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.  

  #LI-Hybrid  #LI-SH1

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. 

  #LI-Hybrid  #LI-GL1

POSITION SUMMARY:

Natera is seeking a highly motivated and experienced Clinical Scientist to support the development and execution of our innovative Oncology programs.

The Director, Clinical Science will ensure the successful execution of clinical development programs and deliverables in partnership across the organization, with external vendors, and with external academicians and collaboration partners. The Director, Clinical Science will be accountable to jointly develop clinical program strategy and work collaboratively together with other functional representatives to assure that activities are executed within expected scope, compliance, budget, and timelines. Specifically, the candidate will work closely with colleagues cross functionally in clinical development, clinical operations, data management safety/pharmacovigilance, regulatory, biostatistics, translational medicine, and program leadership.

PRIMARY RESPONSIBILITIES:

• Develop study concepts, including study design, schedule of assessments, objectives/endpoints, and eligibility criteria  
• Collaborate cross-functionally to develop Protocol and ICF documents / amendments and present these to governance committee and early clinical development team meetings as required
• Provide protocol training and contribute to CRF design
• Ensure study manuals align with protocol and engage investigators in study design
• Seek input from key investigators on study design and methodology to ensure alignment with research objectives, and actively participate in pre-site selection discussions, site initiation visits, and investigator meetings to support successful study execution
• Contribute to and oversee real-time clinical data reviews (including oversight of CROs when applicable)
• Serve as a clinical science representative on internal and external meetings 
• Develop clinical project execution timelines and provide status updates to senior management to ensure the timely delivery of program milestones
• in collaboration with Data Management will develop Data Review Plan, and monitor clinical data for specific trends, ensure CRF design adequately supports data collection in alignment with the protocol in collaboration with Data Management/Programming
• Support meetings (advisory boards, etc) and deliver presentations
• Drive clinical research plans, including company and investigator-initiated studies
• Effectively interact with senior members in other functional areas for strategic planning to ensure optimized clinical development in accordance with corporate objectives 
• Build relationships with KOLs, consortiums, and sites
• Provide scientific input into design & implementation of clinical trial(s), their delivery, clinical data review and data cleaning, interpretation of results, reporting successfully on time, and activities required for registration of the product 
• As appropriate, participates in ongoing enhancements/development of team processes, structures, systems, tools, and other resources; As appropriate, coaches and guides less experienced Clinical Scientists
• Manage one or more direct reports including being responsible for hiring, training, developing, and retaining talent on staff, as needed
• As appropriate, participates in competitive intelligence and/or other market/industry assessment activities and projects
• Maintains scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment
• Ensure HIPAA/PHI compliance and maintain training requirements
• Perform other duties as assigned

QUALIFICATIONS:

• Advanced degree in Life Sciences (MD, PhD, Pharm D, MS, RN or similar scientific field) preferred
• 10+ years of pharma/biotech industry experience in clinical development in oncology clinical trials
• Deep understanding and preferably experience in oncology molecular diagnostics, oncology companion diagnostics or early cancer detection 
• Experience in data review, data cleaning, managing and interpreting clinical trials results as well in writing clinical trial protocols
• Possesses sound foundational knowledge of FDA and other major country regulations and detailed knowledge of Good Clinical Practice other regulations governing clinical research
• Experience with managing direct reports, ensuring that roles are performed in accordance with job descriptions and that training is conducted and maintained appropriately

KNOWLEDGE, SKILLS, AND ABILITIES:

• Problem-solving skills and a fast learner
• Strong communication (oral and written) and attention to detail
• Ability to work independently and collaboratively
• Analytical and creative thinking
• Familiarity with Google and Microsoft suites
• Desire to work in a dynamic environment
• "Hands-on" leadership and a strong work ethic
• Ability to apply business knowledge, exercise judgment, and escalate issues appropriately
• Strong project management, organizational, and interpersonal skills
• Adaptability, initiative, and team-building skills
• Demonstrated success in working in a cross-functional environment
• Successful and superior influencing skills across all levels of the organization and external collaborators
• Conflict resolution and follow-through skills
• Results and goal-oriented
• Strategic and flexible thinking

PHYSICAL DEMANDS & WORK ENVIRONMENT:

• Office or home office setting with internet access
• Ability to use a computer, phone, and read materials 
• Flexibility to work with colleagues in a global setting
• Able to engage in work-related travel up to 25%

POSITION SUMMARY:

Natera is seeking a highly motivated and experienced Clinical Scientist to support the development and execution of our innovative Oncology programs.

The Associate Director, Clinical Science will ensure the successful execution of clinical development programs and deliverables in partnership across the organization, with external vendors, and with external academicians and collaboration partners. The Associate Director, Clinical Science will be accountable to jointly develop clinical program strategy and work collaboratively together with other functional representatives to assure that activities are executed within expected scope, compliance, budget, and timelines. Specifically, the candidate will work closely with colleagues cross functionally in clinical development, clinical operations, data management safety/pharmacovigilance, regulatory, biostatistics, translational medicine, and program leadership.

PRIMARY RESPONSIBILITIES:

• Develop study concepts, including study design, schedule of assessments, objectives/endpoints, and eligibility criteria  
• Collaborate cross-functionally to develop Protocol and ICF documents / amendments and present these to governance committee and early clinical development team meetings as required
• Provide protocol training and contribute to CRF design
• Ensure study manuals align with protocol and engage investigators in study design
• Seek input from key investigators on study design and methodology to ensure alignment with research objectives, and actively participate in pre-site selection discussions, site initiation visits, and investigator meetings to support successful study execution
• Contribute to and oversee real-time clinical data reviews (including oversight of CROs when applicable)
• Serve as a clinical science representative on internal and external meetings 
• Develop clinical project execution timelines and provide status updates to senior management to ensure the timely delivery of program milestones
• in collaboration with Data Management will develop Data Review Plan, and monitor clinical data for specific trends, ensure CRF design adequately supports data collection in alignment with the protocol in collaboration with Data Management/Programming
• Support meetings (advisory boards, etc) and deliver presentations
• Drive clinical research plans, including company and investigator-initiated studies
• Effectively interact with senior members in other functional areas for strategic planning to ensure optimized clinical development in accordance with corporate objectives 
• Build relationships with KOLs, consortiums, and sites
• Provide scientific input into design & implementation of clinical trial(s), their delivery, clinical data review and data cleaning, interpretation of results, reporting successfully on time, and activities required for registration of the product 
• As appropriate, participates in ongoing enhancements/development of team processes, structures, systems, tools, and other resources; As appropriate, coaches and guides less experienced Clinical Scientists
• Manage one or more direct reports including being responsible for hiring, training, developing, and retaining talent on staff, as needed
• As appropriate, participates in competitive intelligence and/or other market/industry assessment activities and projects
• Maintains scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment
• Ensure HIPAA/PHI compliance and maintain training requirements
• Perform other duties as assigned

QUALIFICATIONS:

• Advanced degree in Life Sciences (MD, PhD, Pharm D, MS, RN or similar scientific field) preferred
• 8+ years pharma/biotech industry experience in clinical development in oncology clinical trials
• Deep understanding and preferably experience in oncology molecular diagnostics, oncology companion diagnostics or early cancer detection 
• Experience in data review, data cleaning, managing and interpreting clinical trials results as well in writing clinical trial protocols
• Possesses sound foundational knowledge of FDA and other major country regulations and detailed knowledge of Good Clinical Practice other regulations governing clinical research
• Experience with managing direct reports, ensuring that roles are performed in accordance with job descriptions and that training is conducted and maintained appropriately

KNOWLEDGE, SKILLS, AND ABILITIES:

• Problem-solving skills and a fast learner
• Strong communication (oral and written) and attention to detail
• Ability to work independently and collaboratively
• Analytical and creative thinking
• Familiarity with Google and Microsoft suites
• Desire to work in a dynamic environment
• "Hands-on" leadership and a strong work ethic
• Ability to apply business knowledge, exercise judgment, and escalate issues appropriately
• Strong project management, organizational, and interpersonal skills
• Adaptability, initiative, and team-building skills
• Demonstrated success in working in a cross-functional environment
• Successful and superior influencing skills across all levels of the organization and external collaborators
• Conflict resolution and follow-through skills
• Results and goal-oriented
• Strategic and flexible thinking

PHYSICAL DEMANDS & WORK ENVIRONMENT:

• Office or home office setting with internet access
• Ability to use a computer, phone, and read materials 
• Flexibility to work with colleagues in a global setting
• Able to engage in work-related travel up to 25%

About the Role >>> Associate Director, GCP Quality Assurance   

As the Associate Director, GCP Quality Assurance, reporting to the Senior Director GCP Quality Assurance, you will be partnering with Clinical Development/Operations, Pharmacovigilance and Safety in cross-functional study teams to drive GCP/GVP compliance. This will include identifying and communicating clinical trial-related risks and opportunities for process improvement, as well as reviewing / approving study-related documents and plans and supporting audits.  

This hybrid role is based out of either our San Francisco, CA or Cambridge, MA office and requires up to 20% travel. 

Your work will primarily encompass: 

• Performs internal and external audits as assigned to ensure compliance with GCP/GVP regulations and guidelines 
• Provide GCP/GVP auditing activities, including audit preparation, execution, report preparation, and follow-up to any findings/observations, including corrective and preventive actions (CAPAs), communicate audit results to internal stakeholders  
• Partner with QA leadership during regulatory authority inspections and drive  GxP inspection readiness activities 
• Oversees quality aspects related to clinical study start-up, execution, and close-out by providing leadership, guidance, and direction to staff consistent with GCP/GVP 
• Prepare for health authority inspections, suppliers and or clinical sites 
• Oversee clinical compliance and quality within the context of cross-functional study teams 
• Continue to improve/refine Olema’s risk-based GCP compliance approach globally 
• Manage Quality Management System (QMS) including, but not be limited to, the following activities: QA review/approval of deviations, CAPAs and change controls 
• Draft, review, and approve policies, procedures, and work instructions 

Ideal Candidate Profile >>> Key Requirements 

A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role. 

Knowledge: 

• Bachelor’s Degree or higher in a scientific discipline 
• Strong understanding of clinical trials and pharmacovigilance reporting  
• In-depth knowledge of and ability to interpret and apply GCP, EU, FDA, and ICH regulations and guidelines 
• Understanding of industry quality management tools, quality systems (e.g., QMS, eTMF, EMRs, EDC, etc.) 

Experience: 

• A minimum of 8 years of relevant experience in Quality Assurance or related role in a pharmaceutical, biotechnology, or related environment 
• Demonstrated experience leading and/or conducting internal and external QA audits developing and executing risk-based audit plans 
• Demonstrated ability to develop and foster positive, collaborative relationships with internal staff as well as with external, third-party vendors 
• Hands-on experience with regulatory inspections and inspection readiness activities 
• Experience writing and reviewing SOPs 
• Experience using QMS (Veeva systems preferred) 
• Knowledge and experience in Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP) regulations. In addition, preferred Good Laboratory Practice (GLP) experience 
• Ability to interpret and apply GCP, EU, FDA, and ICH regulations and guidelines 

Attributes: 

• Excellent verbal and written communication skills 
• Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members 
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines 
• Excellent planning, organization, and time management skills including the ability to support and prioritize multiple projects 
• Ability to work hands-on and be a strong individual contributor 

The base pay range for this position is expected to be $190,000 - $205,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits. 

#LI-CK1

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:

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 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:

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:

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:

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:

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 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 

About the Role >>> Vice President, Quality Assurance  

The Vice President, Quality Assurance serves as the senior leader accountable for defining and driving Olema’s global quality strategy, systems, and governance across the full product lifecycle, including clinical development, manufacturing, pharmacovigilance, and commercial. This leader is the primary voice of Quality at the executive level and ensures a phase-appropriate, risk-based approach to quality that reflects the needs of oncology drug development, where patient safety, data integrity, and speed are critical.  

Operating with appropriate independence, this role partners cross-functionally and leads an established Quality leadership team across GCP, GMP, and GPV - aligning priorities, strengthening execution, and ensuring inspection readiness as Olema advances toward late-stage development.

This role is based out of our either our San Francisco, CA or Boston, MA office and will require some travel as needed.  

As Vice President, Quality Assurance, your work will primarily encompass:

Quality Strategy & Leadership  

• Define and drive a pragmatic, phase-appropriate and unified Quality strategy aligned with Olema’s pipeline and corporate objectives   
• Serve as the senior Quality leader, establishing clear governance, decision-making frameworks, and escalation pathways   
• Lead and develop Quality leadership across GCP, GMP, and GPV, enabling strong execution and maintaining clear accountability   
• Foster a culture of quality, integrity, and patient focus across the organization   
• Act as escalation point for significant quality, compliance, and patient safety risks   
• Ensure ongoing inspection readiness across clinical, manufacturing, and safety domains 

Quality Systems & Governance  

• Set expectations and direction for a scalable, integrated, and sustainable Quality Management framework spanning clinical through commercial stages   
• Ensure effectiveness and evolution of Quality systems through oversight of functional leaders across the QA function   
• Drive consistency in quality processes, risk management approaches, and data integrity standards across the organization   
• Establish clear quality metrics and reporting to enable risk visibility and informed decision-making 

Clinical Quality (GCP)  

• Ensure Quality approaches appropriately support the execution of oncology clinical trials   
• Provide oversight of clinical quality and CRO management to ensure patient safety and data integrity   
• Partner with Clinical and Regulatory to support inspection-ready programs and submissions

Manufacturing & Commercial Readiness (GMP)  

• Ensure Quality strategy supports manufacturing scale-up and readiness for late-stage development and commercialization   
• Oversee GMP Quality through established leadership, ensuring appropriate CMO/CDMO oversight and inspection preparedness   
• Provide Quality input into CMC, validation, and supply chain readiness activities

Pharmacovigilance Quality (GPV)  

• Oversee the pharmacovigilance quality framework, ensuring compliance, data integrity, and effective safety surveillance   
• Ensure PV systems and vendors are appropriately governed and inspection-ready   
• Partner cross-functionally to support ongoing evaluation of benefit-risk

Inspection, Audit & Risk Management  

• Lead the Company’s approach to regulatory inspections, including preparation and execution   
• Ensure risk-based audit programs across GCP, GMP, and GPV   
• Drive proactive identification and mitigation of quality and compliance risks

Cross-Functional Leadership  

• Partner with Executive Leadership, Regulatory, Clinical, and Manufacturing, to embed quality across the organization   
• Provide clear, actionable Quality perspectives to support business decisions   
• Represent Quality in executive discussions and external engagements as needed   

Ideal Candidate Profile >>>  

A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role.

Knowledge

• Advanced degree in Life Sciences or related discipline (PhD, PharmD, MS) 
• Deep knowledge of FDA, EMA, ICH, and global GxP and pharmacovigilance (GPV) regulatory requirement 
• Expertise across GCP, GMP, and GPV Quality domains 
• Strong understanding of Quality systems, governance, and inspection readiness practices 
• Working knowledge of oncology drug development

Experience

• Minimum of 15+ years of Quality experience in biotech/pharma with increasing scope and responsibility 
• Significant people management and leadership experience, including leading senior team members 
• Experience overseeing global vendor networks, including CROs, CMOs, CDMOs, and PV vendors 
• Demonstrated experience across GCP, GMP, and GPV environments 
• Proven track record supporting programs from clinical development through late-stage or commercial readiness 
• Experience leading regulatory inspections and interacting with global health authorities 
• Experience implementing and maintaining Quality systems and compliance frameworks

Attributes

• Strong leadership capability with ability to lead through and develop senior leaders 
• Effective communicator with executive presence and influencing skills 
• Sound judgment and decision-making in complex, risk-based environments 
• Ability to operate effectively in a fast-paced, evolving biotech environment 
• Commitment to quality, compliance, and patient safety 

The base pay range for this position is expected to be $315,000 - $340,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits. 

#LI-AD1

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.

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.

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

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.