The Opportunity:

The Director, Global CMC Regulatory is a strategic leadership role responsible for developing, driving, and executing global commercial CMC regulatory strategies to secure and maintain marketing approvals for RevMed’s product portfolio worldwide.

This position provides leadership for commercial-stage CMC regulatory activities, including original marketing applications, global expansions, and post-approval lifecycle management. This role requires deep expertise in global commercial CMC regulatory frameworks, strong cross-functional leadership, and the ability to proactively anticipate regulatory risks while enabling business objectives.

Responsibilities:

• Develop and lead execution of effective global CMC regulatory strategies to support initial marketing approvals and lifecycle management of RevMed's product portfolio.

• Oversee the preparation and submission of high-quality CMC dossiers for global marketing authorization applications and post-approval supplements/variations. Manage/lead interactions with Health Authorities as needed.

• Assess the global regulatory implications of proposed CMC changes and provide proactive, risk-based guidance to optimize implementation and maintain compliance.

• Interpret and apply global CMC regulatory guidance (FDA, EMA, ICH, PMDA, NMPA, MHRA, etc.) to ensure compliant and efficient regulatory pathways.

• Anticipate regulatory risks and proactively develop mitigation strategies aligned with commercial timelines.

• Partner with Regulatory Affairs, technical SMEs, and CROs to ensure alignment of global submission strategies while addressing region-specific CMC requirements and serve as the CMC regulatory representative on global commercial teams to provide guidance that enables efficient global execution.

• Provide strategic leadership, mentorship, and technical guidance to junior team members to foster professional development and team performance.

Required Skills, Experience and Education:

• Bachelor’s degree in Pharmaceutical Science, Chemistry, Chemical Engineering, or closely related scientific discipline.

• Minimum of 15 years of experience in pharmaceutical / biotech drug development, including at least 5 years of hands-on global CMC regulatory affairs experience.

• Deep expertise in CMC development for new chemical entities (NCEs) and small molecules, with proven ability to manage complex technical content.

• Extensive experience leading global CMC regulatory strategy and global marketing approval applications across the US, Canada, Europe, UK, APAC, and LATAM regions.

• Strong knowledge of US and international GMP regulations, current industry practices, with a demonstrated ability to interpret and apply requirements across the product lifecycle.

• Proven track record of building and maintaining productive relationships with global Health Authorities, including direct interactions with the FDA and other regulatory bodies.

• Strong project and team leadership capabilities, with the ability to prioritize effectively, manage multiple complex programs, and foster cross-functional collaboration.

• Effective written and verbal communication skills and interpersonal skills.

• A collaborative, high-energy team player who thrives in a fast-paced, dynamic environment and embraces innovation and continuous improvement.

Preferred Skills:

• Advanced degree (MS or Ph.D) in Pharmaceutical Science, Chemistry, Chemical Engineering, or closely related field.

• Experience supporting global commercial labeling implementation and lifecycle updates, with strong knowledge of global labeling requirements and artwork development/approval processes, including coordination of CMC-related labeling impacts across regions.

• Prior experience in oncology product commercialization is a plus. 

  #LI-Hybrid #LI-CT1

The Opportunity:

Playing a critical role within CMC function, as Senior Scientist I, Analytical Development the position will support the manufacturing and control of drug substances and drug products during clinical development. The position will provide analytical support to API process research and development, formulation development, and assist in regulatory filings in support of Revolution Medicines pipeline compound development and clinical programs.

Specifically, you will be responsible for:

• Provide support and oversight to analytical development activities, such as method development, method validation and testing, at contract partner sites to ensure outsourced activities are executed successfully and meet the objectives.

• Provide analytical support for API process R&D and manufacturing, formulation development and drug product manufacturing, and participate in cross-functional project team meetings.

• Critically review data packages associated with method validations, release testing, and other characterization testing for drug substances and drug products.

• Collaborate with cross functional teams in the establishment of control strategy and setting specifications for drug substances and drug products.

• Prepare, review, and/or approve study protocols, study reports, and CMC regulatory submission document.

• Communicate technical findings to colleagues and collaborators within formal and informal settings, including cross-functional project team meetings.

• Collaborate with cross functional teams including but not limited to Medicinal Chemistry, DMPK, Toxicology, QA, Pharmaceutical Development, Process R&D, Project Management and Regulatory to timely achieve project goals.

• Present work and results in team and group meetings.

Required Skills, Experience and Education:

• Ph.D. with a min of 5 years industry experience or MS degree with a min of 8 years of relevant industrial experience in analytical development.

• Technical knowledge of analytical technologies including HPLC/UPLC, XRPD, LCMS, DSC, DVS and Dissolution.

• Experience managing projects at CROs/CDMOs.

• Experience with analytical method development, validation and method transfer.

• Work experience and knowledge of regulatory submission (IND, IMPD, and / or NDA).

• Knowledge and understanding of current ICH guidelines, GMP guidelines, and related industry practices.

• Strong problem-solving skills with sound technically driven decision-making ability.

• Excellent scientific and business communication skills (verbal, written and technical), strong interpersonal/collaboration skills and planning skills.

• Ability to think critically and creatively and be able to work independently to determine appropriate resources for resolution of problems.

• Ability to multi-task and thrive in a fast-paced innovative environment.

Preferred Skills:

• PhD or MS in analytical chemistry, organic chemistry, or related discipline.

• CMC experience with small Molecules is strongly desired, and experience in solid oral dosage is a plus.

• Familiarity with document management systems (such as Veeva or similar). #LI-Hybrid #LI-CT1

The Opportunity:

As a manager of document management, you will be responsible for overseeing the lifecycle of controlled documents. This role ensures compliance with regulatory requirements, company quality standards, and effective document control practices across internal and external stakeholders. We are looking for a detail-oriented and proactive individual with a strong background in pharmaceutical or biotech industries. This position develops strategic plans related to change control, other ADQC documents, and the implementation of robust corrective actions to support Analytical Development and Quality Control by applying function expertise.

• Manage the creation, review, approval, issuance, and archival of controlled documents, including SOPs, work instructions, and documents initiated at contract organizations.

• Develop and implement effective document management including change control processes and procedures to ensure compliance with regulatory requirements and industry best practices.

• Collaborate with cross-functional teams to evaluate, prioritize, and manage change requests.

• Ensure proper tracking, documentation, and closure of change controls, including impact assessment, change action executions, and required approvals.

• Communicate changes and their impact to relevant stakeholders, including senior management, quality assurance, regulatory affairs and contract organizations.

• Coordinate and/or lead cross-functional meetings with multiple departments to maintain accurate and up-to-date documentation.

• Monitor and track document metrics to identify trends, gaps, and areas for improvement.

• Continuously evaluate and improve document management to increase efficiency and effectiveness.

• Act as a subject matter expert for document management related matters and provide guidance and support to colleagues across the organization.

• Manage multiple assignments and changing priorities through robust organizational, planning, and project management skills.

• Foster a culture of quality and compliance within the organization through proactive communication and collaboration with all departments.

Required Skills, Experience and Education:

• BS in Life Science, Chemistry, Pharmaceutical Science or related discipline.

• 6+ years in document control or relevant experience within pharmaceutical or biotech industry.

• Strong problem-solving skills with sound technically driven decision-making ability.

• Excellent communication skills (verbal, written and technical), strong interpersonal/collaboration skills and planning skills.

• Ability to think critically and creatively and be able to work independently to determine appropriate resources for resolution of problems.

• Ability to multi-task and thrive in a fast-paced innovative environment.

• Have a strong attention to detail.

• Stay current with industry regulations and guidelines related to controlled documents and make recommendations for process improvements as needed. 

  #LI-Hybrid #LI-CT1

The Opportunity:

As part of our expanding European organization, we seek a strategic and hands-on Director, CMC Regulatory, Europe who will be responsible for developing and executing regional CMC regulatory strategies to support early development, marketing authorizations, and lifecycle management across Europe.

This role is responsible for ensuring successful interactions with the European Medicines Agency (EMA), national competent authorities (NCAs), and other regional regulatory bodies. It provides leadership across early- and late-stage CMC regulatory activities, including clinical trial applications, initial marketing authorization applications (MAA), post-approval variations, and lifecycle strategy.

The position requires deep expertise in EU regulatory frameworks, strong cross-functional collaboration, and the ability to proactively identify and manage regulatory risks while supporting business objectives.

Primary Responsibilities:

• Provide CMC regulatory support for clinical trial applications and regulatory interactions, ensuring alignment with EU requirements and timelines.

• Develop and lead execution of European CMC regulatory strategies to support initial marketing authorizations and lifecycle management of the company’s product portfolio.

• Oversee preparation, review, and submission of high-quality CMC dossiers for EU MAAs, variations, renewals, and line extensions.

• Serve as the primary CMC regulatory lead for Europe, managing interactions with EMA, NCAs, and other European regulatory bodies.

• Provide strategic input into global regulatory strategies, ensuring alignment while addressing EU-specific requirements and expectations.

• Assess regulatory impact of CMC changes and provide proactive, risk-based guidance to ensure compliance with EU regulations.

• Interpret and apply EU regulatory requirements (EMA, ICH, EU GMP, and national guidance) to support efficient regulatory pathways, ensure compliance, and proactively monitor and communicate evolving regulatory expectations across functions.

• Anticipate regulatory risks and develop mitigation strategies aligned with European approval timelines.

• Partner with global Regulatory Affairs, Quality, Technical Operations, and external partners to ensure consistent and compliant execution of submissions.

• Represent CMC regulatory on European or global cross-functional teams, ensuring alignment between global strategy and regional execution.

• Provide leadership, mentorship, and technical guidance to team members and contribute to building regional CMC regulatory expertise.

• Oversee external vendors and CROs to ensure timely, high-quality regulatory submissions and approvals.

Required Skills, Experience and Education:

• Bachelor’s degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related scientific discipline. An advanced degree (PhD, PharmD, MSc) is desirable.

• Minimum of 15 years of experience in pharmaceutical/biotech drug development, including at least 5 years in CMC regulatory affairs with European focus.

• Strong expertise in EU CMC regulatory requirements, including MAAs, variations, and lifecycle management.

• Direct hands-on experience in the preparation and submission of large, complex regulatory documentation to support health agency review/approval procedures, post approval activities

• Demonstrated experience supporting EMA submissions and interactions.

• Deep knowledge of EU GMP regulations and ICH guidelines, with ability to apply across the product lifecycle.

• Experience with small molecules (NCEs) and managing complex CMC technical documentation.

• Proven ability to lead regulatory strategy for European approvals within global development programs.

• Strong leadership and project management skills with ability to manage multiple complex programs.

• Excellent communication and stakeholder management skills, including experience working cross-functionally and with external partners.

• Ability to operate effectively in a fast-paced, matrixed, global environment.

Revolution Medicines takes protection and security of personal data very seriously and respects 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. For additional information, please contact privacy@revmed.com. 

#LI-Remote #LI-LO1

The Opportunity:

The Executive Director, Clinical Supply Chain provides strategic leadership and operational oversight for end-to-end clinical supply chain activities across the organization.

Strategic Leadership

• Define and execute the global clinical supply chain strategy aligned with the company’s clinical development pipeline and long-term business goals.

• Establishes strategies and processes to ensure uninterrupted supply for Revolution Medicines portfolio across all phases of development.

• Lead and serve as subject matter expert for clinical supply chain planning, risk management, and execution of clinical supply chain activities.

• Build scalable processes and infrastructure to support early- through late-phase clinical programs.

• Strategic Planning on comparator sourcing management to ensure timely, compliant and cost-effective product availability.

• Effective management of clinical studies executed in conjunction with collaboration partners.

• Identify and implement overall clinical supply chain best practices.

Clinical Supply Operations

• Oversee end-to-end clinical supply activities, including demand forecasting, protocol reviews, packaging, labeling, distribution, and returns.

• Ensure uninterrupted supply of investigational medicinal products (IMP), including RevMed and comparator products.

• Champions monthly Development Operations planning (DnOP) process in collaboration with PDM and Clinical Operation team members.

• Ensures efficient global clinical supply chain distribution networks are in place.

• Oversee comparator products demand and supply planning with expert level knowledge in comparator drugs and co-medications sourcing strategy

Cross-Functional Collaboration

• Partner with Clinical Operations and Clinical Study Execution Teams (CSET) in study planning and execution.

• Collaborate with PDM, Quality, and Regulatory to ensure compliant manufacturing, labeling, and distribution

• Work closely with Finance on budgeting, forecasting, and cost optimization.

• Work effectively with internal and external partners to develop sound strategies, identify and mitigate risks, and resolve issues as they arise.

Compliance & Quality

• Ensure all clinical supply activities comply with GxP, ICH, FDA, EMA, and global regulatory requirements.

• Expert knowledge of applicable GxP requirements and applicable regulatory guidances.

• Lead inspection readiness activities as required for global filings and maintain and inspection ready organization.

Team Leadership

• Build, lead, and mentor a high-performing clinical supply chain organization. Drives for excellence in execution of agreed upon strategies.

• Establish clear performance metrics, development plans, and succession planning.

• Foster a culture of accountability, continuous improvement, and collaboration.

• Drives excellence in setting clear and actionable team goals.

Required Skills, Experience and Education:

• Bachelor’s degree in Supply Chain, Business, Engineering or Life Sciences with 20+ years of experience in pharmaceutical supply chain. Master’s degree (MS, MBA) with at least 18 years of experience in pharmaceutical/biotech supply chain.

• CPIM/CSCP certifications a plus.

• At least 5 years of experience in a leadership/supervisory role.

• Strong knowledge and experience with cGMP operations for small molecules, end- to end supply chain and demand/supply planning.

• Effective vendor management and oversight skills

• Excellent cross-functional leadership skills with effective communication skills.

Preferred Skills:

• Proven leadership experience hiring, managing and developing teams.

• Knowledge and experience with outsourced manufacturing operations. (CMO’s)

• Effective, open and transparent communication skills (verbal and written). Strong analytical, communication and executive level reporting skills.

• Capable of working on multiple projects/tasks and able to meet timelines.

• Self-starter with a high-level of comfort with ambiguity and complexity and the ability to multi-task while consistently delivering quality results.

• Team-oriented, progressive thinker who enjoys participating in an innovative and creative work environment. 

  #LI-Hybrid  #LI-GL1

The Opportunity:

We are seeking a strategic and execution-driven Vice President, Analytical Development & Quality Control (ADQC) to lead the vision, strategy, and execution of analytical development and QC across our growing portfolio.

Reporting to the Senior Vice President, Pharmaceutical Development & Manufacturing, this executive will build and scale a phase-appropriate, forward-looking analytical organization that enables rapid development of small molecule programs while positioning the company for late-stage development and global commercialization.

As a key member of the PDM leadership team, this role will shape analytical strategy at the enterprise level, ensuring robust control strategies, regulatory readiness, and operational excellence across internal and external networks.

Responsibilities:

Strategic & Organizational Leadership

• Define and drive the enterprise-wide analytical development and QC strategy aligned with portfolio and corporate objectives.

• Build, lead, and scale a high-performing ADQC organization to support a multi-asset oncology pipeline.

• Establish a culture of scientific excellence, accountability, and collaboration aligned with RevMed values.

• Serve as a core member of the PDM leadership team, influencing cross-functional CMC and development strategies.

Technical & Analytical Excellence

• Design and implement phase-appropriate analytical strategies, including characterization, specification setting, and control strategies.

• Oversee impurity profiling, degradant analysis, comparability, and lifecycle management of analytical methods.

• Ensure alignment of analytical approaches with clinical and regulatory needs, enabling accelerated development timelines.

• Drive innovation in analytical technologies and approaches for complex, mechanism-driven small molecules.

Quality Control & Operations

• Establish and oversee compliant, efficient QC operations with strong data integrity and digital systems.

• Ensure inspection readiness and adherence to global regulatory standards (FDA, EMA, ICH).

• Implement scalable processes to support late-stage development and commercialization.

External Network & Partnerships

• Lead the strategy and oversight of outsourced analytical development and QC activities.

• Select, qualify, and manage CDMOs and contract laboratories to ensure high performance and compliance.

• Oversee method transfer, validation, and lifecycle management across external partners.

• Proactively manage risks, timelines, and quality across the external network.

Regulatory Leadership

• Provide analytical leadership for global regulatory submissions (IND, IMPD, NDA, MAA, JNDA.

• Represent ADQC in health authority interactions and inspections as needed.

Required Skills, Experience and Education:

• PhD (preferred) or MSc in Analytical Chemistry, Pharmaceutical Sciences, or related field.

• ~18+ years of industry experience with significant leadership in analytical development and QC.

• Proven track record supporting late-stage development and global regulatory filings (IND/NDA/MAA/JNDA).

• Demonstrated success leading and scaling teams (10+ years in leadership roles preferred).

• Deep expertise in GMP, quality systems, and global regulatory expectations (FDA, EMA, ICH).

• Extensive experience managing external analytical networks (CDMOs, CTLs).

• Strong strategic thinking with the ability to make data-driven, risk-balanced decisions.

• Excellent communication and stakeholder influence at executive levels.

Preferred Skills:

• Experience in oncology or targeted therapies.

• Background in accelerated or expedited development pathways.

• Experience building analytical/QC functions in a high-growth biotech environment.

• Ability to balance speed, quality, and risk in a dynamic setting. 

  #LI-Hybrid  #LI-GL1

The Opportunity:

• Serve as Revolution Medicines’ business operations lead interface between internal PDM functions and Contract Research Development Manufacturing Organization (CRDMOs) for clinical packaging, distribution and comparator sourcing.

• Manage CRDMO requests for proposals, proposal review, negotiation, RevMed governance approval, legal review, purchase order issuance and invoice approval.

• Lead preparation and execution of CRDMOs business reviews with SSSM leadership, PDM senior management, and business counterparts.

• Ensure projects/programs meet desired results, compliance, speed, quality, and cost.

• Support contract negotiations in close collaboration with SSSM leadership and cross-functional teams (e.g., Subject Matter Experts (SMEs), Finance, and Legal) to ensure best terms and conditions.

• Support development and implementation of outsourcing strategies for PDM.

• Support the selection process for CRDMOs in collaboration with SSSM leadership and technical SMEs.

• Support cross-functional CRDMO management activities, covering all aspects such as business needs identification, contracting, vendor qualification and set-up, compliant delivery of services, and discontinuation.

• Work with SSSM leadership, PDM senior management, and cross-functional teams to assess and manage supplier performance through use of personal influence, internal business review meetings, and/or joint governance meetings.

• Identify and deliver on cost savings opportunities.

Required Skills, Experience and Education:

• B.Sc. in Supply Chain, Engineering, Business, Life Sciences, or related field plus 5+ years of experience in pharmaceutical strategic sourcing and/or clinical supply chain.

• Experience working with domestic and international CRDMOs.

• Experience managing tactical/operational projects.

• Working knowledge of and experience in clinical packaging and distribution, regulatory, QA, and cGMP requirements for pharmaceutical products.

• Working knowledge of drug development.

• Working knowledge of pharma end-to-end supply chain.

• Strong negotiation skills.

• Solid project management, facilitation, and problem-solving skills.

• Solid organizational and time management skills.

• Effective, open, and transparent communication skills (verbal and written).

• Capable of working on multiple projects/tasks and able to meet timelines.

• Self-starter with a high-level of comfort with ambiguity and complexity and the ability to multi-task while consistently delivering quality results.

• Team-oriented, progressive thinker who enjoys participating in an innovative and creative work environment.

Preferred Skills:

• Experience developing, negotiating, and executing clinical or commercial supply and/or quality agreements.

• Experience in comparator sourcing.

• Experience working with Ex-US suppliers. 

  #LI-Hybrid #LI-CT1

The Opportunity:

Playing a leading role and Subject Matter Expert (SME) of Quality Control within PDM Analytical Development & QC department in support of RevMed clinical and commercial programs, the position will be mainly responsible for managing QC activities from process validation to commercial manufacture of drug substance (DS), drug product (DP) and final product (FP), including managing stability programs, reference materials, and raw materials at contract organization. The candidate will also participate in post-approval QC related activities including lifecycle management regulatory submissions such as CBE, PAS, etc.

• Provide support for stability program management, quality systems and QC documentation (e.g. SOPs) and PAI readiness and inspection as needed.

• Coordinate and manage outsourced QC activities of late phase to commercial programs at CDMOs and / or contract testing labs (CTLs), including but not limited to in-process control test, final release test, and stability study.

• Manage quality events related to QC testing such as lab investigation (e.g., OOS/OOT), deviations, change controls (e.g., CBE 30/CBE 0) and CAPAs.

• Author and/or review QC related documents, including methods, protocols, reports and memos.

• Lead method validation/transfer activities at CDMOs and / or contract testing labs (CTLs)

• Manage reference standards and reference materials including monitoring retest date, facilitating qualification/requalification, and tracking inventory.

• Collaborate with cross functional teams including CMC RA, DS, DP, Supply Chain and Quality Assurance to timely achieve project goals.

Required Skills, Experience and Education:

• BS or MS in Chemistry, Pharmaceutical Science or related discipline.

• 6+ years of relevant industrial experience in analytical development/QC.

• Solid understanding of relevant compliance and regulatory requirements as applicable to data integrity, QbD, process validation, manufacture sampling and testing, stability study, method validation and transfer, etc.

• Effective written and verbal communication skills and interpersonal skills.

• Extensive knowledge and understanding of cGMP guidelines and practices, as well as related / best industry practices.

• Strong problem-solving skills with sound technically driven decision-making ability.

• Excellent communication skills (verbal, written and technical), strong interpersonal/collaboration skills and planning skills.

• Ability to think critically and creatively and be able to work independently to determine appropriate resources for resolution of problems.

• Ability to multi-task and thrive in a fast-paced innovative environment.

Preferred Skills: 

• Experience in solid oral dosage including dissolution testing.

• Commercial QC experience is preferred.

• Work experience and knowledge of global regulatory submissions (IND, IMPD, NDA and MAA, etc.) is preferred.

• Chromatographic experience in development, optimization, and troubleshooting. #LI-Hybrid #LI-CT1

The Opportunity:

Revolution Medicines is seeking Scientist II to join the Drug Product team within Pharmaceutical Development & Manufacturing (PDM). This role will support the development of solid oral dosage forms for small molecule programs across the RVMD pipeline.

The successful candidate will contribute to formulation and process development activities from early-stage through late-stage clinical/commercial development, working closely with cross-functional partners and CDMOs to ensure robust, scalable, and compliant drug product manufacturing processes.

Key Responsibilities:

• Contribute to drug product development activities for new chemical entities (NCEs) from early development through late-stage clinical development, with exposure to commercialization activities.

• Design and execute drug product development and manufacturing activities for solid oral dosage forms, including:

  • Preformulation and formulation development.

  • Manufacturing process development.

  • Process scale-up, technology transfer, and process optimization.

  • Process validation and commercial manufacturing support.

• Support outsourced development and GMP drug product manufacturing activities at CDMOs including manufacturing oversight and troubleshooting.

• Design and execute experiments, analyze and interpret data and present results and conclusions to project teams.

• Work independently with limited supervision to conduct appropriate research and troubleshoot technical challenges, escalating complex issues as needed.

• Author and contribute to CMC documentation for regulatory submissions (e.g., INDs, NDAs, MAAs) and internal technical reports.

• Collaborate cross-functionally within CMC team (Clinical Supply, Analytical Development/QC, Quality Assurance, Drug Substance, Regulatory Affairs, and Project Management) and at enterprise level research/clinical/commercial teams to support aligned development strategy and execution.

• Travel up to 20% to CRO/CDMO sites to support and oversee development and manufacturing operations.

Required Skills, Experience and Education:

• A degree in Pharmaceutical Science, Chemistry, Chemical Engineering, or closely related field is desirable.

• Ph.D. with minimum of 3+ years of experience or a bachelor’s/master’s degree with appropriate experience in the pharmaceutical/biotech industry settings.

• Experience supporting drug product development and manufacturing for small molecules.

• Demonstrated experience in solid oral dosage formulation and process development for small molecules.

• Experience working with external partners (CDMOs/CROs) and overseeing outsourced development and manufacturing activities.

• Working knowledge of global regulatory expectations, including ICH guidelines and FDA, EMA, PMDA etc. requirements.

• Experience contributing to CMC regulatory filings is desirable.

• Strong technical writing, communication, and problem-solving skills.

• Ability to manage multiple priorities and thrive in a fast-paced, innovation-driven collaborative environment.

Preferred Skills:

• Ph.D. degree in Pharmaceutical Science, Chemistry, Chemical Engineering, or closely related field is desirable. 

  #LI-Hybrid #LI-CT1

The Opportunity:

We are seeking an accomplished, strategic and execution-oriented leaders, Executive Director, Global CMC Lead, reporting to SVP of Pharmaceutical Development and Manufacturing (PDM).  The Executive Director, Global CMC Lead provides enterprise-level leadership and accountability for defining and executing the global CMC strategy across the development and commercialization lifecycle. This role sets technical and regulatory direction for late stage and commercial programs, ensures supply continuity, and partners closely with Development, Regulatory, Quality, and Commercial leadership to enable rapid, compliant, and scalable product advancement globally.   The role combines deep technical credibility in small molecule development with strong strategic judgment, people leadership, and external influence.  The role requires expertise in small molecule pharmaceutical development and manufacturing, an understanding of the oncology development lifecycle, and the ability to thrive in a dynamic, fast-paced environment.

Responsibilities:

• Own the integrated global CMC strategy across assigned development and commercial programs

• Serve as the senior CMC leader on program and portfolio teams, accountable for CMC timelines, risks, and deliverables.

• Drive clear, risk-based CMC decision-making that balances speed, quality, and long-term product robustness.

• Anticipate and proactively manage CMC risks impacting development speed, regulatory success, or supply robustness.

• Provide strategic oversight of drug substance development and manufacturing, drug product development and manufacturing, specification and control strategy development, and lifecycle optimization.

• Partner with PDM cross-functional team / leadership to ensure technical readiness for late-stage development, PPQ, validation, and commercial supply, capacity planning, risk mitigation, dual sourcing as needed, and launch readiness, as well as life cycle development.

• Partner with PDM cross-functional team / leadership to define global CMC regulatory strategy for IND/CTA, NDA/MAA, JNDA and post-approval lifecycle activities.

• Provide senior-level review and approval of CMC content for global submissions and health authority interactions.

• Ensure all CMC activities meet global GMP, ICH, and regulatory expectations.

• Act as a strategic partner to Clinical Development, Regulatory, Quality, Nonclinical, and Commercial leadership.

• Clearly communicate CMC risks, trade-offs, timelines, and investment needs to executive leadership.

• Support business development due diligence and integration from a CMC perspective.

Required Skills, Experience and Education:

• PhD (strongly preferred), MS, or equivalent in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related discipline.

• 15+ years of progressive CMC experience in the pharmaceutical or biotechnology industry, with a strong focus on small molecules.

• Demonstrated leadership of CMC activities from early development through commercialization life cycle.

• Proven experience leading global regulatory submissions and interacting with major health authorities (FDA, EMA, PMDA).

• Deep expertise in small molecule API and drug product development, manufacturing, and control strategies.

• Strong understanding of external manufacturing models and CDMO governance.

• Broad knowledge of global CMC regulatory requirements and lifecycle management.

• Strategic, enterprise-minded leader with strong decision-making and risk management capabilities.

• Proven ability to lead through influence in highly matrixed environments.

• Clear, decisive leadership style with strong scientific and regulatory judgment.

• Ability to operate effectively in a fast-paced, highly collaborative, and data-driven environment.

Preferred Skills:

• Oncology drug development, particularly targeted therapies.

• Experience supporting accelerated development timelines and first-in-class programs.

• Experience with commercial launch and post-approval lifecycle management. 

  #LI-Hybrid  #LI-GL1

The Opportunity:

Revolution Medicines is seeking a motivated individual to plan, source, make, and deliver clinical supplies to support RevMed’s clinical development programs.   This is an individual contributor role, reporting to the Clinical Supply Chain Director responsible for RevMed’s lead compound.

Responsibilities:

• Serve as the clinical supply lead for assigned study(s) and develop/manage the clinical supply plan.

• Plan, source, make, and deliver on-time, compliant clinical supply per the clinical development plan.

• Collaborate with cross-functional teams (i.e. Clinical Operations, QA, Regulatory, and other PDM Functions) to ensure continued advancement of the clinical programs.

• Led and managed clinical supply and logistics activities, including but not limited to demand forecasting and supply planning, IRT start-up and maintenance, label generation and approval, packaging and labeling operations, release and distribution, expiry extension, cold chain management, and inventory management.

• Author, review, and/or approve related clinical and technical documents, including but not limited to clinical label text, clinical/master batch record, clinical trial protocol, pharmacy manual, IND, IMPD, and NDA.

• Develop, implement, and improve key clinical supply business processes and SOPs and conduct necessary training.

Required Skills, Experience, and Education:

• B.Sc. or M.Sc. in a scientific field with 5+ years of experience in pharmaceutical supply chain.

• Experience managing both strategic and tactical/operational projects.

• Working knowledge of import and export laws and processes.

• Working knowledge of Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP)

• Working knowledge of end-to-end pharmaceutical supply chain and demand/supply planning.

• Working knowledge of small molecule drug development and commercialization.

• Working knowledge of pharmaceutical clinical manufacturing, regulatory, and quality assurance.

• Strong negotiation skills.

• Solid project management, facilitation, and problem-solving skills.

• Solid organizational and time management skills.

• Effective, open, and transparent communication skills (verbal and written)

• Capable of working on multiple projects/tasks and able to meet timelines.

• Self-starter with a high level of comfort with ambiguity and complexity and the ability to multi-task while consistently delivering quality results.

• A team-oriented, progressive thinker who enjoys participating in an innovative and creative work environment.

Preferred Skills:

• Experience managing clinical supply activities for global phase 3, randomized, oncology clinical trials. 

  #LI-Hybrid #LI-CT1

The Opportunity:

We are seeking an accomplished, strategic and execution-oriented leaders, Vice President, Global CMC Regulatory, reporting to SVP of Pharmaceutical Development and Manufacturing (PDM) Regulatory, to lead our global chemistry, manufacturing, and controls (CMC) regulatory strategy and execution across all development programs and commercial assets.  This leader will drive regulatory strategy development, lead regulatory interactions, and provide expertise throughout the product lifecycle, from early development to post-approval variations ensuring the timely submission and approval of high-quality CMC regulatory filings to support our company’s pipeline and global growth. 

The successful candidate will serve as a senior leadership role within Pharmaceutical Development and Manufacturing (PDM) organization, overseeing CMC regulatory activities and ensuring alignment with health authority expectations globally (FDA, EMA, PMDA, NMPA, etc.).    The role requires expertise in small molecule pharmaceutical development and manufacturing, an understanding of the oncology development lifecycle, and the ability to thrive in a dynamic, fast-paced environment.

Responsibilities:

Global CMC Regulatory Strategy

• Develop and execute global CMC regulatory strategies in alignment with product development plans for clinical and commercial programs / marketed products.

• Provide strategic CMC regulatory leadership to support global filings, approvals, and post-approval lifecycle management.

• Proactively identify and manage CMC regulatory risks, anticipate challenges and develop mitigation strategies to support business objectives and ensure global alignment and compliance.

Health Authority Engagement

• Serve as the primary CMC regulatory interface with global health authorities, including FDA, EMA, EU National Competent Authorities, and PMDA.

• Lead and support CMC-related regulatory meetings, scientific advice, and responses to health authority questions.

Regulatory Submissions & Lifecycle Management

• Oversee the preparation, review, and submission of high-quality CMC sections for NDAs, MAAs, J-NDAs, and global post-approval variations.

• Ensure consistency, compliance, and scientific rigor across global CMC regulatory filings.

• Provide strategic oversight for post-approval changes, including site changes, process improvements, and supply chain optimization.

• Interpret and apply evolving CMC regulatory requirements and guidance globally.

Cross-Functional Collaboration

• Partner closely with Drug Substance, Drug Product, Analytical Development and QC, Manufacturing, Supply Chain, Quality, and Program Management to align regulatory strategy with technical and operational plans.

• Act as a regulatory subject matter expert for tech transfer, global site registration, comparability protocols and control strategy development.

Team Development & Leadership

• Build, mentor, and lead a high-performing global CMC regulatory team, fostering accountability, development, and innovation.

• Manage external regulatory consultants and regional partners to ensure consistent global execution and local expertise.

Required Skills, Experience and Education:

• Advanced degree (PhD, PharmD, or MS) in Chemistry, Pharmaceutical Sciences or related scientific discipline.

• Minimum of 18 years of experience in the biotech/pharmaceutical industry, with at least 10 years in CMC regulatory affairs and global submission experience.

• Demonstrated success leading global CMC regulatory strategies for small-molecule products.

• Proven success scaling CMC regulatory function in a public, late-stage biotech/pharma company.

• Deep understanding of global regulatory frameworks and guidelines (FDA, ICH, EMA, PMDA, NMPA, etc.).

• Strong leadership and collaboration skills with a demonstrated ability to work cross-functionally and influence stakeholders at all levels.

• Strong written and verbal communication skills, with the ability to clearly articulate regulatory strategy and risk.

• Ability to thrive in a fast-paced, matrixed, and science-driven environment.

Preferred Skills:

• Experience with oncology development programs and familiarity with accelerated or expedited pathways.

• Experience with Japan-specific CMC regulatory requirements (e.g., consultations, GQP/GMP compliance, J-NDA format).

• Exposure to lifecycle management activities including global variations, site changes, and supply chain adaptations. 

  #LI-Hybrid  #LI-GL1

The Opportunity:

This internship provides foundational training in clinical supply chain operations, documentation practices, and systems used to support global clinical trials. The intern will develop a working understanding of how supply chain activities directly impact study execution, compliance, and patient safety. As a Clinical Supply Chain Intern, you will gain hands-on exposure to the operational backbone that supports global clinical trials. You will work closely with the Clinical Supply Chain team to understand how investigational product (IP) is planned, documented, distributed, and maintained in compliance with GxP and regulatory standards.

By the end of the internship, the intern will be able to:

• Understand the role of clinical supply chain in clinical trial execution.

• Identify key elements of batch documentation relevant to clinical supply.

• Understand temperature excursion processes and documentation requirements.

• Review depot-level shipment documentation for completeness and compliance.

• Organize and centralize shipment documentation within a TMF structure.

• Apply GxP principles and inspection-ready documentation practices.

Required Skills, Experience and Education:

• Currently pursuing a degree in Supply Chain, Life Sciences, Pharmacy, Engineering, or related field.

• Interest in biotechnology, pharmaceutical operations, or clinical development.

• Strong attention to detail and organizational skills.

• Proficiency in Microsoft Excel and general document management tools.

• Strong communication skills and willingness to learn in a regulated environment.

• Excellent organizational, communication, and problem-solving skills.

• Ability to work independently while collaborating effectively across functions and with external partners. 

  #LI-Hybrid  #LI-AP1

The Opportunity:

Playing a critical role as the stability program lead, the position will be responsible for oversight and management of outsourced stability studies conducted. The director, stability  is a self-motivated individual who works as a member of an integrated team contracting, designing, managing, and evaluating stability studies at contractors for both drug substance and drug product. This individual should have the breadth of experience required to manage stability studies in commercial, late and early clinical development stage.  This individual should have broad knowledge of ICH and cGMP guidelines and the ability to contribute to global regulatory filings for stability.

• Develop and implement the strategic direction of stability programs in alignment with ICH guidelines and regulatory expectations.

• Oversee the design, execution, and management of stability studies (development, registration and commercial).

• Work cross functionally with CMC, quality, regulatory, clinical and related teams to achieve stability objectives.

• Compile stability study results, perform trend and statistical analyses, and prepare reports to support retest/shelf-life date extensions and storage condition recommendations.

• Partner with quality during stability quality events (QEs) or investigations and implementation of CAPAs at contractors.

• Serve as the primary point of contact for contract organization for all stability related activities.

• Oversee sample shipment if applicable, inventory tracking, and chain of custody for stability studies.

• Support, author CMC stability documentation for IND, NDA, AR and IMPD filings, covering all phases of clinical development and commercial activities by ensure completeness and accuracy of stability data.

• Drive continuous improvement of stability management processes, including contract organization performance metrics.

• Collaborate cross-functionally with teams in drug substance, drug product, supply chain, quality, regulatory, sourcing and other related team to ensure alignment of stability design and achieve stability study objectives.

Required Skills, Experience and Education:

• PhD in Chemistry, Pharmaceutical Sciences, or related discipline with 12+ years of industry experience; or MS with 15+ years, or BS with 18+ years.

• 10+ years in stability management or relevant experience within pharmaceutical or biotech industry.

• Strong knowledge of GMP regulations, quality systems, ICH guidelines, and regulatory expectations (FDA, EMA, etc.).

• Extensive experience managing contract organization and working in a virtual development model.

• Excellent leadership, people/team management, project management, and cross-functional collaboration skills.

• Strong problem-solving skills with strategic and technically sound decision-making ability.

• Excellent written and verbal communication skills and interpersonal skills.

• Energetic, team-oriented, and adaptable to a fast-paced, dynamic environment.

Preferred Skills:

• Experience with small molecule oncology drug development. 

  #LI-Hybrid #LI-CT1