

• Support Health Authority inspections and internal/external audits, including document preparation, responses, and CAPA tracking.  

• Contribute to development, revision, and training of Immunome SOPs, work instructions, and PV governance documents.  

Safety Systems & Data Management  

• Support data quality checks, reconciliation activities, and system updates.  

• Ensure robust data governance practices, including consistency, accuracy, and timely reconciliation with clinical databases.  

Cross Functional Collaboration  

• Partner closely with Clinical Operations, Medical Monitoring, Regulatory Affairs, Quality Assurance, and Biometrics to support safety oversight across Immunome clinical programs.  

• Provide operational input into Safety Management Plans (SMPs), Safety Data Exchange Agreements (SDEA), and clinical study documents.  

• Support preparation of aggregate safety deliverables (e.g., DSURs, SUSAR listings, annual reports) through data coordination and operational QC.  

Project & Documentation Management  

• Track PV milestones for multiple clinical programs and ensure timely sponsor review of safety documents (e.g., narratives, CIOMS/MedWatch forms).  

• Oversee documentation of operational decision making, vendor communications, and safety process deviations.  

• Facilitate safety-related communication with investigators/sites as needed.  

Qualifications

• Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Nursing, or related scientific field.  

• Advanced scientific or clinical degree preferred. 

• A minimum of 5+ years of experience in pharmacovigilance or drug safety, including 2+ years in safety operations leadership or vendor oversight.  

• Experience in clinical stage biotechnology or oncology programs preferred.  

• Strong background in safety databases (Argus, ArisGlobal, or equivalent) and global safety regulations.  

Knowledge and Skills

• Deep understanding of PV operations, PV workflows, case processing, MedDRA coding, and regulatory timelines.  

• Strong organizational, analytical, and vendor management skills.  

• Ability to thrive in a fastmoving biotech environment with evolving pipelines and processes.  

• Excellent communication skills with the ability to collaborate cross functionally and represent PV during internal and external meetings.  

• Commitment to patient safety and scientific integrity.  

• Strong problem solving and critical thinking. 

• Adaptability within a growing, innovative biotech environment. 

• High attention to detail and operational rigor.  

• Team-oriented and proactive communicator.  

Position Overview 

The Executive Director / Senior Director, Project Management Lead is responsible for leading and developing Immunome’s Project Management function and ensuring consistent, high-quality project management support across Research and Development programs and functional teams. This role focuses on strengthening alignment, transparency, and execution discipline across cross-functional and program teams, while establishing scalable project management standards, governance practices, and enterprise tools.  

The Executive Director / Senior Director will oversee the project management team, ensure consistent application of planning and reporting frameworks, and partner closely with functional and program leadership to drive operational cohesion across the organization. This role will also lead Immunome’s Smartsheet platform strategy to ensure standardized communication, reporting, and project visibility across programs and functions.  

This role is ideal for a seasoned project management leader who excels at building high-performing teams, driving consistency across diverse functions, and leveraging enterprise tools to enhance transparency and execution discipline. The Executive Director / Senior Director, Project Management Lead will be instrumental in ensuring Immunome’s programs and functional initiatives are supported by standardized, scalable, and aligned project management practices.  

This position reports to the Senior Vice President of Project and Program Management and plays a key role in reinforcing organizational alignment and execution excellence.  

Responsibilities 

Project Management Team Leadership  

• Lead, mentor, and develop the Project Management team, including hiring, onboarding, coaching, and performance management.  

• Establish clear role definitions, expectations, and accountability standards for project managers embedded within program and functional teams.  

• Ensure consistent training and capability development across the PM team.  

• Assess PM capacity and align resources with evolving program and functional priorities.  

• Foster a culture of rigor, transparency, and continuous improvement within the PM function.  

Cross-Functional & Program Team Alignment  

• Partner with leaders across Research, Clinical Development, CMC, Regulatory Affairs, Commercial, Finance, and other operational groups to ensure consistent planning, milestone definition, risk tracking, and reporting practices.  

• Drive alignment between program teams and functional teams to ensure shared visibility into timelines, dependencies, decision points, and resource needs.  

• Standardize integrated planning processes to reduce variability in execution across programs.  

• Ensure transparent identification and management of cross-functional risks and interdependencies.  

• Facilitate structured governance interactions and clear escalation pathways across teams.  

• Smartsheet Platform Leadership & Execution Transparency  

• Lead the strategy, governance, and optimization of Immunome’s Smartsheet platform to support project and program management needs.  

• Establish standardized templates, dashboards, and reporting frameworks to ensure consistent communication across program and functional teams.  

• Drive adoption and disciplined use of Smartsheet as the primary platform for integrated planning, milestone tracking, and status reporting.  

• Ensure data integrity, reporting consistency, and alignment of dashboards with executive governance needs.  

• Partner with functional and program leaders to continuously refine platform utilization to enhance visibility and decision-making.  

• Provide oversight for platform enhancements, integrations, and user enablement to support organizational growth.  

Standardization, Governance & PMO Support  

• Lead development and refinement of project management standards, templates, and governance practices.  

• Ensure consistent integrated development plans, status reports, and performance metrics across all supported programs.  

• Partner with PMO leadership to strengthen executive-level reporting and portfolio transparency.  

• Monitor execution trends and identify opportunities to improve alignment, communication, and operational effectiveness.  

Program & Functional Initiative Support  

• Provide direct project management leadership for high-priority or complex initiatives as needed.  

• Support cross-functional operational initiatives beyond core development programs (e.g., platform teams, alliance support, strategic initiatives, or organizational projects).  

• Expand PM support into additional functional areas as organizational complexity increases.  

• Ensure new programs and functions are integrated into standardized PM frameworks and tools.  

Qualifications 

• Advanced degree (PhD, MD, PharmD, MBA, MS) in Life Sciences, Drug Development, Business Administration, or related field preferred.  

• A minimum of 8-10+ years of experience in biotechnology or pharmaceutical development, including significant cross-functional project management experience.  

• A minimum of 3-5+ years of project management team management experience.  

• Demonstrated experience managing and developing project management professionals.  

• Strong understanding of drug discovery and development processes.  

• Experience implementing standardized project management governance frameworks and enterprise tools.  

• Proven ability to drive alignment across matrixed program and functional teams.  

• Experience leading enterprise-level Smartsheet or comparable project portfolio management platforms strongly preferred.  

• Excellent leadership, communication, and stakeholder engagement skills.  

Knowledge and Skills 

• Deep expertise in cross-functional project management within biotechnology or pharmaceutical development.  

• Strong capability in integrated planning, resource alignment, and risk management.  

• Experience building scalable PMO structures and alignment frameworks.  

• Advanced proficiency in Smartsheet, including dashboard development, reporting frameworks, and governance structures.  
• High proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).  

Position Overview

As the Global Regulatory Lead at Immunome, you will be the key decision-maker responsible for the development and execution of innovative global regulatory strategies for our therapeutic portfolio to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects. You will work collaboratively across teams to ensure compliance and alignment with corporate objectives, driving the regulatory success of our products in development and throughout their life cycle. This position will report to the Vice President, Regulatory Affairs.

Responsibilities

Regulatory Strategy Development

• Define and implement global regulatory strategies that adapt to changing regulatory and business needs.

Cross-Functional Leadership

• Communicate key developments to project teams and stakeholders, ensuring alignment and sound judgment.
• Anticipate risks and devise solutions, understanding the likelihood of technical success for proposed strategies.

Team Leadership

• Lead the Global Regulatory Team, fostering a high-performance culture through coaching and mentoring.
• Collaborate with regional regulatory leads and vendors to ensure compliance with local regulations for global submissions.

Stakeholder Communication

• Communicate effectively with internal and external partners, advocating for regulatory positions in governance and cross-functional committees.

Risk Management

• Identify regulatory risks and opportunities, developing strategies to mitigate risks and enhance success rates.

Regulatory Submission Oversight

• Ensure timely preparation and submission of regulatory submissions (e.g., INDs, BLAs, NDAs) while maintaining compliance with regional and global requirements.
• Act as the primary contact with global health authorities and lead FDA meetings.

Continuous Improvement

• Monitor industry trends and regulatory changes, adapting strategies to mitigate impacts on product development.

Qualifications

• Bachelor’s degree in a relevant scientific discipline.
• A minimum of 10 years experience in global regulatory affairs in the pharmaceutical/biotechnology industry.
• Proven success in leading regulatory submissions and obtaining approvals in major markets.
• Experience developing oncology therapeutics is strongly preferred

Knowledge and Skills

• Direct experience leading regulatory submissions, health authority meetings and interactions with in-depth knowledge of the internal operations and outlook of the FDA, EMA and other global health authorities
• Has a comprehensive and disciplined approach to regulatory risk management and compliance through deep expertise and understanding of the oncology therapeutic area 
• Highly collaborative self-starter and team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders 
• Outstanding communication, analytical, organizational and time management skills. 
• Experience and passion to work with small teams, ability to work comfortably under pressure under evolving scenarios and tight deadlines
• Detail-minded yet flexible work style; manage multiple projects and timelines simultaneously, and rapidly change priorities based on business needs

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

Position Overview

The Senior Director of Statistical Programming provides leadership and oversight across clinical programs within Statistical Programming function.  This position will require managing programming resources, assisting in development of Programming infrastructure and process, providing technical support and guidance for regulatory submissions while adhering to CDISC standards and submission requirements. This role requires high-level oversight of CRO partners, technology innovation, and cross-functional leadership.

Responsibilities

• Provide leadership and line management to Statistical Programming function, ensuring focus on business priorities and values.
• Provide management and oversight of statistical programming resources including FTEs, contractors and CROs involved in early-stage and late-stage studies.
• Ensure quality and timeliness of statistical analysis, reporting, and regulatory submission deliverables. Provide hands-on programming, if required, of critical ADAMs and TLFs.
• Demonstrate strong technical expertise to promote best practices related programming environments, technology and programming skillsets
• Develop and ensure conformation to Programming SOPs and Work Practice guidelines
• Maintain strategy for capability and skill development to meet current and future requirements.
• Maintain an environment to foster creativity and transparency, and a framework for continuous improvement
• Drive standardization and innovation to ensure future fitness of the organization.

Qualifications

• PhD or Master in Biostatistics, Statistics, Computer Science or a related field.
• A minimum of 15 years of experience working in the pharmaceutical, biotech, or CRO industry. A minimum of five years of leadership experience is strongly preferred.
• Significant oncology is experience is required.

Knowledge and Skills

• Track record of leading and overseeing global regulatory submissions in oncology
• Proficiency in statistical programming languages (e.g., SAS, R).
• Solid experience with reporting process, regulatory requirements, and software development life cycle.
• Strong leadership, interpersonal, and organizational skills, and ability to work within cross-functional teams
• Strong communication skills with ability to align the company on complex technical decisions.
• Proven experience in developing and leading high-performing teams.
• Demonstrated ability to multi-task, prioritize options, anticipate challenges, identify and resolve issues, and positively influence the team.
• Thrives in a collaborative team setting and is driven by a desire to deploy innovative approaches and technologies in a high-energy environment.

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