Legend Biotech is seeking an Executive Director, Pipeline Clinical Lead as part of the Clinical Development team based in Somerset, NJ.

Role Overview

The Pipeline Clinical Lead is a senior clinical development leader accountable for the scientific and medical direction of early stage clinical programs. This role provides strategic and operational leadership across first in human through proof of concept studies, with accountability for clinical strategy, trial design, execution, interpretation, and regulatory interactions.

The Pipeline Clinical Lead will lead and develop a team of physicians and scientists, work closely with cross functional partners, and collaborate with external development partners and investigators. Deep expertise in clinical trial design, regulatory frameworks, and compliance in drug development—ideally within cell therapy—is essential.

This role requires strong scientific judgment, leadership presence, and a hands on approach in a fast paced, entrepreneurial environment, with a clear focus on patient safety and clinical impact.

Key Responsibilities

Clinical Development Leadership

• Serve as clinical science lead for early stage programs (pre IND through Phase 1/2), including study design, execution, data interpretation, and reporting.
• Define and integrate clinical strategies, including PK/PD, biomarkers, diagnostics, and translational approaches, particularly for cell and gene therapies.
• Provide clinical input into asset selection, review of preclinical data, and development path decisions.

Regulatory & Compliance

• Lead or support IND preparation and amendments, clinical sections of regulatory submissions, and responses to health authority questions.
• Represent the clinical function in pre IND, IND, and (as applicable) BLA/MAA interactions with regulatory agencies.
• Champion patient safety, ethical conduct, and compliance with GCP, corporate policies, and global healthcare regulations.

Cross Functional & External Collaboration

• Partner closely with Clinical Operations, Biostatistics, Regulatory Affairs, Early Discovery,
• Manufacturing, Biomarkers, and Pharmacovigilance to ensure integrated program delivery.
• Collaborate with external development partners, academic investigators, KOLs, and study sites.
• Act as a credible scientific and clinical representative for programs in internal governance and external forums.

People & Matrix Leadership

• Provide direct line management and mentorship for Medical Directors, Clinical Research Scientists, Medical Writing, Clinical Program management and other clinical staff as applicable.
• Lead effectively in a matrix environment, anticipating cross functional needs and proactively resolving conflicts or risks.
• Contribute clinical leadership to business development, due diligence, and partnership activities when required.

Requirements

• MD or MD PhD (or equivalent) with US board certification or international equivalent.
• ≥8 years of clinical development experience in industry and/or academia, with demonstrated leadership in hematology/oncology.
• Proven experience designing and executing clinical trials from first in human through registrational stages.
• Prior involvement with IND submissions; experience with BLA/MAA filings and health authority meetings strongly preferred.
• Cell therapy and/or CAR T clinical development experience highly desirable IT Skills.
• Strong scientific judgment with the ability to navigate complex clinical and regulatory challenges.
• Demonstrated ability to lead cross functional and geographically distributed teams in a matrix environment.
• Excellent written and oral communication skills, including protocol writing, regulatory documents, publications, and senior level presentations.
• Highly collaborative, influential leader with the ability to represent programs with credibility and confidence.
• Hands on, execution oriented mindset with strong organizational and analytical skills.
• Willingness to travel up to 15–20%.

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Legend Biotech is seeking a Sr. Medical Director/Executive Director, Early Clinical Development as part of the Clinical Development team based in Somerset, NJ.

Role Overview

The Sr. Medical Director/Executive Director of Early Clinical Development is a critical role in the company with significant impact on the development and life cycle of drug development projects. The candidate for this role will be responsible to lead the Early Clinical Development Team, for IND submission and the design, execution and oversight of first-in-human, dose finding clinical trials. Full understanding of tenets of FIH studies (e.g. dose selection rationale, biomarker plans, etc.) and the relevant compliance framework for clinical development activities are essential. Candidate must possess passion for science and patients, as well as entrepreneurial drive to help the organization succeed.

Key Responsibilities

• Lead clinical science aspects of design, execution, interpretation and reporting of early (first in human) stage clinical trials.
• Collaborate with scientists and technical experts to integrate cellular therapy specific aspects of PK/PD, diagnostic, and biomarker plans into the overall clinical development strategy.
• Contribute clinical leadership and expertise in the development of study protocols and clinical study reports, study medical monitoring, safety reporting, regulatory documentation and interactions, and other clinical deliverables.
• Collaborate with academic scientists, clinical experts, and study investigators.
• Represent and advocate for the project in internal and external venues.
• Clinical leadership for business development and partnership activities as needed.
• Act as a champion for high standards of compliance, ethics and safety, and putting patients first.

Requirements

• MD or MD-PhD or equivalent medical degree with US board certification in hematology and/or oncology.
• 3+ (Senior) / 6+ (Executive) years’ industry/ academic clinical development experience in hematology/oncology, leading cross-functional development teams is required.
• Sub-specialization and/or clinical development experience in cell therapies or CAR-T is highly desirable.
• Experience in biotech - preferred but not required.
• Demonstrated capacity to think creatively when addressing complex situations
• Demonstrated excellence and experience in first-in-human clinical development including the design, execution of first in human trial, and submission of INDs.
• Experience leading pre-IND and IND meetings with health authorities is highly desirable.
• Excellent communication and leadership skills; willingness to “roll up the sleeves” to contribute to team efforts in a dynamic, fast-paced environment; stellar writing skills, a track record of publications; superb presentation skills
• Able to anticipate biometrics, regulatory, clinical operations, development sciences, pharmacovigilance, and other development needs to ensure successful program delivery
• Ability to communicate effectively with cross functional teams such as pre-clinical scientists, clinical operations, safety-PV, biomarker, biostatistics, regulatory, and project management including peer to peer interactions with academic scientific experts, KOLs and stake holders.
• Assure that the highest quality, ethical & professional values are demonstrated in all aspects of the team work
• Ensures compliance with corporate policies and procedures, as well as, all related healthcare laws and regulations
• Highly collaborative & effective influencing skills and the ability to operate across multiple geographies
• Strong track record of delivering results through effective team and peer leadership in matrix
• Superior interpersonal skills, & communication skills ensuring full alignment of cross functional teams. Ability to effectively manage conflicts and negotiations while providing impact and influence. Communicate regularly and effectively with senior leaders.
• Excellent leadership & organizational skills, analytical skills, presentation skills, and strong experience in translating medical/clinical information into clinical development strategies.
• Travel requirement up to 15-20 % of the time.

The advertised pay range covers both levels of this position.

Here's the base pay range by level:

Sr. Medical Director, Early Clinical Development- $294,483 - $386,511

Executive Medical Director, Early Clinical Development- $338,656- $444,486

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Legend Biotech is seeking a Sr. Director, Clinical Operations Capabilities and Standards as part of the Clinical Operations team based in Somerset, NJ.

Role Overview

The Sr. Director, Clinical Operations Capabilities and Standards will be responsible for providing strategic leadership and oversight for foundational and centralized trial operations support towards cost-effective scalability of the Clinical Operations department. 

Among other responsibilities, this position will establish, oversee and grow Clinical Operations capability pillars that include Clinical Trial Planning and Analytics, Clinical Trial Operational Technologies, Vendor Alliance Management, Site Contracts & Payments, and Sample & Imaging Management Operations; including managing and developing staff within each pillar.

This position will also be the company subject-matter expert for clinical operations standards applied across the portfolio of Legend IND clinical trials.

Key Responsibilities

Oversee the development and strengthening of the following clinical operations capabilities and functions, with leads/teams in each of these areas:

Clinical Trial Planning & Analytics:

• Clinical Trial Planning and Analytics (CTP&A) is accountable for end‑to‑end clinical trial feasibility activities, supporting protocol optimization, country and site selection, enrollment forecasting, and risk mitigation across clinical programs.
• This function provides data‑driven feasibility insights to enable informed decision‑making during early study planning and partners closely with Clinical Operations Leads, Clinical Development, cross-functional stakeholders and external vendors to ensure trials are designed and placed for successful execution.
• This function is responsible for predictive trial performance modeling to enable proactive implementation of contingency plans

Clinical Trial Operational Technologies:

• The Clinical Trial Operations Technology function is responsible for the strategic ownership, governance, and optimization of clinical trial operations systems that enable compliant, efficient, and inspection‑ready execution of clinical trials.
• This function serves as the business owner for core clinical systems (e.g., CTMS, eTMF, and related platforms), ensuring alignment with clinical operations needs, regulatory requirements, and the company’s development portfolio. The position partners closely with Clinical Operations Leads, Quality, Regulatory, Data Management, IT, and CROs/external vendors.
• Areas of focus for capability building include leveraging technology to enable cost-efficient trial budget builds and ongoing costs optimization during study execution, enabling tools for targeted clinical operations risk management and technology-enabled eTMF oversight.

Vendor Alliance Management:

• Vendor Alliance Management is responsible for the strategic and operational oversight of external clinical operations vendors and CRO partners supporting clinical trials, including coordination of vendor due diligence for vendor qualification. Ensures vendors deliver high‑quality services in compliance with GxP and contractual expectations, while enabling efficient study execution across one or more clinical programs.
• Vendor Alliance Management is the primary interface between internal Clinical Operations Program Leads and external service providers, with accountability for vendor governance, performance management via objective metrics, issue escalation, and continuous improvement.

Site contracts and Payments

• Site Contracts & Payments is responsible for creating and overseeing a scalable and effective operating model for site contracting visibility, investigator payment operations, serving as a central point of accountability for improving operational control, process effectiveness, financial discipline, vendor performance consistency, and sponsor-CRO-site workflow alignment.

Sample and Imaging Management Operations

• Sample and Imaging Management is responsible for end-to-end sample and imaging oversight across Legend pipeline studies. To strengthen visibility, accountability, and coordination across sites, CROs, central labs, specialty labs, imaging vendors.
• Sample and Imaging Management focuses on system‑level consistency and risk reduction, mitigating against loss of patient data, enabling acceleration of data cleaning and reducing site burden for participation in clinical trials.
• Lead business owner for clinical operations standards and practices, including functional owner for clinical operational related SOPs and guidance documents.
• Performs other duties as required.

Key Relationships

• The Head of Clinical Operations Capabilities and Standards works closely with all applicable internal cross-functional leaders and teams as well as external vendors for the clinical operations capability building and strengthening.

Requirements

• Minimum degree requirements of a bachelor’s degree (BA, BS) in scientific or health care discipline. Advance Degree Preferred.
• 12+ years of progressive experience in pharmaceutical or biotechnology clinical operations, with demonstrated leadership responsibility across global clinical development programs.
• Significant experience in establishing, scaling, or transforming centralized Clinical Operations capabilities, including one or more of the following:
  • Clinical Trial Planning & Analytics / Feasibility
  • Clinical Trial Operational Technologies (e.g., CTMS, eTMF, analytics platforms)
  • Vendor Alliance Management
  • Site Contracts and Investigator Payments
  • Sample and Imaging Management Operations
• Proven expertise in end‑to‑end clinical trial conduct, including early‑phase through late‑phase trials, with strong understanding of protocol development, feasibility, start‑up, execution, and close‑out.
• Demonstrated strategic CRO and vendor oversight experience, including governance models, performance metrics, financial oversight, issue escalation, and continuous improvement.
• Experience acting as a functional or enterprise‑level clinical operations subject‑matter expert, defining standards, operating models, and best practices applied across multiple studies or programs.
• Strong background collaborating with Quality, Regulatory, Clinical Development, Data Management, Biostatistics, Medical Writing, Pharmacovigilance, Translational/Bioanalytical, Medical Affairs, Procurement, Legal and IT functions in a matrixed global environment.
• Experience participating in and/or supporting regulatory authority interactions (e.g., FDA inspections) related to clinical operations processes, vendors, systems, or trial conduct is strongly preferred.
• Demonstrated success leading, developing, and retaining high‑performing teams, including functional leaders.
• Willingness to travel as required (approximately 10%).
• Deep knowledge of clinical trial operations frameworks, including industry best practices and regulatory expectations (ICH‑GCP, FDA, and global health authorities).
• Strong capability in clinical operations operating model design, including centralization, standardization, governance, and scalability.
• Demonstrated leadership in clinical operations technology enablement, including business ownership of systems (e.g., CTMS, eTMF), data quality oversight, technology‑enabled risk management, and inspection readiness.
• Expertise in vendor and alliance management, including development of governance structures, KPI frameworks, financial oversight, and performance optimization.
• Understanding of clinical trial sample, imaging, and data flows, with ability to design operational controls that reduce patient data risk, site burden, and cycle times.
• Ability to translate portfolio‑level strategy into executable clinical operations capabilities, standards, and guidance.
• Proven strategic and critical thinking skills, with a data‑driven mindset and ability to anticipate operational risks and mitigation strategies.
• Strong experience developing, authoring, and governing clinical operations SOPs, standards, and guidance documents.
• Exceptional communication, presentation, and stakeholder influence skills, with the ability to engage senior leadership and cross‑functional teams.
• High proficiency with clinical operations–relevant technologies and tools, including MS Office (Excel, PowerPoint, Word) and enterprise clinical systems; ability to leverage analytics for operational decision‑making.

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Position Summary:
The CRA II is a seasoned, experienced professional in monitoring and site management. Responsibilities will be dependent upon the type and timing of the program to which the CRA II is assigned and typically include activities involving start-up and study implementation, on-site monitoring of clinical research studies as well as on-going site management. Incumbents work independently as a study team member. 

Essential functions of the job include but are not limited to:

• Oversees all aspects of study site management to ensure patient safety is protected, quality of data generated by managed sites resulting in consistently low query levels and in acceptable Quality Assurance reports.
• Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
• Updates, tracks and maintains study specific trial management tools/systems, and status reports.
• If required, manages site start up procedures including the feasibility and recruitment of potential investigators, preparation of EC/IRB submissions, collection and review of regulatory documents, review and adaptation in Patient Informed Consents, notifications to IRB, EC and regulatory authorities, as appropriate, translation of study related documentation, organization of meetings and other tasks as instructed by the Clinical Trial Manager/Project Manager.
• If required, assists the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee.
• Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
• Independently conducts all forms of site visits, including pre-study/ qualification, initiation, routine monitoring, and close-out visits, in accordance with the protocol, local laws, ICH-GCP and Precision SOPs. Prepares and submits for review, accurate and timely monitoring reports from all site visits (on-site and remote).
• Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs, Clinical Monitoring Plan/Site Management Plan and client requirements. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.
• Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness.
• Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
• Communicates effectively and proactively with both site personnel and Precision Project and Clinical Trial Management to relay protocol/study issues including any deviations and implements necessary actions in response to those issues.
• Develops and maintains good working relationship with investigators and study staff, serving as an ambassador to promote Precision high quality and professional image.
• Performs investigational product (IP) inventory, reconciliation and reviews storage and security.
• Verifies the IP has been dispensed and administered to subjects/patients according to the protocol.
• Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.
• Performs data review activities, including remote EDC CRF and patient profiles review, query resolution, and assists data management and clinical data quality personnel to resolve data discrepancies.
• Identifies and processes Serious Adverse Events according to the procedures defined by the study team. Also demonstrates a full understanding of the SAE reporting process.
• Identifies site risks and escalates those to Clinical Trial Manager/Project Manager with suggested contingencies. Owns the timely and appropriate resolution of the risk with minimal support from project team.
• Prepares for and attends Investigator Meetings and/or sponsor face-to-face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.
• Travels as necessary according to project needs.
• Performs other duties as assigned by management.

Qualifications:

Minimum Required: 

•  4-year college degree or equivalent experience in a scientific or healthcare discipline.
• Two (2) years or more as a CRA in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies. Site management or equivalent experience in clinical research

Other Required:

• Excellent communication and organizational skills are essential. A team player.
• Experience monitoring oncology trials
• Evidence of a client focused approach
• Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail.
• Ability to travel overnight. Up to 60% travel on average, based on regional requirements. International travel as needed.
• Fluency in English and for non-English speaking countries the local language of country where position based

Preferred:

• Graduate or postgraduate degree
• Auto-immune monitoring experience
• Experience monitoring in rare and complex therapeutic areas
• Experience monitoring EDC trials and EHR records
• Experience in biopharma or relevant therapeutic area
• Relevant site start-up (feasibility, contract negotiations, submissions) experience for the particular country
• Ability to monitor study sites, with supervision, according to protocol monitoring guidelines, SOPs, GCP and ICH guidelines.
• Ability to resolve project related problems and prioritizes workload to meet deadlines with minimal support from management.

Competencies:

• Exhibits self-motivation and is able to work and plan independently as well as in a team environment
• Understands clinical trials methodology, including a working knowledge of protocols and indications being studied
• Demonstrates professionalism as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and teammates, including good interpersonal skills
• Collects data of consistently high standard
• Demonstrated ability to conduct formal presentations to a wide variety of audiences including, colleagues, investigative staff, and clients with a high level of proficiency
• Fluency in English and for non-English speaking countries the local language of country where position based

The Opportunity:

We are seeking a skilled senior safety systems analyst to join our dynamic Global Patient Safety (GPS) department.  The Sr. Systems Analyst position supports the configuration, maintenance, and continuous improvement of the GPS systems and related technologies. This role serves as a key contributor in ensuring data quality, system reliability, and operational efficiency across pharmacovigilance processes.

The Sr. Systems Analyst collaborates closely with cross‑functional partners, vendors, and internal GPS stakeholders to troubleshoot issues, extract and format data, execute configuration updates, and support enhancements that enable scalable, inspection‑ready safety operations.

The successful candidate will be a proactive, detail oriented, team player who exhibits technical proficiency with best-in-class pharmacovigilance systems. The candidate will meet the following requirements:

System Configuration & Administration

• Key contributor to system upgrades and ongoing maintenance through the development of system user and functional requirements, qualification scripts, and other validation deliverables.

• Effectively communicate and coordinate with internal and external stakeholders to gather and implement requirements.

• Execute routine system configuration updates to support evolving safety processes and business requirements.

• Maintain user roles, permissions, and access controls in alignment with governance standards.

• Key contributor to system validation activities including documentation, testing, and change‑control processes.

• Troubleshoot system issues and coordinate resolution with internal teams and external vendors.

Data Quality & Reporting Support

• Perform data extractions from the safety database, ensuring accurate and timely distribution to key stakeholders.

• Format safety output (line listings, tables, graphs) to support regulatory reporting and business‑partner inquiries.

• Experience with safety dashboards and analytics, including operational metrics, signal detection analyses, and compliance monitoring reports, to support operational insights and decision‑making.

• Facilitate routine data‑quality checks to ensure accuracy, completeness, and regulatory readiness.

• Investigate data discrepancies and partner with stakeholders to resolve root causes.

Operational Support & Collaboration

• Serve as a technical resource for GPS users, providing guidance on system functionality and best practices.

• Participate in continuous improvement initiatives through innovative technology solutions and process enhancements.

• Work collaboratively with Safety Operations, Safety Science, and other departments to ensure pharmacovigilance system compliance and best in class operations.

• Participate in cross‑functional projects involving system enhancements, integrations, and process improvements.

• Understand integrations between safety systems and upstream/downstream platforms.

• Document system processes and SOP inputs to support operational consistency and compliance.

• Support vendor coordination for issue resolution, enhancement requests, and release planning.

Compliance & Inspection Readiness

• Conduct safety system training to ensure common understanding of features and functionality, as well as Revolution Medicine’s consistent and proper use of the system.

• Prepare for global inspections by ensuring all processes and trainings reflect global regulatory requirements.

• Ensure system activities align with GxP expectations and internal quality standards.

• Ensure all safety systems and processes comply with global regulatory requirements including FDA, EMA, PMDA, and other relevant authorities.

• Maintain audit‑ready documentation for configuration changes, testing, and data‑quality activities.

• Support inspection and audit requests by preparing data outputs, evidence of system validation, and responding to technical inquiries.

Required Skills, Experience and Education:

• Bachelor’s degree in a scientific, technical, or related field required. At least 5 years in drug safety/pharmacovigilance within the pharmaceutical or biotechnology industry regarding pharmacovigilance safety databases, safety reporting systems, and data analysis tools.

• Hands‑on experience with safety databases and systems (e.g., Safety One Argus, Empirica Signal, Veeva Safety Docs) or similar regulated systems.

• Proficiency in data tools such as SQL, Spotfire, Oracle Analytics Server, or equivalent.

• Awareness of global pharmacovigilance regulations and guidelines (e.g., FDA, EMA, ICH).

Core Competencies

• Strong analytical, problem-solving, and decision-making skills, with the ability to interpret complex safety data to make informed decisions.

• Clear and concise communication with technical and non‑technical stakeholders.

• Ability to manage multiple priorities in a fast‑paced environment.

• Collaborative mindset with a focus on partnership and service delivery.

• Commitment to quality and compliance in all system‑related activities.

• Foster a structured and efficient work environment.

• Excellent written and verbal communication skills, with the ability to effectively liaise with internal and external stakeholders.

• Proven ability to think strategically, drive innovation, and implement process improvements.

Preferred Skills:

• Degree in computer science or related field preferred.

• Working knowledge of pharmacovigilance processes including case processing, ICSR and aggregate reporting, and electronic data exchanges.

• Experience interacting with regulatory agencies and participating in regulatory inspections and audits.  

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The Opportunity:

The Executive Director of GCP QA is a senior leadership role responsible for setting and executing the global GCP quality strategy across clinical development programs. This position ensures compliance with regulatory requirements, industry standards, and company policies governing clinical trials. The role provides strategic oversight of GCP QA activities, including leadership of a high-performing QA team, governance of contract research organizations, and advancement of continuous improvement initiatives to uphold the highest standards of quality and patient safety.

Serving as the GCP QA lead for late-stage clinical programs, this individual is accountable for GCP, GLP, and Pharmacovigilance/Safety oversight across multiple RevMed studies and represents QA in cross-functional and executive forums. The Executive Director will serve as a key advisor to senior leadership on clinical quality risk and regulatory readiness, helping to shape development strategy and enable successful regulatory outcomes. This position reports to the Vice President, Global Quality.

Key Responsibilities:

• Develop and execute the global GCP QA strategy aligned with corporate objectives, regulatory requirements, and RevMed SOPs.

• Serve as the Clinical QA Lead for global Phase 2/3 oncology studies, representing QA in governance forums and providing decision-making oversight on GCP related matters.

• Establish and maintain GCP QA frameworks, including policies, procedures, systems, and risk-based quality management (RBQM) to ensure compliance with global regulations (FDA, EMA, ICH).

• Provide end-to-end QA oversight of clinical studies, including:

• Review and approval of key study documents (protocols, monitoring plans, vendor oversight plans, quality agreements)

• Trial Master File (TMF) quality and inspection readiness

• GxP computerized systems and data integrity controls

• Lead and oversee GCP audit and inspection activities, including investigator sites, vendors, internal processes, and regulatory inspections (e.g., BIMO, PV), ensuring timely resolution of findings and CAPAs.

• Serve as the primary QA interface with global regulatory authorities, leading inspection strategy and representing the organization during health authority interactions.

• Drive global inspection readiness through structured planning, mock inspections, and cross-functional preparedness activities to support successful regulatory submissions and approvals.

• Oversee vendor and CRO quality management, including selection, qualification, governance models, performance monitoring (KPIs), and compliance with quality agreements.

• Proactively identify and mitigate systemic quality risks across the clinical portfolio, influencing development strategies and ensuring effective escalation to senior leadership.

• Monitor, trend, and report quality metrics (e.g., KPIs, QTLs, TMF health, CAPAs), leveraging insights to drive continuous improvement and operational excellence.

• Provide QA oversight of pharmacovigilance activities, ensuring compliance with safety reporting requirements and vendor performance expectations.

• Partner cross-functionally with Clinical Development, Clinical Operations, Regulatory Affairs, and Pharmacovigilance to drive quality, compliance, and continuous improvement.

• Drive innovation in QA through adoption of digital tools, advanced analytics, and modern risk-based quality approaches.

• Build, scale, and lead a high-performing global GCP QA organization, fostering a culture of quality, accountability, and operational excellence.

• Serve as a subject matter expert on GCP/GLP/PV regulations, advising senior leadership and influencing quality strategy across the organization.

Required Skills, Experience and Education:

• Advanced degree in life sciences, pharmacy, chemistry, or a related field (PhD, MS, or equivalent preferred).

• Minimum of 15 years of experience in the pharmaceutical or biotechnology industry, including at least 10 years in GCP QA or clinical quality leadership roles, with demonstrated experience leading and hosting regulatory inspections (e.g., FDA BIMO, EMA, MHRA, PMDA).

• Demonstrated experience interacting directly with global health authorities and leading inspection strategy and execution.

• Experience supporting late-stage clinical development and regulatory submissions (e.g., NDA, MAA), preferably in oncology.

• Proven track record and relevant industry experience in leading GCP QA functions within a global organization, preferably in oncology.

• Strong knowledge of global GCP regulations, ICH guidelines, and clinical trial processes.

• Excellent leadership, communication, team building and people skills, with the ability to influence stakeholders at all levels.

• Analytical thinker with a focus on continuous improvement and innovation.

• Experience working within outsourced clinical trial models and managing global CRO/vendor networks is highly desirable.

• This role may require occasional travel (up to 15%) for audits, inspections, and meetings.

• Flexibility to work in a fast-paced, dynamic environment with evolving priorities.

Preferred Skills:

• Experience implementing advanced RBQM frameworks and leveraging analytics-driven approaches (e.g., centralized monitoring, signal detection) to enhance clinical quality oversight.

• Prior experience in a small-to-mid-size biotech environment, with demonstrated ability to build and scale QA functions within highly outsourced, global clinical development models. 

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Position Summary:

ultradedicated – Your biggest challenges yield rare possibilities

The Senior Director, FP&A will be a key business partner to Ultragenyx’s Development organization, with primary responsibility for strengthening financial governance, budget transparency, and accrual rigor across development activities. The position supports the Chief Medical Officer and senior Development leadership by enabling a clear, consistent understanding of spend to date, remaining budget, and forward‑looking financial exposure across clinical and non‑clinical functions. The role combines hands‑on analytical execution with executive‑level financial storytelling to improve confidence, decision‑making, and stewardship across the development portfolio. 

Work Model: 

Flex: This role will typically require onsite work 2-3 days each week, or more depending on business needs. In many locations, the business will set certain days each week that Flex employees are required to be onsite.

Responsibilities:

1. Establish and maintain strong working relationships with Development leadership and operational stakeholders, serving as a trusted finance partner embedded in clinical study governance, financial oversight, and execution forums.  
2. Provide hands‑on financial support to Program Teams and Development functions by reviewing invoices, tracking actual spend, and identifying total and remaining budget at the study, program, and functional levels.  
3. Lead clinical trial cost modeling, including scenario planning and sensitivity analyses, clearly explaining cost drivers related to study design, timelines, enrollment assumptions, and execution strategies.  
4. Perform regular budget‑to‑actual analyses across clinical and non‑clinical Development activities, synthesizing account‑level, vendor‑level, and study‑level variances into concise, decision‑oriented insights.  
5. Deliver clear, actionable financial updates on spend, forecast changes, risks, and opportunities to minimize surprises and strengthen confidence in Development financial outlooks.  
6. Partner with Accounting and operational teams to support Development accrual processes, ensuring assumptions are timely, well‑documented, and aligned with underlying operational activity.  
7. Lead financial communications related to clinical trials and broader Development spend, including inputs to executive‑level readouts, portfolio reviews, and CMO‑level presentations.  
8. Support annual planning and in‑year reforecasting cycles by reviewing business‑generated forecasts, assessing reasonableness, and providing Development‑wide financial context and challenge.  
9. Design, implement, and continuously improve financial tools, reporting, and processes that enhance budget visibility, accrual understanding, and financial fluency across Development teams.  
10. Balance near‑term execution and stewardship of existing processes with a longer‑term focus on strengthening governance frameworks, standardization, and transparency across Development financial management. 

Requirements:

1. Bachelor’s degree in finance, Accounting, Economics, or a related discipline; MBA, CPA, or advanced degree preferred.  
2. Minimum of 12 years of progressive experience in FP&A, finance, or financial management supporting R&D or development organizations within the biotechnology, pharmaceutical, or life sciences industry.  
3. Demonstrated experience partnering with Development teams, including Clinical Operations and non‑clinical functions such as Regulatory, Pharmacovigilance, Biostatistics, and Statistical Programming.  
4. Deep expertise in clinical trial financial modeling, including cost drivers, scenario planning, and sensitivity analysis, with the ability to translate operational assumptions into credible forecasts.  
5. Strong background in financial governance, including budget oversight, variance analysis, accrual support, and spend‑to‑date transparency.  
6. Proven ability to influence without formal authority and partner effectively with senior leaders, program teams, and functional stakeholders.  
7. Ability to operate seamlessly between strategic and detailed perspectives, including hands‑on engagement with invoices, actuals, and accrual drivers, as well as executive‑level synthesis.  
8. Demonstrated success leading process improvement initiatives that improve budget visibility, accrual rigor, and financial fluency within business teams.  
9. Strong communication skills, with the ability to deliver clear, concise summaries of variances, forecast changes, and drivers to audiences ranging from study teams to executives.  
10. Advanced proficiency in financial modeling, forecasting, and analytics tools (e.g., Excel, Adaptive Insights, and enterprise planning systems) 

#LI-CK1 #LI-Hybrid

Job Summary

The QA Compliance Intern will provide foundational administrative and operational support to the Quality Department. This role is designed to offer a student or recent graduate hands-on experience in oversight of external manufacturing operations and Contract Manufacturing Organization (CMO) partnerships. As an intern, you will assist in ensuring compliance with international regulatory requirements and industry standards and support the internal quality team with various tasks and projects.

Core Responsibilities

• Assist in the initiation and administrative tracking of incoming inquiries, including Product Quality Complaints (PQCs), Adverse Events (AEs), and Medical Inquiries (MIs).
• Support the Quality Team in maintaining seamless communication between internal departments (Supply Chain, Pharmacovigilance, Regulatory Affairs) and external manufacturing partners.
• Learn to support the initiation of investigations, CAPAs (Corrective and Preventive Actions), change controls, and validation documentation within a Good Manufacturing Practice (GMP) environment.
•  Monitor the general QA mailbox, ensuring inquiries are routed to the appropriate stakeholders in a timely manner.
• Assist in the maintenance and implementation of internal policies, procedures, and training programs.
• Contribute to the organization of files and documentation required for internal and external audits.
•  Provide general project management support for the Quality Department, including data entry into Excel and drafting correspondence.

Qualifications & Requirements

• Currently enrolled in or a recent graduate of a BA/BS program in Life Sciences, Chemistry, Pharmacy, or a related field.
• Previous internship or coursework related to Quality Assurance, Quality Control, or Regulatory Compliance is a plus but not required.
• Excellent verbal and written communication skills with a focus on professional email etiquette.
• Proficiency in Microsoft Office Suite (Word, Excel, Outlook) is required.
• High attention to detail and the ability to manage multiple assignments simultaneously while meeting deadlines.
• Ability to ask compelling questions and a desire to understand
• Ability to work both autonomously and collaboratively in a fast-paced environment.
• Basic knowledge of CAPAs, Deviation investigations, Change Controls, and Supplier Qualification Program.

Position Type 

• Remote

Travel

• (5% travel)

Job Summary

The Pharmacovigilance Intern will support the Pharmacovigilance team with day-to-day activities in drug safety surveillance, adverse event (AE) processing, and regulatory compliance. This role provides hands-on exposure to pharmacovigilance processes, including intake and triage of incoming inquiries in compliance with regulatory requirements, management of Individual Case Safety Reports (ICSRs), safety database entry, and literature surveillance.

The intern will collaborate with cross-functional teams, including Quality Assurance, Regulatory, Clinical, and Medical Affairs, to gain a well-rounded understanding of pharmacovigilance within the pharmaceutical industry.

Core Responsibilities

• Assist in the intake, documentation, and triage of incoming inquiries, including adverse events (AEs), product quality complaints (PQCs), and medical inquiries, in accordance with internal procedures and regulatory requirements
• Perform data entry, coding (e.g., MedDRA), and narrative writing within the safety database
• Support follow-up activities to obtain missing or additional information from reporters or internal stakeholders
• Aid in literature surveillance activities, including screening scientific publications for potential adverse events
• Provide support in the preparation of safety reports for submission to regulatory authorities
• Collaborate with cross-functional teams (e.g., Medical Affairs, Regulatory, Quality, Clinical) to support pharmacovigilance activities
• Perform other duties and projects as assigned to support the Pharmacovigilance department

Qualifications & Requirements

• Currently pursuing or recently completed a Bachelor’s or Master’s degree in a scientific discipline (e.g., Biology, Pharmacy, Life Sciences, Public Health or related field)
• Strong interest in pharmacovigilance, drug safety, and pharmaceutical development
• Basic understanding of pharmacovigilance concepts (e.g., adverse events, product quality complaints, case intake/processing) is a plus
• Familiarity with medical terminology is preferred
• Familiarity with FDA regulations and ICH guidelines is a plus
• Excellent written and oral communication skills
• Strong organizational skills and attention to detail
• Ability to manage multiple tasks and meet deadlines in a fast-paced environment
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook)
• Self-motivated with a proactive approach to learning and problem-solving
• Ability to work both independently and collaboratively within a team setting
• Prior internship or coursework experience in pharmacovigilance, quality assurance, clinical research, or healthcare is preferred but not required

Position Type

• Remote/Hybrid

Travel

• Minimal; up to 10%

Job Title: Executive Medical Director, Clinical Development         

Location: Remote OR Hybrid 3 days/week if located near office in either Waltham, MA or Menlo Park, CA will be required.          .          

Role Overview: The Executive Medical Director of Clinical Development plays a key role in leading the design, execution, and oversight of clinical trials at an asset level, ensuring high-quality data generation to support the safety and efficacy of our pipeline products.  This role involves leading and developing a team and contributing to and influencing clinical development strategy across an asset, including study design, implementation, and data interpretation, while working cross-functionally to align clinical activities with overall development plans.  The Executive Medical Director collaborates closely with internal and external stakeholders to ensure trial execution meets regulatory, scientific, and business objectives in a fast-paced environment.  The role reports to the Vice President of Clinical Development. 

Key Responsibilities:

• Strategic Leadership:
• Drives the clinical development strategy for one or more assets
• Identifies critical clinical development milestones and ensures team alignment and accountability toward meeting timelines
• Provides leadership to the clinical team’s contribution to clinical study reports, key clinical documents, and regulatory submissions
• Directly manages and/or mentors Medical Directors, Clinical Scientists and other team members as appropriate
• Clinical Trial Design and Oversight:
• Leads and contributes to the development of clinical trial protocols, including patient selection criteria, study endpoints, and data collection methods
• Oversees the conduct of clinical trials, ensuring adherence to protocols and good clinical practice (GCP) guidelines, working closely with CROs and external partners to ensure efficient execution
• Reviews and interprets clinical data to assess the safety and efficacy of the investigational drug, driving timely, data-driven decisions
• Manages the clinical contribution to documents required during development (including but not limited to: Clinical Study Protocols, Investigator Brochures, Clinical Study Reports)
• Medical Expertise:
• Provides deep medical and scientific expertise in the therapeutic area, disease state, and potential drug effects 
• Reviews clinical data to identify and analyze safety concerns and adverse events, working with the pharmacovigilance team on continual benefit-risk assessment
• Stays current with relevant medical literature and clinical trial methodologies

• Contributes medical expertise to external interactions, including KOL engagement, advisory boards, and regulatory interactions as appropriate

• Cross-Functional Collaboration:
• Works closely with other functions including clinical operations, regulatory affairs, medical affairs, biometrics, pharmacovigilance, pre-clinical and project management teams to ensure alignment between clinical strategy and execution in a fast-paced environment
• Presents clinical data to internal and external stakeholders as appropriate
• People Leadership & Team Development:
• Leads and develops a high-impact team
• Provides coaching, mentorship, and performance management
• Fosters a culture of accountability, collaboration, and scientific rigor
• Supports hiring and resource planning in partnership with leadership

Qualifications:

• Medical degree (MD) ideally with board certification in a relevant specialty
• Extensive experience in clinical research and development, including within the pharmaceutical industry with progression of career demonstrating clinical leadership
• Proven people leadership experience, including managing and developing direct reports in small or growing teams
• Strong understanding of clinical trial design, GCP guidelines, and regulatory requirements, ideally with Phase 2 and 3 clinical study experience
• Excellent communication, leadership, and analytical skills
• Demonstrated ability to contribute to and influence clinical strategy while driving hands-on execution 

Experience working in a small or emerging biotech environment, with comfort operating in a fast-paced setting

Compensation:

• An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.
• The anticipated salary range for candidates is $331,000 to $368,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states.

We're looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.

The Opportunity:

We are seeking an experienced clinical science drug developer to serve as Medical Director in support of Revolution Medicines’ clinical-stage molecule(s). In this critical role, you will support various clinical science deliverables and enable effective and efficient execution of the clinical development plan for a molecule(s) within its particular indication(s).

The physician-scientist will focus on ensuring the accuracy, completeness, and integrity of clinical data supporting regulatory submissions (NDA, BLA, MAA). This role is uniquely positioned at the interface of clinical development, regulatory science, clinical data, and clinical operations, and will be instrumental in preparing pivotal datasets from the pivotal and supportive studies for successful global filings.

The ideal candidate brings a strong foundation in clinical medicine (M.D. or equivalent), oncology experience, and proven expertise in clinical trial data review, cleaning, and regulatory submission preparation. The scope of data review and support activities spans early-stage clinical research to pivotal studies including regulatory submissions. You will play a vital role in leading the clinical science aspects of the Clinical Development Plan (CDP) strategy, driving the development of transformative therapies for patients. Furthermore:

• Serve as the clinical point of accountability for data integrity in ongoing and completed studies across the oncology portfolio.

• Apply medical expertise to guide query resolution, adjudication of outliers, and clinical plausibility review during data cleaning.

• Collaborate with clinical study teams to align protocol design, CRFs, and data standards with downstream regulatory submission requirements.

• Lead clinical science aspects of the clinical development strategy and clinical documentation.

Represent the clinical development plan on appropriate teams, sub-teams and forums; oversee training of study site personnel, act as primary point-of-contact for questions/enquires regarding the CDP at a program level, oversee the conduct of medical/safety data reviews and study reporting.

• Partner with Regulatory Affairs, Biostatistics, Data Management, and Medical Writing to ensure clinical datasets, narratives, and summaries meet FDA, EMA, and ICH standards for NDA/BLA/MAA filings.

• Support the Medical Monitors Medical Lead and other team leads in clinical sections of regulatory dossiers, including Integrated Summary of Efficacy (ISE), Integrated Summary of Safety (ISS), and Clinical Study Reports (CSRs).

• Support in the preparation of responses to regulatory authorities and contribute to advisory committee briefing documents.

• Drive end-to-end data cleaning strategy, ensuring timely resolution of queries and reconciliation of safety, efficacy, and laboratory data.

• Lead clinical data review meetings, escalating issues and recommending solutions to maintain data reliability and consistency.

• Potential assignment to complex and high-priority strategic studies for Revolution Medicines’ molecules, with expectation to perform responsibilities with independence and clear self-directed leadership.

• Work closely with Data Management, Medical Monitors, CRO, Clinical Operations to ensure that site-level data collection, query resolution and other activities align with submission requirements.

• Partner with RevMed’s Pharmacovigilance to reconcile safety databases with clinical trial datasets.

• Cross-functionally align efforts seamlessly with scientific, regulatory, and commercial objects while executing upon the clinical development plan.

• Lead, mentor, and contribute to a high-performing cross-functional team of clinical development professionals, fostering a culture of collaboration, innovation, and excellence.

• Oversee all aspects of clinical trial design and execution, including site selection, patient recruitment, data management, and regulatory compliance.

• Establish and maintain strong relationships with clinical investigators, regulatory agencies, and key stakeholders.

• Gather, analyze and interpret clinical data, providing strategic insights to inform critical decisions and guide program development.

• Manage clinical development timelines effectively, ensuring efficient resource allocation and achievement of milestones.

• Stay abreast of the latest scientific advancements and regulatory trends in the field of clinical development.

Required Skills, Experience and Education:

• M.D. (or equivalent international medical degree, MBBS, MBChB,) with board certification/eligibility in Oncology; with subspecialty training in GI malignancies (strongly preferred).

• Minimum 5+ years’ experience in clinical development required in solid tumors generally, and GI Tumors (strongly preferred) .Pharma R&D experience outside of a clinical development role also considered pending transferability of skills and responsibilities within the biotech/pharmaceutical industry.

• Demonstrated experience with medical data review, cleaning for NDA or BLA filings and regulatory submissions.

• Strong working knowledge of data cleaning, database lock processes, and clinical data review.

• Proven ability to lead cross-functional clinical teams and contribute to strategic development plans.

• Excellent written and verbal communication skills for both scientific and regulatory audiences.

• Extensive experience working with the principles and techniques of data analysis, interpretation, and clinical relevance as related to the pharmaceutical/biotech industry.

• Experience in independent generation of trial design, protocol writing/ICF (writing or amendment), constructing appropriate CRF and coordinating cross-functionally.

• In-depth therapeutic area experience/expertise, and relevant clinical trial experience (or clear ability to adapt with transferable skills).

• Strong knowledge of medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMA and other relevant guidelines and regulations is required.

• Proven ability to work effectively and efficiently within cross-functional teams involved in the drug development process; proven ability to efficiently integrate multiple perspectives into the CDP.

• Experience authoring regulatory briefing packs, write responses to Health Authority questions, and proven ability to contribute to strategic approach and cross-functional coordination in support of regulatory activities/interactions.

• Demonstrated success in driving various aspects of cross-functional study level strategy, e.g. study design, supporting feasibility and timelines/budget projections, protocol amendment requirements. Ability to drive relevant discussion at key internal decision-making bodies/governance.

• Proven ability to build and maintain strong relationships and contribute to interactions with external key opinion leaders to optimize clinical programs (e.g. advisory boards, individual engagements, steering committees, etc.).

• Experience in (or clear ability) investigator engagement to optimize clinical trial conduct. Includes presenting at investigator meetings.

• Strong orientation to teamwork. Excellent leadership, communication, and interpersonal skills with the ability to inspire, motivate and mentor across a diverse team.

• Experience in mentoring other team members. Experience or clear potential as an effective line manager.

• Expertise in building and maintaining strong relationships with internal and external stakeholders.

• Superb strategic thinking and analytical skills, with the ability to make data-driven decisions in a fast-paced environment. Able to recognize trade-off decisions and can determine priorities and goals.

• Strong written and business presentation skills is required.

• Passion for innovation and a commitment to developing therapies that make a meaningful difference in patients' lives.

• Demonstrated strong leadership presence.

• Has demonstrated adaptability and flexibility.

• Anticipates needs, assesses and manages business and organizational risks.

• Ability to thrive in a fast-paced, collaborative biotech environment.

Preferred skills:

• Experience in ongoing enhancements/development of core and sub-team processes, structures, systems, tools and other resources in the pharmaceutical/biotech industry.

• Has led clinical development contributions to major regulatory submissions (e.g. (s)NDA, (s)BLA, PIP/PSP, label negotiation, Breakthrough Therapy Designation, Accelerated Review) is a major plus.

• Proven ability to present the clinical development aspects of a program(s) to key major reference health authorities (FDA, EMA, others.) by teleconference or in-person. Has led Health Authority interaction(s).

• Proven ability to set out the clinical development strategy for CTA/EC submissions and responses to health authority questions.

• Has demonstrated collaborate behaviors on enterprise-level strategic initiatives with a variety of internal and external partners and stakeholders - including clinical investigators/clinicians, scientists and key opinion leaders (KOLs), as well as internal groups, including other groups in development, research, business development, commercial, legal, etc. - resulting in demonstrable outcomes that have further enhanced strategic goals.

• Influential and inspiring leader, with proven ability to bring teams and individuals along with them.

• Has demonstrated courage and conviction in past positions and responsibilities. Demonstrated skills in conflict resolution.

  #LI-Hybrid  #LI-SH1

The Opportunity:

The Safety Scientist within Global Patient Safety Science is an individual contributor who provides safety science and pharmacovigilance support to all products across the RevMed portfolio, which includes early and late phase development activities. The individual will be responsible for supporting clinical studies, review of clinical trial protocols, supporting updates to IBs, ICFs, and authoring of DSURs. Additional safety related activities will involve medical review of individual case safety reports (ICSRs), safety surveillance of assigned products and active member of cross-functional teams.

The Safety Scientist will develop and maintain an understanding of the safety profile of the assigned product(s). Responsibilities include:

• Proactive medical safety surveillance of ongoing clinical trials for identification of safety

• Conduct ongoing safety data reviews; prepare and present summaries to internal stakeholders.

• Medical review of individual case safety reports, routine review of safety data and pertinent scientific literature articles.

• Identify potential clinical safety issues for ongoing clinical trials based on emerging safety data.

• May perform safety reviews of relevant sections of clinical trial protocols, Investigator’s Brochures (including reference safety information), clinical study reports, informed consent forms, DSURs, and other study related documents, as required.

• Supports authoring or otherwise contributes to the preparation of aggregate safety reports and risk management plans (RMPs).

• Conducts signal detection and evaluation activities for assigned products in collaboration with senior Safety Science team member(s) as part of the continuous benefit-risk evaluation throughout the product lifecycle.

• Establish and maintain collaborative working relationships with all key stakeholders (e.g., clinical study teams, study sites, CROs).

• Consistently comply with all governing laws, regulations, RevMed standard operating procedures (SOPs) and other guidelines.

Required Skills, Experience and Education:

• A relevant postgraduate qualification (e.g., MD, PharmD, PHD/MSc in a Life sciences discipline, or other post-graduate health professional qualifications).

• 1 or more years of drug development experience in the pharmaceutical or related industry.

• Detail-oriented with ability prioritize tasks and function independently as appropriate.

• Strong learning orientation, curiosity, and commitment to science and patients.

• Excellent written and verbal communication skills.

Preferred Skills:

• Understanding of the scientific aspects of safety, PV (including GVP, GCP), and clinical/patient risk management.

• Exposure to Safety Operations and experience with individual case review.

• Knowledge and/or experience with clinical trial management and data review. 

  #LI-Hybrid  #LI-SH1

The Opportunity:

We are seeking an experienced clinical scientist to serve as Associate Director, Clinical Science in support of Revolution Medicines’ late-stage clinical programs.  In this role, you will independently lead defined clinical science workstreams within pivotal and supportive studies and support execution of the registrational clinical development strategy for assigned molecule(s) and indication(s). The Associate Director plays a critical role in ensuring high-quality clinical data review, protocol consistency, and submission-readiness for late-stage programs. This position operates with substantial autonomy within assigned scope and collaborates closely with more senior clinical science team members and the study Medical Director to ensure medically sound and regulatory-aligned execution. Furthermore:

• Independently lead defined clinical science workstreams within pivotal and registration-enabling studies (e.g., endpoint strategy, data review oversight, CSR section ownership, data consistency initiatives).

• Contribute substantially to protocol development, CRF design, ICF updates, and alignment of data standards with downstream regulatory requirements.

• Drive ongoing clinical data review activities, including plausibility review, query trend analysis, and preparation for database lock.

• Accountable for assigned clinical science deliverables supporting regulatory submissions, including CSR sections, briefing package content, and health authority response inputs.

• Support preparation of regulatory documentation and responses to health authority questions.

• Collaborate closely with Biostatistics, Data Management, Medical Writing, Medical Directors, Pharmacovigilance, and Clinical Operations to ensure alignment and submission readiness.

• Participate in study team meetings and represent Clinical Science in sub-team discussions.

• May serve as Clinical Science lead for smaller or supportive studies, based on experience and study complexity.

• Mentor Senior Clinical Scientists and Clinical Scientists as appropriate.

• Proactively identify risks, propose mitigation strategies, and escalate significant issues as appropriate to Directors or Senior Directors.

• Contribute to cross-functional discussions to support eSective and eSicient study execution.

Required Skills, Experience and Education:

• Bachelor’s Degree (life sciences preferred); Advanced Clinical/Science Degree is a plus (e.g., PharmD, PhD, MSN, MPH, etc.).

• 5+ years of clinical development or relevant experience within a pharmaceutical, biotech, or academic clinical research setting; late-stage development experience preferred.

• Demonstrated experience contributing to pivotal or registration-enabling studies.

• Strong knowledge of GCP, ICH, FDA, EMA, and other relevant regulatory guidelines.

• Experience contributing to protocol development, CRF design, and regulatory documentation.

• Strong analytical skills and experience interpreting clinical trial data.

• Proven ability to work eSectively in cross-functional teams and integrate multiple perspectives.

• Excellent written and verbal communication skills.

• Strong organizational skills and ability to manage multiple deliverables.

Preferred Skills:

• Experience contributing to NDA/BLA/MAA submission components.

• Experience supporting health authority interactions.

• Demonstrated ability to lead defined study-level initiatives.

• Experience mentoring junior clinical science staffs.

#LI-Hybrid  #LI-SH1

The Opportunity:

This position will be responsible for the management, development, and oversight of Global Patient Safety operational activities in the execution of safety information collection and reporting for the assigned Revolution Medicines’ clinical programs.

• Participates in the development of Global Patient Safety Operations operational objectives, policies, and procedures.

• Represent Global Patient Safety in different cross functional team meetings.

• Collaborate with other functional groups to achieve clinical program goals.

• Oversee Pharmacovigilance Contract Research Organization (PV CRO) in the execution of safety reporting in clinical studies.

• Manage PV CROs to ensure compliance with required timelines, that potential issues are being communicated, and resolution is achieved in a timely manner.

• Oversee reporting of safety reports to global regulatory authorities, central IRB/ethics committees, investigators to ensure compliance with global regulatory requirements.

• Ensure timely and accurate set up of global safety reporting and safety database in assigned clinical programs.

• Support authoring and updates of clinical trial protocols, informed consent forms, Investigator Brochure (including the Reference Safety Information section), and aggregate reports.

• Support the execution and maintenance Safety Data Exchange Agreements

• /Pharmacovigilance Agreements with business partners.

• Collaborate with other functional groups in SAE reconciliation and SAE query resolution activities.

• Support Global Patient Safety team in other PV activities appropriate to experience and expertise.

• May oversee or be responsible for one or more junior team member(s).

Required Skills, Experience and Education:

• Bachelor’s degree in a healthcare field.

• Minimum of 5 years of relevant experience in pharmacovigilance operational activities.

• Hands-on experience working with CROs/vendors and management of external resources.

• Strong background in safety reporting regulatory compliance and global safety reporting/regulations in clinical trials.

• Able to problem solve, focus on details, multi-task, prioritize options, work independently, anticipate challenges and execute assigned deliverables.

• Ability to analyze situations and data that requires conceptual thinking and in-depth knowledge of organizational objectives.

• Ability to persuade others in sensitive/complex situations while maintaining relationships.

• An innovative team-player with capacity to be effective in a dynamic, continuously improving, and fast-paced company environment.

• Excellent interpersonal skills including ability to work in cross-functional team environments and with external vendors.

• Exercise discretion regarding highly confidential internal and external communications.

Preferred Skills:

• Master’s Degree or higher in a healthcare field.

• 7+ years of relevant experience in pharmacovigilance operational activities.

• Experience working with investigator sponsored trials, extended use programs, and business partnerships. 

  #LI-Hybrid  #LI-SH1

The Opportunity:

This position will be responsible for the management, development, and oversight of Global Patient Safety operational activities in the execution of safety information collection and reporting for the assigned Revolution Medicines’ clinical programs.

• Participates in the development of Global Patient Safety Operations operational objectives, policies, and procedures.

• Represent Global Patient Safety in different cross functional team meetings.

• Collaborate with other functional groups to achieve clinical program goals.

• Oversee Pharmacovigilance Contract Research Organization (PV CRO) in the execution of safety reporting in clinical studies.

• Manage PV CROs to ensure compliance with required timelines, that potential issues are being communicated, and resolution is achieved in a timely manner.

• Oversee reporting of safety reports to global regulatory authorities, central IRB/ethics committees, investigators to ensure compliance with global regulatory requirements.

• Ensure timely and accurate set up of global safety reporting and safety database in assigned clinical programs.

• Support authoring and updates of clinical trial protocols, informed consent forms, Investigator Brochure (including the Reference Safety Information section), and aggregate reports.

• Support the execution and maintenance Safety Data Exchange Agreements

• /Pharmacovigilance Agreements with business partners.

• Collaborate with other functional groups in SAE reconciliation and SAE query resolution activities.

• Support Global Patient Safety team in other PV activities appropriate to experience and expertise.

• May oversee or be responsible for one or more junior team member(s).

Required Skills, Experience and Education:

• Bachelor’s degree in a healthcare field.

• Minimum of 5 years of relevant experience in pharmacovigilance operational activities.

• Hands-on experience working with CROs/vendors and management of external resources.

• Strong background in safety reporting regulatory compliance and global safety reporting/regulations in clinical trials.

• Able to problem solve, focus on details, multi-task, prioritize options, work independently, anticipate challenges and execute assigned deliverables.

• Ability to analyze situations and data that requires conceptual thinking and in-depth knowledge of organizational objectives.

• Ability to persuade others in sensitive/complex situations while maintaining relationships.

• An innovative team-player with capacity to be effective in a dynamic, continuously improving, and fast-paced company environment.

• Excellent interpersonal skills including ability to work in cross-functional team environments and with external vendors.

• Exercise discretion regarding highly confidential internal and external communications.

Preferred Skills:

• Master’s Degree or higher in a healthcare field.

• 7+ years of relevant experience in pharmacovigilance operational activities.

• Experience working with investigator sponsored trials, extended use programs, and business partnerships. 

  #LI-Hybrid  #LI-SH1

The Opportunity:

We are seeking an experienced clinical science drug developer to serve as Senior Medical Director in support of Revolution Medicines’ clinical-stage molecule(s). In this critical role, you will support various clinical science deliverables and enable effective and efficient execution of the clinical development plan for a molecule(s) within its particular indication(s).

The physician-scientist will focus on ensuring the accuracy, completeness, and integrity of clinical data supporting regulatory submissions (NDA, BLA, MAA). This role is uniquely positioned at the interface of clinical development, regulatory science, clinical data, and clinical operations, and will be instrumental in preparing pivotal datasets from the pivotal and supportive studies for successful global filings.

The ideal candidate brings a strong foundation in clinical medicine (M.D. or equivalent), oncology experience, and proven expertise in clinical trial data review, cleaning, and regulatory submission preparation. The scope of data review and support activities spans early-stage clinical research to pivotal studies including regulatory submissions. You will play a vital role in leading the clinical science aspects of the Clinical Development Plan (CDP) strategy, driving the development of transformative therapies for patients. Furthermore:

• Serve as the clinical point of accountability for data integrity in ongoing and completed studies across the oncology portfolio.

• Apply medical expertise to guide query resolution, adjudication of outliers, and clinical plausibility review during data cleaning.

• Collaborate with clinical study teams to align protocol design, CRFs, and data standards with downstream regulatory submission requirements.

• Lead clinical science aspects of the clinical development strategy and clinical documentation.

• Represent the clinical development plan on appropriate teams, sub-teams and forums; oversee training of study site personnel, act as primary point-of-contact for questions/enquires regarding the CDP at a program level, oversee the conduct of medical/safety data reviews and study reporting.

• Partner with Regulatory Affairs, Biostatistics, Data Management, and Medical Writing to ensure clinical datasets, narratives, and summaries meet FDA, EMA, and ICH standards for NDA/BLA/MAA filings.

• Support the Medical Monitors Medical Lead and other team leads in clinical sections of regulatory dossiers, including Integrated Summary of Efficacy (ISE), Integrated Summary of Safety (ISS), and Clinical Study Reports (CSRs).

• Support in the preparation of responses to regulatory authorities and contribute to advisory committee briefing documents.

• Drive end-to-end data cleaning strategy, ensuring timely resolution of queries and reconciliation of safety, efficacy, and laboratory data.

• Lead clinical data review meetings, escalating issues and recommending solutions to maintain data reliability and consistency.

• Potential assignment to complex and high-priority strategic studies for Revolution Medicines’ molecules, with expectation to perform responsibilities with independence and clear self-directed leadership.

• Work closely with Data Management, Medical Monitors, CRO, Clinical Operations to ensure that site-level data collection, query resolution and other activities align with submission requirements.

• Partner with RevMed’s Pharmacovigilance to reconcile safety databases with clinical trial datasets.

• Cross-functionally align efforts seamlessly with scientific, regulatory, and commercial objects while executing upon the clinical development plan.

• Lead, mentor, and contribute to a high-performing cross-functional team of clinical development professionals, fostering a culture of collaboration, innovation, and excellence.

• Oversee all aspects of clinical trial design and execution, including site selection, patient recruitment, data management, and regulatory compliance.

• Establish and maintain strong relationships with clinical investigators, regulatory agencies, and key stakeholders.

• Gather, analyze and interpret clinical data, providing strategic insights to inform critical decisions and guide program development.

• Manage clinical development timelines effectively, ensuring efficient resource allocation and achievement of milestones.

• Stay abreast of the latest scientific advancements and regulatory trends in the field of clinical development.

Required Skills, Experience and Education:

• M.D. (or equivalent international medical degree, MBBS, MBChB,) with board certification/eligibility in Oncology or Hematology-Oncology; subspecialty training in GI malignancies strongly preferred.

• Minimum 13+ years’ experience in clinical development required (Pharma R&D experience outside of a clinical development role also considered pending transferability of skills and responsibilities).

• Minimum 5 years of experience in late-stage clinical development within the biotech/pharmaceutical industry.

• Demonstrated experience with medical data review, cleaning for NDA or BLA filings and regulatory submissions.

• Strong working knowledge of data cleaning, database lock processes, and clinical data review.

• Proven ability to lead cross-functional clinical teams and contribute to strategic development plans.

• Excellent written and verbal communication skills for both scientific and regulatory audiences.

• Extensive experience working with the principles and techniques of data analysis, interpretation, and clinical relevance as related to the pharmaceutical/biotech industry.

• Experience in independent generation of trial design, protocol writing/ICF (writing or amendment), constructing appropriate CRF and coordinating cross-functionally.

• In-depth therapeutic area experience/expertise, and relevant clinical trial experience (or clear ability to adapt with transferable skills).

• Strong knowledge of medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMA and other relevant guidelines and regulations is required.

• Proven ability to work effectively and efficiently within cross-functional teams involved in the drug development process; proven ability to efficiently integrate multiple perspectives into the CDP.

• Experience authoring regulatory briefing packs, write responses to Health Authority questions, and proven ability to contribute to strategic approach and cross-functional coordination in support of regulatory activities/interactions.

• Demonstrated success in driving various aspects of cross-functional study level strategy, e.g. study design, supporting feasibility and timelines/budget projections, protocol amendment requirements. Ability to drive relevant discussion at key internal decision-making bodies/governance.

• Proven ability to build and maintain strong relationships and contribute to interactions with external key opinion leaders to optimize clinical programs (e.g. advisory boards, individual engagements, steering committees, etc.).

• Experience in (or clear ability) investigator engagement to optimize clinical trial conduct. Includes presenting at investigator meetings.

• Strong orientation to teamwork. Excellent leadership, communication, and interpersonal skills with the ability to inspire, motivate and mentor across a diverse team.

• Experience in mentoring other team members. Experience or clear potential as an effective line manager.

• Expertise in building and maintaining strong relationships with internal and external stakeholders.

• Superb strategic thinking and analytical skills, with the ability to make data-driven decisions in a fast-paced environment. Able to recognize trade-off decisions and can determine priorities and goals.

• Strong written and business presentation skills is required.

• Passion for innovation and a commitment to developing therapies that make a meaningful difference in patients' lives.

• Demonstrated strong leadership presence.

• Has demonstrated adaptability and flexibility.

• Anticipates needs, assesses and manages business and organizational risks.

• Ability to thrive in a fast-paced, collaborative biotech environment.

Preferred skills:

• Experience in ongoing enhancements/development of core and sub-team processes, structures, systems, tools and other resources in the pharmaceutical/biotech industry.

• Has led clinical development contributions to major regulatory submissions (e.g. (s)NDA, (s)BLA, PIP/PSP, label negotiation, Breakthrough Therapy Designation, Accelerated Review) is a major plus.

• Proven ability to present the clinical development aspects of a program(s) to key major reference health authorities (FDA, EMA, others.) by teleconference or in-person. Has led Health Authority interaction(s).

• Proven ability to set out the clinical development strategy for CTA/EC submissions and responses to health authority questions.

• Has demonstrated collaborate behaviors on enterprise-level strategic initiatives with a variety of internal and external partners and stakeholders - including clinical investigators/clinicians, scientists and key opinion leaders (KOLs), as well as internal groups, including other groups in development, research, business development, commercial, legal, etc. - resulting in demonstrable outcomes that have further enhanced strategic goals.

• Influential and inspiring leader, with proven ability to bring teams and individuals along with them.

• Has demonstrated courage and conviction in past positions and responsibilities. Demonstrated skills in conflict resolution. #LI-Hybrid  #LI-SH1

The Opportunity:

The Senior Safety Scientist within Global Patient Safety Science is an individual contributor who provides safety science and pharmacovigilance support to all products across the RevMed portfolio, which includes early and late phase development activities. The individual will be responsible for safety oversight of clinical studies, review and authoring of clinical trial protocols, IBs, ICFs, and DSURs. Additional safety related activities will involve medical review of individual case safety reports (ICSRs), safety surveillance of assigned products and active member of cross-functional teams.

The Senior Safety Scientist will develop and maintain an understanding of the safety profile of the assigned product(s). Responsibilities include:

• Proactive medical safety surveillance of ongoing clinical trials for identification and management of safety

• Prepare and present safety data summaries to internal and external stakeholders.

• Risk management activities include, but are not limited to medical review of ICSRs, routine review of safety data and pertinent scientific literature articles.

• Acquire and contribute knowledge of relevant drug class and/or competitor safety issues.

• Identify potential clinical safety issues and recommend appropriate risk mitigation measures.

• Involvement in preparation and maintenance of relevant sections of clinical trial protocols, IBs (including the reference safety information section), ICFs, DSURs, RMPs, CCDS, and labelling, as required.

• Perform safety review of clinical protocols, Investigator's Brochure (IB), informed consent form (ICF) and other related documents to ensure alignment with the safety strategy and ensure the appropriateness of risk management strategies and risk communication.

• Accountable for the safety components of study reports (i.e., CSRs), publications, aggregate reports, and other regulatory documents.

• Conducts signal detection and evaluation activities for assigned products for the continuous benefit-risk evaluation throughout the product lifecycle and contributes/leads preparation for escalation to safety governance committees.

• Supports implementation of decisions from the signal evaluation process, including updates to core safety information, Investigator’s Brochure and other key safety documents and deliverables.

• Contributes to input related to regulatory filings, New Drug Applications [NDAs], Biologics License Applications [BLAs]), and responses to safety queries from third parties, such as regulatory agencies.

• Establish and maintain collaborative working relationships with all key stakeholders (study team members, CROs, investigators, study sites, vendors, committees, etc.).

• Consistently comply with all governing laws, regulations, RevMed standard operating procedures (SOPs) and other guidelines.

Required Skills, Experience and Education:

• A relevant postgraduate qualification (e.g., MD, PharmD, PHD/MSc in a Life sciences discipline, or other post-graduate health professional qualifications).

• 3 or more years of drug development experience in the pharmaceutical or related industry with at least 1 year in drug safety.

• Proven success in creating and sustaining strong relationships with internal and external business partners across an organization to create positive partnerships.

• Broad understanding of the scientific aspects of safety, PV (including GVP, GCP), and clinical/patient risk management ​and safety operations.

• Demonstrated ability to lead and influence, with and without authority, in a fast-paced environment.

• Strong presentation skills, effective at summarizing and presenting the key considerations and decision points.

• Thrives in a collaborative team setting and is driven by a desire to deploy innovative approaches and technologies in a high-energy environment.

• Detail-oriented with ability prioritize tasks and function independently as appropriate.

• Strong organizational skills and an ability to interpret, discuss, and report trial level data effectively and identify trends.

• Excellent written and verbal communication skills. 

  #LI-Hybrid  #LI-SH1

The Opportunity:

We are seeking a skilled and experienced Executive Director (ED) of Global Patient Safety (GPS) Quality and Compliance to join our dynamic team. The ED GPS Quality and Compliance is responsible for the strategy, development, oversight, and execution of the pharmacovigilance quality management system (PV-QMS) within the organization. This role ensures the safety of patients and the overall positive benefit-risk of RevMed pharmaceutical products by driving compliance with global pharmacovigilance regulations and fostering a culture of safety and vigilance.  The responsibilities of this role include oversight of the PV-QMS , PV training strategy, PV controlled documentation, inspection and audit management, ensuring inspection readiness, Corrective Action Preventive Action (CAPA) management, Quality Assurance (QA), and maintenance of Good Clinical Practice (GCP), and Good Pharmacovigilance Practices (GVP) in partnership with GPS management, QA, and staff.  The ED of GPS Quality and Compliance will help to develop and implement the pharmacovigilance system in support of Revolution Medicine’s research and development and marketed products. 

The successful candidate will have innate leadership and organization skills, technical expertise in the field, and experience in organizing and overseeing pharmacovigilance quality, compliance, and training. As an ED, you will work closely with the GPS management team to develop and build out the PV-QMS as an important component of a fully compliant pharmacovigilance system; you will be responsible for GCP/ICH quality leadership, strategic development of quality initiatives and support a quality focused culture in the execution of the PV-QMS. This critical role will require strategic thinking, expert knowledge of global PV regulations (i.e. GCP, GVP), the ability to influence and communicate ideas effectively, results orientation, collaboration with cross-functional teams, technical expertise, and vendor management skills to ensure compliance with regulatory requirements to safeguard patient well-being. Additional responsibilities include:

• In cooperation with the GPS leadership team, co-develop and implement the global pharmacovigilance quality management system strategy in alignment with the company’s mission and objectives.

• Develop and implement a PV training strategy that ensures compliance and ensures high quality and consistent performance.

• Provide strategic direction and leadership to GPS and cross-functionally.

• Lead, mentor, and coach GPS staff ensuring high quality compliance support following best practices, global regulations, and internal requirements. 

• Oversee the resourcing, budget, and management of pharmacovigilance contract research organizations (PV CROs) in quality and compliance activities.

• Author and contribute to the preparation of controlled documentation required by health authorities for management of the QMS. 

• Develop and maintain relationships across Revolution Medicines, particularly in Clinical Operations, Clinical Development, Clinical Data Science, Regulatory Affairs, Quality Assurance, Medical Affairs, and other departments as appropriate to ensure a globally compliant QMS. 

• Collaborate to create robust processes to maintain compliance with safety requirements related to safety science processes.

• Work with the EU Qualified Person Responsible for Pharmacovigilance (EU-QPPV) to ensure European compliance as applicable.

• Responsible for ensuring inspection readiness for global inspections by ensuring all processes and training reflect global regulatory requirements. 

• Manage all inspections that include PV and ensure completion and tracking of CAPAs.

• Foster a culture of safety, compliance, and continuous improvement within the pharmacovigilance function and broadly across the organization.

• Ensure compliance with global pharmacovigilance regulations and standards, including FDA, EMA, PMDA, ICH, and other relevant regulatory bodies.

• Lead the GPS response to regulatory inquiries and inspections related to pharmacovigilance inspections.

• Lead the development and maintenance of a pharmacovigilance quality system in line with global regulations (i.e. GCP, GVP) enabling demonstration of quality, effectiveness, and control.

• Partner with pharmacovigilance systems personnel in the development and implementation of advanced safety data analytics in support the PV-QMS.

• Build, mentor, and lead a high-performing global pharmacovigilance team.

• Promote continuous professional development and ensure the team is equipped with the latest knowledge and skills in pharmacovigilance.

• Provide regular updates to senior leadership on the status of pharmacovigilance system effectiveness, and regulatory compliance.

• Ensure clear and effective communication of safety information to internal and external stakeholders.

Required Skills, Experience and Education:

• RN or Bachelor’s degree in biological sciences or health related field required.

• Advanced degree in Pharmacy, or a related field (PharmD, PhD: preferred).

• Minimum of 15+ years of experience in pharmacovigilance or related field within the pharmaceutical or biotechnology industry.

• Minimum of 10+ years of project and line management experience; strong people management skills, willingness to help others, and ability to deal with ambiguity.

• Proven track record of leadership in global pharmacovigilance environments.

• Experience and success in interacting with Regulatory Authorities (i.e. FDA, EMA).

• In-depth knowledge of global pharmacovigilance regulations and guidelines (i.e. ICH, GxP)

• Strong analytical and strategic thinking, problem-solving, and decision-making skills.

• Excellent communication, collaboration, and team management abilities, enabling exertion of strong and successful influence of senior executives as well as strong external representation for the company.

• Demonstrated technical expertise in QA/QC.

• Outstanding emotional intelligence.

• Proven ability to lead and develop people.

Preferred Skills:

• Experience with development of PV-QMS and key operating metrics enabling demonstration of operational control.

• Demonstrated ability to manage complex projects and work effectively in a matrixed organization.

• Proficiency in managing regulatory inspections and interactions.

• Strong organizational and time management skills, with the ability to prioritize and manage multiple tasks effectively.

• Excellent influence and collaboration/teamwork capabilities. 

  #LI-Hybrid  #LI-GL1

The Opportunity:

The Senior Director, Global Patient Safety Science provides safety science and pharmacovigilance support to all products across the RevMed portfolio, which includes early and late phase development activities as a member of the Global Patient Safety team. The individual will be responsible for safety oversight and input into all aspects of study management across the portfolio.  This position may have individual reporting to it depending on the program / portfolio being led. The Senior Director of Safety Science serves as the lead for multiple or large complex strategically important developmental programs. Works closely with the other functions as part of a flexible matrix team to conduct robust safety assessments and safety risk management activities.

The Senior Director, Global Patient Safety Science will develop and maintain an expert understanding of the safety profile of the assigned product(s) as well as an understanding of the relevant strategic context (e.g., disease under study, safety profile of competitors, mechanism of action, etc.) and is accountable for oversight of benefit/risk safety profile of allocated products through the product lifecycle.

Specifically, you will be responsible for:

• Responsible for safety surveillance and risk management activities including, but not limited to medical review of ICSRs, routine review of safety data, and pertinent scientific literature articles. Contribute to the review of assessments for safety signals or in response to Regulatory Authority requests.

• Providing medical safety input into the design and conduct of pharmacoepidemiology and observational studies

• Plan and interpret safety data analyses, prepare and present safety data summaries to internal and external stakeholders.

• Acquire and contribute knowledge of relevant drug class and/or competitor safety issues.

• Lead the development of safety surveillance strategy, identify potential clinical safety issues, and recommend appropriate risk mitigation measures.

• Establish and maintain collaborative working relationships with all key stakeholders (e.g., clinical study teams, safety CROs, business partners) which require expert contribution to the development of the product safety strategy.

• Accountable for risk management activities including preparation and maintenance of relevant sections of clinical trial protocols, IBs (including the reference safety information section), ICFs, DSURs, RMPs, CCDS, and labelling, as required.

• Contribute to regulatory authority submissions (Investigational New Drug applications, New Drug Applications, Marketing Authorization Applications, etc.).

• Developing response strategies in collaboration with safety committee members, providing medical-scientific input to regulatory documents for safety-related requests from health authorities and other external parties.

• Drives risk minimization strategies and takes accountability for the medical-scientific content in the Risk Management Plans, including risk minimization measures, risk minimization action plans and REMS programs, as relevant.

• Accountable for the safety components of study reports (i.e., CSRs), aggregate reports (DSUR, PSUR/PBRER, PADER) and other regulatory documents.

• Participate in internal and external Data Monitoring Committees through review of safety data, insights and leadership and development of DMC Charters.

• Lead representative for Safety Science during Health Authority meetings.

• Reviews publications, including abstracts, manuscripts, and speaker presentations.

• Trains and mentors Safety Scientists.

• Consistently comply with all governing laws, regulations, RevMed standard operating procedures (SOPs) and other guidelines.

Required Skills, Experience and Education:

• 10 or more years of drug development experience in the pharmaceutical or related industry, of which at least 6 years include prior Safety Science experience, which includes performance of medical review, safety surveillance/signal detection, and other related risk management activities.

• A relevant postgraduate qualification (e.g., MD, PharmD, PhD/MSc in a Life sciences discipline, or other post-graduate health professional qualifications).

• Mentor, and lead a high-performing Safety Science team.

• Excellent ability to evaluate, interpret and present scientific data with clarity.

• Proven success in creating and sustaining strong relationships with internal and external business partners across an organization to create positive partnerships.

• Experience with interacting and leading with Regulatory Authorities (i.e. FDA, EMA) at type C, B, pre-BLA/MAA meetings, Advisory Committee meetings, or other scientific advice forums.

• Strong analytical and strategic thinking, problem-solving, and decision-making skills.

• Excellent communication, collaboration, and team management abilities.

• Extensive understanding of pharmacovigilance and risk management.

• Strong clinical leadership and experience.

• Outstanding emotional intelligence.

Preferred Skills:

• Demonstrated ability to lead and influence in a global matrix environment.

• 4+ years of experience in Oncology clinical development.

• Proficiency in managing regulatory interactions, BLA/MAA experience.

• Strong organizational and time management skills, with the ability to prioritize and manage multiple tasks effectively.

• Excellent influence and collaboration/teamwork capabilities.

• Strong interpersonal and communication (written and verbal) skills. 

  #LI-Hybrid  #LI-SH1

The Opportunity:

We are seeking a motivated and experienced professional to join our team as a Director of Medical Information. This role focuses on ensuring the delivery of timely, accurate, and evidence-based responses to healthcare professionals (HCPs), patients, and caregivers.

As a key member of the Medical Affairs team, you will oversee the creation and management of medical information content, support compendia submissions, and provide Medical Information support at congresses. The ideal candidate is a skilled communicator with a strong scientific background and can manage projects in a dynamic environment.

Key Responsibilities:

• Lead oversight and performance management of the global Medical Information call center, ensuring all customer inquiries are handled accurately, compliantly and within established timelines.

• Maintains and monitors KPIs, and quality metrics, driving continuous improvement to ensure high-quality, consistent inquiry handling.

• Prepares and presents regular reports on medical information performance metrics and outcomes to senior management.

• Leads the development and maintenance of internal SOPs and operational processes to ensure compliance with regulatory requirements and industry standards.

• Ensures ongoing quality assurance, audit readiness, and compliance with pharmacovigilance and regulatory requirements related to medical information inquiries.

• Support the development and maintenance of medical information resources such as standard response letters (SRLs), custom response letters (CRLs), FAQs and inquiry response guidance documents to support accurate and timely responses.

• Ensures all medical information content is evidence-based, consistent, and aligned with the latest scientific and clinical data.

• Monitors relevant scientific publications and clinical trial data to inform medical information content and responses.

• Provides Medical Information support for congresses, including staffing Medical Information booths and responding to HCP inquiries.

• Support the Medical Review process, ensuring that materials support evidence-based communication and comply with company policies, industry standards, and regulatory requirements.

• Provides support for other Medical Affairs projects as needed.

Required Skills, Experience and Education:

• Advanced degree in scientific or medical discipline; doctoral degree preferred (PharmD, MD, PhD).

• Proven experience in medical information, preferably within the pharmaceutical or biotechnology industry.

• Excellent verbal and written communication skills.

• Experience creating, reviewing and managing scientific content for diverse audience.

• Strong organizational, problem-solving and project management skills.

• Strong analytical skills with the ability to monitor and analyze data to inform decision-making.

• Knowledge of regulatory guidelines related to medical information and safety reporting.

• Proficiency in medical information databases, content management systems and other relevant software tools.

• Experience with Veeva MedComms and PromoMats.

• Ability to effectively negotiate and collaborate with internal stakeholders and external partners.

• Ability to prioritize and manage multiple projects simultaneously in a fast-paced dynamic environment.

• Self-motivated with ability to make sound decisions and adapt to changing priorities.

• Experience in managing medical information vendors.

• Willingness to travel, approximately 10-20%.

Preferred Skills:

• Minimum of 7 years of experience in Medical Affairs or a related field within the biotech or pharmaceutical industry.

• Experience in oncology therapeutic area is strongly preferred. 

  #LI-Remote #LI-VN1

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

The Manager, Patient Safety & Pharmacovigilance (PSPV) Compliance, Standards, and Training is responsible for supporting and managing activities for the execution and day-to-day oversight of PSPV compliance activities, including metrics/KPIs, maintenance of procedures, training programs, and quality system processes supporting both investigational and marketed products. This role partners closely with PSPV sub-functions, Quality Assurance, Clinical, Regulatory, and external vendors to ensure ongoing regulatory compliance.

Key Responsibilities

• Support operation and maintenance of the PSPV Quality Management System (QMS), ensuring procedures and processes are implemented consistently and in alignment with regulatory requirements
• Author, review, revise, and maintain PSPV procedures, work instructions, and related controlled documents in compliance with global PV regulations (FDA, EMA, ICH)
• Contribute to and manage activities for the development, implementation, and maintenance of role-based PV training programs, including initial and refresher training as well as monitoring of training completion and related compliance metrics/key performance indicators (KPIs)
• Contribute to and manage activities for the development, compilation and reporting of PV compliance metrics and KPI activities, including assessment of performance trends, compliance status, and identification of potential areas for improvement
• Support PSPV inspection readiness activities, including preparation of documentation, participation in mock inspections, and support of regulatory inspections
• Manage deviation, CAPA, and change control activities related to PSPV processes, including investigation support, documentation, and effectiveness checks
• Monitor changes in pharmacovigilance regulations and guidelines and support implementation of required procedural or training updates
• Support activities for the review, update, and ongoing maintenance of the Pharmacovigilance System Master File (PSMF), including coordination of routine reviews and contribution updates across functions and vendors

Required Skills and Qualifications

• Ability to operate effectively in a regulated, fast-paced environment while managing multiple priorities
• Strong working knowledge of pharmacovigilance regulations and guidelines, including FDA, EMA, and ICH requirements
• Experience with Quality Management Systems (e.g., Veeva or similar systems) are a plus
• Strong organizational, documentation, and attention-to-detail skills
• Effective written and verbal communication skills with the ability to collaborate across functions and with external vendors

Education and Experience

• Bachelor's degree in life sciences, healthcare, or a related discipline; advanced degree (e.g., RN, BSN, PharmD) preferred
• Minimum of 5 years of experience in Patient Safety/PV with 2+ years of related experience in PV compliance, standards, training, or quality system activities
• Experienced in managing quality events (deviations, CAPAs, change controls)
• Inspection/audit support experience and project management skills preferred

The pay range that the Company reasonably expects to pay for this headquarters-based position is $160,000 – $200,000; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.

 Applicants must be currently authorized to work in the United States on a full-time basis.

Please note that this position is based in Princeton, NJ. Acadia's hybrid model requires this role to work in our office three days per week on average.

Position Summary

The Director of Drug Safety & Pharmacovigilance is a medical safety expert within the Drug Safety & Pharmacovigilance (PV) function, reporting to the Executive Director of Medical Safety. This role serves as the primary medical safety resource for assigned products across the Acadia portfolio, providing hands-on medical evaluation of safety data, signal detection and assessment, and clinical oversight of pharmacovigilance activities throughout the product lifecycle. The Director contributes product-level medical input to cross-functional safety governance, collaborates with the Executive Director of Medical Safety on complex or escalated safety issues, and supports regulatory submissions and health authority interactions for assigned products. 

Primary Responsibilities

• Serves as the primary medical safety resource for assigned Acadia products, providing product-level clinical safety and pharmacovigilance expertise across all stages of development and post-marketing surveillance
• Performs medical evaluation and interpretation of aggregate safety data for assigned products, including signal detection and evaluation, ad hoc safety assessments, and benefit-risk analyses; escalates complex or novel safety issues appropriately
• Assesses safety signals and trends for assigned products and proactively manages potential safety issues in collaboration with cross-functional stakeholders
• Contributes product-level medical input to the Medical Safety team and other cross-functional safety governance bodies
• Performs medical review of all serious adverse events from Acadia clinical trials for assigned products
• Performs retrospective medical review of adverse events for post-marketed products
• Authors Analysis of Similar Events (AOSE) and individual case narratives and comments for ICSRs for assigned products
• Provides oversight for the safety aspects of clinical studies for assigned products, including development and maintenance of product-specific core safety information
• Reviews and approves safety sections of clinical documents for assigned products, including protocols, DSURs, final study reports, and other documents as required
• Formulates response strategies and authors health authority responses for safety-related queries pertaining to assigned products, in collaboration with the Head of Medical Safety
• Provides medical input into Periodic Benefit Risk Evaluation Reports (PBRERs) for assigned products, including clinical interpretation of safety data
• Provides medical and scientific input into Risk Management Plans (RMPs/dRMPs) and REMS programs for assigned products
• Ensures all PV Medical Safety activities for assigned products are performed in compliance with applicable regulations and Acadia standards
• Maintains current knowledge of global regulatory authority regulations and guidance
• Other responsibilities as assigned

Education/Experience/Skills

• MD (Doctor of Medicine) or equivalent medical degree from an accredited institution, with relevant postgraduate clinical training and experience; candidates who are eligible for U.S. medical board certification are preferred. MPH or pharmacoepidemiology training is a plus. 
• 6 to 7 years of relevant drug safety experience, including expertise in safety signal management (signal detection, evaluation, aggregate data review, ICSRs), preferably in a pharmaceutical or biotech environment.  
• Neurology, psychiatry, rare disease, or CNS-related therapeutic area experience strongly preferred
• Advanced knowledge of FDA, EU, and ICH regulations and guidelines related to pharmacovigilance, including clinical trial safety monitoring, post-marketing surveillance, ICSR processing, aggregate reporting, and health authority reporting requirements
• Ability to assess product benefit-risk profiles and interpret clinical and post-market safety data
• Demonstrated expertise in safety signal detection methodologies and medical evaluation of aggregate safety databases
• Ability to author and critically review regulatory safety documents (DSURs, PBRER safety sections, health authority responses)
• Strong analytical and critical decision-making skills; ability to manage competing priorities and meet deadlines with minimal oversight
• Experience with pharmacovigilance safety databases (Argus) and signal detection tools
• Familiarity with pharmacoepidemiology concepts and study design
• Excellent interpersonal, written, and oral communication skills; ability to effectively communicate complex safety findings to internal and external stakeholders
• Proficiency in MS Office Suite (Word, PowerPoint, Excel)
• Ability to manage multiple priorities and work cross-functionally in a fast-paced environment
• Must be willing and able to travel both domestically and internationally

Physical Requirements

This role involves regular standing, walking, sitting, and the use of hands for handling or operating equipment. The employee may also need to reach, climb, balance, stoop, kneel, crouch, and maintain visual, verbal, and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds.  This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.

#LI-HYBRID 

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

Affiliate Overview

Eidos Therapeutics, an affiliate within BridgeBio Pharma, is a commercial-stage biopharmaceutical company focused on Transthyretin Amyloid Cardiomyopathy (ATTR-CM).

What You'll Do

The Sr. Medical Director, Drug Safety and Pharmacovigilance, is responsible for the overall risk management and safety strategy of assigned products, including both internal and external engagement with key collaborators.

• Oversight and understanding of all aspects of the assigned product’s safety profile from clinical development to post-approval safety surveillance, including management of CROs and other partners that provide clinical and safety data
• Chair of the Safety Management Committee for designated product(s), responsible for identifying any emerging safety trends, defining the safety profile, and recommending safety actions based upon cumulative safety data 
• In collaboration with the regulatory and clinical development team, establish the safety strategy for marketing authorization applications, including the preparation of CTD documents, engagement with regulatory authorities, and authoring responses to inquiries

Responsibilities

• Support the clinical development team in the review of key documents, including protocol and ICFs
• Manage the drug safety contract service organizations (CROs) for clinical programs to ensure compliance with expedited reporting, manage on-time and scientifically sound DSUR preparation, and ensure the drug safety functions of the CROs meet corporate goals and key performance indicators 
• Assist in the medical review of adverse event reports; manage preparation and submission of drug safety expedited reporting in compliance with regulations, when necessary
• Develop and prepare assessments of safety data, safety signals, and benefit/risk for internal senior management as well as external partner or regulatory authorities
• Assist in the authoring of aggregate reports 

Where You'll Work

This a U.S-based remote role that will generally require three visits per year, or as needed visits to our San Francisco Office.

Who You Are

• Medical Degree
• Requires at least 12 years of drug safety and pharmacovigilance experience (clinical trials safety experience in the biotechnology, pharmaceutical, drug safety contract service organization (CSO)) with at least two years of oversight management experience (line management or CSO management)
• Extensive experience with all aspects of safety signal evaluation, including review and analysis of data, collaboration with cross-functional team members and senior management, authoring of required regulatory correspondence, and safety label updates.
• Experience in both clinical development and post-marketing safety
• Experience with Regulatory submissions for NDAs, EU MAAs, and other countries’ Regulatory reviews
• Demonstrated ability to successfully manage a drug safety team or drug safety CRO for a clinical development program with responsibilities for expedited reporting, on-time DSUR preparation
• Experience in drug safety audits and agency inspections
• Intimate knowledge of GCP and strong working knowledge of FDA, Good Clinical Practices, and ICH regulations and guidelines
• Proven ability to collaborate successfully with clinical trial teams, including data management, clinical sciences, medical monitors, clinical operations, biostats, regulatory, medical writing, and QA
• Experience in managing all clinical safety aspects of product quality defect investigations and assessments
• Management of compliance deviations and formulation of CAPAs
• Familiar with clinical trial safety database use and CIOMS II and DSUR reporting generation (Argus, ArisG, or VeevaSafety) and Microsoft Office Suite required (Word, Excel, PowerPoint, Project, Outlook)
• Must be able and willing to travel periodically for face-to-face engagements with regulatory authorities, and occasional on-site meetings (if based remotely)
• 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

#LI-NT1

GENERAL SUMMARY

The Director of Clinical Quality Assurance (CQA) will be responsible for Quality Assurance oversight of multiple, global, 4DMT sponsored clinical trials, ensuring trials are executed in compliance with all applicable international regulatory requirements for Good Clinical Practice (GCP). This position reports to the Senior Director, GCP Compliance and Quality Systems and contributes to the development, implementation, and successful execution of the CQA mission, objectives, and strategic plan.

MAJOR DUTIES & RESPONSIBILITIES:

Provide Quality oversight for multiple 4DMT Clinical Studies, including the following study-specific activities:

• Develop and implement Clinical Study Quality Plans for specific 4DMT clinical studies,
• focused on ensuring subject safety/rights, study data integrity, and GCP compliance.
• Provide guidance and support to clinical study teams, including via attendance at Study
• team meetings and via investigation and management of Clinical Study Quality Events
• Ensure principles of Risk Management are applied to the Clinical Study per ICH E6
• Identify, communicate, and escalate significant incidents of GCP non-compliance and
• follow to resolution, acting at all times with an appropriate sense of urgency
• Plan, perform, and/or oversee GCP Compliance audits of high-risk clinical vendors/sites,
• including clinical investigator sites
• Ensure audit findings are communicated to audit stakeholders and collaborate with auditees and vendors to track, review, approve, and assess the adequacy of CAPAs
• Perform Clinical Document reviews, ensuring the quality, accuracy and completeness of various documents, including as applicable Clinical Protocols, IBs, DSURs, Module 2.6 Tabulated and Written Summaries, and Integrated Summaries

Support investigation and management of specific Clinical Study Quality Events as assigned:

• Monitor, track, and facilitate the completion of formal corrective and preventive actions (CAPAs) to address identified Clinical Study Quality Events, including potential serious breaches of GCP.

Support a quality-focused work environment in Clinical that fosters learning, respect, open communication, collaboration, integration, and teamwork:

• Work with Clinical stakeholders to develop GCP compliance training materials and conduct training
• Partner with Clinical team to review, update and maintain related SOPs, identify the need for new SOPs, and support the review of new SOPs as needed
• Work with Clinical stakeholders to support Training, Development, and Implementation of 4DMT Clinical Study Risk Management Process/Tools to ensure principles of Risk Management are applied to 4DMT Clinical Studies per ICH E6
• Drive the development and continuous improvement of the Clinical Quality Management System through the development / refinement of Clinical QA processes

Support preparedness / readiness / management of BIMO inspections:

• Develop/support GCP inspectional readiness plans and lead inspectional readiness activities
• Host and/or assist with management of GCP-related inspections
• Partner with GMP Quality and Clinical Operations teams to facilitate the investigation of clinical supply quality issues such as temperature excursions, product complaints and deviations reported from clinical sites.

QUALIFICATIONS: 

Education:

• S./B.A. degree in a science or related life science field or equivalent; advanced scientific degree preferred.

Experience:

• 10+ years of experience or advanced degree with 7+ years of experience within a regulated environment such as Regulatory, Quality, Pharmacovigilance or Clinical Development / Operations within the Biotech or similar Industry
• Proven experience with GCP Quality Management Systems, quality support, and quality oversight of global clinical trials
• Minimum of 4 years of significant experience in clinical quality assurance, including experience performing/supporting GCP audits and overseeing global clinical trials, including in APAC.
• Extensive practical experience and understanding of clinical quality assurance as applied throughout the clinical development life-cycle
• (Optional) 5+ years of management experience or other specific work experience

Other Qualifications/Skills:

• In-depth understanding of GCP requirements for investigational products
• Excellent communication skills, both oral and written
• Excellent interpersonal skills, collaborative approach essential
• Comfortable in a fast-paced small company environment with minimal direction and able to adjust to workload based upon changing priorities

Travel: %5

Physical Requirements and Working Conditions:

• Physical Activity - Repetitive motions: Making substantial movements (motions) of the wrists, hands, and/or fingers. Fingering: Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling. Talking: Expressing or exchanging ideas by means of the spoken word.
• Physical Requirements - Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally, and all other sedentary criteria are met.
• Working Conditions - The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work).

Base salary compensation range: $205,000 - $235,000

Please note, the base salary compensation range and actual salary offered to the final candidate depends on various factors: candidate’s geographical location, relevant work experience, skills, and years of experience.

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.  

Job overview:

The Director, Product Quality provides strategic direction for Compass product manufacture and distribution through internal and external partnership development.

This role ensures quality strategies across Compass operations and throughout the product lifecycle for all Compass products, maintaining alignment with GMP/GDP requirements. The Director, Product Quality also guides the Compass QMS to ensure processes adapt to changing business needs, company goals, and GxP regulatory requirements.

Location: Hybrid in our New York City office or remote on the East coast, USA. 

Reports to: Vice President, Quality.

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

QA Expertise

• Maintain oversight of current and evolving global regulatory requirements, proactively assessing impact to Compass products and developing remediation plans where required

• Provide subject matter expertise in GMP and GDP, ensuring consistent application across internal and external operations

Leadership

• Drive enterprise Quality strategy across Supply Chain, Manufacturing, and QMS to reduce operational risk, optimize performance, and support the Compass business through growth and transformation

• Lead, develop, and coach the Product Quality team, building strong Quality capability and enabling effective Quality partnerships across the organization

• Act as the primary Quality point of contact for Compass Supply and Contract Manufacturing Organizations (CMOs)

• Provide Quality support and oversight for Manufacturing and Supply, spanning both IMP and commercial supply chains

• Deputize for VP, Quality when required

Product Quality Management

• Define and implement phase‑appropriate ways of working with external partners, ensuring alignment with Compass strategies and regulatory expectations

• Manage all Quality aspects of commercial readiness activities, within Compass and across the extended supply chain

• Drive strong, collaborative Quality relationships with CMOs, ensuring alignment with Compass QMS requirements and commercialization objectives

• Build a robust and resilient supply chain while ensuring compliant, cost-effective processes that support profitable growth

• Provide strategic Quality direction to support dual supply for clinical (IMP) supply and a fully commercial supply chain

Candidate Profile:

• Broad based knowledge of the pharmaceutical industry at least 12 years’ experience in the industry of which 7 should be at a managerial level.

• Scientific/engineering degree or equivalent combination of education and experience

• Postgraduate qualification in Quality Management or equivalent combination of education and experience

• A proven understanding of GMP, GCP, Pharmacovigilance and Quality Management requirements as applied in the industry

• Excellent understanding of continuous improvement in a pharmaceutical environment

• A passion for continuous improvement and experience applying techniques such as RCA root-cause analysis, CAPA, Lean, Six Sigma

• Ability to identify appropriate KPI’s, implement and use as control mechanisms and drive change and improvement

• Extensive experience of establishing and leading the QMS system and process, in a highly regulated environment across multiple sites, GxPs and locations

• Proven ability to present effectively to all levels of an organization to include project rationale and updates, strategic plans

• Ability to build effective relationships (internal and external)

• Excellent verbal and written communication skills, including the ability to interact effectively with different audiences

• Excellent networker with the ability to collaborate and agree outcomes

• Ability to understand quality issues in a complex a highly regulated environment and make data driven recommendation/decisions and take appropriate action

• Proven record of leading management and staff to deliver business plans

Company Profile

Rakuten Medical, Inc. is a global biotechnology company developing precision, cell-targeting investigational therapies on its Alluminox™ technology platform, which utilizes antibodies conjugated with payloads that are specifically activated at the tumor site.

Our first clinical product received marketing approval in Japan from the Ministry of Health, Labour and Welfare for ASP-1929 PIT to treat unresectable locally advanced or recurrent head and neck cancer - and is also in Phase III pivotal clinical testing globally to treat terminal cancer patients. This is a first-in-class product with unique pharmacological activity and with the potential to have a broad impact in cancer.

Rakuten Medical is committed to its mission to conquer cancer and aims to realize a society where cancer patients can lead fulfilling lives. Headquartered in the United States, Rakuten Medical has 5 locations in 5 countries: the United States, Japan, Taiwan, Switzerland and India. For more information, visit www.rakuten-med.com.  

Position Summary

The Manager/Senior Manager of Clinical GCP Quality will be responsible for evaluating and mitigating risk of the global clinical development programs, from initiation through completion of clinical trials, with inspection readiness in mind throughout. The ideal candidate will advise on company clinical quality strategy, ensure compliance to regulations, oversee quality management systems and interact directly with cross functional clinical, regulatory and quality teams. The ideal candidate will have at least 10 years of experience in clinical quality, process improvement, regulatory inspection management and at least two years of clinical auditing experience as lead auditor. The candidate will have an excellent working knowledge of Good Clinical Practices (ICH E6), quality requirements and other international regulations (e.g. US, EU, Taiwan, India, Japan) are desirable.

Key Duties and Responsibilities

• Provide strategic and operational leadership in the planning and executing of GCP Quality activities to support companywide and clinical development/clinical trial Quality activities.

• Successfully lead global and cross-functional quality projects

• Maintains current knowledge of ever-changing clinical quality guidance and regulations.

• Excellent communication and people skills to ensure cohesive and collaborative teamwork. 

• Demonstrated ability to implement and collaboratively drive company initiatives and policies.

• Experience in clinical inspection readiness and acting as the point person for sponsor clinical inspections. Lead Quality hosting clinical site inspection by regulatory agencies highly preferred.

• Direct experience to successfully manage and oversee CAPA plans (write, review, approve, close).

• Successfully demonstrates ability to both conduct and manage sites, internal GCP and vendor audits as well as direct and guide audit follow-up actions. 

• Establish Quality and Cross-Functional SOPs, processes and associated documents. 

• Working closely with clinical pharmacovigilance team on supporting clinical trial safety. 

• Responsible for presenting & updating CGP quality metrics and reporting to Sr. Management. 

• Other duties as assigned. 

Desired Education, Skills and Experience

• B.S. Degree in life sciences with advanced degree in a scientific discipline preferred.
• Minimum of 10 years direct experience in GCP Quality Assurance and/or GCP Compliance.
• Minimum of two years of GCP auditing (e.g. clinical site/clinical vendor) as lead auditor experience preferred.
• Demonstrates strong problem-solving skills, written and verbal communication, and experience in critical QA review of clinical documents.
• Previous experience with oncology, combination drug-device studies, and/or multi-regional with US based clinical trial experience is a plus.
• Pharmacovigilance/Safety QA experience is a plus.
• Medical Device GCP experience is a plus.
• ISO Standard (e.g. ISO13485, ISO9001, ISO27001) understanding is a plus.
• Medical Device Reporting (MDR) – FDA 21 CFR Part 803.
• Pharmacovigilance laws -EU Regulation 520/2012 for drug safety monitoring.
• Experiences with Clinical Quality Management on a risk-based approach is needed.
• Electronic TMF, document, quality, and learning management systems experience
• Strong organizational and project management skills.
• Flexible thinking and team-oriented communication and coordination skills to be able to collaborate in a team environment.
• Professional working proficiency in English

REQUIREMENTS:

Physical Demands

• None, other than those necessary to perform the essential job functions

Manual Dexterity

• None, other than those necessary to perform the essential job functions

Audible/Visual Demands

• Ability to interpret the letters and numbers when viewed on a personal computer screen, PDA, reports and other documents.

Environment

• None, other than those necessary to perform the essential job functions.

Travel

• Up to 30%

The expected salary range for this position based in California is $150,000 to $170,000 annually. Actual pay will be determined based on experience, qualification, geographic location, and other job-related factors.

This will serve as the PSPV lead for cross-functional activities and commercial initiatives, ensuring successful product launch and lifecycle management with patient safety integrated throughout the organization. This highly visible role will act as a strategic partner to Medical Affairs, Quality, Legal, and Commercial teams, driving operational and compliance excellence across all touchpoints. This is a hybrid role typically requiring on-site presence at least 3 days per week at company headquarters in Redwood City.

Responsibilities:

Cross-Functional Leadership & Collaboration:

• Build strategic partnerships and alignment of patient safety objectives and deliverables with internal stakeholders (Medical Affairs, Quality, Legal, Commercial) and external vendors/partners
• Establish and lead cross functional governance forum with PSPV, Medical Affairs, Quality, Legal, Commercial to review all commercial initiatives/activities for cross functional planning and execution
• Act as the Safety Lead for implementation and oversight of call center and commercial programs (e.g., specialty pharmacies, patient support programs, market research, distributors, etc.) including:
  • Reviewing vendor agreements and program materials to ensure inclusion of safety-related reporting requirements and deliverables
  • Ensuring appropriate systems and processes are in place for reporting safety information to Corcept in compliance with binding obligations and global reporting timelines
  • Developing and coordinating adverse event reporting training
  • Overseeing reconciliation processes between vendors and internal PV systems to ensure completeness and accuracy of safety data
  • Ensuring appropriate quality controls are in place for the call center and commercial programs, including source data verification and quality sampling of safety data
  • Maintaining tracking of vendors/providers for the pharmacovigilance system master file
  • Collaborate closely with Medical Affairs to integrate key safety messages into scientific communications and materials

Compliance & Quality Oversight:

• Contribute to review of deviations and CAPAs for commercial programs and call center
• Monitor and report compliance key performance indicators for commercial programs and call center to PSPV compliance lead
• Support audit and inspection readiness, including being the PSPV SME for commercial programs and call center activities

Strategic Planning & Process Optimization:

• Identify opportunities for process improvements and technology solutions to enhance PV systems and workflows
• Stay current with evolving global PV regulations and assess impact on organizational practices
• Support development of PV strategies aligned with corporate objectives and patient safety goals

Preferred Skills, Qualifications and Technical Proficiencies:

• Ability to work in a dynamic environment to meet patient and corporate needs
• Deep knowledge of global PV regulations (ICH, GVP, FDA, EMA)
• Proven ability to lead cross-functional teams and influence commercial strategies
• Ability to manage multiple projects in a fast-paced environment
• Excellent communication (written and verbal) and stakeholder management skills
• Proficiency in safety database systems (e.g., Argus) and electronic reporting requirements
• Able to travel for up to 10% of time

Preferred Education and Experience:

• Degree in Healthcare or Life Sciences; advanced degree preferred
• 10+ years in pharmacovigilance biopharma
• 5+ years in leadership roles with cross-functional and commercial exposure
• Experience with vendor management and regulatory inspections

The pay range that the Company reasonably expects to pay for this headquarters-based position is $240,000- $280,000; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.

 Applicants must be currently authorized to work in the United States on a full-time basis.

Job overview:   

The (Senior) Manager, REMS plays a key leadership role in the management of our Risk Evaluation and Mitigation Strategies (REMS) Program for COMP360.  The REMS manager will work closely with REMS team members to ensure REMS compliance, operational excellence and quality documentation is in place for the program. 

Location: East Coast, United States (proximity to New York City preferred).  

Reports to: Sr. Director, Clinical Safety and Pharmacovigilance. 

Role and Responsibilities:
(include but not limited to)

• Support delivery of REMS activities to agreed timelines according to company quality standards and REMS procedures. 

• Conduct reconciliation of various REMS data sources including compliance data, shipment data, Key performance indicator data to ensure proper oversight and compliance of the REMS program 

• Manage the REMS shared mailbox, respond to REMS queries and triage questions/issues as needed for resolution amongst REMS team members 

• Manage REMS specific issues and escalations, as applicable 

• Coordinate regular team meetings; track outstanding action items and activities per the project plan 

• Help manage and reconcile contracts, POs and invoices 

• Support REMS processes and procedures with execution of key deliverables 

Candidate Profile:  

• Bachelor’s degree (preferably in medical or biological science) or equivalent by experience 

• Relevant clinical/medical experience in the pharmaceutical industry, with experience in pharmacovigilance and/or quality assurance 

• Previous demonstration of basic project management skills including tracking deliverables 

• Prior REMS experience 

• Strong communication skills and fluency in English 

• Prior experience tracking metrics and/or compliance and safety data including trending and interpreting data 

• Detail oriented and  

• Proficient in Microsoft applications 

• Broad knowledge and understanding of FDA regulations and compliance requirements in a GxP environment 

• Project Management Certification a plus 

• Audit or Inspection experience Working with third-party vendors advantageous 

• Aligned to our values and mission  

Job Title: Director, Clinical Quality Assurance

Location: Remote; Waltham, MA area candidates preferred. 

Role Overview:

The Director, Clinical Quality Assurance is responsible for providing strategic quality leadership, support, and oversight for Oruka’s clinical development activities, with primary focus on Good Clinical Practice (GCP) and related quality systems supporting clinical trials. This role will establish, improve, and lead phase-appropriate clinical quality processes, ensure robust oversight of clinical trial execution and vendor performance, and drive inspection readiness for global health authority inspections, including FDA Bioresearch Monitoring (BIMO) inspections.

This role will partner closely with Clinical Operations, Clinical Development, Biometrics, Pharmacovigilance, Regulatory Affairs, Medical Writing, and external service providers to ensure that clinical studies are conducted in accordance with GCP, applicable global regulations, internal procedures, and protocol requirements. The Director, Clinical QA will provide proactive quality input across the clinical trial lifecycle, support continuous improvement, and help build a quality-focused culture as the organization advances its pipeline.

 Key Responsibilities:

• Clinical Quality Oversight: Provide Clinical QA oversight for new and ongoing clinical studies to ensure compliance with GCP, applicable regulatory requirements, and internal procedures. Serve as the primary quality business partner to Clinical Operations and other development functions to identify, assess, and mitigate quality and compliance risks across the clinical trial lifecycle. Review key study-level documents for quality and compliance, including protocols, informed consent forms, investigator brochures, monitoring plans, vendor oversight plans, data review plans, study reports, and essential trial documentation. Support development and implementation of phase-appropriate clinical quality procedures and processes.
• Quality Systems Support for Clinical Development: Provide quality support for clinical deviations, protocol deviations, investigations, root cause analysis, CAPA development, effectiveness checks, and change control activities related to clinical development. Ensure appropriate escalation, documentation, trending, and management visibility for significant quality issues. Partner cross-functionally to identify recurring themes, systemic risks, and opportunities for process improvement. Establish and maintain clinical quality metrics and dashboards to support management review and continuous improvement.
• Vendor and CRO Quality Oversight: Provide quality oversight of CROs, central laboratories, clinical software vendors, and other GCP-relevant service providers supporting Oruka’s clinical programs. Support qualification, selection, ongoing oversight, and performance evaluation of GCP vendors, including participation in vendor audits or due diligence activities as needed. Contribute to vendor governance processes to ensure appropriate quality expectations, responsibilities, and issue escalation pathways are defined and maintained.
• Audit Program Execution: Develop and execute a phase-appropriate GCP audit strategy and annual audit program based on risk, program priorities, and business needs. Conduct and/or manage investigator site, vendor, study-specific, and for-cause audits as needed. Author audit plans, reports, observations, and follow-up actions, and ensure timely resolution of audit findings through appropriate CAPA management and verification of effectiveness. Travel to clinical sites, vendors, and investigator meetings as needed.
• Inspection Readiness and Health Authority Support: Lead GCP inspection readiness activities across the organization, including development of inspection readiness plans, mock inspections, storyboards, SME preparation, document review, and inspection response coordination. Serve as the primary Clinical QA lead for FDA BIMO inspection readiness and support for other global regulatory inspections involving clinical trial activities. Partner with internal teams and external vendors to ensure inspection-facing documentation, processes, and responsibilities are inspection-ready at all times.
• Risk-Based Quality Management: Embed risk-based quality management principles into study oversight and clinical quality processes. Partner with Clinical Operations and cross-functional teams to support quality risk assessments, critical data/process identification, quality tolerance considerations where appropriate, and evaluation of key risk indicators and centralized quality signals. Ensure quality oversight activities are focused on matters most relevant to subject safety, rights, data integrity, and trial reliability.
• Inspection-Ready Documentation and TMF Support: Provide quality support and oversight related to Trial Master File (TMF) health, inspection-ready documentation practices, and completeness of essential records. Collaborate with study teams and vendors to ensure that documentation standards, reconciliation processes, and issue escalation practices support an inspection-ready state throughout study conduct.

Minimum Qualifications:

• Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or related discipline; advanced degree preferred.
• 10+ years of experience in Clinical QA/GCP Quality within biotechnology, pharmaceuticals, or a CRO environment.
• Strong knowledge of GCP and applicable global clinical regulatory requirements.
• Experience supporting quality oversight for Phase 1–3 clinical trials.
• Demonstrated experience with GCP audits, including investigator site and/or vendor audits.
• Experience supporting clinical deviations, investigations, CAPAs, and related quality system activities.
• Experience leading or supporting inspection readiness and regulatory inspections, including FDA BIMO inspections.
• Strong working knowledge of sponsor oversight expectations for CROs and other outsourced clinical vendors.
• Excellent judgment, communication, and collaboration skills, with the ability to influence across functions in a fast-paced environment.
• Willingness to travel as needed for audits, site visits, and inspection readiness activities (10-15%).

Preferred Qualifications:

• Experience as an early Clinical QA hire in a growing biotech company.
• Experience supporting biologics development programs.
• Familiarity with eQMS tools and clinical systems relevant to quality oversight.
• Experience with risk-based quality management and quality metrics.

Compensation:

• An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.
• The anticipated salary range for candidates is $213,000 - $240,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states.

 Job Location:

• Remote; Waltham, MA candidates preferred

We're looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.

Position Summary

The Director/Senior Director of Global Regulatory Affairs (GRA) will report to the Senior Vice President of Regulatory Affairs and serve as a key leader in shaping and executing global regulatory strategies. This role will partner closely with the GRA team and cross-functional stakeholders to ensure compliance with international regulatory requirements and alignment with company objectives. The candidates major responsibilities will include the following:

• Regulatory Strategy & Advice: Develop and execute integrated regulatory strategies that optimize approval pathways for drug and device across all regions where clinical studies are conducted. Provide expert guidance on global regulatory requirements, life cycle management and evolving policies where RM is pursuing development and commercialization.

• Submission Oversight: Lead cross-functional teams to prepare high-quality regulatory submissions. Review and ensure consistency of regulatory documents with company strategy and health authority standards; manage submission strategies for all Rakuten Medical projects from early-stage (IND/CTA) through NDA/BLA and lifecycle management. Oversee planning and execution of global regulatory authority meetings, including briefing packages, strategy, positioning, and negotiations.
• Documentation & Compliance: Ensure compliance with all applicable global laws, regulations, and standards (eg FDA CFR, EMA guidelines, ICH, PMDA standards, EU MDR/IVDR, GCC regulations). Maintain regulatory filing and archiving systems; ensure documentation meets health authority requirements and guidance.
• Project Management: Develop regulatory project plans and timelines; coordinate submission team and regulatory department meetings; track goals, action items, and submission progress. Manage various regulatory vendors and contractors toward budget- and time-efficient completion of corporate goals. Proven ability to apply strong influence skills in leading cross-functional regulatory submission teams.
• Cross-Functional Collaboration: Work closely with teams in CMC, nonclinical, clinical development, medical writing, safety/PV, quality assurance, medical affairs, and program management to support timely and compliant submissions. Assess regulatory risk and drive mitigation strategies to support business continuity.
• Global Tracking: Monitor regulatory commitments, deliverables, and submission content across regions.

This position spans all functional areas requiring regulatory input, including early research, CMC, device, nonclinical, clinical development and commercial. The ideal candidate will bring strong leadership, strategic thinking, and deep knowledge of global regulatory frameworks to drive successful outcomes.

Key Duties and Responsibilities 

• Develop and execute integrated global regulatory strategies for drug and device programs across all regions as required.
• Maintain a thorough understanding of current and emerging global and regional regulations, guidance documents, and ICH standards for all application types and procedures, in all regions where the organization seeks to develop and commercialize products.
• Stay informed on regulatory requirements for biologics and combination products across all regions.
• Develop and manage submission strategies for all Rakuten Medical projects and planned submissions. Ensure regulatory documents are scientifically sound, consistent, and aligned with company strategy and health authority expectations.
• Coordinate and oversee the planning, preparation, and delivery of regulatory submissions throughout the product lifecycle—from preclinical and IND/CTA through clinical development, NDA/BLA, and ongoing lifecycle management.
• Serve as the primary interface with publishing and other regulatory vendors; review submissions for completeness and compliance with regulatory guidance and health authority expectations.
• Lead implementation of new regulatory systems and develop associated processes and SOPs.
• Manage regulatory project tracking tools to monitor deliverables, commitments, submission content, amendment and approval dates, and provide proactive status updates for all regions.
• Act as the primary regulatory lead on assigned project teams, providing strategic input and regulatory support.
• Ensure timely storage and archiving of regulatory documentation in a manner that facilitates efficient retrieval.
• Conduct regulatory review of external-facing materials (e.g., manuscripts, posters) as appropriate.
• Review clinical, CMC, and safety documentation to ensure regulatory compliance and completeness during authoring and finalization.
• Coordinate safety reporting and collaborate with Safety/Pharmacovigilance to ensure systems are in place for efficient tracking and reporting of safety information.
• Assist with onboarding new employees and manage consultants and related contracts as needed.
• Contribute to continuous improvement of operational processes for regulatory submissions and document trackin. 

Qualifications:

• Education:
  • Advanced degree in Life Sciences, Pharmacy, Regulatory Affairs, or related discipline (M.S., Ph.D., or Pharm.D.).

• Experience:

• • 10+ years of regulatory affairs experience in the biopharmaceutical industry, with at least 5 years in a leadership role.
  • Proven track record of managing global regulatory submissions (IND/CTA, NDA/BLA, MAA) and lifecycle management.
  • Experience in oncology or biologics preferred; combination product/device experience is a plus.

• Knowledge:

• • Deep understanding of global regulatory frameworks (FDA, EMA, PMDA, and other major health authorities).
  • Familiarity with ICH guidelines, GCP, and evolving regulatory trends.

• Technical Skills:

• • Expertise in regulatory strategy development and execution.
  • Strong document review and submission planning skills.
  • Proficiency with regulatory information management systems and electronic submission platforms (eCTD).

Key Competencies:

• Strategic Thinking: Ability to anticipate regulatory challenges and develop proactive solutions aligned with business objectives.
• Leadership & Collaboration: Skilled at leading cross-functional teams and influencing stakeholders across global regions.
• Communication: Exceptional written and verbal communication skills for health authority interactions and internal alignment.
• Project Management: Strong organizational skills with the ability to manage multiple priorities and meet tight deadlines.
• Problem-Solving: Analytical mindset to resolve complex regulatory issues and adapt to changing requirements.
• Integrity & Compliance: Commitment to ethical standards and regulatory compliance in all activities.

We are proud to offer a competitive compensation plan with an excellent benefits package including flexible time off, stock options, 401k, medical, dental, vision plans and more.

Rakuten Medical Inc. is proud to be an Equal Opportunity Employer. We celebrate diversity and are committed to building a team that represents a variety of backgrounds, perspectives and skills.

The expected salary range for this position based in California is $150,000 to $190,000 annually. Actual pay will be determined based on experience, qualification, geographic location, and other job-related factors.

Location:  This position may be performed remotely, but requires the flexibility and willingness to travel as needed.

The Opportunity

Reporting to the Head of Pharmacovigilance, the Senior PV Scientist supports the medical oversight, analysis, coding, interpretation, and reporting of pharmacovigilance data at Praxis. This role contributes to high-quality safety surveillance, signal detection, benefit-risk evaluation, and regulatory compliance across clinical development programs.  

As Praxis advances its pipeline and prepares for regulatory submissions, this position plays a critical role in strengthening U.S.-based pharmacovigilance footprint, enhancing vendor oversight, supporting implementation of evolving safety infrastructure, and ensuring inspection readiness. The Associate Medical Director, PV Scientist enables the PV Lead to focus on clinical safety strategy, regulatory submission activities, and labeling development by providing both strategic and operational support across safety activities. 

Primary Responsibilities

• Serve as the U.S. facing PV leader, ensuring timely follow-up on safety actions across global teams and time zones. Proactively identify and resolve operational gaps before they become compliance risks. 
• Own oversight of end-to-end PV service providers, including governance meetings, KPI monitoring, TMF documentation, and continuous process improvement. Ensure quality, timeliness, and regulatory compliance at all times. 
• Contribute to the development and evolution of PV SOPs, safety management plans, and database migrations. Lead or support implementation of new safety tools (e.g., signal detection platforms, monitoring systems) to strengthen proactive surveillance. 
• Support signal detection activities, literature review, aggregate report preparation, and safety governance meetings. Author signal assessments, benefit-risk evaluations, and health hazard evaluations with scientific rigor and clarity. 
• Prepare and/or QC safety narratives, regulatory safety responses, IND/NDA/MAA components, and DSMB materials. Ensure TMF documentation is complete, accurate, and inspection ready. Maintain compliance with global safety reporting requirements. 
• Collaborate with Clinical Operations, Regulatory, Medical Affairs, Commercial, and Quality to ensure aligned safety processes, including call center setup, partner safety data exchange, and commercialization readiness activities. 
• Ensure safety data exchange complies with partner agreements. Author searches for strategies for regulatory queries and internal requests. Maintain rigorous documentation standards to support inspections and audits. 

Qualifications and Key Success Factors

• Nurse, Nurse Practitioner, Pharmacist, or Allied Health Professional.  
• Minimum 3-5 years of experience in pharmacovigilance within the pharmaceutical/biotechnology industry.  
• At least 1 year of clinical trial experience highly desirable.  
• Experience with regulatory filings (INDs, NDAs, MAAs).  
• Strong knowledge of FDA, EMA, ICH, and GVP pharmacovigilance regulations.  
• Experience in individual case safety reporting (clinical and post-marketing), aggregate reporting, signal detection, risk management planning, regulatory inspections, and PV SOP development.  
• Experience implementing safety databases and signal detection tools preferred.  
• Familiarity with MedDRA and WHO-Drug coding.  
• Excellent written and verbal communication skills. 

Key Success Factors at Praxis 

• Ownership mindset: You act like the safety infrastructure is yours. You don’t wait for direction to solve problems. 
• Operational rigor: You create clarity in ambiguity and ensure documentation withstands inspection scrutiny. 
• Scientific judgment: You understand the difference between noise and signal and contribute meaningfully to benefit-risk discussions. 
• Speed with precision: You move quickly without sacrificing quality. 
• Cross-functional credibility: You build trust across Clinical, Regulatory, Medical Affairs, Commercial, and external partners. 
• Builder mentality: You enjoy scaling systems, not just operating within them. 
• Candid communicator: You raise risks early, directly, and constructively. 

The physical and mental requirements of our roles include but are not limited to regular use of a computer, devices or other office equipment, clear communication, and occasional movement.  You'll need comfort with screen work, basic hand coordination, and focus.  Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.

Compensation & Benefits

At Praxis, we believe that taking care of our people (and their people) is important, so we provide a world class benefits package to help you thrive.  This includes 99% of the premium paid for medical, dental and vision plans.  We also provide company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage. Thinking about the future?  We match dollar-for-dollar up to 6% on eligible 401(k) contributions and sweeten the deal with long-term stock incentives and ESPP.  We provide a discretionary quarterly bonus, an extremely flexible wellness benefit, generous PTO, paid holidays and company-wide shutdowns.  Not to mention, you'll also be joining a phenomenal crew of colleagues who are smart, engaged and inspiring.  We aim high, collaborate hard, and produce results.  Let’s achieve the impossible together! 

To round out our world-class total rewards package, we provide annualized base salary compensation in the range listed below.  Final salary range may be modified commensurate with job level, education, and experience.

About the Role

Reporting to the Director of Clinical Quality Assurance, the Manager II, Clinical Quality Assurance, is responsible for clinical quality support and management of the Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and Good Pharmacovigilance Practice (GVP) supplier qualification program.

The successful candidate will assist in inspection readiness activities across the company, training and ensuring adherence with current ICH GCP E6 guidance and applicable regulations.

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

• Provide day-to-day clinical quality support and training, as appropriate, to ensure adherence with applicable regulatory requirements, company policies and procedures.
• Coordinate all GCP/GLP/GVP related internal and supplier audit activity including management and maintenance of the qualification program’s audit schedule within the Quality Management System (QMS).
• Perform supplier audits and prepare author reports, as needed.
• Compile audit responses and review implementation evidence.
• Support the implementation of quality systems and processes within the Clinical Quality area.
• Review and approve QMS records (deviations, corrective and preventive actions (CAPAs), change controls, etc.) for completeness and adherence to Standard Operating Procedure (SOPs) and applicable regulations.
• Assist in remediation and corrective action plans and monitor quality issues to resolution.
• Assist with the review of Clinical Quality Management Plans (CQMPs) for clinical trials and/or vendor performance, as needed.
• Responsible for the management of clinical training curricula.
• Assist in the creation of tracking tools to report quality metrics, as necessary.
• Support the review of and/or perform Risk Assessments, as needed.
• Assist with oversight and conduct periodic reviews of clinical trial systems (e.g. Clinical Trial Management System (CTMS), Trial Master File (TMF), etc.).
• Work closely with Quality Management to ensure compliance with applicable guidelines, regulations, and SOPs.
• May serve as a resource for Clinical Development/Operations and Quality.

Factors for Success:

• 8 years of experience in clinical
• 5 years of experience within the pharmaceuticals industry
• Bachelor’s Degree in Scientific Field Preferred
• In-depth knowledge of clinical trial related FDA regulations, ICH Guidelines, and experience with international GCP/GLP/GVP regulations and guidelines is desired.
• Extensive knowledge in Risk-Based Management (RBM), global clinical regulations and clinical development.
• Experience with investigations using root cause analysis, corrective and preventive actions (CAPA) and CAPA effectiveness checks.
• In-depth knowledge of auditing planning, principles, techniques and communication skills to clearly and efficiently convey findings and report deficiencies.
• Ability to work closely with both internal and external personnel to increase the level of compliance and cooperation while creating opportunities to improve operations and implementing them effectively to reduce errors.
• Ability to adapt to shifting priorities in a fast‑paced environment.
• Strong computer and organizational skills.
• Strong attention to detail.
• Decision Making - Demonstrates strong decision-making by applying structured analysis to complex challenges, balancing competing priorities and long-term impacts while engaging stakeholders and driving solutions aligned with organizational goals.
• Collaboration and Team Building - Promotes collaboration by aligning diverse teams around shared goals, fostering healthy debate to advance outcomes, and building strong networks that strengthen organizational effectiveness and cross-team learning.
• Outcome Driven - Demonstrates strong outcomes focus by aligning teams around shared priorities, proactively addressing risks and dependencies, and driving cross-functional accountability to sustain progress and deliver results.

A Few Other Details Worth Mentioning:

• The position will be based in our beautiful Irvine office, complete with onsite gym, pool, snacks, drinks, and occasional catered meals. We provide a hybrid work environment. .
• We are passionate about our culture! Our Tarsans live our values of commitment to patients, empowerment to champion innovation, and teamwork to amplify impact!
• This position reports to the Director of Clinical Quality Assurance.
• Some travel may be required – up to 20%.

At Tarsus, we understand the importance of attracting and retaining top talent. The expected base pay range for this position is $120,000 - $168,000 plus bonus, stock equity, and comprehensive benefits. The base pay range reflects the target range for this position, but individual pay will be determined by additional factors such as job-related skills, experience and relevant education or training. Our benefits include health, dental and vision insurance benefits to ensure your well-being. We believe in work-life balance and offer generous paid time off, including vacation, holidays, and personal days. For more details regarding Tarsus benefits, please visit: https://eb.alliant.com/26tarsusbenefitssnapshot.

#LI-Hybrid

About the job

We are seeking an experienced and strategic Regional Director, Field Medical Affairs, to lead our East region. This newly created role will oversee a team of Medical Science Liaisons (MSLs) and serve as a key driver of scientific engagement, medical operations strategy, and cross-functional collaboration.

The ideal candidate brings expertise in Eyecare, strong leadership experience within Medical Affairs, and a demonstrated ability to build meaningful relationships with Key Opinion Leaders (KOLs) and Eye Care Practitioners (ECPs). The role plays a critical part in advancing the organization’s medical strategy and supporting cross-functional collaboration across teams. The successful candidate will combine scientific acumen with strong leadership and strategic thinking, driving excellence in field medical execution while contributing to the broader goals of the Medical Affairs organization.

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

Leadership & Team Management:

• Lead, mentor, and manage a team of MSLs (N=6), fostering a collaborative, high-performing, and scientifically rigorous culture.
• Set clear expectations on the development and execution of territory plans, objectives, and key performance indicators (KPIs) for each MSL.
• Conduct regular performance evaluations, identify skill gaps, and support MSL development through coaching, training, and career growth opportunities.
• Collaborate with the Medical Affairs Operations leadership team to align MSL activities with organizational priorities and strategic initiatives.

Strategic Planning & Execution:

• Serve as a disease state and product expert, providing strategic input into MSL educational initiatives and product launch planning.
• Contribute to the development of Field Medical Strategy and Tactics in line with corporate and medical strategic goals.
• Ensure MSLs are equipped with the latest scientific data and clinical information and support their integration into both regional and national-level initiatives.
• Partner with Medical Affairs Strategy Leads to oversee the Medical Strategy Tactical Team (MSTT), ensuring medical affairs insights are synthesized and translated into actionable plans.
• Collaborate with Field Medical Trainer and Medical Operations Leadership to develop and partake in field medical training and being a resource for our field team.
• Support medical conference strategy and planning, attend conferences to provide scientific expertise and collaborate with ECPs.
• Identify gaps in ECP education and clinical evidence; propose ideas on how to address unmet educational and evidence needs and collaborate with medical experts on disease state and product related education.

Scientific Exchange & KOL Relationship Management:

• Provide strategic oversight of MSL-led engagement with KOLs, ECPs, clinician scientists and researchers, and key stakeholders across the region to ensure consistent, high-quality scientific exchange.
• Oversee team participation in scientific congresses, advisory boards, and other external engagements to strengthen relationships and advance scientific understanding.
• Stay current on scientific literature and market and keep tabs on KOL engagement and opportunities for disease state education and awareness.

Cross-Functional Collaboration:

• Oversee team adherence to pharmacovigilance and safety requirements, ensuring accurate and timely adverse event reporting.
• Compliantly partner with regional Sales leadership (RDLs) for field related needs and solutions.

Compliance & Reporting:

• Ensure all MSL activities comply with regulatory, ethical, and company standards, including GxP (Good Clinical Practice) and HIPAA regulations.
• Provide regular updates to Medical Affairs VP and Operations on MSL team progress, KOL engagement, and key initiatives, incorporating metrics on impact and outcomes, as well as feedback, identified opportunities, and potential solutions.
• Stay abreast of the competitive landscape and emerging trends in ophthalmology, ensuring MSL activities reflect the latest scientific advancements.

Leadership Competencies - This role requires mastery of the Tarsus Leadership Competencies for Leading People, including:

• Decision Making - Demonstrates strong decision-making by applying structured analysis to complex challenges, balancing competing priorities and long-term impacts while engaging stakeholders and driving solutions aligned with organizational goals.
• Collaboration and Team Building - Promotes collaboration by aligning diverse teams around shared goals, fostering healthy debate to advance outcomes, and building strong networks that strengthen organizational effectiveness and cross-team learning.
• Outcome Driven - Demonstrates strong outcomes focus by aligning teams around shared priorities, proactively addressing risks and dependencies, and driving cross-functional accountability to sustain progress and deliver results.
• Empowering Others - Fosters empowerment by aligning authority with accountability, developing leaders’ decision-making capability, and creating systems that support performance and growth.
• Emotional Intelligence - Foster trust and psychological safety, navigating complex interpersonal dynamics with compassion and accountability, and adapting leadership style to support others while maintaining composure under pressure.

Factors for Success:

• OD, PhD, PharmD, MD, or other advanced degree in a relevant scientific discipline with experience in Eyecare.
• Minimum of 10 years of experience in Medical Affairs or related scientific roles, with at least 5 years of leadership experience in managing a team of MSLs.
• In-depth knowledge of Eye Care/Ophthalmology/Optometry (preferred).
• Previous experience leading a Field Medical Team within a biopharmaceutical company (preferred).
• Proven track record of successful relationship-building with KOLs, ECPs, and key stakeholders within the medical community.
• Experience working in cross-functional teams, with a demonstrated ability to collaborate effectively with commercial, clinical, regulatory, and other business functions.
• Strong leadership skills, ability to inspire and motivate others, and collaborate cross-functionally.

A Few Other Details Worth Mentioning:

• This position is primarily remote with required travel at approximately (50-75% for KOL engagement, field rides, scientific meetings, and team management activities.
• We are passionate about our culture! Our Tarsans live our values of commitment to patients, empowerment to champion innovation, and teamwork to amplify impact!
• This position reports directly to our Vice President, Medical Affairs Operations.

At Tarsus, we understand the importance of attracting and retaining top talent. The expected base pay range for this position is $203,200 - $284,600 plus bonus, stock equity, and comprehensive benefits. The base pay range reflects the target range for this position, but individual pay will be determined by additional factors such as job-related skills, experience and relevant education or training. Our benefits include health, dental and vision insurance benefits to ensure your well-being. We believe in work-life balance and offer generous paid time off, including vacation, holidays, and personal days. For more details regarding Tarsus benefits, please visit: https://eb.alliant.com/26tarsusbenefitssnapshot.

#LI-Remote

Position summary:  

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

Key Responsibilities:  

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

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

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

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

• Support safety monitoring and pharmacovigilance activities.  

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

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

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

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

• Lead clinical trial data publication efforts.  

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

Qualifications:  

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

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

Knowledge and Skills 

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

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

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

Caribou Biosciences is a leading clinical-stage CRISPR genome-editing biopharmaceutical company dedicated to developing transformative therapies for patients with devastating diseases. Our next-generation genome-editing technology enables superior precision to develop cell therapies that are armored to potentially improve activity against diseases. We believe the future of cell therapy is off-the-shelf, and we are advancing our pipeline of off-the-shelf, or allogeneic, cell therapies from our CAR-T cell therapy platform as readily available treatments for patients with hematologic malignancies and autoimmune diseases.

Members of the Caribou herd open their minds to new ideas and welcome diverse perspectives. We proudly assert that teams do their best work when their members are personally engaged, their ideas are taken seriously, and contributions are recognized. Members of the herd work from our headquarters in Berkeley, California, or remotely.

Summary:

Responsible for leading in the development, implementation and maintenance of QA systems and activities supporting quality oversight towards GCP, GLP, and PV operations. The incumbent will assist in the development of quality systems to ensure clinical trials are conducted in accordance with appropriate regulations, guidelines, procedures, and protocols.

The incumbent is also responsible for developing specific internal procedures, training of staff, and hosting regulatory inspections. The position involves managing clinical quality operations and liaison of clinical quality related issues with Company’s functional areas. The candidate will perform audits of service providers, study sites, and internal processes.

The successful candidate must have the ability to execute QA tasks independently; effectively represent QA in a GCP, PV, and GLP focused team settings and manage quality related activities related to clinical vendors, investigator sites and regulatory agencies. In addition, the candidate must actively manage an appropriate level of inspection readiness of Company’s clinical stakeholders and act as a catalyst for continuous process improvement.

Responsibilities:

• Compliance Oversight: Ensure that all clinical trial activities comply with guidelines and international regulations (e.g., ICH-GCP and ICH-PV), and applicable laws.
• Documentation Review: Conduct thorough reviews of study-related documentation, including protocols, investigator brochures, informed consent forms, and CSRs, to verify compliance with GCP requirements.
• Provide Clinical Quality Assurance (GCP) strategic and technical leadership and Subject Matter Expertise (SME) to clinical study teams; Partner with the teams to effect appropriate and timely documentation of quality event management, including CAPA plans in support of product pipeline.
• Plan and oversee activities in support of regulatory submissions and inspections; Lead GCP Inspection Readiness efforts, ensure implementation and prepare internal and external teams for Pre-Approval Inspections (PAI).
• Implement, monitor, and promote best practices of all Quality Assurance Systems to ensure compliance with relevant FDA, EU and ROW regulations/directives/requirements and ICH guidelines.
• Quality Management System (QMS): Maintain and enhance Caribou’s QMS by implementing processes and procedures that ensure consistent adherence to GCP, GLP and PV standards throughout the clinical trial lifecycle.
• Develop and implement the appropriate suite of Standard Operating Procedures (SOPs), quality manuals, policies, and other related quality documents. Ensure that these systems are effectively communicated, understood, and followed by relevant stakeholders.
• Create and implement clinical quality risk management strategies to identify, assess, and mitigate risks associated with clinical development and operations. This involves conducting risk assessments, developing risk mitigation plans, and overseeing their implementation.
• Build training and approve curricula based on the key elements of the Quality System; Provide leadership and oversight for training programs related to pre-clinical, clinical and PV. Ensure that employees and relevant stakeholders receive appropriate training on quality standards, regulations, and procedures.
• Establish and monitor quality metrics and key performance indicators for the effectiveness of pre-clinical, clinical, and PV quality assurance activities. Prepare routine reports and presentations for senior/executive management review highlighting quality performance, trends, and areas for improvement. Assist with tracking compliance audit trends and present to management.
• Collaborate with cross-functional teams, including pre-clinical, clinical operations, regulatory affairs, pharmacovigilance, and other relevant departments, to ensure alignment and integration of quality assurance activities. Build and maintain effective relationships with internal and external stakeholders, including regulatory agencies and service providers.
• Perform internal and external audits to ensure stakeholder system compliance with existing policies and procedures, and requirements, standards, and guidelines.
• Lead and/or manage additional Quality Assurance (GxP) initiatives or programs as business needs evolve.

Qualifications:

• Undergraduate or graduate degree(s) in Biological Sciences, Chemistry, or related Science discipline with at least 15 years of experience in clinical quality assurance (GCP, GLP and PV) in cell & gene therapy/biotechnology and/or pharmaceutical industry. Experience working in biologics is strongly preferred.
• Subject Matter Expert (SME) working knowledge on current interpretation/implementation of United States Code of Federal Regulations, ICH Guidelines and other local government regulatory requirements governing clinical research.
• Proven track record in developing and implementing quality systems and processes in a clinical setting.
• Expertise in creating and executing audit plans outlining all service providers (vendor) audits, clinical investigator site audits, CSV audits and process audits.
• Advanced knowledge of Quality Assurance principles, concepts, industry practices, and standards.
• Prior GLP experience with quality oversight and auditing studies/vendors (preferred).
• Excellent verbal and written communication skills, ability to lead cross-functional teams and independently prioritize work, manage multiple projects while maintaining quality and being an advocate for quality and regulatory compliance.
• The position requires a highly diplomatic, and tactful individual with excellent critical reasoning skills.
• Conscientiously detail-oriented and organized, impeccable attention to data review.
• Ability to deal with ambiguity and use expertise and skills to contribute to the development of company objectives and principles, and to achieve goals in creative and effective ways.
• Must be flexible and able to multi-task, prioritize, meet deadlines in a fast-paced environment, and be adaptable to setbacks.
• Detail-oriented mindset with a proactive approach to problem-solving and decision-making.
• Certification in quality assurance (e.g., Certified Quality Auditor) and/or GCP (e.g., Certified Clinical Research Professional) is desirable.
• Ability to travel up to 25-30% based on business needs.

Caribou compensation and benefits include:

• Comprehensive compensation package, which includes competitive salary, bonus, and equity for all employees
• Salary Range: $220,000 to $235,000- This represents the present low and high end of the Company’s pay range for this position. Actual pay will vary based on various factors, including but not limited to location, skill, experience, and performance.
• Generous paid vacation time, in addition to company-observed holidays
• Excellent medical, dental, and vision insurance
• 401(k) retirement savings plan, which includes matching employer contributions
• Employee stock purchase plan (ESPP)
• Tuition reimbursement program

The benefits and stock purchase described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility.

Caribou is an equal opportunity employer and does not discriminate based on race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical conditions, veteran status, sexual orientation, gender (including gender identity and gender expression), sex (which includes pregnancy, childbirth, and breastfeeding), genetic information, taking or requesting statutorily protected leave, or any other basis protected by law. In addition, Caribou prohibits the harassment of any individual on any of the bases listed above or any other characteristics protected under federal, state, or local laws.

Legal authorization to work in the United States is required. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.

We do not accept unsolicited resumes or candidate submissions from staffing agencies. All agencies must have a valid written agreement with Caribou Biosciences, Inc. for service in place. Any resume or candidate submitted by a staffing agency without such an agreement in place will be considered unsolicited, and Caribou Biosciences, Inc.  will not be obligated to pay any referral or placement fee.