Revolution Medicines
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Revolution Medicines (RevMed) is committed to revolutionizing treatment for patients with RAS-addicted cancers, specializing in oncology drug discovery and development. With the mi
134 Jobs
Director, Global Pre-Approval Patient Access
Revolution MedicinesRevolution Medicines (RevMed) is committed to revolutionizing treatment for patients with RAS-addicted cancers, specializing in oncology drug discovery and development. With the mi
Role Description The Director of Global Pre-Approval Patient Access will lead the strategy, design, and execution of global early access programs for Revolution Medicines’ pipeline. This role is critical to enabling appropriate patient access to investigational therapies targeting RAS-addicted cancers while ensuring alignment with clinical development/operations, regulatory requirements, and company priorities. This role will report into the Head of Advocacy and Society Engagement and play an integral role in our commitment to supporting appropriate patient access to medicines. - Develop and support global early access strategy aligned with clinical and regulatory milestones; ensure distinction with other patient access initiatives considered or implemented. - Design and implement free of charge named-patient and cohort early access programs globally. - Serve as overall cross-functional leader of the programs, liaising across Clinical, Regulatory, Medical Affairs, Commercial, Legal, Supply Chain, as needed. - Establish governance for global evaluation and prioritization of potential new programs. - Oversee program operations, including vendors. - Build policies, SOPs, and frameworks for ethical and compliant access decisions and ensure adherence to global SOPs and regulatory requirements. - Partner with Development to ensure early access planning is aligned with Lifecycle strategy. - During integrated strategic planning, coordinate closely with Supply Chain, Medical Affairs and Development to ensure supply readiness and feasibility assessments. - Partner with global commercial teams around timing and transitions based on regulatory milestones and reimbursement. - Manage budget, forecasting, and program KPIs. Qualifications - Bachelor degree in a healthcare field with advanced degree preferred. - Minimum of 8 years of clinical trial operations and Oncology EA experience in a biotech/pharmaceutical company. - Demonstrated ability to design and execute global EA programs. - Deep understanding of key regulatory authorities’ programs and timelines. - Excellent organizational savvy with willingness and ability to work independently, think creatively, and shift gears depending on changing priorities and deadlines. - Strong relationship management with a keen understanding of different roles inside of a biotech/pharmaceutical company. - Significant experience leading large cross-functional teams. - Proven ability to take initiative and consistently deliver high-quality solutions. Requirements - Experience with global product launches including support of launch planning. - Strong knowledge of oncology drug development, including challenges associated with precision medicine and biomarker-driven trials. - Ability to navigate complex ethical and operational decisions in high unmet need patient populations. - Experience interacting with CROs, treating physicians, patient advocacy groups, and health authorities. - Understanding of HTA/reimbursement timing impacts on pre-commercial access demand. Benefits - Competitive cash compensation. - Robust equity awards. - Strong benefits. - Significant learning and development opportunities. Company Description Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company’s RAS(ON) inhibitors currently in clinical development include: - daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; - elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; - zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; - RMC-5127, a RAS(ON) G12V-selective inhibitor.
Executive Director, Investor Relations
Revolution MedicinesRevolution Medicines (RevMed) is committed to revolutionizing treatment for patients with RAS-addicted cancers, specializing in oncology drug discovery and development. With the mi
Role Description The Executive Director, Investor Relations will serve as a strategic leader responsible for defining, elevating, and executing Revolution Medicines’ global investor relations strategy during a pivotal transition to a commercial-stage organization. This individual will act as a key advisor to senior leadership, helping shape how the company’s evolving clinical, regulatory, and commercial story is communicated to the investment community. This role will be instrumental in positioning the company for long-term value creation as it approaches product launches, advances and expands its pipeline, and navigates increasingly complex capital markets dynamics. The Executive Director will lead all aspects of the investor relations function, oversee engagement with the investment community, and ensure the company’s narrative effectively reflects its transition from a development-stage to a commercial-stage enterprise. This position will report to the Senior Vice President of Corporate Affairs and work closely with the CEO and broader executive team. The role will also be responsible for building and leading a high-performing investor relations function. Key Responsibilities - Accountable for enterprise-level IR strategic planning, long-term external positioning, and integration of IR strategy with broader corporate objectives. - Serve as a spokesperson to the investment community, building trusted relationships with institutional investors, analysts, and key stakeholders. - Advise senior leadership on investor sentiment, market dynamics, and external perception, particularly as the company approaches key inflection points. - Collaborate with Corporate Communications to shape and continuously evaluate the company’s narrative to reflect its evolution, including clear articulation of clinical data, R&D strategy, and commercialization. - Lead the quarterly earnings process and broader financial communications strategy, ensuring messaging reflects both near-term execution and long-term growth potential. - Drive investor targeting and engagement strategies, including conferences, non-deal roadshows, and investor events, with an emphasis on expanding the company’s shareholder base to include high-quality, long-term oriented investors. - Partner cross-functionally with R&D, clinical, regulatory, commercialization, finance, and corporate affairs teams to ensure consistency, accuracy, and strategic alignment of external communications. - Anticipate and proactively address investor questions. - Align investor communications with broader corporate messaging, including ESG strategy and external positioning. - Ensure best practices in disclosure, compliance, and governance as the company’s external visibility and complexity increase. Qualifications - Experienced executive with a strong track record of leadership in investor relations within the biopharmaceutical industry, ideally with experience supporting companies through late-stage development and into commercialization. - Bachelor’s degree required; advanced degree (MBA, PhD, or equivalent) strongly preferred. - 10+ years of relevant experience, including progressive leadership experience in investor relations, corporate affairs, or finance within biotech/pharmaceuticals. - Demonstrated experience supporting a company through late-stage clinical development, regulatory milestones, and/or commercial launch. - Deep understanding of capital markets, investor expectations, and valuation drivers for both development-stage and commercial-stage biopharmaceutical companies. - Strong knowledge of clinical development, regulatory pathways, market access, and commercialization strategies. - Proven ability to influence and advise senior executives. - Exceptional communication skills, with the ability to translate complex scientific, clinical, and commercial information into clear, compelling narratives. - Proven experience managing high-profile investor interactions during periods of significant corporate transition. - Strong analytical, strategic, and problem-solving capabilities. - High level of executive presence, credibility, and judgment. - Ability to operate effectively and independently in a fast-paced, dynamic, and evolving organization. Requirements - Base Pay Salary Range: $252,000 — $315,000 USD. Benefits - Competitive cash compensation. - Robust equity awards. - Strong benefits. - Significant learning and development opportunities. Company Description Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins.
Director, Supply Chain & Wholesaler Relations
Revolution MedicinesRevolution Medicines (RevMed) is committed to revolutionizing treatment for patients with RAS-addicted cancers, specializing in oncology drug discovery and development. With the mi
Role Description The Director, Japan Supply Chain & Wholesaler Relations will play a critical role in building Revolution Medicines’ Japan commercial supply chain infrastructure from the ground up to ensure operational readiness for commercial launch and ongoing supply continuity. This is a highly hands-on role requiring both strategic thinking and operational execution. - Personally lead wholesaler selection, contract negotiations, 3PL setup, distribution process design, and launch readiness activities. - Collaborate with QA, CMC, Regulatory, Finance, and Commercial teams. - Thrive in a fast-paced biotech environment with limited infrastructure and evolving processes. - Combine deep knowledge of the Japanese pharmaceutical distribution landscape with the ability to execute independently and pragmatically. Key Responsibilities - Japan Supply Chain Strategy & Launch Readiness: - Develop and implement Japan supply chain and distribution strategies to support product launch and commercialization. - Establish scalable and compliant supply chain processes aligned with Japan regulatory and commercial requirements. - Support launch readiness activities including inventory planning, distribution setup, serialization readiness, and product flow design. - Collaborate with Global Supply Chain to ensure alignment between global and local supply strategies. - Coordinate launch readiness activities across internal and external stakeholders to ensure uninterrupted commercial supply. - Build-from-Scratch Commercial Infrastructure: - Lead the establishment of Japan commercial distribution and supply chain operations from the ground up. - Develop practical and scalable operational processes in a resource-constrained, pre-commercial environment. - Identify operational gaps proactively and implement pragmatic solutions to support launch readiness. - Create operational frameworks and governance processes appropriate for a growing biotech organization. - Wholesaler Strategy & Relationship Management: - Lead evaluation, selection, negotiation, and onboarding of pharmaceutical wholesalers in Japan. - Drive contract negotiations and operational alignment with wholesalers and distribution partners. - Build trusted relationships with key external stakeholders across wholesalers, logistics providers, and service vendors. - Coordinate inventory management, order fulfillment, and distribution KPIs with wholesalers. - Monitor wholesaler performance and implement continuous improvement initiatives. - Support development of distribution models aligned with commercial strategy and patient access objectives. - 3PL & Distribution Operations: - Lead end-to-end selection and implementation of third-party logistics (3PL) providers in Japan. - Establish compliant warehousing, transportation, and distribution operations in collaboration with QA and Regulatory teams. - Work directly with QA and CMC teams to establish compliant and scalable distribution operations. - Support operational execution activities as needed, including process mapping, SOP development, issue resolution, and launch coordination. - Oversee logistics operations including cold chain handling, returns, recalls, and destruction processes as applicable. - Cross-functional Collaboration: - Partner closely with QA on GDP/GQP compliance, deviation management, supplier qualification, and change control activities. - Collaborate with CMC and Global Technical Operations on supply planning, packaging configuration, artwork implementation, and release timelines. - Work with Regulatory Affairs to support importation, labeling, and local compliance requirements. - Coordinate with Finance and Commercial teams on inventory planning, demand forecasting, and gross-to-net considerations. - Act as a key local operational partner to global teams while maintaining strong ownership of Japan execution activities. - Compliance & Risk Management: - Ensure all supply chain and distribution activities comply with applicable Japan regulations and company quality standards. - Support inspection readiness and audit activities related to supply chain operations. - Identify and mitigate supply chain risks and develop business continuity plans. - Ensure compliant management of product traceability, inventory controls, and distribution documentation. Qualifications - 12+ years of relevant pharmaceutical supply chain and distribution experience in Japan. - Strong understanding of the Japanese pharmaceutical distribution ecosystem and wholesaler operations. - Demonstrated experience on creating, developing, and implementing strategic initiatives aligned with organizational goals. - Proven experience supporting commercial launch preparation or building new supply chain capabilities in Japan. - Hands-on experience with wholesaler selection, contract negotiation, and 3PL implementation. - Experience with strategic frameworks, business modeling, and performance metrics. - Working knowledge of GDP/GQP requirements and Japan pharmaceutical regulations. - High adaptability and execute effectively with limited resources and evolving organizational structure. - Strong stakeholder management and cross-functional collaboration skills with QA, CMC, Regulatory, Finance, and Commercial organizations. - Excellent critical thinking, negotiation, and communication skills. - Business-level Japanese and English communication skills. Preferred Skills - Experience in pre-commercial biotech or launch-stage organizations. - Experience establishing Japan commercial infrastructure for first product launch. - Oncology or specialty pharmaceutical experience. - Experience with limited distribution or specialty distribution models. - Experience working in highly matrixed global organizations while maintaining strong local execution ownership. - Experience with SAP, NetSuite, or other ERP systems. - Individuals with a highly execution-oriented and hands-on working style. Key Success Factors - Builder mindset with strong ownership and accountability. - Comfortable operating in ambiguity and creating structure where none exists. - Willingness to remain close to operational details while driving strategic initiatives. - Ability to balance speed, compliance, and pragmatism in a launch-stage biotech environment. - Strong external stakeholder management and negotiation capability. - Ability to influence cross-functional teams without large organizational infrastructure or resources. Additional Candidate Profile Considerations Candidates who are most successful in this role are typically those who enjoy building organizations and processes from an early stage rather than operating within mature, highly resourced structures. This role is best suited for individuals who are motivated by creating new capabilities, solving operational challenges directly, and working hands-on in a dynamic launch environment.
Director, Medical Science Liaison, Oncology
Revolution MedicinesRevolution Medicines (RevMed) is committed to revolutionizing treatment for patients with RAS-addicted cancers, specializing in oncology drug discovery and development. With the mi
Role Description We are seeking a highly motivated and experienced professional to join our team as a Lung Medical Science Liaison. Key aspects of this role will include: - Engage in peer-to-peer scientific dialogue with healthcare professionals that translate into meaningful insights. - Serve as a therapeutic expert and thought partner to internal teams. - Liaison between Revolution Medicines and clinical study sites / investigators. - Provide support for medical education, advisory boards, and medical congresses. Medical Science Liaisons (MSLs) are an essential member of the Medical Affairs team who will work as an extension of the Medical Affairs organization. The Lung MSL team will serve as a key liaison between Revolution Medicines and healthcare professionals. Within an assigned geographic territory, the MSL will be responsible for: - Cultivating and strengthening professional relationships with key opinion leaders (KOLs), healthcare providers, and academic centers of excellence involved in various phases of product development. - Collaborating with stakeholders within medical affairs and across the organization, including but not limited to Clinical Development, Commercial, Program Management, Clinical Operations, and Compliance teams. This role covers Washington, Oregon, Alaska, Montana, Idaho, Wyoming, and Utah. The candidate should be located within an hour drive of a major airport. Qualifications - Doctoral degree in scientific or medical discipline. - 8+ years experience as an MSL or in a similar role within the pharmaceutical or biotech industry. - 3+ years experience as a MSL working in the lung cancer disease state area. - Strong understanding of clinical research methodologies and drug development processes. - Knowledge and experience within the oncology therapeutic area. - Excellent verbal and written communication skills. - Proven ability to analyze and synthesize scientific information effectively. - Excellent presentation skills, with the ability to effectively communicate complex scientific data to diverse audiences. - Strong networking skills with proven ability to successfully build and maintain relationships with KOLs and healthcare professionals. - Self-directed and able to thrive in a fast-paced and dynamic environment. - Willingness to travel up to 60% of time. Requirements - Preferred experience in lung and gastrointestinal cancers. - Experience with both early and late stage clinical assets as well as approved therapies. Benefits - Competitive cash compensation. - Robust equity awards. - Strong benefits. - Significant learning and development opportunities. Company Description Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company’s RAS(ON) inhibitors currently in clinical development include: - Daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor. - Elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor. - Zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor. - RMC-5127, a RAS(ON) G12V-selective inhibitor. As a new member of the Revolution Medicines team, you will join other outstanding professionals in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.
Manager, Regulatory Affairs
Revolution MedicinesRevolution Medicines (RevMed) is committed to revolutionizing treatment for patients with RAS-addicted cancers, specializing in oncology drug discovery and development. With the mi
Role Description As a new member of the Revolution Medicines team, you will join other outstanding professionals in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway. The Opportunity: - Manage planning, preparation (including authoring when appropriate), coordination, and submission of regulatory documents to global National Health Authorities that meet ICH and FDA standards, and other local or regional regulatory requirements. - Such submissions may include Clinical and Preclinical content. - Assist and keep detailed timelines for regulatory activities and submissions. - Perform regulatory research to assess regulatory implications and inform business strategy for drug development and approval. - Assess and communicate risks. - Ensure that there are no significant interruptions to the business due to regulatory compliance issues. - Correspond and collaborate across the organization at all levels, across functional groups, and with executive management. - Support NDA filing activities and assist with developing regulatory process supporting the filing. - Prepare and manage routine submissions and related activities. - Develop regulatory strategies to inform associated budgets, tools and specialized support necessary for efficient operations. - Stay abreast of changes in the regulatory environment and guidelines (e.g., FDA, ICH) in areas relevant to company projects. Qualifications - Bachelor’s degree or equivalent in Regulatory Science or related degree in Life Science or Health Science fields. - Three (3) years of experience in Regulatory Affairs department at a drug or biologics company. - Employer will accept a Master's degree or equivalent in Regulatory Science or related degree in Life Science or Health Science fields and one (1) year of experience in Regulatory Affairs department at a drug or biologics company. - Work experience to include: - Manage the preparation and submission of initial IND (Investigational New Drug) application and subsequent amendments; - Manage the development of regulatory submissions in eCTD (electronic Common Technical Document) format; - Interpret and apply FDA (Food and Drug Administration), ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use), EMA (European Medicines Agency), or PMDA (Pharmaceuticals and Medical Devices Agency) regulations to oncology drug development; - Manage global regulatory health authority filings and subsequent amendments. Requirements - Successful completion of background checks and employment history verification required. - 100% remote position reporting to Revolution Medicines, Inc. in Redwood City, CA. Candidate may live anywhere in the continental U.S. Benefits - Base pay salary range for this full-time position is $168,064 — $178,000 USD. - Base pay salary ranges are determined by role, level, and location. - Individual base pay salary is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training. - Overall total rewards program includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities.
Senior Director, Clinical Pharmacology
Revolution MedicinesRevolution Medicines (RevMed) is committed to revolutionizing treatment for patients with RAS-addicted cancers, specializing in oncology drug discovery and development. With the mi
Role Description We are seeking a passionate and experienced Clinical Pharmacologist with strong early development background to be part of the Nonclinical Development and Clinical Pharmacology (NDCP) Organization. As a member of the Early Development Clinical Pharmacology group, you will: - Provide strategic insight and technical leadership within the Clinical Pharmacology function. - Author technical reports and/or regulatory documents for major milestones of clinical development, specifically IND, EOP1 & EOP2 Briefing Documents. - Participate in regulatory interactions and responses to regulatory questions. - Apply state-of-the-art quantitative modeling, including translational PK/PD, population PK, and exposure-response analyses, to guide recommended phase 2 dose/schedule (RP2Ds) selection for pivotal studies. - Work with the Discovery organization to support assets in the IND-enabling stage, including collaboration with DMPK and Toxicology groups in assessment of human start dose and assessment of the need for human DDI studies. - Work with the Clinical Development team in designing FIH study. - Design and report Clin Pharm studies such as hADME, Food-Effect and DDI studies. - Engage and work with CROs on clinical pharmacology activities. - Represent the Clinical Pharmacology function in project teams and build strong working relationships with cross-functional teams to impact critical decisions. Qualifications - A Ph.D. or Pharm.D (with Fellowship) with Pharmaceutical Sciences background with 8-10 years of relevant industry experience in Clinical Pharmacology. - Prior experience with small molecules oncology drug development. - Familiar with FDA’s Project Optimus guidance. - Well-informed in current and emerging standards of regulatory requirements and expectations for clinical pharmacology. - Hands-on experience with WinNonlin and Clin Pharm study designs. - Strong understanding of DMPK, CMC and Toxicology and related regulatory guidance is required. - Excellent verbal and written communication skills, and ability to clearly convey complex concepts and findings to both non-specialist and specialist audiences. - A critical thinker and passionate team player and quick learner with high energy who thrives in a dynamic and fast-paced environment. - Prior management experience. Preferred Skills - Prior experience interacting with FDA on dose optimization. - Hand-on experience with PBPK models. Benefits - Competitive cash compensation. - Robust equity awards. - Strong benefits. - Significant learning and development opportunities. Base Pay Salary Range $232,000 — $290,000 USD
Executive Director, Quality, Europe
Revolution MedicinesRevolution Medicines (RevMed) is committed to revolutionizing treatment for patients with RAS-addicted cancers, specializing in oncology drug discovery and development. With the mi
Role Description The Executive Director, Head of Quality, Europe is responsible for leading and overseeing all Quality functions across the European region, ensuring compliance with European regulatory requirements. This role provides strategic and operational leadership across GxP Quality (GMP, GDP, GCP as applicable). In addition, this role serves as the key Quality representative for Europe, partnering closely with: - Regulatory Affairs - Manufacturing - Supply Chain - Clinical Operations - External partners Key Responsibilities: - Lead and develop the European Quality organization, ensuring alignment with global quality strategy and supporting the transition from clinical to commercial operations. - Act as the primary Quality representative for Europe, providing leadership in regional and global governance forums and serving as the main interface with European regulatory authorities (e.g., EMA, national agencies). - Ensure Quality oversight of MAH responsibilities, including lifecycle management, product complaints, recalls, and fulfillment of regulatory commitments in close collaboration with Regulatory Affairs. - Establish, implement, and maintain an effective EU Quality Management System (QMS) in compliance with EU GMP, GDP, GCP (as applicable), and ICH guidelines. - Participate in cross-functional review of Global SOPs, ensuring timely harmonization and effective implementation within the EMEA region. - Oversee key quality system processes, including deviations, CAPAs, change control, risk management, product quality complaints, and document management. - Monitor QMS performance through KPIs, risk indicators and management review process. - Review quality agreements to ensure compliance with EU GMP, GDP and other regulatory requirements across the supply chain. - Define and oversee the EU QP framework, ensuring compliant batch certification and appropriate governance of internal and/or contracted QPs. - Ensure full compliance with EU GDP requirements, including oversight of distribution activities, wholesale authorizations, and Responsible Person (RP) functions within the EU supply network. - Provide end-to-end Quality oversight of external partners (e.g., CMOs, 3PLs, distributors), including quality agreements, performance monitoring, and risk-based governance. - Lead inspection readiness across Europe and manage regulatory inspections and internal/external audits, ensuring consistent positioning and effective interaction with authorities. - Support regulatory submissions and lifecycle activities by ensuring quality oversight of relevant documentation and CMC components. - Provide Quality leadership for new product introductions, technology transfers, and commercial launches in Europe, ensuring readiness of systems, processes, and partners. - Collaborate cross-functionally with Regulatory Affairs, Technical Operations, Supply Chain, Clinical Operations, and Global Supplier Quality to ensure integrated and compliant execution across the product lifecycle. - Drive a strong, proactive quality culture across all European operations, promoting continuous improvement and accountability. Qualifications - Degree in Life Sciences, Pharmacy, Chemistry, or related field (PhD, PharmD, or MSc preferred). - 20+ years of GxP Quality experience within the pharmaceutical industry. - Track record of building and scaling Quality organizations. - Track record of working in a GMP/GDP regulated environment. - Deep knowledge of European regulatory requirements (EMA, EU GMP/GDP, ICH guidelines). Requirements - Biotech experience. - Significant leadership experience, including managing regional or global teams. Company Description Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company’s RAS(ON) inhibitors currently in clinical development include: - daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor - elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor - zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor - RMC-5127, a RAS(ON) G12V-selective inhibitor As a new member of the Revolution Medicines team, you will join other outstanding professionals in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.
Associate Director, Qualified Person, Europe
Revolution MedicinesRevolution Medicines (RevMed) is committed to revolutionizing treatment for patients with RAS-addicted cancers, specializing in oncology drug discovery and development. With the mi
Role Description The Qualified Person (QP) holds ultimate responsibility for the certification and release of medicinal products in accordance with EU GMP, Directive 2001/83/EC, Dutch pharmaceutical legislation, and applicable Marketing Authorisations. - Provides independent, authoritative quality leadership across site operations. - Serves as a key member of the site leadership team, ensuring patient safety, product quality, regulatory compliance, and reliable supply. - Provides strategic oversight of the Pharmaceutical Quality System. - Partners closely with senior stakeholders across Quality, Technical Operations, Supply Chain, and Regulatory Affairs. - Represents the site in interactions with Health Authorities. Qualifications - Master's degree in Pharmacy, Chemistry, Biotechnology, or relevant scientific discipline. - 9+ years experience working in quality related roles with increasing responsibility. - Eligibility for registration as a Qualified Person under Dutch pharmaceutical legislation. - Extensive experience as a Qualified Person with direct batch release accountability. - Deep working knowledge of EU GMP and relevant regulatory frameworks. - Proven inspection experience and senior stakeholder engagement capability. - Fluency in English; Dutch language skills are an advantage. - Risk-based, pragmatic mindset balancing compliance and supply reliability. Requirements - Act as the legally registered Qualified Person with full authority for certification and release of clinical and commercial medicinal products. - Ensure batch certification in compliance with EU GMP, Directive 2001/83/EC, national legislation, EU GMP Annex 16, and applicable Marketing Authorisation. - Exercise independent decision-making authority, including batch rejection and escalation when required. - Ensure timely batch disposition aligned with supply commitments and compliance requirements. - Responsible for the certification and release of Investigational Medicinal Products (IMPs) in accordance with EU Clinical Trial Regulation and EU GMP Annex 13. - Maintain QP oversight of the end-to-end GMP supply chain. - Provide oversight of the Pharmaceutical Quality System, ensuring inspection readiness and regulatory alignment. - Oversee deviations, CAPAs, change controls, investigations, complaints, and recalls. - Approve critical GMP documentation including SOPs, validation documentation, and quality agreements. - Ensure that third-country manufacturing sites comply with EU GMP requirements. - Provide QP oversight of data integrity governance across GMP processes and computerized systems. - Oversee continued process and product verification activities. - Act as a strategic quality partner to site and functional leadership. - Lead quality risk assessments related to manufacturing operations and change initiatives. - Mentor QA professionals and support QP succession and capability building. - Serve as primary QP representative during inspections and Health Authority interactions. - Define and present quality KPIs, trends, and risk assessments to senior management. - Drive continuous improvement using data-driven insights and benchmarking. - Maintain an effective interface with Pharmacovigilance to ensure timely assessment and escalation of quality-related safety signals. Benefits - Revolution Medicines takes protection and security of personal data very seriously. - We respect your right to privacy while using our website and when contacting us by email or phone. - We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy.
Senior Director, Payor and Health Systems Liaison
Revolution MedicinesRevolution Medicines (RevMed) is committed to revolutionizing treatment for patients with RAS-addicted cancers, specializing in oncology drug discovery and development. With the mi
Role Description Reporting to the Executive Director of Field Medical Affairs, the Payor and Health Systems Liaison will own and shape the scientific payer/access strategy for the US region. They will develop and cultivate relationships with key decision-makers and other influencers in managed care organizations, government programs, employers, hospital systems, and product distribution companies, to support appropriate patient access and evidence-based utilization for Revolution Medicine’s products. A key aspect of the Payor and Health Systems Liaison responsibilities is to keep payers and other key external constituents or influencers abreast of new product launches, line extensions, and Medical Affairs research. The Payor and Health Systems Liaison leads high-impact clinical, scientific, and population health engagement with external access stakeholders, including Payers, Group Purchasing Organizations (GPOs), Community Aggregators, and Integrated Delivery Networks (IDNs), while ensuring strong integration between Medical Affairs, HEOR, and Market Access strategy. - Collaborates with Field Medical Executive Director, MSL Regional Sr. Directors, and US Strategy leads to define the US clinical value strategy and population health scientific messaging for both marketed and pipeline assets, from pre-approval through lifecycle management. - Partners closely with Market Access, HEOR, and Evidence Generation leaders to align payer value strategy, evidence planning, and field execution. - Leads high-level scientific and clinical value discussions with commercial and government payers, GPOs, IDNs, community and regional aggregators, and other risk-bearing entities. - Engages access stakeholders in credible, non-promotional dialogue on clinical outcomes, real-world evidence, and unmet medical needs aligned with approved scientific exchange frameworks. - Supports pathway, guideline, and formulary-relevant engagement by providing medical insight into clinical evidence, value narratives, and population-level considerations. - Participates in executive-level payer forums, advisory boards, and access-focused conferences as a senior medical representative of the company. - Serves as a senior Medical Affairs voice for managed care insights across internal stakeholders, including Medical, Market Access, and cross-functional leadership. - Synthesizes and communicates actionable insights on: - Access barriers and opportunities - Payer evidence expectations - Population-level treatment trends - Contributes to medical strategy, launch readiness, and lifecycle planning from a managed care and access perspective. - Identifies opportunities to support compliant and effective cross-functional collaboration across Medical Affairs and Commercial teams, as needed and appropriate. - Exhibits significant leadership experience in the pharmaceutical and managed care industries with the ability to work independently and collaboratively in a cross-functional team environment. Qualifications - Advanced, medical/scientific doctoral level degree required: MD, PharmD, PhD. - 10-13+ years of progressive experience in pharmaceutical/biotechnology Medical Affairs, managed care, market access-adjacent, or outcomes-focused roles. - Significant experience engaging payer and access decision makers at a senior or executive level. - Prior MSL, Managed Care Liaison, or Clinical Value/Outcomes role strongly preferred. - Oncology and product launch experience strongly preferred. - Thorough understanding of applicable regulatory requirements for field-based personnel and PhRMA guidelines, including geographic regulatory related guidelines. - Effective oral, written, and interpersonal skills required. Requirements - Exhibits significant leadership experience in the pharmaceutical and managed care industries with the ability to work independently and collaboratively in cross-functional team environments. Benefits - Competitive cash compensation. - Robust equity awards. - Strong benefits. - Significant learning and development opportunities. Company Description Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company’s RAS(ON) inhibitors daraxonrasib (RMC-6236), elironrasib (RMC-6291), zoldonrasib (RMC-9805), and RMC-5127 are currently in clinical development.
Senior Director, Payor and Health Systems Liaison, East
Revolution MedicinesRevolution Medicines (RevMed) is committed to revolutionizing treatment for patients with RAS-addicted cancers, specializing in oncology drug discovery and development. With the mi
Role Description Reporting to the Executive Director of Field Medical Affairs, the Payor and Health Systems Liaison will own and shape the scientific payer/access strategy for the US region. They will develop and cultivate relationships with key decision-makers and other influencers in managed care organizations, government programs, employers, hospital systems, and product distribution companies, to support appropriate patient access and evidence-based utilization for Revolution Medicine’s products. A key aspect of the Payor and Health Systems Liaison responsibilities is to keep payers and other key external constituents or influencers abreast of new product launches, line extensions, and Medical Affairs research. The Payor and Health Systems Liaison leads high-impact clinical, scientific, and population health engagement with external access stakeholders, including Payers, Group Purchasing Organizations (GPOs), Community Aggregators, and Integrated Delivery Networks (IDNs), while ensuring strong integration between Medical Affairs, HEOR, and Market Access strategy. - Collaborates with Field Medical Executive Director, MSL Regional Sr. Directors, and US Strategy leads to define the US clinical value strategy and population health scientific messaging for both marketed and pipeline assets, from pre-approval through lifecycle management. - Partners closely with Market Access, HEOR, and Evidence Generation leaders to align payer value strategy, evidence planning, and field execution. - Leads high-level scientific and clinical value discussions with commercial and government payers, GPOs, IDNs, community and regional aggregators, and other risk-bearing entities. - Engages access stakeholders in credible, non-promotional dialogue on clinical outcomes, real-world evidence, and unmet medical needs aligned with approved scientific exchange frameworks. - Supports pathway, guideline, and formulary-relevant engagement by providing medical insight into clinical evidence, value narratives, and population-level considerations. - Participates in executive-level payer forums, advisory boards, and access-focused conferences as a senior medical representative of the company. - Serves as a senior Medical Affairs voice for managed care insights across internal stakeholders, including Medical, Market Access, and cross-functional leadership. - Synthesizes and communicates actionable insights on: - Access barriers and opportunities - Payer evidence expectations - Population-level treatment trends - Contributes to medical strategy, launch readiness, and lifecycle planning from a managed care and access perspective. - Identifies opportunities to support compliant and effective cross-functional collaboration across Medical Affairs and Commercial teams, as needed and appropriate. - Exhibits significant leadership experience in the pharmaceutical and managed care industries with the ability to work independently and collaboratively in a cross-functional team environment. Qualifications - Advanced, medical/scientific doctoral level degree required: MD, PharmD, PhD. - 10-13+ years of progressive experience in pharmaceutical/biotechnology Medical Affairs, managed care, market access–adjacent, or outcomes-focused roles. - Significant experience engaging payer and access decision makers at a senior or executive level. - Prior MSL, Managed Care Liaison, or Clinical Value/Outcomes role strongly preferred. - Oncology and product launch experience strongly preferred. - Thorough understanding of applicable regulatory requirements for field-based personnel and PhRMA guidelines, including geographic regulatory related guidelines. - Effective oral, written, and interpersonal skills required. Requirements - The base pay salary range for this full-time position is $264,000 — $290,000 USD. - Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. - The amount and availability of any bonus, commission, incentive, field kit benefits, or any other form of compensation and field kit benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. Benefits - Competitive cash compensation - Robust equity awards - Strong benefits - Significant learning and development opportunities Company Description Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company’s RAS(ON) inhibitors daraxonrasib (RMC-6236), elironrasib (RMC-6291), zoldonrasib (RMC-9805), and RMC-5127 are currently in clinical development.
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