GenScript is a global leader in life sciences research tools and services, providing innovative solutions in gene synthesis, protein expression, antibody development, and cutting-edge mRNA/LNP technologies. Our mRNA & LNP Services team delivers end-to-end solutions for vaccine and therapeutic development — from sequence design and IVT mRNA synthesis to LNP formulation, analytics, and QC release testing.

We are seeking a detail-oriented and technically skilled QC Technician to join our rapidly growing mRNA & LNP Service Team. In this role, you will perform analytical testing and quality control assays to ensure the integrity, purity, potency, and consistency of mRNA products and lipid nanoparticle formulations. You will work closely with R&D, Manufacturing team, QA and Project management teams  to support client projects and internal process improvements .

Responsibilities:

• Responsible for supporting communication with production manager and team, contributing to a working environment that encourages employee involvement and collaboration.
• Conduct analytical assays including but not limited to:
• RNA concentration and purity (UV spectrophotometry, fluorometry)
• RNA integrity (Agilent Bioanalyzer, gel electrophoresis)
• dsRNA contamination (ELISA, immunoblot, HPLC)
• LNP particle size and polydispersity (DLS, others)
• Encapsulation efficiency (ribogreen assay, dye exclusion)
• Endotoxin testing
• pH, osmolality, sterility (as applicable)
• Reports out-of-specification results and deviations to the manager. Assists with investigations, root cause analysis, and reports for out-of-specification results and deviations.
• Responsible for timely completion of QC report after production job is finished. Accountable for the QC report compliance with good documentation practices.
• Support process improvement initiatives within scope of responsibility.
• Monitors supply inventory and identifies any products required.
• Maintains work area, equipment, department and all storage areas in a clean, neat and orderly manner.
• Perform other duties as needed.

Requirements:

• Bachelor's degree in molecular biology, chemistry, biochemistry, pharmaceutical science or related field, master’s is preferred.
• Experience with HPLC, LC-MS, ELISA, cell culture, and flow cytometry is preferred.
• Ability to communicate efficiently verbally and in writing.
• Ability to perform in a fast-paced environment with high product throughput.
• Ability to follow detailed instructions, maintain accurate records and notes, and carry out assignments in a thorough, conscientious fashion while adhering to safe laboratory practices.

A sense of humility and an eagerness to continue to learn and contribute to a supportive team.

Benefit:

• Medical Insurance/ Vision Insurance/ Dental Insurance
• 401(k) & Retirement Savings Plan (RSP)
• Short Term Disability Insurance
• New Child Leave
• Paid Time Off
• Paid Company Holidays per year
• Paid Sick Days (earned based on hours worked)
• Compassionate Leave
• Jury Duty Leave
• Float day
• Personal days

Perks: 

• Free colleague meals during shift
• Onsite massages Charis
• Onsite gyms

Compensation:
Salary range: $55,000 – $65,000 total compensation, including bonus, depending on experience and qualifications.

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

Description:

Architect and develop mission-critical software for a next-generation automated oligo synthesizer, enabling precise control of mechanical, fluidic, and electrical systems. You’ll own the full-stack software infrastructure, from low-level hardware communication (USB/SPI/serial) and embedded firmware integration to GUI design, data analysis tools, and database management — ensuring seamless operation for end-user scientists.

Responsibilities:

Own the Software Development Life Cycle (SDLC) for instrument control software: design, implement, debug, test, and deploy across Java/Python/C++ codebases.

Modernize and refactor legacy systems while ensuring backward compatibility with low level software + embedded firmware (custom PCB controller) and hardware messaging protocols.

Collaborate cross-functionally with engineers, scientists, and IT to translate user feedback into scalable software improvements (UI/UX, performance, reliability).

Develop data analysis pipelines (Python scripts, databases) and real-time monitoring tools for high-speed acquisition and process optimization.

Act as SME for software architecture: document APIs, mentor junior engineers, and align technical decisions with long-term product roadmaps.

Onsite Requirement: This is a fully onsite role due to the hands-on nature of instrument control, hardware integration, and close collaboration with engineering and scientific teams.

Qualifications:

Requires Bachelor’s degree in Computer Science, Computer Science & Engineering, Software Engineering, Electrical Engineering or a related field.

Technical Non-Negotiables: 6–8 years in full-stack software development for instrumentation/robotics/embedded systems.

Expertise in:

Java: core codebase, multi-threaded code and GUI desktop applications (JavaFX or Swing).

Java, Maven, NetBeans IDE and Mercurial.

Python: scripting, data analysis tools.

Low-level comms protocols: USB, Serial, SPI, I2C.

Microcontrollers/embedded firmware (hands-on debugging).

GUI development (e.g., Java FX, Swing, Qt, or other modern frameworks).

Proven leadership in architecting complex systems (design patterns, version control, continuous improvement (CI) / continuous development (CD)).

Soft Skills & Culture Fit:

“Product mindset”: Balance technical rigor with end-user needs (scientists’ workflows).

Communicate complex ideas clearly to both engineers and non-technical stakeholders.

Autonomy: Self-driven in ambiguous, R&D-paced environments.

Benefit:

• Medical Insurance/ Vision Insurance/ Dental Insurance
• 401(k) & Retirement Savings Plan (RSP)
• Short Term Disability Insurance
• New Child Leave
• Paid Time Off
• Paid Company Holidays per year
• Paid Sick Days (earned based on hours worked)
• Compassionate Leave
• Jury Duty Leave
• Float day
• Personal days

Perks: 

• Free colleague meals during shift
• Onsite massages Charis
• Onsite gyms
  
  

Compensation:
Salary range: $150,000 – $170,000 total compensation, including bonus, depending on experience and qualifications.

Description:

Architect and develop mission-critical Java software for next-generation automated instruments, enabling precise control of microcontrollers, valves, sensors, and pressure regulators. Own the full-stack software infrastructure, from low-level hardware communication (USB/SPI/serial) and embedded firmware integration to GUI design, data pipelines, and database management, ensuring reliability for end-user scientists.

Responsibilities:

1. Java-Centric Development:
2. Lead high-level Java development for instrument control, including multi-threaded applications, GUI frameworks (JavaFX/Swing), and hardware abstraction layers.
   • Modernize legacy Java codebases while maintaining backward compatibility with embedded systems (custom controller PCB based on industry standard microcontroller).
3. Hardware Integration:
   • Interface with microcontrollers, sensors, and actuators via protocols (SPI/I2C/serial) and real-time messaging systems.
   • Debug and optimize low-level communication between software and hardware components.
4. Database & Systems Management:
   • Design and maintain relational databases for instrument metadata, experiment logs, and process analytics.
   • Implement data analysis pipelines (Python/Java) for real-time monitoring, post-processing analysis and process optimization.
5. Technical Leadership:
   • Act as SME for software architecture: document APIs, enforce good design practices, and mentor junior engineers if needed.
   • Drive CI/CD pipelines, version control (Mercurial/Git), and automated testing frameworks.

Onsite Requirement: This is a fully onsite role due to the hands-on nature of instrument control, hardware integration, and close collaboration with engineering and scientific teams.

Qualifications:

Requires Bachelor’s degree in Computer Science, Computer Science & Engineering, Software Engineering, Electrical Engineering or a related Engineering field.

Experience: 6–8 years in Java development for instrumentation/robotics/embedded systems (or equivalent).

Technical Skills:

Java Expertise: Core Java, multi-threading, JavaFX/Swing, Maven, NetBeans.

Hardware Protocols: USB, Serial, SPI, I2C (hands-on debugging).

Bonus: Python scripting, Qt/GUI frameworks, embedded firmware (C/C++).

Soft Skills & Culture Fit:

“Product mindset”: Balance technical rigor with end-user needs (scientists’ workflows).

Communicate complex ideas clearly to both engineers and non-technical stakeholders.

Autonomy: Self-driven in ambiguous, R&D-paced environments.

Benefit:

• Medical Insurance/ Vision Insurance/ Dental Insurance
• 401(k) & Retirement Savings Plan (RSP)
• Short Term Disability Insurance
• New Child Leave
• Paid Time Off
• Paid Company Holidays per year
• Paid Sick Days (earned based on hours worked)
• Compassionate Leave
• Jury Duty Leave
• Float day
• Personal days

Perks: 

• Free colleague meals during shift
• Onsite massages Charis
• Onsite gyms

Compensation:
Salary range: $140,000 – $170,000 total compensation, including bonus, depending on experience and qualifications.

Location: Remote - Geography based

Do you have a consistently strong record of sales performance in a fast-paced selling environment where your work has a critical impact on patients?  At Invivyd, we’re building a category and disrupting the status quo. We’re looking for experienced and driven Senior Virology Care Specialists who are ready to utilize their industry experience bringing passion, persistence, and a strong desire to help patients.

• Develop strong, compliant relationships across a broad range of health care providers (HCPs) across multiple specialties and account types (IDNs, health systems and community clinics) by understanding their needs and sharing accurate, balanced information about Invivyd’s products and solutions
• Facilitate clinical dialogue that compels the customer to act on behalf of their patients and engage the entire account to understand any obstacles that exist to provide appropriate solutions
• Identify shared priorities and leverage knowledge and tactics within full account to develop a territory business plan that drives product demand by meeting the needs of key partners and ultimately their patients to drive superior results
• Utilize your understanding of the broader healthcare landscape for account selling, including provider offices and health systems, and how decisions are made across these settings
• Manage your territory with a business owner mindset with accountability, energy, and drive by owning the outcome of your results with a sense of urgency while staying compliant with company policies and industry regulations
• Deliver compelling product presentations and educational discussions to support patient care decisions by utilizing all approved resources in line with company training and compliance requirements
• Collaborate as a positive energy multiplier cross-functionally with colleagues in marketing, market access, and other teams to support customer needs and win together
• Operate with an enterprise mindset to gather and share customer insights, feedback, and questions to help Invivyd continuously improve how we serve providers and patients
• Collaborate with cross-functional partners on overall account and territory strategy to maximize internal/external knowledge on how to access products and services
• Aggregate customer, market data, and insights to effectively apply multiple channels to drive total selling engagements
• Utilize data driven approach to prioritize customers/accounts to maximize impact aligned to strategic plan

 Required: 

• Bachelor's degree strongly preferred; candidates without a degree with significant relevant, related industry experience will be considered
• 5+ years of experience in sales in biotech, pharmaceuticals or medical device customer-facing roles is preferred

• Candidates must live within the stated territory
• Able to fulfill requirement to be in the field five days a week, including overnights as required, conducting visits, while also completing all administrative tasks related to the role
• Ability to drive and/or fly within the territory, as required
• Proven winning attitude with a growth mindset
• Strong communication and interpersonal skills, with the ability to build relationships and engage in meaningful conversations with healthcare providers
• Coachable and eager to learn - open to feedback, willing to adapt, and motivated to grow into a high-performing sales professional
• Demonstrated persistence, resilience, agility, and a strong work ethic; comfortable working in a fast-paced, evolving environment
• Ability to manage time effectively, prioritize tasks, and take ownership of territory responsibilities
• High standards of integrity, professionalism, and a commitment to compliance in every interaction
• Passion for making a difference in the lives of patients and a desire to be part of a mission-driven company
• Strong ability to communicate clinical product information in a compelling and compliant way
• Must be results oriented and can demonstrate time management skills with ability to gain access to hard to see customers
• Demonstrated effective organizational and interpersonal skills to prioritize opportunities

Pay Range

$120,000 - $160,000

The pay range represents the expected full-time base salary for this role at the time of posting. Actual base pay will be determined based on a variety of factors, including relevant experience, skills, and education. In addition to base pay, this role is eligible for both an annual short-term incentive (e.g., bonus or sales incentive) and an annual long-term incentive (e.g., equity), reflecting our commitment to rewarding strong performance and long-term impact. Learn more about our total rewards by visiting https://www.invivyd.com/careers/.

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. 

2026 Summer Internship

Genscript USA Inc. will support a Summer Internship Program that provides growth and learning opportunities to students currently pursuing an Undergrad/ Post-Grad degree. 

Interns will be involved in a cohort training program designed to provide students with professional experience in the furtherance of their education. Internships assist students in reaching their educational goals by giving them the opportunity to augment classroom instruction with exposure to real world employment settings.

Overview:

Genscript is currently hiring for a Summer QA Intern to join our Quality Assurance team in Redmond reporting into the group Supervisor. This internship will be based in Redmond, WA and the hourly pay-rate is estimated at $20 - $25 per hour. 

This intern will assist GenScript QA team members with day to day tasks. Working on a wide range of Quality related Compliance, Research, and administrative tasks. 

Responsibilities:

• Review controlled and executed documentation to support checks for good documentation practices and compliance against Document Control procedures
• Review SOPs and affiliated forms to support assessments/opportunities for improvements
• Support document processing (operations) to ensure timely relay of document creation/revision requests
• Assist in training program documentation reconciliation reviews
• Assist in raw materials management documentation reconciliation
• Assist in internal audit preparations
• Assist in data analysis to identify trends and process improvement opportunities
• Assist in other QA related tasks

Qualifications:

• Currently enrolled in Bachelor's (Senior Status), Master's Program (any status), or recent graduate (within the last year)
• Communication skills (able to say when they have any confusion or have questions; willing to ask for help and/or escalate when there is a problem)
• Able to jump from task to task
• Willing to take on repetitive work
• A strong sense of responsibility and a proactive work attitude
• Effective time management and organizational skills
• Good communication skills, organized, responsible

Benefit:

• Paid Time Off
• Paid Company Holidays per year
• Paid Sick Days (earned based on hours worked)
• Personal days

Perks: 

• Free colleague meals during shift
• Onsite massages Chairs
• Onsite gyms

#GS

#LI-IP1

About the Role
We are seeking an experienced research engineer to join our team. As a critical member of our interdisciplinary group, you will collaborate closely with AI scientists, engineers, and drug discovery experts to develop and deploy AI models that accelerate the identification and development of novel therapeutics. This role offers the opportunity to apply cutting-edge AI techniques in production settings to address pressing challenges in healthcare and contribute to improving human health globally.

We are particularly interested in candidates who have demonstrated experience building and delivering machine learning systems in industry environments, where rigor, scalability, and cross-functional collaboration are essential. The ideal candidate has experience translating research ideas into robust, production-ready solutions that drive measurable impact.

The role is open to the following locations: San Francisco Bay Area, Seattle

Qualifications

• Bachelor's degree in Computer Science, Engineering, or related fields; advanced degree preferred
• Minimum of five years of industry experience in AI, machine learning, or related roles, with a track record of implementing, scaling, and deploying AI models in production environments.
• Expertise with modern deep learning toolchains and experience with large scale model training.
• Strong understanding of deep learning fundamentals.
• Excellent problem-solving skills, with a keen eye for detail and a passion for tackling complex challenges in the life sciences.
• Effective communication and collaboration abilities, with the capacity to work effectively in a fast-paced, multidisciplinary team environment.
• Publication track record at conferences such as NeurIPS, ICML, or ICLR is a plus, though demonstrated industry impact is prioritized
• If you are a motivated individual with a passion for applying AI to advance drug discovery and improve human health, we encourage you to apply!

Compensation

We offer a competitive compensation and benefits package, seeking to provide an open, flexible, and friendly work environment to empower employees and provide them with a platform to develop their long-term careers. A Summary of Benefits is available for all applicants. We offer a competitive package that includes base salary, bonus, and equity. The base pay range for this position is expected to be $190,000 - $280,000 annually; however, the base pay offered may vary depending on the market, job-related knowledge, skills and capabilities, and experience.

Xaira Therapeutics an equal-opportunity employer. We believe that our strength is in our differences. Our goal to build a diverse and inclusive team began on day one, and it will never end.

TO ALL RECRUITMENT AGENCIES: Xaira Therapeutics does not accept agency resumes. Please do not forward resumes to our jobs alias or employees. Xaira Therapeutics is not responsible for any fees related to unsolicited resumes.

Position Overview

Xaira is seeking enthusiastic and motivated candidates to join our team! As an AI Scientist, you will have prior experience in developing and implementing new deep learning methods while upholding a track record of AI Innovation demonstrated through publications in Artificial Intelligence/Machine Learning or projects applying them to interdisciplinary fields. You will be a crucial member of our core AI team, comprising highly creative and talented peers who are all experts in developing state of the art AI models. With your team, you will initiate and drive new projects that advance the SOTA AI models for biology impacting drug discovery and clinical development. You will also have the chance to work closely with interdisciplinary experts with world-class biology, drug discovery, and clinical expertiseWe welcome candidates with diverse backgrounds and experiences. We welcome candidates across the spectrum of experience. Teams thrive when they are diverse (across all axes), and we encourage all eligible applicants to apply.

The role is open to the following locations: San Francisco Bay Area, Seattle and London.

Key Responsibilities

• Completed (or within one year of completing) a PhD in an AI or AI-adjacent field.
• Excited to work, learn and teach within a collaborative team working on challenging problems.

Desirable

Below is a list of qualities/experiences that align with the kinds of things that we are looking for. Please do not read this as an extension of the “requirements” section! We recognise that experiences, opportunities and life-paths vary.

• Publications in journals or ML conferences.
• Public codebases or contribution to public GitHub repositories.
• Industry experience in an AI company, such as an internship or full-time position.
• Knowledge or experience in BioAI.
• Experience building and training neural networks.
• Experience training models across multiple GPUs.

If you are a motivated individual with a passion for applying AI to advance drug discovery and improve human health, we encourage you to apply and join us in our mission to make a positive difference in the world.

Compensation

We offer a competitive compensation and benefits package, seeking to provide an open, flexible, and friendly work environment to empower employees and provide them with a platform to develop their long-term careers. A Summary of Benefits is available for all applicants. We offer a competitive package that includes base salary, bonus, and equity. The base pay range for this position is expected to be $120,000 - $240,000 annually; however, the base pay offered may vary depending on the market, job-related knowledge, skills and capabilities, and experience.

Xaira Therapeutics an equal-opportunity employer. We believe that our strength is in our differences. Our goal to build a diverse and inclusive team began on day one, and it will never end.

TO ALL RECRUITMENT AGENCIES: Xaira Therapeutics does not accept agency resumes. Please do not forward resumes to our jobs alias or employees. Xaira Therapeutics is not responsible for any fees related to unsolicited resumes.

Job Scope:

This Equipment Engineer reports to the Equipment Manager based in New Jersey and is critical for providing onsite equipment engineering leadership at our Redmond, WA facility. The ideal candidate is a highly organized and independent professional with strong communication skills, experienced in managing the full lifecycle of laboratory and production equipment. This role requires taking full ownership of equipment-related events in Redmond, with strategic support from the NJ-based team.

The primary initial focus will be on managing the site's calibration and preventive maintenance program by scheduling and overseeing third-party vendors. The engineer will ensure equipment reliability and compliance within a GMP/ISO framework through effective asset management and vendor coordination.

Details: This is a full-time role based onsite in Redmond, WA. The estimated salary range is $65,000 - $95,000 dependent upon experience level.

Primary Responsibilities: 

Vendor & Maintenance Program Management:

• Own the site's calibration and preventive maintenance (PM) program by scheduling, coordinating, and overseeing third-party vendors and service contractors.
• Serve as the primary point of contact for external vendors; audit their work on-site to ensure quality and compliance.
• Manage the spare parts strategy and inventory.

Asset & System Management:

• Administer the Computerized Maintenance Management System (CMMS - e.g., Limble) to schedule vendor services, manage work orders, and maintain accurate asset histories.
• Maintain and update the site's equipment inventory database, which includes a range of critical instruments such as analyzers, liquid handlers, HPLC systems, spectrophotometers, synthesizers, thermal cyclers, and general lab equipment.
• Develop, review, and improve technical Standard Operating Procedures (SOPs) related to equipment operation and maintenance.

Equipment Support & Troubleshooting:

• Act as the first point of contact for equipment issues, performing initial troubleshooting and coordinating with vendors for advanced repairs as needed.
• Lead root cause analysis (RCA) for equipment deviations and implement effective Corrective and Preventive Actions (CAPA).
• (Future State) Progressively build in-house capabilities to perform hands-on PM and calibration activities.

Compliance & Quality:

• Ensure all equipment activities comply with GMP, ISO, and other relevant regulatory standards.
• Support Quality Assurance and Control objectives by ensuring equipment is maintained in a validated state.
• Manage documentation for equipment maintenance, vendor service reports, and deviations.

Communication & Collaboration:

• Communicate effectively with site staff, management, and the remote NJ equipment team on equipment status, vendor performance, and projects.
• Work autonomously while seamlessly integrating with Redmond stakeholders.

Qualifications: 

• Bachelor’s degree in Engineering or a related scientific field.
• 3+ years of experience in an equipment engineering, maintenance, or calibration role within a biotech, pharmaceutical, or medical device environment.
• Proven experience scheduling, managing, and overseeing third-party service vendors for calibration and preventive maintenance.
• Strong experience managing assets and work orders within a CMMS (e.g., Limble, Maximo, Blue Mountain).
• Familiarity with GMP and ISO quality standards is required.
• Excellent organizational skills and the ability to manage multiple priorities and vendor schedules independently.
• Strong verbal and written communication skills are essential for effective remote collaboration and vendor management.

#LI-EB1

#GS

The Sr. Specialist, eQMS serves as the primary system administrator for the MasterControl electronic Quality Management System (eQMS), responsible for system configuration, user administration, lifecycle management, and continuous improvement of the platform and its governed processes. This role also serves as Training Coordinator, provides backup coverage for the Document Coordinator function, and owns the collection, reporting, and visual management of quality metrics and KPIs presented at key site forums at the LyFE site.

KEY ROLE AND RESPONSIBILITIES: 

MasterControl eQMS System Administration:

• Administer user accounts, roles, and permission groups; provision and deprovision access in accordance with site SOPs.
• Evaluate, plan, and execute system configuration changes and version upgrades; author and manage all Mastercontrol change controls through the eQMS workflow.
• Design, build, and deploy electronic form solutions within MasterControl to automate and standardize quality data capture and approvals.
• Serve as the primary point of contact for system incidents; diagnose and resolve user-reported issues and escalate complex technical problems to MasterControl vendor support as needed.

Quality System Process Support:

• Execute the Training Coordinator function within MasterControl; configure training assignments to ensure accurate mapping to job codes, roles, and user profiles.
• Maintain user training records by managing job code assignments, personas, trainer group memberships, and course curricula within the eQMS.
• Perform the Document Coordinator role in MasterControl; review and edit controlled documents for template conformance, correct formatting, and grammatical accuracy prior to release.
• Coordinate with document owners and stakeholders to meet targeted effective dates, ensuring alignment with quality event drivers and regulatory timelines.
• Partner with functional area representatives to identify new document types and configure corresponding templates within the eQMS document management module.
• Author and complete impact assessments for the document management and training sections of change controls.
• Provide system-level and procedural Quality guidance for quality events including deviations, out-of-specification, nonconformance, CAPAs, and change controls, as applicable.
• Deliver end-user training on quality system processes (CAPA, Deviation, OOS, Change Control, etc.) documented and executed within the MasterControl eQMS platform.

Quality Metrics Reporting and Visualization:

• Extract, compile, and present quality metrics and KPIs for site governance forums including Management Review, Tier meetings, and Quality Council; ensure data accuracy and traceability to source systems.
• Collaborate with IT/IS to design, build, and maintain data visualization dashboards that surface key quality metrics and trend data for site leadership and functional teams.

PREFERRED EDUCATION: 

• Bachelor’s degree (BA/BSc) or equivalent in Computer Science, Information Systems, Microbiology, Biochemistry, Chemical Engineering, Bioengineering, or a related scientific or technical field.

PREFERRED EXPERIENCE: 

• Minimum 10 years’ experience in biopharmaceutical or life sciences environments, with demonstrated technical depth in regulated GMP systems.
• Minimum 5 years’ experience in Quality Assurance and Quality Systems roles within GMP manufacturing or clinical operations.
• Proven hands on experience as a system administrator for an enterprise eQMS platform (e.g., MasterControl, Veeva Vault QMS, or equivalent); experience with system configuration, user lifecycle management, and validated system change control strongly preferred.

KNOWLEDGE, SKILLS AND ABILITIES:

• Hands on experience administering systems in cGMP clinical or commercial manufacturing environments required; familiarity with 21 CFR Part 11, Annex 11, and computer system validation (CSV) principles preferred.
• Deep functional expertise with eQMS modules and quality event management workflows (deviations, CAPAs, change management, document control, training management) required.
• Demonstrated ability to work effectively both independently and cross-functionally with Manufacturing, MSAT, Regulatory, Patient Operations, Supply Chain, and external partners to define system requirements, manage project plans, and communicate outcomes to stakeholders.
• Detail-oriented and organized, with strong analytical and problem-solving skills; able to independently prioritize and manage multiple system administration tasks in a dynamic environment.
• Adaptable self-starter with a continuous improvement mindset and the ability to thrive in a fast-paced, clinical-stage biotech environment with evolving system needs.
• Excellent written and verbal communication skills; ability to translate technical system concepts for non-technical audiences and prepare clear documentation for GMP-regulated environments.

Lyell offers its employees a range of compensation and benefits. To assist you with your decision to apply for this role, the following decision to apply for this role, the following information and links to our site highlight our competitive market position and support to our employees and their dependents.

The salary range for this position is $124,000 - 155,000, annually, with the opportunity to earn an annual bonus. The salary range is an estimate, and the actual salary may vary based on Lyell’s compensation practices and an applicant’s qualifications and experience. Employees are also eligible to participate in Lyell’s Equity Incentive Plan.

Our Employee Benefits program is extensive and includes subsidized medical, dental and vision plans from your first day of employment, FSA, Company provided Life and AD&D Insurance as well as STD and LTD Insurance, ESPP, a 401(k) Plan with Company match, mass transit commuter benefits, cell phone reimbursement and a range of supplemental benefits that you may choose to elect. Our paid time-off benefits currently include flexible time off,  8 observed holidays as well as a floating holiday. We also have a winter office shutdown.

At Lyell, we believe that highest performing teams include people from a wide variety of backgrounds and experiences who respectfully challenge each other. We are committed to building an open, diverse and inclusive culture for all employees. Lyell is proud to be an equal opportunity employer and does not discriminate on the basis of race, color, citizenship status, national origin, ancestry, sex, sexual orientation, age, religion, creed, physical or mental disability, medical condition, marital status, veteran status or any other characteristics protected under applicable federal, state and local laws.

Position Overview

Immunome is seeking a highly experienced and collaborative Senior Manager, Analytical Development and QC, Small Molecule to lead analytical method development, validation, and quality control activities supporting our small molecule programs from early development through regulatory submissions and commercialization.

The successful candidate will bring deep technical expertise in small molecule analytical chemistry, understanding of cGMP and ICH expectations, and proven experience operating in an outsourced development model with CDMOs and contract testing laboratories. Reporting to the Director, Analytical Development & QC, this individual will shape Immunome’s small molecule analytical development and QC strategy and advance our oncology pipeline.

Responsibilities

Strategic Leadership

• Develop and execute phase-appropriate analytical development and QC strategies for ADC linker payload components, small molecule intermediates, and drug substance, including specifications and control strategies.
• Provide technical leadership for analytical method development, qualification, validation, and lifecycle management.
• Establish and maintain analytical development plans, stability strategies, and comparability/bridging approaches to support process changes, scale-up, and technology transfers.

Program Oversight and Execution

• Manage execution of analytical testing to support in-process controls, release, stability, and characterization.
• Partner with cross-functional leaders across CMC, Process Chemistry, Manufacturing, QA, and Regulatory to ensure seamless integration of analytical deliverables within development timelines.
• Critically review and interpret analytical data to troubleshoot methods, manufacturing issues, investigate OOS/OOT results, and drive root-cause analysis and CAPA activities.
• Support review of batch records from an analytical perspective.

Vendor and Partner Management

• Manage and provide technical oversight of CDMOs, and contract testing labs to ensure high-quality, timely, and compliant method development, validation, and routine QC testing.
• Lead scope definition, issue resolution, deviations, change controls, and inspection readiness activities.

Regulatory and Documentation Support

• Author and review analytical sections of CMC documents and regulatory submissions (e.g., IND/CTA, NDA/MAA, CTD), including method descriptions, validation summaries, specifications, and stability data.
• Support responses to analytical and quality-related questions from global health authorities and internal stakeholders.
• Ensure all analytical activities comply with cGMP and relevant regulatory/compendial guidance (e.g., ICH Q2, Q3, Q6A, Q7; USP/EP/JP).

Leadership and Collaboration

• Communicate complex analytical concepts, results, and recommendations clearly and effectively to diverse audiences.
• Contribute to building Immunome’s internal analytical capabilities and best practices, including evaluation of new technologies and analytical approaches where appropriate.

Qualifications

• A minimum of a Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, Chemistry, or a related field with 5+ years of industry experience; or an M.S. with 10+ years; or a B.S. with 12+ years. Experience must be in small molecule analytical development and QC within the biopharmaceutical industry.
• Demonstrated experience developing, validating, and transferring analytical methods, small molecule intermediates and drug substance in cGMP environment.
• Hands-on expertise with chromatography and related techniques (HPLC/UPLC, GC, LC-MS, Karl Fischer, spectroscopy) and impurity profiling.
• Experience managing external partners (CDMOs/contract testing laboratories) and stability programs.
• Prior oncology drug development experience preferred.
• ADC linker payload experience preferred.
• Up to 25% travel.

Knowledge and Skills

• Highly skilled in method development using chromatographic and supporting techniques (LC, GC, IC)
• Solid understanding of phase-appropriate control strategies for small molecules (specifications, impurities, stability, and comparability).
• Working knowledge of cGMP expectations and analytical-related ICH/compendial guidance (e.g., ICH Q2, Q3, Q6A, Q7; USP/EP/JP).
• Excellent communication skills — capable of clearly conveying complex data, technical concepts, and recommendations to diverse audiences.
• Exceptional organizational, analytical, and problem-solving skills.
• Ability to work effectively in a fast-paced, dynamic biotech environment and balance multiple priorities.

We are seeking  a Contract Program Manager II to join our Clinical Development Operations team.  This role can be based out of our South San Francisco, CA office, our Bothell, WA office or our Seattle, WA office.  This is a hybrid role with three days in the office.

POSITION SUMMARY:

The incumbent will work with technical product leaders and cross-functional teams and is responsible for developing, delivering and managing integrated project plans, track team progress and support program development to meet business objectives.

KEY ROLE AND RESPONSIBILITIES:

• Partner with team leaders to develop and execute program strategy and goals
• Develop and manage integrated project plan, timelines, deliverables and budgets as necessary, maintaining and updating project schedules and communication dashboard
• Provide meticulous attention to detail tracking team members' workflow to ensure project tasks are Prepare and review project documents including meeting minutes, memos, and emails. Ensure project documentation is current and properly stored
• Facilitate cross-functional team meetings, decision making, risk management and escalation
• Drive execution using timelines, dashboards, action logs and other tools
• Enable cross-functional communication to ensure alignment with internal stakeholders and external collaborators
• Communicate, document and archive project team activities, action items and decisions
• Contribute to building project team system, business processes and culture

PREFERRED EDUCATION:

• BA/BSc in a life science discipline or related field with a minimum of 10 years' experience in the biotech industry with a minimum of 7 years direct project management experience
• MA/MSc in a life science discipline or related field with a minimum of 7 years' experience in the biotech industry with a minimum of 5 years direct project management experience

PREFERRED EXPERIENCE:

• A minimum of 3 years cross-functional clinical development program management experience- experience with late stage clinical development is preferred
• Experience building, managing cross-functional teams for decision making and risk management
• Professional certification-including PMP and/or Agile

KNOWLEDGE, SKILLS AND ABILITIES:

• Demonstrated excellent interpersonal skills, ability to develop relationships with stakeholders and manage conflicts
• Highly motivated, self-starter, willing to help build project management capabilities, team system and processes
• Exceptional verbal and written communication skills and the ability to effectively interact with all levels within the company
• Strong organization and multi-tasking Possesses an understanding of overall drug development process and early phase clinical studies
• Proficient with project management practices, tools, and methodology
• Demonstrated ability to build, lead and motivate project teams across multiple functions
• Collaborative and inclusive management style
• Demonstrated ability to lead discussions, focus on detail and think methodically

Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple late-stage development programs addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain’s biggest problems so patients and their loved ones can flourish. For more information, please visit us at www.axsome.com and follow us on LinkedIn and X.

About This Role

Axsome Therapeutics is currently searching for a field based Long-Term Care (LTC) Specialty Account Manager (SAM) to drive LTC commercial activities for an assigned geography by executing marketing strategies to ensure a successful launch and make a meaningful difference through the execution of commercial activities.

SAMs will be responsible for product performance at a territory level and expected to be a disease state expert, product champion and an account specialist. The SAM will provide account management support and exhibit business knowledge of the local landscape to assess key stakeholders plus future trends within the marketplace.

Job Responsibilities and Duties include, but are not limited to, the following:

• Drive product adoption in LTC facilities
• Proficient in both virtual and live customer engagements
• Effectively call on LTC Care teams, building meaningful relationships across the entire LTC ecosystem: Psychiatrists, Neurologists, nurse practitioners, Physician assistants, Nurses and LTC staff, Closed-door pharmacies, clinical pharmacists, case managers and care coordinators.
• Develop a comprehensive and effective territory business plan inclusive of account plans for targeted LTC facilities aimed at achieving and exceeding quarterly & annual goals established by commercial leadership
• Promote within our approved labeling in a comprehensive, fair, and ethical manner that is consistent with industry specific and corporate legal and regulatory guidelines
• Develop strong customer relationships by better understanding the customer’s needs
• Serve as a resource/consultant to customers and staff regarding payer policies and processes (i.e., eligibility and benefit verification, prior-authorization, and appeals/denials)
• Navigate Market Access and Reimbursement. LTC SAMs must understand: payer requirements, pharmacy fulfillment processes, patient access programs, reimbursement tools such as cover my meds
• Maximize use of marketing resources to maintain and develop customer relationships for the purpose of growing the customers’ confidence to prescribe Axsome medications for appropriate patients
• Communicate territory activity in an accurate and timely manner as directed by management
• Provide feedback to sales and commercial leadership, colleagues, marketing, and other internal departments about changing environment and results
• Successfully complete all training classes in a timely manner
• Complete administrative duties in an accurate and timely fashion
• Manage efforts within assigned promotional budget
• Effectively collaborate across all corporate functions
• Attend medical congresses and society meetings as needed
• Ensure timely access for patients through patient services and savings programs
• Overnight travel as indicated by the needs of the business
• Additional responsibilities as assigned

Qualifications / Requirements 

• Bachelor’s degree from an accredited college or university 
• Minimum of 5 years of pharmaceutical/biotech sales experience, including 2+ years in LTC or account-based selling environments
• Demonstrated experience delivering outstanding results, including Top 10% or Elite/President’s Club performance
• Launch experience strongly preferred 
• Must live within the geography of the assigned territory
• Experience collaborating with cross-functional teams, utilizing differential resources to achieve business goals 
• Proven ability to successfully manage multiple tasks concurrently under accelerated timelines in a dynamic environment 
• Ability to thrive with ambiguity and business environments with high expectations
• Patient support services experience a plus 
• Strong digital marketing aptitude 
• Strong interpersonal, presentation, and communication skills 
• Frequent driving, including extended periods of time behind the wheel
• Prolonged sitting and standing as part of daily job functions
• Ability to lift and carry up to 30lbs regularly
• Overhead reaching required to close and secure liftgates or similar equipment

Salary & Benefits

The anticipated salary range for this role is $100,000 - $150,000. We encourage candidates of all levels to apply as there may be flexibility on final job title and responsibilities. The salary offer will be based on a variety of factors, including experience, qualifications, internal equity and location. Axsome offers a competitive employment package that includes an annual bonus, significant equity and a generous benefits package.

Axsome is committed to equal employment opportunity and providing reasonable accommodations to applicants with physical and/or mental disabilities. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, gender, sex, age, religion, creed, national origin, sexual orientation, gender identity, ancestry, citizenship, marital status, physical or mental disability, medical condition, veteran status, genetic information, or any other characteristic protected by federal, state, or local law.

Axsome Therapeutics does not accept unsolicited resumes from recruiters or third-party recruitment agencies and will not pay placement fees for unsolicited candidates that are sent to hiring managers, the HR team or other Axsome team members. Only approved vendors who have been explicitly asked to support a specific search will receive access to our Applicant Tracking System to submit candidates for consideration.

POSITION SUMMARY

The Associate Director, Statistical Programming will be responsible for strategic planning, executing and quality checking of data programming and statistical analysis deliverables to support clinical trial conduction and prepare submission readiness package. This role provides technical and operational leadership to ensure compliant, high-quality analysis datasets, tables, listings, and figures (TLFs) in accordance with CDISC standards and FDA guidance. This role will operate as an individual contributor and is responsible for enhancing the statistical programming infrastructure of the Biometric department, building and leading a highly efficient data and matrixed statistical programming team (contractors, vendors, CROs, FTEs) over time.

This role will partner closely with Biostatistics, Clinical Data Management, Clinical Operations, and Regulatory Affairs to support submission readiness and successful regulatory interactions.

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

CORE ACCOUNTABILITIES

Specific responsibilities include:  

• Lead statistical programming activities for clinical trials and ensure the timely delivery of high-quality outputs throughout the full study life cycle.
• Review clinical trial protocols, SAP, CRF designs, and EDC deployments, and provide input for EDC edit checks to enhance clinical trial data quality.
• Guide and review outputs from CROs, which may encompass submission datasets, programs, and outputs to ensure the submission package (SDTM and ADaM specifications, SDTM and ADaM programs and datasets, Tables, Listings, and Figures (TLFs) outputs, define.xml, and reviewer guides, etc.)  adheres to regulatory requirements and is compliant with CDISC standards.
• Lead and support statistical programming activities for regulatory submissions including INDs, NDAs, and/or BLAs.
• Review data management plans, data transfer plans, and test EDC deployment to ensure readiness for downstream programming.
• Provide hands-on SAS programming support for key safety and efficacy analyses of clinical trials, as well as ad hoc exploratory and publication analyses as required.
• Mentor and provide technical oversight to statistical and data programmers and contractors.
• Collaborate closely with biostatisticians, study physicians, data management, clinical operations, and safety review teams to review data or programming issues and improve the overall quality of clinical trial data.
• Support internal and external audits, inspections, and regulatory inquiries related to statistical programming deliverables.
• Assist the department head in building the infrastructure of the biometrics department, which may include creating macros and programs, TLF shells, departmental SOPs, and best practices for statistical programming and data traceability.

The successful candidate will have:

• MS in biostatistics, statistics, computer science, or a closely related field, coupled with extensive quantitative analysis methodologies and statistical programming proficiency with a minimum of 10 years of experience in pharmaceutical companies or CROs is required.
• At least 5 years of demonstrated leadership experience in projects and managing, mentoring, and developing teams.
• A solid comprehension of statistical programming principles, advanced SAS programming expertise, extensive experience in the preparation of regulatory submission packages, and substantial knowledge of CDISC standards.
• Exceptional attention to detail and a strong risk-mitigation mindset, a self-driven learner to continuous learning and updating programming skills and therapeutic area (TA) knowledge.
• Excellent verbal, written, and interpersonal communication skills are mandatory for clear and efficient communication and collaboration with cross-functional teams, which may include clinical operations, data management, study physicians, statisticians, and medical writers.
• A sound working knowledge of ICH, FDA, and GCP regulations and guidelines.

Preferred Qualifications:  

• Prior experience with NDA/ BLA submission and interaction with regulatory agencies is highly desirable, as is leading early and late-phase clinical trials.
• Experience in immunology, hematology, or oncology clinical trials is preferred
• Experience with using R in clinical analysis

Physical Requirements:  

• Ability to sit for prolonged periods of time
• Ability to read, interpret, and review detailed technical documents, datasets, tables, listings, figures, and on‑screen material
• This role will ideally be based out of our Seattle, WA office and will be onsite 2 days/week
• If this role is remote, the ability to travel up to 20% as needed

Salary Range: $185,100 - $228,700

Position 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. 

What You'll Do #LI-RV1

The Associate Director/Director, Regulatory Advertising & Promotion is responsible for providing strategic regulatory leadership for promotional materials and external communications across assigned programs or brands. This role ensures that all promotional activities are compliant with FDA regulations, industry guidance, and company policy, while enabling the business to communicate effectively and competitively.

In addition to timely review of materials, the Associate Director/Director is expected to help shape messaging strategy early, anticipate regulatory risk and opportunities, and influence cross-functional partners to drive compliant, compelling communications that enable the business to deliver content and messaging effectively to its stakeholders.

Responsibilities

Strategic Regulatory Leadership

• Serve as the Ad Promo regulatory lead for assigned products (commercial and/or pipeline).

• Provide proactive guidance on promotional strategy, claims development, and risk positioning.

• Partner with Commercial, Medical, Legal, and Clinical teams to align messaging with labeling and data.

• Interpret and apply FDA regulations, OPDP guidance, enforcement trends, and industry standards to business initiatives.

• Assess regulatory risk and recommend clear, practical mitigation strategies.

Promotional Review & Governance

• Lead review and approval of promotional materials through the Medical, Legal and Regulatory review committee (MLR).

• Ensure materials are accurate, balanced, and supported by substantial evidence.

• Provide strategic direction on disease awareness, HCP and patient materials, digital content, and launch campaigns.

• Support advisory boards, speaker programs, and field training materials as needed.

• Contribute to development and refinement of internal SOPs and review processes.

Labeling & Claims Strategy

• Partner with Regulatory Labeling to ensure promotional claims align with approved labeling and clinical data.

• Anticipate labeling implications for promotional planning, especially during launch readiness.

• Support development of core claims documents and messaging frameworks.

Inspection & Enforcement Readiness

• Monitor FDA enforcement actions and emerging trends.

• Support responses to OPDP inquiries or regulatory questions related to promotional materials.

• Contribute to inspection readiness activities related to promotional review processes.

Where You'll Work

This role requires onsite presence at our San Francisco office.

Who You Are

Required

• Advanced scientific degree (PharmD, PhD, MD) or equivalent.

• 8+ years of pharmaceutical experience with 5+ years plus relevant ad promo experience

• Deep understanding of FDA promotional regulations, OPDP expectations, and relevant guidance documents.

• Experience supporting commercial launches and/or late-stage development programs.

• Demonstrated ability to influence cross-functional stakeholders in a matrixed environment.

Preferred

• Experience in rare disease or specialty therapeutics.

Competencies

• Strategic thinker: Balances compliance with business enablement.

• Sound judgment: Makes clear, defensible decisions under ambiguity.

• Influence without authority: Navigates cross-functional dynamics effectively.

• Risk calibration: Knows when to hold firm and when to flex.

• Clear communicator: Delivers direct, actionable guidance.

• You have demonstrated curiosity and adaptability in adopting AI-powered tools and technologies

Impact

This role directly shapes how the organization communicates its science and value to healthcare professionals and patients. The Associate Director/Director is a critical safeguard for regulatory compliance and a strategic partner to the business during growth and launch phases.

Rewarding Those Who Make the Mission Possible

We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return. 

Financial Benefits:

• Market leading compensation 

• 401K with 100% employer match on first 3% & 50% on the next 2%

• Employee stock purchase program

• Pre-tax commuter benefits

• Referral program with $2,500 award for hired referrals

Health & Wellbeing:

• Comprehensive health care with 100% premiums covered - no cost to you and dependents

• Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions)

• Hybrid work model - employees have the autonomy in where and how they do their work 

• Unlimited flexible paid time off - take the time that you need

• Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents

• Flex spending accounts & company-provided group term life & disability 

• Subsidized lunch via Forkable on days worked from our office

Skill Development & Career Paths:

• People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility

• We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp Coaching

• We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities

What You'll Do #LI-TC1

BridgeBio is establishing a dedicated, senior U.S. public policy leadership role focused on CMS, HHS, and coverage and payment policy that directly affects patient access and innovation across the BridgeBio portfolio.

The Executive Director, U.S. Public Policy will own the end-to-end U.S. public policy strategy related to Medicare, Medicaid, and payment models, and will be accountable for shaping policy positions that influence access, reimbursement, and long-term portfolio value, and advising on implementation internally.

This role operates at the enterprise level, advising executive leadership, shaping portfolio strategy, and serving as BridgeBio’s primary public policy authority with U.S. regulators.

Responsibilities

Lead U.S. public policy strategy

• Define and lead BridgeBio’s U.S. public policy strategy, particularly Medicare (Parts B and D), Medicaid, alternative and value-based payment models, IRA implementation, CMMI initiatives, and coverage and reimbursement policy
• Serve as the company’s internal expert on U.S. public policy, advising leadership on policy design, implementation risk, and long-term implications
• Translate complex public policy developments into clear strategic options and recommendations for executive leadership

CMS, HHS, and external engagement leadership

• Act as BridgeBio’s primary interface with CMS and HHS, engaging directly with agency leadership, career staff, and relevant HHS offices
• Bring and leverage an extensive existing network across CMS and HHS to inform strategy and anticipate policy direction
• Represent BridgeBio externally in public policy coalitions, trade associations, and forums where coverage, payment, and access policy are central

Analytical leadership and policy modeling

• Apply strong analytical and modeling skills to assess financial, access, and portfolio-level impacts of U.S. public policy proposals and payment models
• Partner closely with Strategic Finance, Commercial, Market Access, and Government Affairs teams to model implications of Medicare and Medicaid policy changes, reimbursement dynamics, and payment reform initiatives
• Develop rigorous, data-driven policy analyses to support advocacy positions and executive decision-making

Cross-functional executive partnership

• Work collaboratively with Commercial, Government Affairs, Market Access, Strategic Finance, Medical, and Patient Advocacy teams to ensure public policy strategy is fully integrated across the organization
• Serve as a trusted advisor to executive leadership on U.S. public policy matters
• Prepare executive level briefings, scenario analyses, and policy updates

What Success Looks Like

• BridgeBio is recognized as a credible, informed, and effective policy voice with CMS and HHS
• Policy risks and opportunities are proactively identified and integrated into portfolio and commercial strategy
• Executive leadership has clear, data-driven policy guidance to support access, reimbursement, and long-term value creation
• Durable policy frameworks are in place to support multiple affiliates and evolving assets

Where You'll Work

This is a hybrid role and requires in-office collaboration in our Washington DC office.

Who You Are

• 15+ years of experience in U.S. health policy
• Graduate-level degree required (MPH, MPP, JD, PhD, MBA)
• Prior CMS experience, payor, and/or top-tier management consulting experience with deep CMS and HHS exposure strongly preferred
• Extensive expertise in Medicare, Medicaid, and U.S. payment models
• Recognized public policy expert with demonstrated experience engaging CMS and HHS as regulators
• Extensive professional network across CMS and HHS
• Strong analytical, quantitative, and policy modeling capabilities
• Proven ability to operate independently and lead public policy strategy in a complex organization
• You have demonstrated curiosity and adaptability in adopting AI-powered tools and technologies

Rewarding Those Who Make the Mission Possible

We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return. 

Financial Benefits:

• Market leading compensation 
• 401K with 100% employer match on first 3% & 50% on the next 2%
• Employee stock purchase program
• Pre-tax commuter benefits
• Referral program with $2,500 award for hired referrals

Health & Wellbeing:

• Comprehensive health care with 100% premiums covered - no cost to you and dependents
• Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions)
• Hybrid work model - employees have the autonomy in where and how they do their work 
• Unlimited flexible paid time off - take the time that you need
• Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents
• Flex spending accounts & company-provided group term life & disability 
• Subsidized lunch via Forkable on days worked from our office

Skill Development & Career Paths:

• People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility
• We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp Coaching
• We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities

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 Overview

The Associate Director / Director, Total Rewards will strengthen engagement and retention by building a competitive, scalable, and employee-centered total rewards. This role will lead the design and administration of compensation practices, benefits, leave programs, 401(k), equity planning, and rewards & recognition ensuring our offerings attract, motivate, and retain top talent while remaining compliant, cost-effective, and aligned to our culture.  

Responsibilities

Engagement and Retention 

• Develop and execute a total rewards strategy that supports talent attraction, engagement, and retention.  

• Partner with other functions of HR and business leaders to ensure rewards programs reinforce performance, internal equity, and our culture.  

• Translate company growth and workforce needs into scalable and fiscally responsible rewards programs.   

Compensation Programs 

• Lead the development, implementation, and ongoing management of compensation plans, including salary structures, incentive programs, market pricing, pay equity analysis, and compliance oversight.  

• Support equity planning (new hire grants, promotions, refresh cycles, and annual planning) in coordination with Finance, Legal, and the equity administration partner.  

• Prepare for and support the annual compensation cycle (merit, promotion, bonus planning as applicable): tools, timelines, manager guidance, calibration support, and reporting.  

• Assist Chief Financial Officer by researching trends, gathering data and preparing compensation information to be reviewed by executive team, compensation committee, and board of directors.  

Benefits Administration  

• Oversee day-to-day benefits administration including medical, dental, vision, life/AD&D, disability, FSA, and related programs.  

• Own leave administration processes (e.g., FMLA, state leaves, disability coordination), ensuring an excellent employee experience and compliant practices.  

• Manage 401(k) administration: vendor partnership, annual testing support, audits as needed, enrollment and education initiatives.  

• Lead annual benefits renewal: plan design evaluation, cost modeling, vendor negotiations, open enrollment project management, and employee communications.  

• Ensure compliance with applicable regulations (e.g., ERISA, COBRA, HIPAA, ACA) in partnership with legal/benefits vendors and internal stakeholders.  

Rewards & Recognition  

• Own and improve recognition programs that reinforce values and performance (spot awards, peer recognition, and milestone/service awards).  

• Partner with people leaders to ensure recognition is timely, inclusive, and consistently applied across teams.  

Stakeholder Partnership & Influence  

• Serve as a strategic advisor to leaders on total rewards decisions, tradeoffs, and communications.  

• Collaborate closely with HRBPs, Talent Acquisition team, Payroll, Finance, Legal, and People Operations to ensure seamless program delivery.  

• Lead vendor relationships (brokers, carriers, leave administrator, 401(k) provider, compensation survey partners, recognition platform).  

Measurement & Continuous Improvement  

• Monitor costs, utilization, participation, and employee feedback to refine offerings and improve experience.  

• Create scalable documentation, SOPs, and governance for all total rewards programs.  

Qualifications

• Bachelor’s Degree required. 

• A minimum of 8+ years of progressive experience in Total Rewards, Compensation, Benefits, or HR, including program ownership in a scaling organization. 

• Biotech/life science industry experience is strongly preferred.  

Knowledge and Skills

• Hands-on experience with benefits administration (health plans, leave administration, 401(k)) and vendor management.  

• Strong compensation experience including benchmarking roles, creating job architecture/leveling frameworks administering annual compensation cycles, and supporting sales incentive programs.   

• Demonstrated experience with equity administration platforms and stock plan basics.  

• Strong analytical skills (modeling, reporting, and presenting insights) and ability to translate data into clear recommendations.   

• Strong stakeholder influence and experience partnering cross-functionally with Finance, Legal, Payroll, and senior leaders.  

• Excellent facilitation, program design, and communication skills.  

Position Overview

The Director / Associate Director, Learning, Development & Performance Management will be responsible for determining and executing People and Culture Programs that will enhance performance, develop leadership capabilities, and ensure the organization has the capabilities and engagement to thrive as we rapidly scale our team. 

Responsibilities

Engagement, Performance & Development  

• Build an enterprise L&D strategy explicitly focused on enhanced engagement, retention, and performance.  

• Partner with people leaders and executives to continue highlighting the importance of embedding learning and development into the culture.  

Leadership Development & Manager Enablement  

• Design and deliver leadership development programs for new, experienced, and senior leaders.  

• Equip managers to engage and retain their teams through strong fundamentals: coaching, feedback, recognition, inclusive leadership, career development, and performance conversations.  

• Develop toolkits and training that make it easy for leaders to apply learning on the job.  

Performance Management Programs  

• Own and continuously improve performance management processes (goal setting, check-ins, development plans, calibration, and performance reviews).  

• Ensure managers are trained and supported to engage in growth conversations that are clear and motivating.  

• Use performance insights to identify where teams need additional support and development.  

• Create and implement competency framework for enhanced performance.  

Capability Assessment & Talent Building  

• Help leaders assess current team skill capabilities by determining strengths, talent gaps, and actions to enhance current capabilities and minimize talent gaps.   

• Build and maintain practical capability frameworks (leadership + function-specific) that connect role expectations to development actions.  

• Enable succession planning and internal mobility by identifying talent, readiness, and development pathways.  

Measurement & Continuous Improvement  

• Define success metrics tied to engagement and retention and determine actions to improve metrics.  

• Use data and feedback to evolve programs to meet the needs of a fast-growing organization.  

  Qualifications

• Bachelor’s Degree required.  

• A minimum of 8+ years of HR experience, focused on supporting and administering learning and development, including building programs at scale.  

Knowledge and Skills

• Demonstrated success driving engagement and retention through talent development (leadership programs, manager enablement, performance management).  

• Strong stakeholder influence and demonstrated successful partnership with executives and leaders to shift behaviors and build accountability.  

• Excellent facilitation, program design, and communication skills.  

• Experience in pharma/biotech/life sciences or other regulated environments preferred. 

• Experience implementing competency frameworks, 360s assessments, and learning technology preferred.  

• Experience scaling L&D in a high-growth organization preferred. 

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

Job overview:  

The Regional Sales Director is a first-line sales leadership role responsible for building, developing, and leading a high-performing specialty sales team supporting the launch and growth of an innovative mental health therapy. This leader will drive regional execution of commercial strategy by partnering with certified treatment centers, psychiatrists, and integrated care systems while ensuring alignment with regulatory, safety, and patient-access frameworks. The Regional Sales Director will play a critical role in shaping a new therapeutic category, and creating a culture of integrity, collaboration, and patient-centricity.

Location: Remote in Mid-Atlantic (Raleigh, NC, Washington DC).

Reports to: Director, National Sales.

Roles and responsibilities 
(Include but are not limited to): 

• Recruit, onboard, and lead a team of Territory Account Managers
• Foster a high-accountability, psychologically safe culture that promotes coaching, development, and collaboration
• Set clear expectations and performance standards aligned with company launch objectives
• Drive successful regional execution of the commercial launch strategy and identify opportunities to expand the treatment ecosystem
• Ensure field readiness around clinical data, patient identification, treatment protocols, and site-of-care logistics
• Foster strategic relationships with psychiatrists, treatment centers, behavioral health systems, academic centers, and Key Opinion Leaders (KOLs)
• Partner cross-functionally with Medical Affairs, Market Access, Training, Patient Support, etc.
• Provide field insights to inform brand strategy and launch optimization
• Analyze regional performance metrics and develop action plans to drive results
• Manage regional budgets, forecasting, and territory alignment
• Conduct regular field coaching to strengthen clinical selling skills and consultative engagement with mental health providers

Candidate Profile:

• Bachelor’s degree required (advanced degree preferred)
• 8-10+ years of pharmaceutical or biotech sales experience
• 5+ years of first-line sales leadership experience
• Demonstrated success launching specialty or neuroscience therapies
• Experience in psychiatry, CNS, or behavioral health markets
• Experience launching therapies requiring site certification, REMS, or specialized administration models and/or a background working with IDNs, academic medical centers, and specialty treatment sites
• Experience building teams in startup or pre-launch biotech environments

What You'll Do 

The Vice President, Regulatory Affairs will oversee BridgeBio’s Operations and Labeling  functions, and will also support regulatory strategy as needed. This leader will manage a team of subject matter experts and leaders responsible for Regulatory Operations, Regulatory Business Operations, and Labeling, ensuring excellence, compliance, and strategic alignment across all regulatory activities.

The VP will ensure the organization has the right infrastructure, technology, and governance to support global submissions, and compliant labeling, while integrating advanced capabilities such as artificial intelligence to drive efficiency and insight.

The ideal candidate brings previous broad global regulatory expertise spanning for both development and commercial products, labeling, and operations, combined with understanding and experience in regulatory affairs, and the ability to lead in a fast-paced, entrepreneurial environment. #LI-TC1

Responsibilities

Strategic & Functional Leadership

• Provide overarching leadership and strategic direction for the Regulatory Operations, Regulatory Business Operations, and Labeling, each led by experienced subject matter experts and team leaders

• Partner with the Chief Regulatory Officer and Regulatory Leaders to ensure alignment of operational strategy with regulatory goals

• Foster an infrastructure that enables  innovation, speed, and accountability within and across the regulatory organization

• Lead the integration of artificial intelligence and advanced digital tools across systems and processes to enhance productivity, compliance, and decision-making

• Establish and maintain the framework for regulatory SOPs, work instructions, and desk procedures to ensure consistency, compliance, and clarity

• Lead and develop a team of team leaders and subject matter experts, fostering a collaborative and high-performance culture

• Ensure effective resource planning, talent development, and staff augmentation as needed to support corporate priorities

• Promote continuous learning and professional development within the broader regulatory organization

Where You'll Work

This is a hybrid role based either in San Francisco, or Washington, D.C. Remote will also be considered.

Who You Are

• Advanced degree in a scientific discipline (PharmD, PhD, MD, or MS) required.

• 15+ years of progressive regulatory experience in the biopharmaceutical industry, including leadership of multidisciplinary regulatory teams.

• Proven experience in labeling strategy and operations for development and commercial products, with deep understanding of global submission requirements and post-approval obligations.

• Demonstrated expertise in establishing and managing regulatory systems (e.g., Veeva Vault, RIM) and process governance frameworks (SOPs, WIs, desk procedures).

• Strong working knowledge of clinical and nonclinical regulatory strategy and interactions with global health authorities.

• Track record of leading or enabling digital transformation or AI integration within regulatory or adjacent functions.

• Exceptional leadership, communication, and influencing skills, with the ability to operate effectively in a matrixed, fast-paced environment.

• You have demonstrated curiosity and adaptability in adopting AI-powered tools and technologies.

Rewarding Those Who Make the Mission Possible

We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return. 

Financial Benefits:

• Market leading compensation 

• 401K with 100% employer match on first 3% & 50% on the next 2%

• Employee stock purchase program

• Pre-tax commuter benefits

• Referral program with $2,500 award for hired referrals

Health & Wellbeing:

• Comprehensive health care with 100% premiums covered - no cost to you and dependents

• Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions)

• Hybrid work model - employees have the autonomy in where and how they do their work 

• Unlimited flexible paid time off - take the time that you need

• Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents

• Flex spending accounts & company-provided group term life & disability 

• Subsidized lunch via Forkable on days worked from our office

Skill Development & Career Paths:

• People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility

• We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp Coaching

• We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities

Position Overview

BridgeBio is seeking a reliable and highly organized Office Assistant to support the day-to-day operations for the Office of the Chief Regulatory Officer (OCRO), in our Washington, DC office. This role is fully in-office and is responsible for maintaining an efficient, professional, and welcoming workplace environment at BridgeBio’s DC site. The ideal candidate is proactive, detail-oriented, and comfortable providing light administrative support to BridgeBio leadership and staff as needed.

Key Responsibilities

• Serve as the primary on-site point of contact for BridgeBio Washington, DC office operations and facilities needs.
• Coordinate office logistics, including mail distribution, shipping/receiving, and supply inventory management for the BridgeBio DC office.
• Order and maintain office supplies, kitchen supplies, and other necessary materials for BridgeBio staff.
• Ensure common areas, conference rooms, and workspaces are organized and presentable to BridgeBio standards.
• Support meeting logistics, including scheduling BridgeBio conference rooms, setting up meeting spaces, and coordinating catering when needed.
• Liaise with building management, landlord, vendors, and service providers for maintenance or operational needs on behalf of BridgeBio.
• Assist with onboarding logistics for new BridgeBio OCRO hires (workspace setup, badge coordination, BridgeBio IT/security account coordination, office orientation).
• Provide executive/administrative support to BridgeBio OCRO leadership such as calendar coordination, document preparation, expense submission, and travel booking assistance.
• Help plan and coordinate small BridgeBio office events or team gatherings.
• Maintain BridgeBio DC office documentation, procedures, and vendor/contact lists.
• Perform other administrative and operational duties as assigned to support BridgeBio’s Washington, DC operations.

Qualifications

• 5+ years of experience in office management, administrative, or office assistant role.
• Strong organizational skills with the ability to manage multiple tasks simultaneously.
• Excellent written and verbal communication skills.
• Proficiency in Microsoft Office (Outlook, Word, Excel, PowerPoint) and/or Google Workspace.
• Professional demeanor with strong interpersonal skills.
• Ability to work independently in a fully in-office environment.
• High level of discretion and ability to handle sensitive information.
• Flexible and adaptable in a dynamic work environment.

Preferred Qualifications

• Experience supporting senior leadership.
• Prior experience in a corporate, biotech, or professional services environment.
• Experience coordinating vendors or managing small office budgets.
• Ability to learn and develop proficiency in using a wide range of office technologies including business applications, software, printers, and computer hardware and accessories.
• Comfortable troubleshooting common office technology issues in support of printing, desktop displays, computer accessories, etc.
• Experience managing complex executive calendars and shared mailboxes
• Experience in website content administration via Microsoft SharePoint
• Familiarity with procurement and expense management systems, E.G. Coup and SAP Concur

Work Environment & Schedule

• This position is based in BridgeBio’s Washington, DC office and requires full-time, in-office presence during standard business hours. This is a temporary/contract role with an anticipated duration to be determined based on BridgeBio’s business needs.

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 SUMMARY

Umoja Biopharma is seeking a driven Scientist to understand and assess the potency of lentiviral drug products. This role will develop early- and late-stage potency methods for release of drug substance/product and generate data packages to support regulatory submissions. The position will work closely with other functions to deliver qualified/validated QC release and characterization assays, generate associated documentation, and oversee transfer of methods internally or externally to a CMO/CRO.

As a laboratory-based position within the technical operations organization, this position will play a critical role in advancing Umoja’s pipeline and analytical development capabilities.

This role will be onsite 5 days/week based out of our Seattle, WA location.

CORE ACCOUNTABILITIES

Specific responsibilities include:  

• Successful design, execution, analysis, and documentation of experiments to develop analytical methods and key data packages for lentiviral gene therapies.

• Perform experiments to support analytical development and product characterization using advanced techniques including multicolor flow cytometry, ELISAs, Western blots, qPCR/dPCR, signal transduction and cytokine assays.

• Oversee the qualification of analytical methods.
• Author, review and approve technical documents including electronic notebook entries, standard operating procedures, test methods, technical reports, etc.

• Present findings on method development and communicate interpretation and strategic plans related to the potency of our drug product to cross-functional teams.
• Foster good teamwork and communication. Build a reputation of excellence as an individual and as a team.
• Collaborate with stakeholders within Analytical Development (Product Sciences and Process Analytics teams) and cross-functionally with Quality Control, CMC, Translational Medicine, Process Sciences, Discovery, and Vector Biology
• All other duties as assigned

The successful candidate will have:

• PhD/MS/BS in Immunology, Cellular Biology, Molecular Biology or related discipline with at least 0+/8+/10+ years of experience, respectively; equivalent combination of education and experience will be considered
• Proven track record in cell-based method development, including troubleshooting assays, experimental design, execution, and evaluation of data
• Ability to work in a fast-paced environment with broad responsibilities, meet deadlines, and prioritize work on multiple projects
• Strong communication skills in technical writing and oral presentation. Respectful of others and open to new ideas.

Preferred Qualifications:  

• Hands-on experience with multicolor flow cytometry, cell-based assays, ELISAs, viral transduction, and qPCR/dPCR
• Experience qualifying and transferring analytical methods to a QC lab or CMO/CRO
• Experience developing and qualifying potency methods according to ICH/USP guidelines and authoring method documentation

Physical Requirements:  

• Ability to perform standard laboratory tasks with appropriate PPE

• Perform physical tasks required to support laboratory work, including standing, walking, bending, kneeling, sitting, working with your hands in a biosafety cabinet, and occasionally moving materials up to 50 pounds
• Ability to spend prolonged periods of time working on a computer
• Ability to work onsite 5 days/week

Salary Range: $122,000 - $150,800

Kx Advisors provides strategic support to executives at leading Pharmaceutical and Medical Device companies. 

The primary role of a Manager, Life Sciences Strategy Consulting is to handle the day-to-day management of multiple engagements at a time. Managers set the project schedule, provide direction to the consultants on the projects, and serve as a coach and mentor to consultants. Managers may act as the primary contact for the client and are expected to be able to engage with the client independently on day-to-day matters. Managers support business development by providing consistent project delivery with repeat clients and may support the full lifecycle of BD activities as directed by practice leaders. 

As a Manager, you’ll: 

• Be responsible for managing multiple engagements from start to finish, including setting project schedules, guiding team members, and interacting directly with clients 

• Lead small project teams of consultants, providing direction and coaching to help the team complete research and prepare documentation for client presentations 

• Support and contribute to the business development lifecycle by delivering high-quality work to existing clients and establishing client relationships 

• Serve as a strategy and thought partner to clients and senior officers of the firm 

• Act as a key point of contact between the team, senior officers of the firm, and clients 

Required Qualifications: 

• 5-6 years of strategy consulting, market research, or other relevant project-based work experience 

• B.S. or B.A degree from a top four-year college or university in Science, Health, or Business concentration 

• Ph.D. or Master’s degree preferred 

• Healthcare experience preferred at either of the following: 

• A leading management consulting firm 

• Pharmaceutical, BioTech, or Medical Device company preferably in Strategy, Marketing, Operations, or Business Development function 

• Business research and analysis experience, with demonstrated ability to synthesize data and draw accurate, logical conclusions 

• Demonstrated experience successfully leading workstreams and small project teams 

• Demonstrated experience working and presenting to senior business leaders 

• Foreign language skills preferred, but not required 

• Excellent verbal and written communication 
• Excellent people management skills

Salary range: $160,000-170,000 base plus bonus eligible

The salary range provided represents what a potential hire may expect to earn in this role at Kx Advisors. Actual salary decisions will be influenced by several factors that we use to determine overall fit, including experience (both direct and indirect), education, training, demonstrated qualifications, and organizational need. Salary is only one component of the total rewards package offered at Kx Advisors. Kx Advisors offers medical, dental, and vision healthcare benefits for eligible roles.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, or any other legally protected basis, in accordance with applicable law.

Role Description:

We are seeking a dynamic Project Manager to lead customer-facing mRNA and lipid nanoparticle (LNP) projects, with a primary focus on LNP development and delivery. You will be responsible for ensuring all project deliverables are executed on time, within scope, and aligned with client expectations.

The ideal candidate brings a solid scientific foundation, exceptional communication skills, sharp problem-solving abilities, and strong business acumen. You’ll serve as the key liaison between external clients and internal cross-functional teams — from R&D to manufacturing — requiring agility, diplomacy, and a results-driven mindset. Success in this role demands someone who thrives in GenScript’s fast-paced, collaborative, and high-performance culture.

Key Responsibilities:

• Partner with Commercial and Production teams to ensure seamless project execution and customer satisfaction.
• Capture detailed project requirements, clarify specifications, and align expectations with clients.
• Develop and communicate customized project plans to clients and internal stakeholders.
• Monitor order production progress, evaluate performance metrics, and implement process improvements.
• Provide scientific troubleshooting for unexpected results and propose data-driven solutions.
• Deliver timely project updates to clients via email/telecom, adhering to agreed milestones.
• Lead cross-functional coordination across all project phases (initiation to closure).
• Address client complaints or quality concerns, collaborating with Production to resolve issues.
• Maintain comprehensive project documentation (reports, records, and compliance files).
• Support Production in analyzing and expanding service offerings for the US market.
• Serve as an R&D consultant, translating client needs into actionable research plans.
• Represent the company at customer visits and scientific events (conferences, workshops).
• Fulfill additional tasks assigned by Project Leaders, upholding service excellence.

Qualifications:

• Master’s degree or higher in Chemical Engineering, Pharmaceutical Sciences, or a related field.
• Strong technical foundation in RNA biology and lipid nanoparticle (LNP) formulation, with hands-on laboratory or process development experience.
• Prior project management experience preferred — demonstrated success in coordinating cross-functional teams to deliver projects on time, within scope, and on budget.
• Direct research or development experience with mRNA and LNP platforms is a strong plus.
• Customer-centric mindset with excellent interpersonal and client-facing communication skills — both written and verbal.
• Proficient in Microsoft Office Suite and familiar with common bioinformatics or lab data management tools.
• Highly organized with strong analytical, prioritization, and time management skills.
• Proven ability to juggle multiple projects simultaneously without compromising quality or deadlines.
• Resilient under pressure — thrives in fast-paced, high-stakes environments.

Benefit:

• Medical Insurance/ Vision Insurance/ Dental Insurance
• 401(k) & Retirement Savings Plan (RSP)
• Short Term Disability Insurance
• New Child Leave
• Paid Time Off
• Paid Company Holidays per year
• Paid Sick Days (earned based on hours worked)
• Compassionate Leave
• Jury Duty Leave
• Float day
• Personal days

Perks: 

• Free colleague meals during shift
• Onsite massages Charis
• Onsite gyms

Compensation:
Salary range: $70,000 – $85,000 total compensation, including bonus, depending on experience and qualifications.

GenScript is looking for a highly motivated and scientifically rigorous Nanoparticle Formulation Scientist to join our RNA team. This position will focus on developing novel lipid nanoparticle formulations for RNA delivery.   

Responsibilities:

• Develop new lipid nanoparticle formulations (lipid or other polymers) platform for mRNA, DNA, RNA, peptide delivery, to achieve targeted delivery for different disease needs, like neuronal, brain, muscle, bone marrow cell, etc.
• Develop method for characterizing and evaluating physical characteristics for antibody decorated LNPs.
• Process development for high throughput LNP preparation and downstream process to improve production efficiency.
• Produce formulations for related RNA projects, supporting functional assays for in vitro evaluation.
• Maintain relationships with customers, participate in scientific meetings or customer meetings.
• Write study protocols, technical reports, and SOPs to support mRNA product development projects.
• Interact with IP counsel to assist with patent prosecution.
• Monitors supply inventory and identifies any products required.
• Maintains work area, equipment, department and all storage areas in a clean, neat and orderly manner.
• Perform other duties as needed.

Requirements:

• Master or PhD's degree in pharmaceutical science, chemistry, biochemistry, chemical engineering or related field. 
• Strong knowledge of lipid and polymeric nanoparticle delivery technologies
• >4 years of relevant experience in nucleic acid delivery with hands-on experience in lipid nanoparticle formulation and characterization
• Extensive experience with production and analytical characterization of nanoparticles
• Proficiency in all molecular biology techniques for mRNA and protein expression (RT-PCR, ELISA, Western blot, Flow-cytometry, etc) and RNA-related analytics (ribogreen, gel electrophoresis, capillary electrophoresis, etc).
• Works collaboratively with team members to support each other
• Excellent communication and problem-solving skills
• A sense of humility and an eagerness to continue to learn and contribute to a supportive team

Benefit:

• Medical Insurance/ Vision Insurance/ Dental Insurance
• 401(k) & Retirement Savings Plan (RSP)
• Short Term Disability Insurance
• New Child Leave
• Paid Time Off
• Paid Company Holidays per year
• Paid Sick Days (earned based on hours worked)
• Compassionate Leave
• Jury Duty Leave
• Float day
• Personal days

Perks: 

• Free colleague meals during shift
• Onsite massages Charis
• Onsite gyms

Compensation:
Salary range: $80,000 – $120,000 total compensation, including bonus, depending on experience and qualifications.

Position Overview

Immunome is seeking a highly experienced and strategic HCP Personal Promotions Marketing Lead to lead the U.S. HCP promotional strategy and drive best-in-class field/personal execution for Varegacestat. This role serves as the primary architect of the brand’s HCP clinical narrative—shaping positioning and claims strategy to enable high-quality, compliant HCP engagement. Reporting to the Marketing Brand Lead, this leader will spearhead development of HCP promotional messaging and campaigns, lead creation of field-facing resources, and partner closely with Sales, Sales Training, Medical, Market Development, Legal, Regulatory, and Commercial Operations to deliver launch readiness and sustained field adoption and execution. Success in this role requires deep commercialization expertise in oncology, strong field acumen, and an ability to operate effectively in an entrepreneurial biotech environment.

Responsibilities

HCP Promotional Strategy and Core Messaging Development

• Lead the U.S. HCP promotional strategy for Varegacestat, ensuring alignment to overall brand strategy and evolving market dynamics.
• Develop and maintain HCP positioning, core narrative, messaging architecture, and claims strategy grounded in customer insights and clinical evidence.
• Translate market research, competitive intelligence, and field feedback into clear, actionable strategic briefs that guide creative development and promotional execution.
• Define success metrics for HCP promotion (e.g., message pull-through, call effectiveness, material utilization) and drive continuous improvement based on performance insights.

Personal Marketing Tactical Development and Execution

• Lead development of the unbranded DSE plan to build pre-launch market readiness.
• Lead development of personal promotion assets and field resources to enable high-impact engagements.
• Drive end-to-end execution from concept through approval, production, and deployment—ensuring high quality, on-time delivery, and practical usability in the field.
• Partner with MLR/PRC to ensure materials are compliant, accurate, balanced, and consistent with FDA regulations, OPDP expectations, and Immunome standards.

Field Stewardship

• Lead the field advisory committee and translate learnings into improvements across messaging, materials, and execution.
• Partner with Sales and Sales Training to build launch and ongoing training that reinforces the brand story, clinical narrative, and compliant message delivery.
• Collaborate with the Market Development team to analyze and synthesize market insights and drive education effectiveness through KOL engagement and partnership.

Brand Leadership and Operational Excellence

• Collaborate with all HCP marketing channel leads to ensure HCP promotion strategy and messaging are consistently executed across marketing executions.
• Support the Brand Lead in annual brand planning, including objectives, priorities, and launch-critical milestones.
• Own HCP personal promotion budgets, timelines, and scope of work; drive disciplined project management and clear accountability across internal and external teams.

Qualifications

• Bachelor’s degree required; advanced degree (e.g., PharmD, MBA) preferred.
• A minimum of 10 years of experience in pharmaceutical, biotech, or healthcare marketing, with a strong focus on HCP marketing
• Oncology launch experience required.
• Oncology sales experience preferred.
• Proven track record translating clinical data into compelling, compliant promotional narratives, messaging frameworks, and creative direction.
• Strong understanding of MLR/PRC processes, claims substantiation, and OPDP regulations.
• Demonstrated ability to thrive in a fast-paced biotech environment.
• Ability to travel ≥30%, including occasional weekends.

Knowledge and Skills

• Deep knowledge of U.S. HCP promotion and field sales dynamics, including the realities of call execution and the drivers of field adoption.
• Ability to build clear, differentiated messaging and equip the field with tools that are clinically credible, customer-relevant, and compliant.
• Strong analytical and problem-solving skills, with the ability to leverage market research and performance data to inform decisions and optimize impact.
• Strong project management and operational execution skills; able to manage multiple workstreams and launch-critical deadlines in a fast-paced environment.
• Excellent communication, storytelling, and presentation skills—able to simplify complex clinical information for varied audiences.
• Experience managing agencies/vendors, budgets, and complex project plans with strong operational rigor and attention to detail.
• Strong cross-functional leadership skills, including the ability to influence without authority and effectively mentor and develop junior marketers.

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 an onsite Senior IT Systems and Support Technician to serve as an experienced technical lead and key contributor to enterprise systems administration, infrastructure operations, IT service management, and cybersecurity within a regulated biotech environment. 

This role blends advanced Tier 3 support with hands-on systems administration across Microsoft 365, identity and endpoint management, enterprise applications, and laboratory systems. The ideal candidate has strong experience in ITIL-based environments and hands-on expertise with ServiceNow IT Service Management (ITSM). 

This person will help ensure the reliability, security, scalability, and regulatory compliance of corporate and GxP-regulated IT systems supporting teams across the organization. 

Responsibilities

Advanced Technical Support 

• Serve as Tier 3 escalation for complex technical issues across endpoints, infrastructure, applications, and cloud environments. 
• Mentor and provide guidance to Tier 1 and Tier 2 support technicians.  
• Serve as a senior power user and operational subject matter expert for ServiceNow. 
• Ensure complete and high-quality documentation of incidents, changes, and resolutions within ServiceNow. 
• Support continuous improvement of ITSM processes aligned with ITIL best practices. 
• Develop SOPs, knowledge base articles, and technical documentation. 
• Coordinate support activities with IT Managed Service Providers (MSPs), vendors, and internal partners. 
• Participate in on-call rotation and after-hours support as required. 

Systems Administration and Enterprise Application Support

• Administer Microsoft 365 (Exchange Online, Teams, SharePoint, Cloud PC, Entra ID). 
• Serve as system administrator for business-critical enterprise applications (ERP, CRM, HRIS, EDMS).
• Provide IT support for research and development laboratory systems 
• Oversee endpoint management platforms (Intune, JAMF, NinjaOne).
• Manage Windows and macOS workstations, mobile devices (iOS and Android), and client software applications. 
• Follow formal change management processes for regulated systems. 
• Contribute to infrastructure planning and lifecycle management initiatives.

Cybersecurity and Compliance Support 

• Serve as secondary administrator for selected cybersecurity systems. 
• Assist with security incident response and risk remediation efforts in collaboration with internal leadership and external SOC/MSP partners. 
• Support Endpoint Detection and Response (EDR), patch management, and device compliance programs. 
• Help manage identity and access controls (MFA, SSO, RBAC, conditional access). 
• Maintain GxP-regulated systems in compliance with FDA 21 CFR Part 11 and data integrity requirements. 
• Partner with Finance, Legal, and Quality during regulatory audits and inspections.

Qualifications

• A minimum of 5+ years of progressive IT support and systems administration experience. 
• A minimum of 2+ years in a Tier 3 or senior technical role. 
• Experience in life science regulated industries (biotech, pharma, medical device) strongly preferred.

Preferred Certifications

• Microsoft (M365, Azure, Intune, Windows Server) 
• ITILv4 Foundation 
• ServiceNow Certified System Administrator (CSA) 
• CompTIA A+, Network+, Security+ 
• Security-related certifications (CySA+, CISSP, or equivalent) a plus 

Knowledge and Skills

• Strong hands-on experience with ServiceNow ITSM. 
• Experience supporting on-premise and cloud computing environments. 
• Strong troubleshooting, documentation, and communication skills. 

Sales Development Representative

The Inside Sales, Sales Development Representative is responsible for lead generation and qualification for all platforms, Chromium, Visium and Xenium, across new and existing academic, government and medical center research institutions as well as biotech/pharma and service providers. Additionally, this role will work independently to engage with new and existing potential customers for platform/product awareness through various channels (e.g., web inquiries, email campaigns, webinars) to generate qualified leads and coordinate with Account Managers, Xenium Capital Specialists and Scientific & Technology Advisors for scheduling meetings and presentations.  This is a remote position.

What you will be doing:

• Develop and execute independent lead generation strategies, utilizing research techniques to identify high-value prospects; maintaining strong collaboration with the Marketing team to leverage targeted campaigns and optimize lead flow
• Responsible for lead generation and qualification for all platforms – Chromium, Visium, and Xenium.
• Track, report on, and participate in cross-functional initiatives aimed at driving revenue growth
• Foster strong working relationships and execute clear process flows for handoffs with cross-functional departments (e.g., Marketing, Product Management) to develop and execute territory-specific sales plans
• Support the broader Commercial organization to improve the sales cycle time. 
• Responsible for updating the CRM system to reflect accurate opportunities and pipeline.

Minimum Requirements:

• Bachelor's degree in Biology, Molecular Biology, Biochemistry or related field; equivalent industry experience
• 0-1+ years experience in inside sales or business development roles; preferably in the academic, life sciences or biotechnology industries
• Adept at identifying ideal customer profiles and utilizing various research techniques to generate qualified leads
• Skilled at uncovering customer needs and pain points, effectively demonstrating how the company's products and services provide compelling solutions
• Proficiency in following established sales methodologies and navigating the sales cycle from initial contact to qualification and opportunity creation
• Proficiency in using CRM software and other sales tools for efficient lead management, activity tracking, and reporting
• Skilled at coordinating with internal teams to address customers queries in an outbound or inbound sales generation
• Outstanding relationship building, interpersonal and communication skills
• Proficient with Microsoft Word, Excel and Outlook and CRM database
• Fluency in English; ability to speak additional languages highly desirable.

 Preferred Skills and/or Experience:

• NGS Sales experience
• Experience of using SFDC
• Proven successful sales experience with a technical product line

#LI-Remote

#LI-JF1

Company Overview

Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics, drawing on leadership that previously played key roles in the design, development, and commercialization of cutting-edge therapies, including antibody-drug conjugate therapies. Our pipeline includes varegacestat, a late-clinical stage GSI; IM-1021, a clinical-stage ROR1 ADC; and IM-3050, a FAP-targeted radiotherapy that recently received IND clearance. We are also advancing a broad portfolio of early stage ADCs pursuing undisclosed solid tumor targets.

Position Overview

Immunome is seeking a strategic Patient Marketing Lead to design and deliver a best-in-class, end-to-end patient experience. Reporting to the Marketing Brand Lead, this individual will shape how patients are identified, educated, activated, and supported throughout their disease and treatment journey. Serving as the internal champion for the patient voice, the role translates complex clinical data into meaningful, patient-centric resources and drives high-impact media strategies to reach those in need. In close collaboration with HCP marketing and patient services, this leader will help ensure a seamless transition from awareness to access and ongoing support. The ideal candidate brings deep oncology expertise and a strong foundation in patient-centric marketing.

Responsibilities

Patient Strategy

• Develop and execute a comprehensive U.S. patient marketing strategy across the product lifecycle, including unbranded disease awareness and branded campaigns
• Maintain and continuously refine the patient journey by identifying new inflection points, emotional hurdles, and barriers to treatment through ongoing insights collection
• Lead patient-focused market research, in collaboration with the market insights team, to ensure all brand messaging resonates with the lived experience of patients with desmoid tumors

Resource and Digital Ecosystem Development

• Lead the creation of all patient-facing materials (i.e., patient discussion guide, patient starter kit) and partner closely with the HCP Marketing Lead to ensure patient resources are effectively utilized by the field in the clinical setting
• Design and implement an integrated digital ecosystem (e.g., branded patient websites, paid search, social, CRM, programmatic) that supports education, activation, and treatment adherence
• Establish foundational metrics/KPIs and optimize performance in real-time

Leadership and Collaboration

• Lead the internal integration of patient insights across the organization, partnering with cross-functional teams to bridge the gap between clinical data and patient experience, ensuring a seamless and unified brand journey
• Partner with patient services and market access teams to build messaging and support tools that address affordability, reimbursement, and treatment continuity
• Coordinate with the Patient Advocacy team to ensure brand strategies align with the broader goals of the desmoid tumor community

Qualifications

• Bachelor’s degree required; Advanced degree (e.g., PharmD, MBA) preferred
• Oncology launch experience required
• 7+ years of experience in pharmaceutical, biotech, or healthcare marketing, with a strong focus on patient marketing
• Proven success in digital patient marketing (web, social, SEO/SEM, CRM, and paid media strategy) and media planning and execution
• Deep understanding of the patient journey and emotional drivers of behavior in rare oncology disease populations
• Experience collaborating with patient services (patient advocacy and PSP) to develop aligned messaging and support tools
• Demonstrated ability to thrive in a fast-paced biotech environment
• Ability to travel ≥20%, including occasional weekends

Knowledge and Skills

• Ability to build clear and differentiated patient-friendly messaging to convey clinical benefit
• Strong analytical and problem-solving skills, with the ability to leverage market research and performance data to inform decisions and optimize impact
• Strong project management and operational execution skills; able to manage multiple workstreams and launch-critical deadlines in a fast-paced environment
• Excellent communication, storytelling, and presentation skills—able to simplify complex clinical information for varied audiences
• Experience managing agencies/vendors, budgets, and complex project plans with strong operational rigor and attention to detail
• Strong understanding of MLR/PRC processes, claims substantiation, and OPDP regulations
• Strong cross-functional leadership skills, including the ability to influence without authority

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.

We are seeking a Vice President to help lead strategic communications efforts for our biotech, AI-supported health research, and bio sciences clients. This is a high-impact role for a seasoned communications leader who understands the intersection of breakthrough science and compelling storytelling. You will serve as a strategic advisor to senior-level clients, help lead cross-functional teams, and drive earned media placements in top-tier, scientific and philanthropic outlets.

• GMMB has a hybrid work schedule with at least three days in office presence.

• Ideally, this position will be based in Seattle, WA or San Francisco, CA. We are open to candidates located in Washington, DC if you're able to work West Coast hours.

• Salary range - $110,000 - $150,000 

You are... a Vice President who knows...

• Client Strategy & Consultation
  • Provide strategic counsel to biotech, life sciences, nonprofit and philanthropic clients on communications positioning, media strategy, narrative development, and crisis communications
• Media Relations & Placement
  • Cultivate and expand relationships with key journalists covering advances in biotech—including mainstream and non-traditional outlets and influencers (e.g. podcasts, Substack authors, etc.)
  • Advise on proactive and reactive media, messaging, and crisis mitigation strategies
  • Shape proactive media strategies and contribute ‘outside the box’ opportunities that elevate client narratives
  • Pitch stories proactively; secure high value earned media placements
  • Translate complex scientific and technical topics into compelling narratives that resonate with policymakers, media, and the public
• Account Management
  • Develop and execute integrated communications strategies
  • Project manage complex initiatives with tight deadlines and multiple stakeholders
  • Manage to client budgets efficiently and effectively
• Team Leadership & Development
  • Foster a collaborative, inclusive and high-performing culture
  • Lead and mentor account teams; provide coaching and professional development for junior staff
  • Help shape account team structure and workflows to support high-quality client delivery 

You have…

• 8+ years in life sciences or biotech communications (agency, in-house, or consulting)
• Strong media relationships in scientific, trade, and/or mainstream and non-traditional media (demonstrable track record of placements)
• Background working with foundations, nonprofits, research institutions, and/or mission-driven organizations
• Understanding of the players, issues and trends in biotech and emerging technologies
• Excellent written and oral communications skills (all formats: pitches, op-eds, talking points, presentations)
• Ability to translate complex science into compelling narratives for diverse audiences
• Client-facing experience—comfortable consulting with C-suite executives
• Experience managing multiple client accounts
• Ability to work West Coast hours and be available for client needs after hours as needed
• Bachelor's degree in communications, journalism, life sciences, or related field

It's a bonus (not required) if you have…

• Scientific background and/or science writing experience — in biology, chemistry, medicine, or related field
• Integrated agency experience — demonstrated success coordinating across multiple teams (creative, digital, production, paid media, etc.)
• Experience supporting new business pitches and/or expanding work within existing client relationships

About you...

You are a communications leader who understands science and sees communications as a critical tool for advancing breakthroughs that matter. You're energized by the pace and complexity of the biotech/life sciences space. You thrive in a collaborative, integrated agency environment where you're working across disciplines with creative partners, strategists, and digital experts. You're comfortable being both a strategic advisor and a hands-on problem-solver. You lead with curiosity, not ego, and you're as comfortable coaching junior staff as you are consulting with organizational leaders. You believe in getting things right, moving fast, and celebrating wins together. If this describes you, we invite you to apply.

Position Overview

The HCP Non-Personal & Omnichannel Marketing Lead will lead the development of an integrated non-personal promotion, media, and omnichannel plan in support of the U.S. launch of Varegacestat. This role will play a critical part in building and optimizing a seamless, data-driven HCP experience across digital and non-personal channels to drive disease awareness, education, and brand adoption. In addition, this role will champion innovation by identifying and implementing emerging digital capabilities, including the responsible use of AI, to enhance HCP engagement, personalization, content development, and marketing effectiveness. The role requires a strategic thinker with strong digital marketing expertise, launch experience, and a deep understanding of HCP engagement in the oncology marketplace.

Responsibilities

Digital Marketing & Non-Personal Promotion

• Develop and execute data-driven HCP digital campaigns, content, and modular journeys based on time to diagnosis, specialty, prescribing behavior, and real-time engagement signals to drive disease education and product adoption
• Manage marketing automation platforms and digital engagement tools to enable personalized HCP communication
• Monitor and analyze campaign performance and engagement metrics to continuously refine targeting, creative assets, and channel mix
• Partner with media agencies to develop and optimize channel strategy, media planning and activation, ensuring precise audience targeting and efficient budget allocation

Omnichannel Strategy & Execution

• Lead the development and execution of the HCP non-personal promotion and omnichannel engagement strategy
• Design customer journeys that coordinate field promotion, digital engagement, and non-personal channels to deliver a cohesive HCP experience
• Design and implement an integrated digital ecosystem (e.g., websites, search, social, CRM, programmatic media, and paid search) that supports education, activation, and sustained engagement

Innovation & AI Enablement

• Champion the adoption of AI-driven marketing capabilities, including predictive analytics, machine learning models, and automated decisioning engines to enhance targeting, personalization, and campaign performance
• Leverage AI and advanced analytics to enable next-best-action/next-best-message frameworks, dynamic content personalization, and real-time optimization of HCP engagement
• Partner with analytics and technology teams to pilot and scale new AI-enabled marketing solutions while ensuring compliance with regulatory and data governance standards

Qualifications

• Bachelor’s degree required; Advanced degree (e.g., PharmD, MBA) preferred
• 5+ years of experience in pharmaceutical, biotech, or healthcare marketing, with a strong focus on digital, NPP, and omnichannel strategy
• Oncology launch experience required
• Proven success in digital HCP marketing (web, social, SEO/SEM, CRM, and paid media strategy) and in media planning and execution
• Strong understanding of MLR/PRC processes, claims substantiation, and OPDP regulations.
• Demonstrated ability to thrive in a fast-paced biotech environment
• Ability to travel ≥20%, including occasional weekends

Knowledge and Skills

• HCP digital and NPP expertise: Deep understanding of HCP digital engagement tactics and how to integrate channels into cohesive omnichannel journeys
• Strong analytical and problem-solving skills, with the ability to leverage market research and performance data to inform decisions and optimize impact
• Strong project management and operational execution skills; able to manage multiple workstreams and launch-critical deadlines in a fast-paced environment
• Excellent communication, storytelling, and presentation skills—able to simplify complex clinical information for varied audiences
• Experience managing agencies/vendors, budgets, and complex project plans with strong operational rigor and attention to detail

Position Overview

The Associate Director/Director, Patient Services Operations will lead and own the operational design, implementation, and governance of Immunome’s first Patient Support Program (PSP) in preparation for the company’s first commercial launch. 

This leader will translate PSP strategy into operational execution, own vendor selection and performance governance, establish compliance and reporting infrastructure, and drive launch readiness to deliver a compliant, scalable program and a best-in-class patient experience. 

This role requires a hands-on builder with strong operational discipline, cross-functional leadership skills, vendor management expertise, and data fluency in a fast-moving environment. 

Responsibilities

PSP Operational Leadership 

• Translate PSP design into detailed operational requirements and implementation plans. 
• Lead RFP development, vendor evaluation, and selection with cross-functional partners. 
• Support contract negotiations including SLAs, deliverables, and performance expectations. 
• Oversee vendor onboarding and implementation of key PSP services, including enrollment/intake, benefits verification, prior authorization and appeals support, financial assistance pathways, specialty pharmacy coordination, case management/escalations, and adherence/persistence support. 
• Develop patient and HCP materials, communication scripts, and educational assets in collaboration with Marketing. 
• Develop and deploy operational training for field teams in partnership with Sales Training, Marketing, and Compliance. 

Vendor Management & Governance

• Serve as the primary operational owner for hub and related PSP vendors. 
• Establish structured operating cadence (regular ops calls, performance reviews, risk logs). 
• Define and monitor performance dashboards and SLA attainment. 
• Ensure adherence/persistence support services are integrated into vendor workflows and governance (staffing models, documentation standards, QA monitoring, SLAs, and reporting). 
• Oversee issue escalation pathways and remediation planning to ensure delivery excellence. 

Compliance, Risk & Quality 

• Build and maintain the PSP SOP library, quality assurance framework, and audit readiness documentation. 
• Partner with Legal, Compliance, Regulatory, and PV/Safety to ensure adverse event reporting, privacy, and medical/legal review processes are fully integrated. 

Data, Analytics & Patient Journey Optimization 

• Define operational reporting requirements and vendor data architecture. 
• Establish readiness indicators prior to launch and performance KPIs post-launch. 
• Map and optimize the patient journey using patient insights and operational data; define, monitor, and report PSP metrics across access and adherence/persistence (e.g., time-to-start, outreach effectiveness, and documented reasons for therapy delays or discontinuation where available) to identify friction points and drive measurable improvements in patient experience. 
• Prepare executive-level summaries and trend reporting for leadership and cross-functional partners. 

Cross-Functional Collaboration 

• Work closely with Market Access, Medical Affairs, Legal/Compliance, Regulatory, PV/Safety, Marketing, Finance, and Field functions. 
• Partner with Commercial Enablement/Distribution on channel integration requirements, ensuring alignment with channel strategy. 
• Support enterprise readiness activities and ensure alignment with commercial strategy and patient engagement priorities. 

Qualifications

• Bachelor’s degree required; Advanced degree preferred. 
• A minimum of 5 years of experience in the pharmaceutical or biotech industry.
• A minimum of 3  years’ experience in patient services operations. 
• Oncology experience required. 

Knowledge and Skills

• Demonstrated cross functional teamwork capabilities. 
• Excellent verbal and written communication skills for a wide range of audiences. 
• Strong cross-functional leadership skills and ability to influence without authority. 
• Excellent strategic and analytical thinking abilities. 
• Agile and adaptable with a growth mindset. 
• Demonstrated experience building and implementing a Patient Support Program. 

This role is not open to remote applicants and would require relocation to Seattle, WA.

Starting Salary Range: $75,000 - $88,000 annually

Exemption Status: Exempt

Location Expectations: Onsite

Reporting To: Manager II, Technical Operations

At A-Alpha Bio, we’re on a mission to improve human health by unlocking the potential of protein-protein interactions – and we’re now seeking a Research Associate II to support execution of our yeast-based AlphaSeq platform for drug discovery and optimization.

In this role you will execute yeast transformations, matings, Next-Generation Sequencing, and cell sorting/analysis to support production of yeast libraries and interrogation of protein-protein interactions. As a teammate, you’ll work collaboratively to execute tasks in multiple workflows. The ideal candidate will have strong organizational skills, impeccable attention to detail, and an interest in executing screening assays at scale.  

Key Responsibilities

• Execute DNA library preparation and sequencing workflows for Oxford Nanopore Technologies and Illumina platforms.
• Perform cell sorting and flow cytometry.
• Perform yeast transformation and matings.
• Execute DNA library construction as assigned.
• Support development and optimization of standard operating procedures for existing and new experimental workflows.
• May contribute to project teams or execute project-related tasks.
• As requested, train new Research Associates.
• Develop foundational understanding of and executional expertise in Technical Operations methods.
• Perform other duties as assigned.  

Qualifications & Experience

Required

• Bachelor’s degree in a relevant field with 2+ years of relevant postbaccalaureate laboratory experience in the biotechnology industry; or an equivalent combination of education and experience.
• Proficiency in standard molecular biology techniques, including DNA extractions, quantitative PCR, Gibson assembly, and fragment analysis.
• Experience with multi-parametric flow cytometry.
• Experience in a high-throughput screening or manufacturing environment.
• Experience working within LIMS/ELN.
• Strong work ethic, good organizational skills, team orientation, and exquisite attention to detail.
• Flexibility in day-to-day schedule and willingness to work outside of standard hours when necessary, including weekends.  

Preferred

• Operator experience in a regulated environment (e.g., CLIA, cGXP).
• Hands-on experience with Illumina, ONT, and/or PacBio next-generation sequencing platforms.
• Experience with cell sorting.
• Experience using yeast as a model organism.
• Experience with Benchling platform.
• Experience using Lab Automation. 

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