The Opportunity:

This newly created role represents a unique opportunity to shape the future of patient engagement at Revolution Medicines. The Omnichannel Strategy & Operations Team is seeking a forward-thinking, digitally fluent marketing leader to drive patient non-personal promotion (NPP) across our oncology portfolio.

The Senior Manager, Omnichannel Marketing (Portfolio Patient NPP) will lead the design and execution of innovative patient omnichannel capabilities and campaigns that support brands and disease state education. The Senior Manager will oversee the creation and management of omnichannel-ready content derivatives—ensuring cohesive, high-impact patient engagement across channels.  This role also offers the opportunity to build and scale best-in-class digital engagement models in close partnership with our Brand Patient Leads, Insights, and IT teams.

In addition to leading campaign execution, this individual will partner to identify measurement opportunity, optimize performance through data-driven insights, and identify emerging digital technologies that accelerate market readiness and enhance the patient experience.

Note: Branded & Unbranded Patient Marketing strategy, imperatives, objectives & content will be created by the brand aligned Patient Marketing Business Lead.

Key Responsibilities:

• Lead the Patient Non-Personal Promotion (NPP) Omnichannel Operations across oncology launches while identifying & designing integrated omnichannel engagement opportunities aligned to patient journey insights and brand objectives.

• Partner with Patient Marketing Business Lead(s) to understand the Patient engagement Strategy, Objectives and market research (per Asset/Tumor)

• Translate brand objectives and market research into engaging and effective Patient NPP campaigns to meet patients’ needs and preferences while ensuring consistent messaging across multiple channels.

• Develop and execute comprehensive Patient NPP marketing plan for all oncology launch products and indications, including creating strategic proposals and actionable options for effectively targeting patients. For example, what is the approach, channel, optimal media usage & measurement?

• Leverage existing or derivative assets.

• This includes vendor management to achieve transparent & optimal performance.

• Analyze and interpret Patient NPP campaign performance data to derive actionable insights and optimize future NPP initiatives.

• Partnering with the Insights team, present marketing performance insights and recommendations to Commercial Leadership Team.

• Collaboratively work with cross functional omnichannel partners to think strategically to solve/impact key business solutions/opportunities and present these complex ideas with clarity. For example: what hypothesis should we be testing for patients to engage more optimally? Specifically- Channels, Tactics, Orchestration, Impact/Measure, Cos

• Offer targeted digital solutions and strategies to enhance Patient, NPP, product & Disease State education launch strategies and reach the right patients/caregivers.

• Identify and evaluate new marketing technology platforms that support future readiness and patient engagement models.

• NPP Content Owner the PRC weekly team to manage & move assets from creation to execution as needed for NPP channels.

• Collaborate closely with cross-functional stakeholders (Medical Affairs, Market Access, Commercial, Legal) to ensure alignment of Patient NPP brand strategy and execution is compliant.

• Manage Patient NPP Omnichannel tactics marketing budgets effectively to ensure efficient resource allocation.

Required Skills, Experience and Education:

• Bachelor’s degree required; MBA or advanced degree strongly preferred.

• Minimum of 6-8 years of progressive experience in marketing within the pharmaceutical or biotech industry, including oncology product experience.

• Demonstrated examples of experience in Digital Marketing, Media Channel Marketing or Personal Promotion Marketing experience.

• Track record of being a collaborative team player, building positive partnerships, and adaptive to meet the needs of a growing business.

• Experience managing external vendors, budgets, and promotional reviews in a regulated environment

• Strong analytical skills and ability to interpret complex datasets to drive marketing decisions.

• Proven ability to influence cross-functional teams and stakeholders without direct authority.

• Strong analytical skills and ability to interpret complex datasets to drive marketing decisions.

• Thorough knowledge of current digital marketing platforms, media channels, and regulatory considerations.

Preferred Skills:

• Experience launching targeted oncology therapies or rare disease products.

• Experience optimizing Branded & Unbranded Patient NPP channels and/or journeys.

• Familiarity with modular content management, dynamic content creation, or AI-enhanced promotional tools.

• Experience in a high-growth, pre-commercial environment. 

  #LI-Hybrid  #LI-SS2

The Opportunity:

This newly created role represents a unique opportunity to shape the future of HCP engagement at Revolution Medicines. The Omnichannel Strategy & Operations Team is seeking a forward-thinking, digitally fluent marketing operations leader to drive optimal performance while also delivering high-quality customer experiences across our HCP engagement channels.

The Associate Director, Omnichannel HCP Marketing Operations is a highly collaborative, execution-focused leader responsible for partnering with Brand Leads in translating oncology brand strategies into high-impact, compliant, and innovative customer engagement experiences.

In a fast-paced, growth-stage biotech environment, this role serves as the connector between strategy and execution partnering cross-functionally to operationalize omnichannel campaigns with precision, agility, and measurable impact. This leader will help build scalable capabilities, optimize customer journeys, and elevate omnichannel maturity as the organization prepares for commercialization and further portfolio growth through in-line brands & commercial launches.

This role is ideal for someone who thrives in a hands-on environment, balances strategic thinking with operational excellence, and is motivated by building best-in-class engagement models in oncology.

This role reports to the Executive Director, Omnichannel Portfolio Strategy & Operations.

Note: Branded & Unbranded Marketing strategy, imperatives, objectives & content will be created by the brand aligned Marketing Business Lead and/or as output from the brand plan.

Key Responsibilities:

Strategic Omnichannel Enablement

• Partner with Brand, Sales, REIDS (RML & KOL), Market Access, Patient Access and Medical to operationalize independent & integrated oncology HCP customer strategies.

• Translate strategic plans into executable customer journeys across personal and non-personal channels driving optimal product utilization.

• Partner with Brand HCP Leads to develop and execute comprehensive marketing plan for all oncology PDAC/GI launch products and indications, including creating strategic proposals and actionable options for effectively targeting HCP via function, campaign & content.

• Support pre-launch, launch, and in-line brand initiatives through scalable omnichannel frameworks.

• Ensure options are aligned for potential sequencing and orchestration across field engagement, digital, media, email, congress activation, and emerging channels (push/pull and NPP/PP).

• Partnering with the Insights team and IT, present marketing performance insights and recommendations to Commercial Leadership Team.

• As the Omnichannel capability lead for PDAC & GI Tumors, all of the above also require concerted collaboration with HQ based functions including Insights & Data, Sales Ops, Commercial IT, Compliance, Procurement, MLR/PRC and others.

  • Act as the Omnichannel strategic thought partner to Brand and Commercial teams.

  • Align stakeholders (and agency partners) establishing clear processes and governance to drive speed while maintaining compliance rigor.

  • Influence without formal authority in a matrixed, resource-constrained environment.

  • Partner across the above to implement new omnichannel capabilities and improve existing capabilities/gaps/challenges.

  • Attend the PRC weekly team meeting to manage & move assets from creation to execution as needed for NPP channels.

Operational Excellence & Campaign Execution

• Connect the HCP Omnichannel campaign development, configuration, and deployment within and across CRM and marketing automation platforms (e.g., Veeva CRM, Speaker Program, Salesforce Marketing Cloud).

• Define and evolve HCP and account-based customer journeys in oncology.

• Develop and socialize critical data attributes available for both input and output of campaigns.

  • Create a shared catalog of key data attributes (both inherent and computer) ahead of time to effectively prepare the campaign for impact.

  • Ensure accuracy and ease of data access for targeting, segmentation, routing, consent management, and content distribution with rigorous QA and compliance checks.

  • Partner with Analytics to establish KPIs, dashboards, and performance monitoring frameworks.

  • Drive data-informed improvements to engagement effectiveness and ROI.

• Implement test-and-learn approaches to optimize engagement and personalization.

• Manage external vendors and agency partners to ensure quality and timeliness.

• Develop repeatable workflows to improve execution efficiency and reduce errors.

• Champion customer centricity via connected experiences & digital innovation while ensuring compliance within a regulated oncology environment.

• Help define and advance the organization’s omnichannel roadmap.

• Identify and implement new tools and capabilities that enhance personalization and automation.

• Contribute to building foundational omnichannel processes for scale.

• Identify and evaluate new marketing technology platforms that support future readiness and HCP engagement models.

Required Skills, Experience and Education:

• Bachelor’s degree required; MBA or advanced degree strongly preferred.

• Minimum of 8-10 years of progressive experience in marketing or marketing operations within the pharmaceutical or biotech industry.

• Demonstrated examples of experience in Digital Marketing, Media Channel Marketing or Personal Promotion Marketing experience.

• Track record of being a collaborative team player, building positive partnerships, and adaptive to meet the needs of a growing business.

• Experience managing external vendors, budgets, and promotional reviews in a regulated environment.

• Strong analytical skills and ability to interpret complex datasets to drive marketing decisions.

• Proven ability to influence cross-functional teams and stakeholders without direct authority.

• Strong analytical skills and ability to interpret complex datasets to drive marketing decisions.

• Thorough knowledge of current digital marketing platforms, media channels, and regulatory considerations.

Preferred Skills:

• Experience launching targeted oncology therapies or rare disease products.

• Experience optimizing Branded & Unbranded channels and/or journeys

• Demonstrated experience across NPP and PP is a definite plus.

• Familiarity across digital channels with experience with modular content management, dynamic content creation, or AI-enhanced promotional tools.

• Experience in a high-growth, pre-commercial environment. 

  #LI-Hybrid  #LI-SS2

The Opportunity:

We are seeking a QSP modeling & simulation scientist to be part of the Nonclinical Development and Clinical Pharmacology (NDCP) organization. This position will be responsible for developing, validating, and executing modeling projects with a focus on mechanistic PBPK-QSP mathematical models for small molecule programs to increase mechanistic understanding of compound PK behavior and drug distribution, pharmacological effects on RAS targets, support clinical translation, and drive future discovery and development efforts.  As a Quantitative Systems Pharmacologist, you will:

• Develop, validate, execute, and refine quantitative systems pharmacology (QSP) models, minimal physiologically based pharmacokinetic (PBPK) models, semi-mechanistic PK/PD models, and tumor growth models to support development and discovery phase projects including next-generation inhibitor design and assessment of combination potential.

• Propose and perform in silico simulations to answer complex mechanistic questions, create data visualizations to effectively communicate modeling results to a wide-ranging audience, and devise strategies to improve model outputs.

• Survey the related literature to understand key physiological and biological processes, abstract the basic mechanistic elements, identify the relevant data, and summarize assumptions to be incorporated into existing or new PBPK-QSP models.

• Propose new mechanistic in vitro and in vivo experiments to test model assumptions and structure. Provide in silico support for preclinical translation including clinical efficacious doses/exposure projection, potential combination dosing regimens with other cancer therapeutics.

• Work collaboratively with other functions to build internal infrastructure supporting data transfer and quality control.

• Document contributions, including assumptions, mathematical models, data analyses, and data visualizations, to be shared with other scientists or used for archival purposes.

Required Skills, Experience and Education:

• A Ph.D. in a quantitative discipline (systems pharmacology, computational biology, engineering, mathematics, physics, etc.) and 0-2 years of industry experience is desired.

• Strong understanding of the principles and limitations of mathematical modeling, pharmacokinetic models, pharmacodynamic models, and quantitative systems pharmacology/biology models.

• Proficiency in mathematical and computational methods including ordinary differential equations (ODEs), nonlinear systems, statistics, optimization, and parameter inference.

• Proven record developing, calibrating, and validating dynamical system models in pharmacological and biological systems.

• Demonstrable hands-on experience with programming languages used in scientific computing, such as MATLAB, Python, Julia, and R.

• Capable of working proactively and independently to deliver high–quality modeling results in a timely manner.

• Able to effectively communicate modeling assumptions, limitations, and simulation results to non-specialist and specialist audiences.

• A critical thinker and team player who can work cross-functionally with others.

Preferred Skills:

• Experience with diverse dynamical system methods like ODE-based, PDE-based, nonlinear mixed effects, agent-based, Markov, Boolean, etc.

• Experience with integrating large data sets into QSP.

• Experience with agentic coding workflows such as Copilot, Cursor, Codex, and Claude Code.

• Experience with data-driven methods such as ML-based predictive regression models and physics-informed neural network models.

• Experience with modeling software such as SimBiology, NONMEM, Pheonix WinNonlin, Monolix, Simcyp designer, etc. 

  #LI-Hybrid #LI-CT1

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.

Required Skills, Experience and Education:

• 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.

• 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.

The Opportunity:

The Vice President, Regulatory Affairs will manage several key U.S. based regulatory functions and report to the SVP of Regulatory and Quality. The position is responsible for expanding and leading a large, high functioning regulatory group and ensuring global alignment.

• Provide ethical and mission-driven leadership of the Regulatory Affairs functions. Embody and practice the company’s mission-driven culture. Ensure that our core values guide our strategic vision and our day-to-day decision making.

• Provide a vision for the Regulatory Affairs organization and develop a plan to achieve it. Design and rapidly scale a group to meets the needs of an explosive pipeline in areas of high unmet medical need and intense industry competition.

• Influence decision-making of senior leadership and ensure globally aligned regulatory decision-making.

• Collaborate closely and form effective relationships with other functional heads and regional counterparts to ensure high quality, cross-functionally sound decision-making.

• Collaborate with peer leaders and management to ensure regulatory considerations are integrated upstream appropriately, e.g., target product profiles, clinical development plans, financial planning.

• Ensure consistency in approach (one playbook) and that learning occurs across staff and disciplines.

• Continue to build the Regulatory Affairs group, strategizing with other leaders to maximize enterprise-wide impact locally and globally.

• Actively lead the function and support team member career development.

Required Skills, Experience and Education: 

• Local to San Francisco Bay Area or able to travel to headquarters frequently and for adequate durations (up to 25%).

• BA/BS degree in life sciences or related disciplines.

• At least 15 years of experience in drug development regulatory affairs.

• Minimum of 10 years of experience in regulatory leadership or executive role.

• Significant oncology experience.

• Expertise in navigating global regulatory environments in a commercial setting.

• Ability to successfully work in a fast-paced, demanding and highly cross-functional environment.

• Experience scaling an organization rapidly.

• Clearly understands the role of regulatory science in drug development and global commercialization, and is comfortable with ambiguity, risk, and optimizing for business needs.

Preferred Skills:

• Advanced degree in life sciences enabling technical fluency in oncology.

• Prior senior regulatory executive in oncology drug development at a medium or large pharmaceutical enterprise but who also understands the startup environment.

#LI-Hybrid  #LI-GL1 

The Opportunity:

Revolution Medicines is seeking a motivated Summer Intern to support a strategic Clinical Operations initiative focused on optimizing study-level execution and alignment with internal Clinical Operation tools such as the Clinical Operations Handbook. This individual contributor role will partner with the Clinical Operations Execution (CORE) Team to assess consistency, tool utilization, and workflow execution from protocol finalization through site activation. The intern will gain hands-on exposure to cross-functional clinical trial operations while delivering actionable process improvement insights.

Responsibilities:

• Review one to two active clinical studies for detailed operational assessment.

• Evaluate utilization of key study management tools including logs used for study tracking, e.g., risks, actions, issues, decisions.

• Study Dashboards, Vendor Oversight Plans, and Study Startup Timelines.

• Document end-to-end workflows from protocol finalization through site activation.

• Identify gaps, redundancies, and inconsistencies in process execution across studies.

• Conduct structured interviews with Clinical Operations Leads (COLs) and Clinical Trial Assistants (CTAs).

• Shadow Clinical Study Execution Team (CSET) meetings to observe dashboard and RAID log utilization.

• Review Smartsheet tools and Egnyte folder structures to assess organization and consistency.

• Compare real-world study execution against documented Clinical Operations Handbook processes.

Required Skills, Experience and Education:

• Currently pursuing a Bachelor’s or Master’s degree in Life Sciences, Public Health, Clinical Research, Business, or related field.

• Strong analytical and organizational skills.

• Effective written and verbal communication skills.

• Proficiency in Microsoft Office (Word, Excel, PowerPoint).

• Interest in clinical trial operations and process optimization.

Preferred Skills:

• Familiarity with Smartsheet or similar project management tools.

• Prior exposure to clinical research or regulated environments. 

  #LI-Hybrid  #LI-AP1

The Opportunity:

We are seeking an experienced drug developer and effective leader to serve as Executive Director of Clinical Development in support of Revolution Medicines’ clinical-stage molecule(s) and/or pre-clinical molecule(s). In this critical role, you will be responsible for developing the strategic plans and ensuring efficient operational execution of the molecule(s)’ clinical development program in one or more disease indications, from early-stage studies to regulatory submissions and potential commercialization. You will play a pivotal role in shaping the future of our pipeline and driving the development of transformative therapies for patients.

• Provide critical insights/contributions and implement comprehensive/execute upon the clinical development plans for Revolution Medicines’ molecules, ensuring alignment with scientific, regulatory, and commercial objectives.

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

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

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

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

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

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

• Partner with cross-functional teams, including research, regulatory affairs, commercial, and finance, to ensure seamless program execution and achieve shared goals.

• Manage multiple direct reports; potentially be a manager of managers.

Required Skills, Experience and Education:

• MD, PhD or similar advanced biomedical graduate degree with 13+ or more years experience in pharmaceutical/biotech industry or academic background at the level of Associate Professor or higher.

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

• Proven track record of successfully designing and conducting multiple clinical trials as part of a wider clinical development programs from early-stage to late-stage, direct experience with Phase 1 drug development.

• Experience authoring and clinical development strategy(ies) and bringing forward for governance.

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

• Proven experience to steer an IMP during its clinical development plan through major and varied Health Authority interactions (e.g. FDA, EMA, others). Has led Health Authority interaction(s).

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

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

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

• Outstanding written and business presentation skills. Experience publishing results of a clinical trial in a peer-reviewed journal is required.

• Proven ability to manage budgets and timelines effectively.

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

Preferred skills:

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

• Experience creating clinical development strategy(ies) that led to label-enabling outcomes and commercialization.

• Experience submitting an NDA/BLA/MAA to global health authorities is a significant plus.

• Has led regulatory and other internal partners/stakeholders in the completion and submission of regulatory documentation. Successfully provided clinical science information and input for regulatory development of label(s) and packaging language, etc.

• Has led or overseen data generation to address unmet medical needs and identify new or extended Clinical Development studies for the assigned program or other programs.

• Direct experience with Phase IV drug development.

• Has proven abilities to present [a] compelling business case and facilitates effective and expeditious decision-making. Has demonstrated the ability to serve as a company spokesperson both internally and externally.

• Has demonstrated collaborate behaviors on enterprise-level strategic initiatives with a variety of internal and external partners and stakeholders - including clinical investigators/clinicians, scientists and key opinion leaders (KOLs), as well as internal groups, including other groups in development, research, business development, commercial, legal, etc. - resulting in demonstrable outcomes (e.g. new study proposals or new disease indications).

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

  #LI-Hybrid  #LI-GL1

The Opportunity:

Playing a critical role as a filing and program lead statistician for clinical Late-Stage program(s) and the subject matter expert (SME) in Biostatistics within Quantitative Sciences function, this position is to serve as a program level lead statistician and provide statistical leadership and support for clinical development strategy and programs through product life cycle.

• Lead strategic, statistical thinking and contributions to clinical development plans.

• Represent Biostatistics function on cross-function teams at program level and serve as a lead statistician for oncology studies.

• Collaborate with various functions on study design and planning, protocol development, statistical analysis plan and analysis specifications.

• Provide statistical support for study protocol development, analysis plan and specification through direct involvement and/or providing guidance to junior staff.

• Plan and prepare independent data monitoring committee (DMC), coordinate with independent statistical data analysis center for DMC and study team for periodic DMC reviews.

• Collaborate with data management and clinical operations over the course of clinical studies to provide statistical input to study conducts and database development as well as data collection and cleaning activities.

• Collaborate with statistical programming to ensure that appropriate programs and documentations are being developed for datasets development and outputs generation, and ensure the statistical analyses specified in scientific protocols and/or analysis plans are conducted appropriately.

• Provide statistical input and leadership to the development of global health authority documents, regulatory interaction and response to health authority submissions.

• Provide statistical support for clinical publications, assist in data interpretation to ensure consistency and accuracy in data presentation.

• Drive and lead department initiatives, best practices, and guidelines.

• Keep abreast in new developments in statistics, drug development, and regulatory guidance and share knowledge with functional and cross-functional team members.

Required Skills, Experience and Education:

• Ph.D. or M.S. in Statistics/Biostatistics, minimum 10 years (for Ph.D.) and 14 years (for M.S.) of experience in biotech/pharma industry as a statistician. Level will be determined based on the relevance of experience.

• Extensive experience in design and conduct of phase 3 oncology trials.

• Solid knowledge in ICH and other regulatory requirements related to biostatistical activities and clinical trials.

• Excellent verbal and written communication skills are required.

• Good interpersonal and project management skills are essential.

• Proficiency in SAS and/or R.

Preferred Skills:

• Experience with lead role in NDA/BLA filing desirable.

#LI-Hybrid  #LI-SH1

The Opportunity:

We are seeking an experienced clinical science drug developer to serve as Medical Director of Clinical Development in support of Revolution Medicines’ molecule(s) in clinical or late pre-clinical development. In this critical role, you will support various clinical science deliverables and enable effective and efficient execution of the clinical development plan for a molecule(s) within its particular indication(s). The scope of activities spans early-stage clinical research and may extend to studies supporting regulatory submissions including Breakthrough-Therapy-Designation (BTD) or Accelerated Approvals (AA). You will play a vital role in leading the clinical science aspects of the Clinical Development Plan (CDP) strategy, driving the development of transformative therapies for patients.

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

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

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

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

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

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

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

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

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

• Potential to manage multiple direct reports.

Required Skills, Experience and Education:

• MD (oncology training preferred) with 5+ years of experience in clinical development in the pharmaceutical/biotech industry and/or academic/other clinical trial setting; some experience in and understanding of early phase drug development preferred.

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

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

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

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

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

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

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

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

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

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

• Experience in mentoring other clinical scientists. Experience or clear potential as an effective line manager.

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

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

• Strong written and business presentation skills is required.

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

• Demonstrated strong leadership presence.

• Has demonstrated adaptability and flexibility.

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

Preferred skills:

• Has made significant contributions to clinical development plan conception, conduct and delivery, including successful alignment with scientific governance.

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

• Has led or supported clinical development contributions to major regulatory submissions (e.g. IND for First-in-Human studies, EOP2 briefing books (Type C/D); PIP/PSP, label negotiation, Breakthrough Therapy Designation, Accelerated Review is a major plus.

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

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

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

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

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

#LI-Hybrid  #LI-SH1

The Opportunity:

Reporting to the Senior Director, U.S. Forecasting, the Director, U.S. Forecasting will be responsible for developing and executing forecasting models and analyses that support product strategy, performance management, and operational planning.

This role focuses on building and maintaining short-term demand forecasts and patient-based models across U.S. oncology assets, enabling manufacturing, supply chain, and commercial decision-making. The Director will partner closely with cross-functional stakeholders to align on forecast inputs, assumptions, and outputs, while ensuring high-quality, timely deliverables.

As a key contributor within the U.S. Forecasting function, this individual will execute forecasting processes in alignment with the broader U.S. forecasting strategy and contribute to ongoing improvements in forecasting capabilities, tools, and data integration.

This position is based at our Redwood City, CA headquarters, with flexibility for remote candidates willing to travel regularly to the office.

Responsibilities include:

• Develop, maintain, and refine short-term demand forecasts across U.S. oncology products, including SKU-, dose-, and channel-level projections to support supply chain and commercial planning.

• Build and manage patient-based forecasting models incorporating oncology-specific dynamics such as incidence, biomarker segmentation, lines of therapy, treatment duration, and market evolution.

• Conduct scenario, sensitivity, and risk analyses to evaluate key business drivers and inform near-term decision-making.

• Translate complex data, assumptions, and model outputs into clear, actionable insights to support launch planning, performance tracking, and operational readiness.

• Partner cross-functionally with Commercial, Finance, Market Access, Medical Affairs, Supply Chain, and Manufacturing to gather inputs, validate assumptions, and ensure alignment on forecast outputs.

• Support development of production and inventory strategies by providing accurate and timely forecast updates and analyses.

• Integrate real-world data, secondary data sources (e.g., IQVIA), and competitive intelligence into forecasting models to enhance accuracy and responsiveness.

• Execute forecasting activities in alignment with U.S. Forecasting strategy and methodologies established by senior leadership, ensuring consistency and rigor.

• Support enhancements to forecasting processes, tools, and data infrastructure, including model standardization and automation initiatives.

• Maintain clear and transparent documentation of forecasting methodologies, assumptions, and data sources.

• Manage external vendors and data partners to ensure delivery of high-quality inputs and analyses.

• Escalate key risks, assumptions, and forecast variances to senior leadership with clear summaries and recommendations.

• Stay current on Revolution Medicines’ portfolio, competitive landscape, and evolving oncology market dynamics.

Required Skills, Experience and Education:

• Bachelor’s degree in business, life sciences, statistics, or economics required; advanced degree (MBA, MS, MPH, or PhD) preferred.

• 8+ years of experience in pharmaceutical, biotechnology, or consulting roles, including at least 5 years in forecasting, analytics, or demand planning.

• Demonstrated experience building and maintaining patient-based and/or demand-based forecasting models supporting commercial and operational decision-making.

• Strong understanding of forecasting methodologies, including patient-based modeling, scenario analysis, and data-driven forecasting approaches.

• Experience working with oncology data and/or oncology markets preferred.

• Proficiency in analytics and visualization tools (e.g., Excel, Tableau, Power BI or equivalent).

• Experience working with secondary data sources (e.g., IQVIA) and integrating multiple data streams into forecasting models.

• Strong analytical and problem-solving skills, with the ability to synthesize complex data into actionable insights.

• Demonstrated ability to collaborate effectively across cross-functional teams and contribute to decision-making processes.

• Strong organizational skills and attention to detail, with the ability to manage multiple priorities in a fast-paced environment.

• Effective communication skills, including the ability to clearly present analyses and insights to diverse stakeholders.

Preferred Skills:

• Experience in oncology forecasting, including patient flow modeling and treatment dynamics.

• Experience supporting product launches or pre-commercial forecasting.

• Familiarity with supply chain or manufacturing planning processes.

• Experience working in a fast-paced, growth-stage biotechnology organization.

• Experience managing vendors or external analytics partners. 

  #LI-Hybrid #LI-SS2

The Opportunity:

We are seeking a highly motivated Research Associate II to support day-to-day laboratory operations within the Sample Management function. This role is ideal for a hands-on laboratory professional who thrives in a fast-paced research environment and takes pride in operational excellence, data integrity, and high-quality execution.

The successful candidate will play a critical role in supporting compound and biological sample workflows, ensuring accurate tracking, storage, and distribution of materials that enable discovery and development programs.

Key responsibilities

• Execute core sample management activities, including sample receipt, accessioning, storage, tracking, retrieval, distribution, and disposal.

• Operate and maintain automated storage systems, LIMS, and supporting laboratory infrastructure.

• Perform routine quality control checks to ensure sample integrity, data accuracy, and system reliability.

• Accurately document all activities in LIMS and associated databases in compliance with SOPs and data integrity standards.

• Troubleshoot routine equipment or process issues and escalate complex problems as needed.

• Support implementation, maintenance, and continuous improvement of SOPs and best practices.

• Partner closely with cross-functional teams to ensure timely and accurate delivery of compounds and samples.

• Assist with onboarding of new technologies, automation platforms, and laboratory systems.

• Contribute to process improvement initiatives to enhance efficiency, scalability, and reliability of sample management workflows.

• Maintain laboratory organization, compliance, and operational readiness.

Required Skills, Experience and Education:

• BS or MS in chemistry, biology, engineering, or related scientific discipline.

• Typically 3+ years of relevant laboratory experience with increasing technical responsibility.

• Proven ability to independently execute and prioritize laboratory workflows.

• Experience troubleshooting laboratory equipment or operational processes.

• Demonstrated contributions to process optimization or workflow improvements.

• Strong commitment to data integrity and operational discipline.

• Clear written and verbal communication skills.

• Proficiency with standard laboratory software and data systems.

Preferred Skills:

• Experience supporting small-molecule drug discovery programs.

• Familiarity with automated compound/sample storage platforms.

• Exposure to laboratory automation systems.

• Experience with Cenevo’s Sample Management Software Mosaic.

• Experience contributing to continuous improvement initiatives.  

  #LI-Hybrid  #LI-LN1

The Opportunity:

Revolution Medicines is seeking a motivated individual to play a critical role in the payroll team. Reporting directly to the Associate Director, Payroll, this position requires a meticulous individual who thrives in a fast-paced environment and has experience in high-volume, deadline-driven payroll operations. This position will work closely with internal stakeholders and external vendors to drive impactful improvements within the Sr. Payroll Specialist area of focus.    

Key Responsibilities: 

• Perform accurate and timely semi-monthly payroll processing for US employees including special runs such as off-cycle processing using ADP Workforce Now.

• Work with the HR team regarding payroll related items such as benefit deductions, leave-of-absences, onboarding of new employees, termination of existing employees, and data validation in ADP.

• Serve as the primary point of contact for payroll-related inquiries and foster a collaborative and high-performance work environment with an open and two-way communication ambience.

• Assist with new state payroll tax registrations and ensure that Payroll is in compliance with federal, state, and local tax regulations, wage and hour laws and company policies.

• Analyze payroll data to identify trends, discrepancies and opportunity areas, and provide payroll reports as needed.

• Handle year-end processes including W2 preparation, process tax amendments and payroll reconciliations.

• Provide payroll information to auditors, tax firms, and internally as requested.

• Participate in process improvements and special projects as needed.

Required Skills, Experience and Education:

• Bachelor’s Degree in Finance, Accounting or Business with 7+ years of experience in payroll within a public company.

• Minimum 5+ years of recent hands-on experience with ADP Workforce Now.

• Working knowledge and deep understanding of the state and federal labor laws and regulations.

• Ability to work independently, protect and safeguard confidential information, great attention to detail, and able to adapt to changing priorities with a strong focus on quality and accountability.

• Strong project management skills with the ability to anticipate events, prioritize assignments, deal with interruptions, and meet deadlines in a fast-paced and growth-oriented environment.

Preferred Skills:

• Experience in Workday and global payroll.

• Proficient in Microsoft Office including advanced Excel skills with large amounts of data and pivot tables. 

  #LI-Hybrid #LI-TS1 

The Opportunity:

Revolution Medicines is seeking an experienced Travel & Expense professional to serve as a hands-on Operations Lead to support our expense management function. This role will take ownership of end-to-end T&E operations, with an initial focus on manual expense auditing and policy enforcement, and a longer-term focus on supporting automation and process optimization initiatives.

This is a highly independent, individual contributor role suited for someone who can operate with strong judgment, manage ambiguity, and drive consistency across a growing organization. Responsibilities include:

• Own day-to-day T&E operations, including end-to-end expense report review and audit.

• Perform high-volume audits of expense reports, ensuring compliance with company policies and regulatory requirements.

• Identify and resolve exceptions, enforce submission requirements, and follow up with employees as needed.

• Serve as a key point of contact for employee inquiries related to expenses, travel, and corporate cards.

• Partner cross-functionally with Finance, Payroll, and external vendors (e.g., Concur, travel management company).

• Support corporate card program administration, including troubleshooting, and user support.

• Monitor trends and identify opportunities for process improvement and standardization.

• Assist in the transition from manual audit processes to automated/AI-driven solutions, including testing and validation.

• Maintain documentation and ensure consistent application of policies and controls.

Required Skills, Experience and Education:

• Bachelor’s degree in Accounting, Finance, or a related field preferred, or equivalent relevant experience.

• 3–5+ years of experience in Travel & Expense or a related function.

• Strong experience with Concur T&E (required).

• Experience managing or supporting corporate card programs (preferred).

• Experience with Sunshine Act or Stark Law reporting (strongly preferred).

• Proficiency in Excel, including pivot tables, VLOOKUPs, and working with large datasets.

• Demonstrated ability to operate independently and manage end-to-end processes.

• Strong attention to detail with the ability to apply judgment in ambiguous situations. 

  #LI-Hybrid  #LI-YG1

The Opportunity:

Position requires 14+ years of Statistical Programming experience with exploratory-stage oncology clinical trials, providing programming support and oversight of one or more clinical programs (early or late phase) within Statistical Programming function. In addition to hands-on Programming, this position requires providing oversight and programming support and guidance for internal deliverables and regulatory submissions while ensuring conformance to CDISC standards and submission guidelines. Based on company needs, this position will be required to lead one or more early Phase or late phase studies/programs. Specific responsibilities include:

• Effective collaborating with cross functional teams to provide programming timelines for various deliverables.

• Provide SAS Programming technical support and guidance to programming team.

• Oversight/participation in any internal/mock or regulatory authority audits.

• Timeline and vendor management for deliverables, including submission-related activities,  complying with regulatory standards (e.g., FDA 21 CFR Part 11, GxP).

• Oversee the programming support for relevant deliverables, such as Investigator Brochures, publications, US and ex-US regulatory submissions, including CDISC compliant datasets (SDTM, ADaM) and data documentation, Reviewer’s Guide, TLFs, Statistical Analysis Plans (study specific, ISS, ISE, Exposure-Response), blank and annotated CRFs, and actual patient CRFs.

• Hands-on programming and management of in-house deliverables including but not limited to Dose Committee meetings, Board of Director meetings, Exploratory Analysis, etc.

• Oversight and Verification Review of documents, spreadsheets, slides for in-house presentations and external publications.

Titles may vary based on candidate experience.

Required Skills, Experience and Education:

• 14+ years of Statistical Programming experience with early or late phase oncology trial studies.

• BS/BA degree or other suitable qualification with relevance to the field.

• Experience leading one or more statistical programming contractors, and programming vendors.

• Proficiency in providing hands-on SAS Programming support for production or validation of analysis datasets, tables, listings and figures.

• Demonstrated ability to multi-task, prioritize options, anticipate challenges, and execute goals as a member of an interdisciplinary team is extremely important.

Preferred Skills:

• A demonstrable record of strong leadership and teamwork.

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

• Experience working in a small to mid sized biotech/pharma environment.

• Experience collaborating on development of processes, SOPs and guidance documents for the Statistical Programming function. 

  #LI-Hybrid  #LI-DN1

The Opportunity:

This is a unique opportunity for a Clinical Operations Professional. As a Clinical Program Manager (CPM), you will be responsible for acting as a central contact for the Clinical Study Team(s) and assist with the execution and management of Revolution Medicines (RevMed) clinical trials.

• Adhere to Clinical Standard Operating Procedures (SOP), Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) Guidelines.

• Be a team leader, providing guidance and oversight for the successful management of all aspects of clinical trials within timelines and designated program budgets.

• Partner with cross-functional teams to manage, adjust, and revise project timelines and budgets as needed.

• Analyze data health metrics to be shared with stakeholders.

• Actively partner with cross-functional teams and vendors to drive the query resolution and data listings review process to meet objectives in a timely and efficient process.

• Conduct risk management, contingency, and scenario planning.

• Supervise, communicate project status/issues, and problem solve to ensure project team goals are met.

• Participate in the development of all study-related documentation, including study protocols.

• Actively contributes in the selection and management of contract research organizations (CROs) and/or vendors, including development of requests for proposals (RFPs).

• Use all available tools to track, oversee, and communicate on program status to all key stakeholders.

• Participate in other Clinical Operations activities as appropriate.

• Leads a larger, more complex trial with some oversight from senior members of Clinical Operations.

• With minimal support, lead cross-functional Clinical Study Execution Team (CSETs).

• Participate in and contribute to SOP development, implementation, and training.

• Support junior team members through mentorship.

Required Skills, Experience and Education:

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

• 8+ years direct Clinical Operations experience in the pharmaceutical or biotech industry, preferably in Clinical Operations or Clinical Research-related experience. Relevant indirect experiences may also meet the requirement.

• Minimum of 4 years of cross-functional study management or related leadership experience in life sciences, including multiple years’ experience managing project teams.

• Strong working knowledge of FDA Regulations, ICH Guidelines, and GCP.

• Proven ability to successfully start-up, manage, and close-out clinical trials, including authoring clinical study and regulatory documentation and SOPs.

• Experience in selection of CROs/vendors and management of external resources.

• Thrives in a collaborative team setting that demonstrates flexibility required to maintain a fast pace and is driven by a desire to deploy innovative approaches and technologies in a high-energy environment.

• Be solution-oriented by anticipating obstacles and difficulties, and proactively providing risk assessment and mitigation strategies to achieve project goals.

• Excellent written/verbal communication and interpersonal skills.

• High sense of priority and commitment to excellence in the successful execution of deliverables.

• Ability to analyze operational data, contribute with a mind on quality, timeliness and fiscal responsibility, make and drive decisions, multi-task, prioritize tasks, anticipate challenges, and execute on goals as a member of an interdisciplinary team.

• Demonstrate proficiency in Microsoft Office Suite (Outlook, MS Word, Excel, PowerPoint); MS Project and/or Smartsheet a plus.

• Travel may be required (~25%).

Preferred Skills:

• Familiarity working with vendor systems/portals (e.g., eTMF, EDC, IRT, CTMS).

• Oncology experience, early and/or late stage, strongly preferred.

• Knowledge and/or familiarity with Ex-US region(s) clinical trial operations.

• Some experience mentoring jr staff. 

  #LI-Hybrid  #LI-DN1

The Opportunity:

This role represents a unique opportunity to serve as a senior scientific and strategic leader within Cancer Immunology, with primary responsibility for driving the discovery and advancement of novel immuno-oncology targets and therapeutic modalities. We are seeking an accomplished leader who combines deep scientific expertise with strong people leadership to shape strategy, guide portfolio decisions, and advance high-impact discovery programs.

The successful candidate will lead a multidisciplinary team to progress innovative immuno-oncology programs from early discovery through Development Candidate nomination, while providing senior oversight of scientific integration across Discovery and Translational Cancer Immunology. This role reports to the Vice President and Head of Cancer Immunology and partners closely with Research and Development leadership to support portfolio prioritization and governance. Key aspects of the role include:

• Discovery Program Leadership & Protfolio Oversight: Provide executive-level leadership of Cancer Immunology discovery programs from project qualification through Development Candidate nomination. Drive the identification and validation of novel immuno-oncology targets, ensuring seamless progression of programs into Translational Cancer Immunology.

• Scientific Strategy & Platform Leadership: Define and evolve the scientific vision and long-term strategy for Cancer Immunology discovery. Provide senior oversight of the development and optimization of experimental platforms, including in vitro and in vivo models, phenotypic screening, and advanced assay toolkits. Champion the exploration and implementation of new therapeutic modalities, such as TCEs, ADCs, and bispecifics.

• Scientific Integration & Operational Excellence: Provide senior oversight of scientific integration across Discovery and Translational Cancer Immunology, ensuring operational rigor, platform support, and alignment of resources. Leverage enabling functions and data-driven insights to enhance experimental design, reproducibility, and program execution. Promote the development and deployment of modern data systems and analytics to advance scientific and operational excellence, enabling the establishment of a digitally empowered Cancer Immunology team within the broader organization.

• Cross-functional Collaboration: Act as a key partner to Research Leadership to support advancement of programs from early discovery into the clinical development portfolio. Foster collaboration across multidisciplinary teams to ensure that discovery efforts, platform capabilities including data platforms, and translational priorities are coordinated and integrated.

• Team Leadership & Mentorship: Lead, mentor, and inspire a multidisciplinary team of PhD and non-PhD scientists. Cultivate a culture of scientific excellence, innovation, and collaboration.

• External Engagement: Spearhead collaborations with academic partners and external organizations. Partner with key stakeholders to define publication strategies and support advancement of the company’s scientific reputation in the field.

Required Skills, Experience, and Education:

• Education & Scientific Expertise: Ph.D. in immunology, cancer biology, or a related discipline, with deep expertise in tumor immunology, immune-evasive oncogenic signaling pathways, and/or immunotherapy. Demonstrated track record of excellence in research, evidenced by high-impact publications.

• Industry Experience: 20+ years of post-PhD experience in biomedical research and oncology drug discovery, including substantial experience in biotech or pharmaceutical settings. Demonstrated leadership in oncology drug discovery and development, including experience with antibody-directed therapies such as T cell engagers, ADCs, or bispecific antibodies, is required. Experience setting early discovery strategy is highly desirable.

• Senior Leadership & Organizational Impact: Proven ability to lead complex, multidisciplinary organizations and influence across functions and levels. Demonstrated experience in portfolio decision-making, program governance, and developing scientific leaders.

• Strategic & Analytical Thinking: Enterprise-level strategic thinker capable of prioritizing initiatives, anticipating challenges, and executing effectively in a dynamic, high-energy environment. Rigorous, quantitative, and detail-oriented experimentalist.

• Collaboration & Communication: Thrives in a collaborative, interdisciplinary team setting. Excellent written and verbal communication skills, with the ability to influence and align diverse stakeholders.

Preferred Skills:

• Experience with chemistry-based therapies, including small molecules or ADC payloads.

• Familiarity with bioinformatics-driven discovery and integrating computational insights into experimental design.

• Demonstrated proficiency with modern data platforms, machine learning approaches, and advanced analytics to support Cancer Immunology research and decision-making.

• Prior experience as a Program Team Leader, with a track record of driving cross-functional strategy and execution across discovery and development stages.

 #LI-Hybrid  #LI-LN1

The Opportunity:

Revolution Medicines is seeking an Associate Director, Clinical Quality Assurance, who will play a key role within Quality Assurance and is responsible for providing leadership and compliance support for RevMed sponsored clinical trials with respect to RevMed’s Standard Operating Procedures, applicable regulatory requirements (FDA, EU, ICH & country-specific), and current industry standards and practices.

• Support the development and maintenance of applicable Quality Systems and procedures that comply with applicable GCP standards and guidelines.

• Collaborate with clinical functions (e.g., Clinical Operations, Clinical Development) to provide GCP compliance support.

• Participate in clinical study execution teams (CSETs) to enable risk-based quality management and a culture of quality and open dialogue.

• Perform quality review of clinical trial documents with a focus on compliance / regulatory requirements and risk management.

• Collaborate with internal stakeholders, external auditors, and auditees to support the planning, preparation, conduct, reporting, and closure of GCP audits.

• Provide risk-based quality oversight for clinical trial activities and perform routine clinical vendor assessments.

• Provide support for Inspection Readiness activities (e.g., TMF activities, study documentation).

• Assess and coordinate activities relevant to potential quality issues associated with GCP and clinical trial conduct including but not limited to investigations, and root cause analysis, CAPA planning and management.

• Escalate identified issues to QA Management and other relevant leadership as needed in a timely manner.

• Enable other assigned GCP or GXP related tasks, as appropriate.

• Support GCP audits and inspections of RevMed, Vendors, and clinical investigator sites by regulatory authorities or business partners.

• Build positive professional relationships and trust to support learning, respect, open communication, collaboration, and teamwork.

Required Skills, Experience and Education:

• Bachelor’s degree in scientific or technical discipline.

• A minimum of 10+ years of experience in GCP Quality in the pharmaceutical or biotechnology industry.

• 8 years in any of the following areas: audit or audit management experience, inspection readiness, Deviation/CAPA management, or related quality management system responsibilities.

• Extensive knowledge of ICH GCP, other relevant ICH guidelines and regulatory requirements (minimally US FDA) regarding applicable drug development regulations.

• Effective communication (verbal and written).

• Ability to build and sustain positive relationships with GxP colleagues, internal stakeholders, and external partners.

• Ability to create innovative solutions to problems, while integrating stakeholder input and feedback.

• Ability to critically evaluate and troubleshoot complex problems with diligence.

• Ability to manage multiple priorities and aggressive timelines.

• Highly responsible, self-motivated professional with enthusiasm and passion for the work.

• Highly proficient with various Microsoft and other computerized systems (e.g., Word, Outlook, Excel, PowerPoint, Visio, etc.).

Preferred Skills:

• Good knowledge of Computer System Validation. 

  #LI-Hybrid #LI-JC1

The Opportunity:

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

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

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

System Configuration & Administration

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

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

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

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

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

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

Data Quality & Reporting Support

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

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

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

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

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

Operational Support & Collaboration

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

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

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

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

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

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

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

Compliance & Inspection Readiness

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

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

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

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

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

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

Required Skills, Experience and Education:

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

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

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

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

Core Competencies

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

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

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

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

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

• Foster a structured and efficient work environment.

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

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

Preferred Skills:

• Degree in computer science or related field preferred.

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

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

  #LI-Hybrid  #LI-SH1

The Opportunity:

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

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

Key Responsibilities:

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

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

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

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

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

• Trial Master File (TMF) quality and inspection readiness

• GxP computerized systems and data integrity controls

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

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

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

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

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

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

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

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

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

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

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

Required Skills, Experience and Education:

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

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

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

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

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

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

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

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

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

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

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

Preferred Skills:

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

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

  #LI-Hybrid  #LI-GL1

The Opportunity:

The DMPK Scientist will be a key member of the Drug Metabolism and Pharmacokinetics (DMPK) team within the Nonclinical Development and Clinical Pharmacology (NDCP) department.

Specifically, you will:

• Design and execute in vitro and in vivo metabolite identification studies using liver microsomes, hepatocytes, recombinant enzymes, and biological samples (blood, plasma, tissue, urine, bile, etc.), and perform metabolite profiling and structural elucidation.

• Characterize major, unique, or disproportionate metabolites to support candidate selection, MIST (Metabolites in Safety Testing) analysis, and metabolite regulatory strategy.

• Design and perform mechanistic studies to understand metabolic pathways and enzyme kinetics; work with pharmaceutical product teams to characterize drug degradation products and impurities.

• Author and review DMPK sections of regulatory submissions and respond to questions from regulatory agencies.

• Build and maintain strong collaborative partnerships across functional areas, e.g., Discovery research, Clinical Pharmacology, Medicinal Chemistry, Pharmaceutical Development, Toxicology, and Translational Research.

Required Skills, Experience and Education:

• A highly motivated individual with a PhD in Pharmaceutical Sciences, Chemistry, Biochemistry, or related field, with 3+ years of experience after graduation.

• Demonstrated hands-on experience in metabolite profiling using high resolution mass spectrometry.

• Solid understanding of drug metabolism, pharmacokinetics, and ADME principles.

• Demonstrated hands-on experience in using PK software (e.g. WinNonlin).

• Excellent verbal and written communication, problem-solving and critical thinking skills.

• Ability to independently design experiments, analyze data, and communicate results.

Preferred Skills:

• Prior experience with oncology drug discovery is preferred.

• Previous experience with PBPK modeling and DDI risk assessment is preferred.

• Effective communication and documentation skills.

#LI-Hybrid #LI-CT1

The Opportunity:

We are seeking an experienced and strategic leader to serve as Director, Information Sciences Governance, Risk & Compliance (IS GRC), reporting directly to the VP, IS Security, Risk, and Compliance. This person will be responsible for leading and maturing the IS GRC program, ensuring that IS governance processes, technology risk management practices, third-party risk management, and compliance activities effectively support business objectives and protect the organization.

As a key leader within Information Sciences, this individual will partner closely with Security, Infrastructure, Enterprise Applications, Data & Analytics, Legal, Privacy, Quality, Finance, HR, Procurement, and other cross-functional stakeholders to establish a scalable and pragmatic IS GRC framework. They will help the organization navigate a dynamic regulatory, technology, and business environment by strengthening controls, driving compliance readiness, improving risk visibility, managing third-party risk, and enabling informed decision-making across IS.

This role is ideal for a leader who can balance strategic program development with operational execution, build trusted partnerships across the organization, and translate regulatory, technical, and control requirements into practical processes that enable the business.

Key Responsibilities:

• IS GRC Program Leadership: Lead and evolve the Information Sciences Governance, Risk & Compliance program, including policies, standards, risk frameworks, compliance processes, and reporting.

• IS Governance: Develop, implement, and maintain governance structures, policies, standards, and procedures to support IS objectives, regulatory obligations, and internal accountability.

• Technology Risk Management: Establish and manage processes to identify, assess, prioritize, track, and report key IS, cybersecurity, data, third-party, and operational risks. Partner with stakeholders to develop mitigation and remediation plans.

• Third-Party Risk Management: Lead and mature the third-party risk management program for Information Sciences, including risk assessment and oversight of vendors, service providers, and technology partners. Partner with Procurement, Legal, Security, Privacy, and business stakeholders to evaluate third-party controls, contractual requirements, and remediation plans to ensure third-party services meet company risk and compliance expectations.

• Compliance Management: Oversee IS compliance initiatives related to applicable laws, regulations, contractual obligations, and internal policies. Coordinate control assessments, compliance reviews, and readiness efforts for audits and inspections.

• Internal Controls: Partner with IS and business teams to design, document, evaluate, and improve IT and IS-related controls and monitor their effectiveness over time.

• Policy and Standards Management: Drive the development, review, communication, and maintenance of IS policies, standards, baselines, and related procedures to ensure consistency, usability, and alignment with company requirements.

• Audit and Assessment Support: Coordinate and support internal and external audits, risk assessments, and evidence requests related to Information Sciences systems, processes, and controls. Track observations and corrective actions through closure.

• Cross-Functional Partnership: Build strong relationships across the business to understand technology risks, compliance obligations, and operational challenges, and to promote a culture of accountability and continuous improvement.

• Metrics and Reporting: Develop meaningful dashboards, metrics, and executive reporting to communicate IS program health, compliance posture, risk trends, and remediation progress to senior leadership.

• Training and Awareness: Promote awareness of IS governance, risk, and compliance responsibilities across Information Sciences and the broader organization through communication, training, and stakeholder engagement.

• Continuous Improvement: Stay informed about emerging regulations, industry trends, and best practices in IT/IS governance, cybersecurity compliance, privacy, and risk management, and incorporate them into program enhancements.

• This person will also coordinate with existing service delivery teams in Information Sciences to ensure that high levels of service and support are maintained.

Required Skills, Experience and Education:

• Bachelor’s degree or equivalent and a minimum of 10+ years of experience in Information Technology, Information Sciences, governance, risk management, compliance, internal audit, cybersecurity compliance, or related functions, including leadership experience in a regulated industry.

• Proven track record of building, managing, and scaling IS or IT GRC programs in complex organizations.

• Experience partnering across IS, security, legal, privacy, quality, procurement, finance, and business teams to drive risk-informed and compliant technology practices.

• Strong understanding of IT governance, technology risk management, internal controls, policy management, third-party risk management, and compliance operations.

• Experience working in regulated environments and with relevant frameworks and requirements such as SOX, GxP, GDPR/CCPA, ISO 27001, HITRUST, cybersecurity, privacy, IT general controls, vendor risk management, and audit readiness, as applicable.

• Experience supporting or leading control design, risk assessments, remediation activities, and audit or certification readiness efforts related to ISO 27001, HITRUST, or other relevant compliance frameworks.

• Ability to translate regulatory, audit, and control requirements into practical, business friendly IS processes, standards, and guidance.

• Entrepreneurial spirit; thrives in a fast-paced, high-growth, midsize company environment.

• Comfortable handling ambiguity and navigating through evolving processes, priorities, and organizational needs.

• Highly organized, with strong attention to detail and accuracy.

• Committed to meeting and exceeding high standards for quality and continuous improvement.

• Builds rapport and credibility as an effective strategic partner.

• Fosters team collaboration, breaks down silos, and is able to influence without authority.

• Skilled at conflict resolution, negotiation, and driving alignment across diverse stakeholder groups.

• Acts with urgency and sound judgment. Enjoys enabling others and solving complex problems.

• Ability to manage multiple initiatives, activities, and priorities simultaneously and autonomously.

• Strong written and verbal communication, presentation, and facilitation skills, with the ability to distill complex information for senior leadership.

Preferred Skills:

• Master’s degree or equivalent in Information Technology, Business, Risk Management, Cybersecurity, or a related field.

• Relevant certifications such as CISA, CISM, CRISC, CISSP, CGEIT, ISO 27001 Lead Implementer, ISO 27001 Lead Auditor, HITRUST CCSFP, or similar are preferred.

• Experience leading or supporting ISO 27001 and/or HITRUST implementation, certification, surveillance, or readiness programs is strongly preferred.

• Experience leading or supporting IT/IS governance, cybersecurity compliance, privacy, audit, or risk programs in the pharmaceutical, biotechnology, life sciences, or other highly regulated industries.

• Experience with third-party risk management, policy governance platforms, GRC tooling, control automation, and audit management solutions is a plus.

• Experience developing and operationalizing IS policies, standards, procedures, and control frameworks across enterprise applications, infrastructure, cloud environments, and data platforms is desirable.

• Experience developing executive-level reporting and dashboards for IT or IS risk and compliance programs is desirable.

• Experience standing up or maturing enterprise IT governance, security governance, third-party risk management, or technology compliance monitoring programs is a plus.

• Experience working with cross-functional stakeholders to align security, privacy, compliance, and business requirements into scalable operational processes is preferred. 

  #LI-Hybrid  #LI-YG1

The Opportunity:

Discovery Sciences & Technologies is an integrated functional discovery team that supports a growing oncology and immuno-oncology portfolio. This role is for an experienced drug discovery scientist who can provide hands-on scientific and people leadership across functional discovery, cell-based assays, and screening strategies from hit identification through progression. The position sits at the intersection of assay development, screening, and multiparametric data analysis, translating molecular perturbations into actionable biological insight to enable data-driven target and program decisions. In this role you will:

• Be a key contributor to discovery project teams, partnering closely with Medicinal Chemistry, Structural Biology, Discovery Biology, Screening, and other functions to drive progression from hit identification through lead generation.

• Design and execute predictive screening strategies linking small-molecule perturbation to mechanistic pathway modulation and functional cellular outcomes.

• Provide hands-on scientific leadership across functional discovery and cell-based screening, spanning assay development, cellular target engagement, hit discovery and follow-up, with direct contribution to the development, optimization, and interpretation of biochemical, biophysical, and cellular assays including in vitro pharmacology.

• Lead efforts to generate and interpret multiparametric and multi-modal biological data sets (e.g., imaging, transcriptomics, other complex cellular readouts) to drive actionable insights.

• Partner cross-functionally to align experimental strategy, prioritization, and execution.

• Mentor and develop scientists through hands-on technical guidance, coaching, and feedback, strengthening experimental rigor, scientific judgment, and team impact.

Required Skills, Experience and Education:

• PhD in pharmacology, cell-biology, biochemistry, or a related scientific discipline.

• Minimum of 10 years of industry experience in early-stage drug discovery.

• Demonstrated breadth of experience across multiple stages of discovery with substantial experience in early stages including target identification and validation, hit discovery, hit follow-up and lead generation.

• Experience integrating in vitro biochemical, biophysical, and cellular data to develop mechanistic understanding and inform project decisions.

• Track record of participating on cross-functional project teams in a matrixed discovery environment as a leader and as a contributor.

• Strong experimental design, data interpretation, and problem-solving skills.

• Experience managing scientific teams and demonstrated ability to mentor and develop scientists through technical leadership and scientific coaching.

• Excellent communication skills and ability to influence across disciplines.

Preferred Skills:

• Experience with multiparametric or high-content cellular assays, including imaging-based approaches.

• Familiarity with multi-omics data (e.g., transcriptomics) and their application in early discovery.

• Experience partnering with Advanced Analytics, Systems Biology, or Computational Biology and AI/ML teams.

• Experience contributing to go/no-go decisions at project or portfolio review stages

• Familiarity with oncology drug discovery. #LI-Hybrid  #LI-LN1

The Opportunity:

This role will be critical in ensuring operational excellence, cross-functional coordination, and launch readiness via project and program leadership of the Global Medical Affairs Team (GMAT) for one or more programs.  The Medical Project Manager (MPM) serves as a strategic partner to the Medical Strategic Leader of the disease area while serving as the primary cross-functional operational contact and liaison for the assigned program (s) and teams for effective alignment, communication flow, and governance within Medical Affairs while also enhancing integration with product team (PT), development, commercial/brand teams.  This role will lead annual medical planning, budget planning and management, to support seamless execution and a unified view of the GMAT.  

As a senior member of the Medical Operations function, the Director will serve as a central point of contact for program planning, delivery, and governance of critical Medical Affairs projects—spanning scientific communications, congress strategy, advisory boards, medical education, and post-marketing data generation.

Key responsibilities include:

Strategic Program and Project Leadership

• Lead cross-functional medical planning and execution for launch readiness, integrated evidence generation plans, scientific platform development, and field medical enablement.

• Define and oversee medical workstreams for new product launches, indication expansions, and lifecycle management.

• Serve as program lead for cross-functional medical workstreams, ensuring strategic alignment with Medical Affairs, Clinical Development, Regulatory, and Commercial goals.

Program Oversight & Governance

• Establish and maintain program-level dashboards, KPIs, and governance frameworks to monitor progress, identify risks, and drive accountability.

• Facilitate strategic reviews, cross-functional planning meetings, and Medical Affairs quarterly business reviews.

Cross-functional Collaboration

• Partner closely with leaders in Field Medical, Medical Communications, Medical Information, HEOR, and Clinical Operations to ensure unified execution and prioritization.

• Act as a trusted advisor to Medical Strategic Lead in shaping strategy, resourcing, and long-range planning.

Operational Infrastructure & Process Excellence

• Drive the evolution of Medical Affairs operations through process optimization, SOP development, and adoption of best practices.

• Champion the implementation of medical planning tools and platforms, including Veeva Medical, Smartsheet, publication planning tools, and project dashboards.

Congress & External Engagement Readiness

• Lead project management to support operational planning for major scientific congresses (e.g., ASCO, ESMO, AACR), including alignment across abstracts, symposia, and booth activities.

• Oversee project management supporting coordination and execution of high-impact stakeholder engagements (ad boards, medical education programs, scientific exchange events).

Team Leadership & Vendor Management

• Provide strategic oversight to project managers and contractors supporting Medical Affairs initiatives.

• Manage relationships with key vendors and external partners to ensure high-quality, on-time, and on-budget delivery.

The position responsibilities are not limited to the above and might change as the team’s needs evolve.

Required Skills, Experience and Education:

• Bachelor’s (BS) degree required; advanced degree (MS, MBA, PharmD, PhD) or PMP certification preferred.

• 15+ years of experience in biotechnology or pharmaceutical industry (with BS), 13+ years (with MS) or 11+ years (with PharmD/PhD), including 8+ years in Medical Affairs or biotechnology project or program management roles.

• Strong understanding of the Medical Affairs function, including scientific communications, MSL engagement, medical congresses, and data dissemination.

• Proven track record of leading large, cross-functional initiatives with significant visibility and complexity.

• Highly skilled in influencing without authority, driving alignment, and fostering collaboration across functions and leadership levels.

• Expertise in project governance, planning tools and operational frameworks.

• Experience in oncology or precision medicine highly preferred.

• Ability to work in fast-paced, matrixed environments and lead cross-functional initiatives.

• Strong project management skills to oversee multiple priorities, timelines, and stakeholders effectively.

• Excellent communication, interpersonal, and presentation skills to engage internal and external stakeholders effectively.

Preferred Skills:

• Experience in precision oncology and targeted therapies.

• Previous leadership in launch planning and medical communications/publications strategy.

• Familiarity with digital tools and innovative solutions for medical communication. 

  #LI-Hybrid  #LI-YG1

The Opportunity:

RevMed is seeking an experienced Senior Corporate Paralegal to support the Company’s public company reporting and corporate governance functions. This role will play a critical part in managing SEC reporting processes, Board and committee governance operations, securities law compliance administration, and entity management activities.

The Senior Corporate Paralegal will report to the Senior Director, Corporate Disclosure & Governance and will work closely with Legal, Finance, Investor Relations, and external advisors. The ideal candidate brings deep public company experience, strong drafting and document management skills, and the ability to operate effectively in a fast-paced, highly regulated environment. Responsibilities include:

SEC Reporting & Disclosure

• Support preparation and coordination of SEC filings, including Forms 10-K, 10-Q, 8-K, proxy statements, and Section 16 filings.

• Assist with drafting, formatting, proofing, and assembling disclosure documents and exhibits.

• Partner closely with Finance during quarterly and annual reporting cycles to manage timelines, document flow, tie-outs, and version control.

• Coordinate EDGAR filings and filing logistics, including signature pages and exhibit management.

• Maintain reporting calendars and track disclosure deliverables to ensure timely and accurate filings.

• Monitor and maintain documentation supporting disclosure controls and procedures.

Corporate Governance & Board Support

• Support Board of Directors and committee operations, including preparation and organization of governance materials and records.

• Maintain corporate governance documents, including committee charters, corporate governance guidelines, and related policies.

• Prepare and maintain Board and committee resolutions, minutes, and action records.

• Support annual meeting preparation and proxy-related documentation.

• Ensure corporate records and minute books are organized, complete, and audit-ready.

Securities Compliance & Insider Trading Administration

• Assist with administration of insider trading compliance processes, including trading window communications and pre-clearance tracking.

• Support documentation related to Rule 10b5-1 plans and Section 16 reporting.

• Coordinate compliance-related communications and documentation as needed.

Entity Management

• Maintain subsidiary and entity records, including officer and director information and annual compliance filings.

• Coordinate with external service providers to ensure timely and accurate entity maintenance.

• Support documentation and recordkeeping related to intercompany governance matters.

Process & Operational Support

• Develop and improve templates, checklists, and workflows to enhance efficiency and consistency.

• Maintain organized electronic and physical filing systems to support audits, diligence, and regulatory inquiries.

• Contribute to the continued scaling of disclosure and governance infrastructure as the Company grows.

Required Skills, Experience and Education:

• Bachelor’s degree.

• 10+ years of experience as a corporate or securities paralegal.

• Significant experience supporting a publicly traded company is required.

• Demonstrated experience supporting SEC reporting processes and Board governance functions.

• Strong knowledge of public company reporting cycles and securities compliance administration.

• Exceptional organizational skills and attention to detail.

• Demonstrated ability to manage multiple deadlines and high-volume documentation in a fast-paced environment.

• Strong written and verbal communication skills.

Preferred Skills:

• Life sciences, biotech, or other highly regulated industry experience.

• paralegal certificate

• Experience supporting proxy statement preparation and annual meeting processes.

• Familiarity with EDGAR filing processes and disclosure management systems, including active disclosure.

• Experience partnering cross-functionally with Finance teams in a public company setting. 

  #LI-Hybrid  #LI-YG1

The Opportunity:

This is a unique opportunity for a Clinical Operations Professional who has innate leadership and organizational skills, technical expertise in clinical drug development in an industry setting and a drive to promote excellence. As an Associate Director (AD) Clinical Operations Enablement & Knowledge Systems, you will be a key member of the Clinical Operations Excellence team. You will be responsible for building and scaling the Clinical Operations “knowledge ecosystem”—including how information is structured, accessed, and applied—to enable consistent, efficient, and high-quality study execution across roles and programs. This is an execution-focused role that strengthens the capabilities of the Clinical Operations organization.

• The ideal candidate is a Clinical Operations leader who combines deep study execution experience with the ability to design scalable, user-centered systems that enable others to perform at their best.

• Lead the design and deployment of a scalable Clinical Operations knowledge ecosystem, including playbooks, toolkits and structured resources that enable consistent high quality study execution.

• Develop role-based enablement frameworks aligned to Clinical Operations responsibilities, study activities, and key transition points.

• Design and deliver multi-modal learning solutions (e.g., live sessions, on-demand modules, short-form videos, playbooks, and interactive resources) to maximize accessibility and adoption.

• Apply adult learning principles and user-centered design to ensure content is practical, engaging, and immediately applicable.

• Apply knowledge of Clinical Operations workflows and regulatory context (e.g., GCP, ICH) to ensure learning content is relevant, practical, and aligned with real-world study execution (this role does not own SOP development, GxP training, or inspection readiness activities).

• Support the successful onboarding of new Clinical Operations team members.

• Design and deliver targeted, “just-in-time” learning tools and experiences (e.g., checklists, quick guides, decision aids) to support critical activities and study milestones.

• Align learning and knowledge resources to key study lifecycle stages (e.g., study start-up, conduct, database lock, close-out).

• Define and implement a scalable structure for Clinical Operations knowledge, including how resources, tools, and guidance is organized, accessed, and maintained.

• Create intuitive, role-based pathways for accessing information across study lifecycle stages.

• Establish standards for maintaining and continuously improving operational knowledge.

• Own day-to-day planning, coordination, and delivery of learning activities, ensuring timeline, quality and outcomes are met.

• Track adoption, effectiveness and impact of learning and knowledge initiatives.

• Use feedback and performance insights to identify capability gaps and continuously improve tools, resources, and learning solutions.

• Evolve learning materials and resources to maintain alignment with Clinical Operations and cross-functional partner growth and needs.

• Partner with Clinical Operations and cross-functional team members to improve processes that will impact clinical trial management, quality and efficiency.

• Line management responsibilities including hiring, performance management, career development, and mentorship.

• This role does not own SOP authoring, GxP training delivery, or inspection readiness activities, but partners with relevant functions to ensure alignment.

• Participate in other Clinical Operations Excellence and Clinical Operations Activities as appropriate.

Required Skills, Experience and Education:

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

• 11+ years direct Clinical Operations experience in the pharmaceutical or biotech industry, Relevant indirect experiences may also meet the requirement.

• Minimum of 5 years of line management experience.

• Strong working knowledge of FDA Regulations, ICH Guidelines, and GCP.

• Demonstrated experience successfully developing and authoring Clinical Operations and cross-functional handbooks, guidances or process templates in support of clinical operations or clinical study team management.

• Experience with leading organizational change efforts.

• Minimum of 6 years of cross-functional study management or related leadership experience in life sciences.

• Demonstrated experience building or scaling learning programs, knowledge systems, or operational frameworks within Clinical Operations.

• Experience translating complex clinical workflows into practical tools, guidance, or training materials.

• Strong systems thinking and ability to design scalable, user-friendly solutions.

• Experience in selection and management of external resources (e.g., CROs, vendors, contractors).

• Thrives in a collaborative team setting that demonstrates flexibility required to maintain a fast pace and is driven by a desire to deploy innovative approaches and technologies in a high-energy environment.

• Be solution-oriented by anticipating obstacles and difficulties, and proactively providing risk assessment and mitigation strategies to achieve project goals.

• Ability to deal with time demands, incomplete information, or unexpected events.

• Outstanding organizational skills with the ability to multi-task and prioritize.

• Excellent interpersonal, verbal and written communication skills.

• High sense of priority and commitment to excellence in the successful execution of deliverables.

• Ability to contribute with a mind on quality, diligence, timeliness and fiscal responsibility, make and drive decisions, multi-task, prioritize tasks, anticipate challenges, and execute on goals as a member of the Clinical Operations Excellence team.

• Decision-making skills.

• Comfortable in a fast-paced company environment and able to adjust workload based upon changing priorities.

• Demonstrate proficiency in Microsoft Office Suite (Outlook, MS Word, Excel, PowerPoint); MS Project and/or Smartsheet a plus.

• Travel may be required (~25%).

Preferred Skills:

• Experience deploying AI-enabled solutions to support Clinical Operations activities.

• Familiarity working with in-house or vendor systems/portals (e.g., eTMF, EDC, IRT, CTMS).

• Oncology experience, early and/or late stage, strongly preferred.

• Experience in start-up, management, and close-out of clinical trials, including authoring clinical study and regulatory documentation.

• Knowledge and/or familiarity with Ex-US region(s) clinical trial operations. 

  #LI-Hybrid  #LI-DN1

The Opportunity:

• The Associate Director (AD) Good Laboratory Practice Quality Assurance (GLP QA) is responsible for ensuring Good Laboratory Practices (GLP) compliance at RevMed and external vendors contracted to perform regulated work on behalf of RevMed including all GLP vendors.

• The AD GLP QA responsibilities include for research laboratory vendors that perform work to support regulated clinical studies.

• The AD GLP QA develops the annual vendor audit plan.

• The AD GLP QA performs and/or manages vendor audits including:

  • Development of the audit plan, audit conduct, and reporting

  • Tracking and coordination of audit closure tasks including review of observation responses from vendor(s) in conjunction with operational subject matter experts (SMEs), as applicable.

  • Provision of vendor approval recommendations

  • Maintenance of vendor approval status in Veeva.

• The AD GLP QA performs or participates in internal audits.

• The AD GLP QA provides QA review of CRO study protocols and reports for compliance utilizing a risk-based approach, as needed and serves as an advisor to the Nonclinical Development and Clinical Pharmacology (NDCP) to resolve compliance issues.

• The AD GLP QA monitors vendor QA units for compliance with applicable regulations including review of vendor study specific QA audit reports.

• The AD GLP QA advises Sponsor(s) on compliance requirements for test and control article used in GLP studies.

• The AD GLP QA liaises and/or consults with GLP vendor QA departments on study-related issues such as deviations, investigations, CAPAs and other compliance issues.

• The AD GLP QA provides annual GLP training or liaises with an external trainer to provide GLP training to RevMed functional team(s).

• The AD GLP QA attends functional area meetings (e.g., NDCP and Biomarker group) to discuss and review new or on-going issues, projects, and/or studies.

• The AD GLP QA works with QA management for resource planning, as needed.

• The AD GLP QA attends periodic clinical QA group meetings, as needed.

• The AD GLP QA provides periodic quality and compliance updates to QA management.

• The AD GLP QA develops/prepares standard operating procedure (SOPs) content to GLP audits, and reviews functional area and QA SOPs for GLP compliance.

• The AD GLP QA provides consultative QA guidance for computerized system vendors (and systems) supporting GLP studies.

Required Skills, Experience and Education:

• Bachelor’s or Master’s Degree.

• 12+ years of experience in global Good Laboratory Practice (GLP) Quality Assurance (QA).

• Extensive audit and inspection management experience.

Preferred Skills:

• Registered Quality Assurance Professional – Good Laboratory Practice (RQAP-GLP).

• Planning and scheduling expertise.

• Experienced in effective prioritization of competing initiatives and tasks across multiple projects.

• Ability to communicate effectively with senior leadership, management and cross functional teams.

• Ability to manage workstreams to maintain delivery timelines through disciplined planning, tracking and follow-up.

• Ability to balance detail-oriented execution with strategic oversight.

• Experienced with the proactive identification, assessment and mitigation of risks and with timely issue escalation, as applicable.

• Regulatory expertise with at least the following regulations and guidance:

  • 21CFR Part 58 Good Laboratory Practice

  • 21 CFR Part 11 Electronic Records; Electronic Signatures

  • OECD #1 – 24 Standards and Advisory Documents on Good Laboratory Practices

  • ICH E6 (R2 and R3) Good Clinical Practices

  • Japanese Ministry of Health Labor and Welfare (MHLW) – Good Laboratory Practice

  • Applicable US and EU guidance documents including bioanalytical, in vitro and in vivo genetic, Phototox, and hERG toxicology studies

• Experience with the following audit types.

• Testing facilities.

• Bioanalytical and PK data analysis Labs.

• hERG and Phototoxicity testing facilities.

• Archives – biorepositories, paper and electronic data storage.

• Computer Systems Validation.

• Biomarker Labs (including Artificial Intelligence and Machine Learning).

• Central Laboratories. 

  #LI-Hybrid #LI-JC1

The Opportunity:

We are seeking a highly motivated individual eager to develop their program management skills. This position reports to the Business Operation Team, which is part of the Program Management Group.

As a Project Coordinator, you will work closely with various members of the Business Operation team and cross-functional leaders to support departmental and project goals. You are able to “roll up your sleeves” and thrive in a fast-paced, highly cross-functional environment. You have a desire to streamline and organize project work and build dashboard and report that enables decision making. You enjoy working in a collaborative setting and strive to bring out the best of your teammates.

Activities as part of your typical day may include:

• Working with project managers to create integrated project plans with established goals, milestones, and timelines. In doing so, you will develop and expand your competencies with program management processes and tools.

• In working with program teams, you will gain depth of understanding drug development processes and the approaches critical to effectively advance programs to key milestones.

• Building interpersonal skills to enhance your ability to positively influence the performance of the teams your support.

• Fostering an open, inclusive, and collaborative culture with a focus on shared learnings within the Program Management group.

Required Skils, Experience and Education:

• B.A. or BSc. in Life Sciences with 2-3 years’ experience in a scientific or similarly related field.

• Demonstrated willingness to live by the RVMD Core Values and excitement about our mission.

• Excellent verbal and written communication skills.

• Strong interest in learning and developing professional skills.

• Quick study, able to grasp concepts and apply to related areas.

• Highly organized, have strong interpersonal skills, and is detailed oriented.

• Ability to prioritize key scientific questions and relevant studies to address those within multiple programs.

• Ability to multi-task across multiple projects.

• Leverages discretion to determine probability of likely success and meaningfulness of data.

• Contributes to building a positive team spirit, shares expertise with others.

• Exhibits impeccable integrity and sound judgment with sensitive information.

• Able to adapt to changes in the work environment.

• Possess the ability to quickly assess problems/situations, provide effective resolution/solutions and raise and manage risks and discrepancies where needed using scientific knowledge.

• Proficient with Microsoft Suite (Word, PowerPoint, Excel, Outlook), Power BI Smartsheet, MS Project, Timeline Office Pro, a plus.

Preferred Skills:

• MSc., MBA or Ph.D. in a scientific or similarly related field a plus

• PMP (Project Management Professional) or other PM certification or equivalent is a plus.

• Experience in Oncology therapeutic area is strongly preferrable. 

  #LI-Hybrid #LI-EM1

The Opportunity:

As a Scientist II in the Cancer Pharmacology team within the Translational Research group, in the Biomedical Discovery Research Department, you will:

• Contribute to advancing RAS(ON) inhibitor programs by applying cancer pharmacology and tumor biology expertise, with a focus on mechanistic understanding of RAS biology.

• Design, execute, and interpret in vivo efficacy and PK/PD studies (internally and via CROs) to support forward and reverse translation of RAS(ON) inhibitors

• Collaborate with the cross-functional quantitative modeling group, providing data, biological context, and critical evaluation to support translational PK/PD modeling (no requirement for hands-on mathematical model experience).

• Analyze, interpret, and communicate data clearly to internal teams and external scientific audiences.

• Maintain high-quality documentation, protocols, and data integrity.

Required Skills, Experience and Education:

• Ph.D. in pharmacology or cancer biology, or a related discipline with direct relevance to oncology drug development.

• 2+ years of relevant postdoc or industry experience in cancer drug discovery and development.

• Solid knowledge of tumor biology and RAS signaling pathways

• Demonstrated experience in designing, executing and analyzing in vivo experiments with oncology disease models.

• Working knowledge of PK and PK/PD relationships, with the ability to analyze and interpret data.

• Rigorous and detail-oriented with proven excellence in experimental design, data analysis, data management, and presentation.

• Excellent written and verbal communication skills. Able to effectively communicate results to non-specialist and specialist audiences.

• Thrives in a collaborative team setting and is driven by a desire to be innovative in a dynamic and fast-paced environment.

Preferred Skills:

• Familiarity with RAS biology and RAS-targeted therapies

• Experience with designing and executing PKPD studies in tumor models.

• An understanding of preclinical to clinical translational concepts desired.

• Strong track record of research productivity as evidenced by high-quality, impactful publications.

• A strong theoretical understanding of the core concepts, assumptions, and limitations associated with PK/PD mathematical modeling.

#LI-Hybrid   #LI-NE1

The Opportunity:

The Senior Manager, Compliance - Field Commercialization is responsible for providing hands-on support to Commercial and Medical field teams during product commercialization and indication expansion. This role serves as a primary field-facing compliance partner, ensuring compliant execution of field activities while enabling business objectives.

Reporting to the Senior Director, Compliance the Senior Manager will implement and continuously enhance a comprehensive field-facing compliance program, embedding compliance into daily field operations while supporting the company’s growth as commercial stage oncology organization.

Field Compliance Support

• This role will support the Senior Director, Compliance in providing field-facing corporate compliance support for all Revolution Medicines (RevMed) field roles, including field Sales, field Marketing, Medical Science Liaisons, and field Reimbursement and Access teams.

• This role will serve as primary compliance contact for questions related to field activities.

• The Senior Manager will partner with Headquarter Compliance, Marketing and Medical teams to communicate field observations, training and governance needs.

Field Training & Communication

• The Senior Manager will have direct responsibility for the design, delivery, and continuous improvement of field-focused compliance training programs. This includes:

• Ownership of onboarding training for new field hires

• Launch and indication-specific training, with targeted refreshers based on emerging risks, monitoring insights, or changes in regulations.

• The role will deliver live, in-person and virtual training sessions and ensure training content is practical, scenario-based, and aligned with real-world field execution.

• The role will track and maintain training records.

• The Senior Manager will periodically communicate compliance updates to field employees to reinforce compliance governance and best practices.

Policies and SOP Support

• The Senior Manager will support the development, implementation, and operationalization of compliance policies and standard operating procedures (SOPs) that impact Commercial and Medical field activities.

• This includes partnering with Legal and Compliance leadership to translate policy requirements into clear, field-ready guidance, job aids, FAQs, and training materials. The role will help ensure policies and SOPs are understood, consistently applied, and scalable as the product portfolio and indications expand.

Field Auditing and Monitoring

• This role will partner with the RevMed Compliance Auditing and Monitoring team to support field auditing and monitoring activities.

• The Senior Manager will track and maintain records for assigned auditing and monitoring activities, and will escalate any audit findings / monitoring observations to the Senior Director, Compliance.

Regulatory Knowledge & External Engagement

• With support from the Senior Director, the Senior Manager is expected to maintain current working knowledge of laws, regulations, and guidance impacting field activities including healthcare laws and PhRMA Code, FDA and CMS regulations, HIPAA, data privacy laws, DOJ and OIG guidance.

Required Skills, Experience and Education:

• Bachelor’s degree required.

• Minimum of 8 years healthcare compliance experience.

• Experience supporting Commercial and Medical field teams.

• Demonstrated ability to build strong partnerships and collaborate with internal and external partners.

• Proven track record of implementing compliance initiatives.

Preferred Skills:

• Certified Compliance & Ethics Professional (CCEP) certification.

• Experience in developing and implementing training content, including managing vendor-created content.

• Experience launching content via Learning Management Systems (LMS).

• Prescription drug product launch / indication expansion experience.

• Strong presentation, organizational, and project management skills, capable of handling multiple high-priority projects simultaneously.

• Team-oriented approach to work, fostering a culture of development, collaboration, and ethical business practices. 

  #LI-Remote #LI-YG1

The Opportunity:

The Senior Manager, Compliance - Field Commercialization is responsible for providing hands-on support to Commercial and Medical field teams during product commercialization and indication expansion. This role serves as a primary field-facing compliance partner, ensuring compliant execution of field activities while enabling business objectives.

Reporting to the Senior Director, Compliance the Senior Manager will implement and continuously enhance a comprehensive field-facing compliance program, embedding compliance into daily field operations while supporting the company’s growth as commercial stage oncology organization.

Field Compliance Support

• This role will support the Senior Director, Compliance in providing field-facing corporate compliance support for all Revolution Medicines (RevMed) field roles, including field Sales, field Marketing, Medical Science Liaisons, and field Reimbursement and Access teams.

• This role will serve as primary compliance contact for questions related to field activities.

• The Senior Manager will partner with Headquarter Compliance, Marketing and Medical teams to communicate field observations, training and governance needs.

Field Training & Communication

• The Senior Manager will have direct responsibility for the design, delivery, and continuous improvement of field-focused compliance training programs. This includes:

• Ownership of onboarding training for new field hires

• Launch and indication-specific training, with targeted refreshers based on emerging risks, monitoring insights, or changes in regulations.

• The role will deliver live, in-person and virtual training sessions and ensure training content is practical, scenario-based, and aligned with real-world field execution.

• The role will track and maintain training records

• The Senior Manager will periodically communicate compliance updates to field employees to reinforce compliance governance and best practices.

Policies and SOP Support

• The Senior Manager will support the development, implementation, and operationalization of compliance policies and standard operating procedures (SOPs) that impact Commercial and Medical field activities.

• This includes partnering with Legal and Compliance leadership to translate policy requirements into clear, field-ready guidance, job aids, FAQs, and training materials. The role will help ensure policies and SOPs are understood, consistently applied, and scalable as the product portfolio and indications expand.

Field Auditing and Monitoring

• This role will partner with the RevMed Compliance Auditing and Monitoring team to support field auditing and monitoring activities.

• The Senior Manager will track and maintain records for assigned auditing and monitoring activities and will escalate any audit findings / monitoring observations to the Senior Director, Compliance.

Regulatory Knowledge & External Engagement

With support from the Senior Director, the Senior Manager is expected to maintain current working knowledge of laws, regulations, and guidance impacting field activities including healthcare laws and PhRMA Code, FDA and CMS regulations, HIPAA, data privacy laws, DOJ and OIG guidance.

Required Skills, Experience and Education:

• Bachelor’s degree required.

• Minimum of 8 years healthcare compliance experience.

• Experience supporting Commercial and Medical field teams.

• Demonstrated ability to build strong partnerships and collaborate with internal and external partners.

• Proven track record of implementing compliance initiatives.

Preferred Skills:

• Certified Compliance & Ethics Professional (CCEP) certification.

• Experience in developing and implementing training content, including managing vendor-created content.

• Experience launching content via Learning Management Systems (LMS).

• Prescription drug product launch / indication expansion experience.

• Strong presentation, organizational, and project management skills, capable of handling multiple high-priority projects simultaneously.

• Team-oriented approach to work, fostering a culture of development, collaboration, and ethical business practices. 

  #LI-Hybrid  #LI-YG1

The Opportunity:

We are looking for motivated structural biologist to join tour team to support multiple oncology therapeutic programs. The ideal candidate will have previous, hands-on experience in sample preparation, data acquisition and data analysis from both X-ray crystallography and cryo-EM. They will apply their expertise to form compound driven complexes, identify, and optimize crystallization/CryoEM conditions with the aim of determining high resolution structural information to drive small molecule design and mechanistic understanding. We’re seeking a team player with enthusiasm to work in an interdisciplinary setting to drive toward new, cutting edge oncology therapeutics. 

Responsibilities

• Plan and execute experiments with the aim of determining small molecule driven multi-protein complex structures by CryoEM and X-ray crystallography.

• Perform cryo-EM grid screening, optimization, data collection and refinement to enable high-quality structure determination.

• Interact with interdisciplinary teams (including chemists, computational chemists, biologists, project teams, and management) and clearly articulate structural data in a broader drug discovery context.

• Maintain excellent records and communication among internal and external colleagues.

• Be driven by a desire to be innovative in a high energy, fast paced environment and work collaboratively with a variety of collegues across the organization.

Required Skills, Experience and Education:

• PhD in structural biology or protein biochemistry or a related scientific discipline with 2-5 years of post-doctoral experience.

• Hands-on experience and expertise in cryo-EM sample optimization and grid preparation, data collection, map generation, and structure determination.

• Strong track record of solving challenging CryoEM problems such as preferred orientation, small proteins/complexes, modeling into low resolution maps, or iterative rounds of protein optimization.

• Hands on experise with modern software packages for data collection, refinement and visualization of structural biology data, and the ability to seamless switch between them based on need (e.g. CryoSPARC, RELION, Phenix, REFMAC, Coot, ChimeraX, Pymol).

• Excellent written, verbal communication, interpersonal and organization skills.

• Conscientious team-player interested in a fast-paced biotech environment.

Preferred Skills:

• Hands-on experience and expertise in protein crystallization, crystal optimization and harvesting for data collection.

• Experience with biophysical characterization methods, including mass spectrometry, SEC-MALS, DLS, SPR, NMR and thermal shift assays.

• Experience with protein-protein complexes including antibodies/Fabs, molecular glues, PROTACs, etc.

• Experience working in a multidisciplinary team environment.

• Experience in gene construct design, expression and purification of recombinant proteins. 

  #LI-Hybrid  #LI-LN1

The Opportunity:

We are seeking an experienced clinical science drug developer to serve as Senior Director of Clinical Development in support of Revolution Medicines’ clinical-stage molecule(s). In this critical role, you will support various clinical science deliverables and enable effective and efficient execution of the clinical development plan for a molecule(s) within its particular indication(s). The scope of activities spans early-stage clinical research to pivotal studies including regulatory submissions. You will play a vital role in leading the clinical science aspects of the Clinical Development Plan (CDP) strategy, driving the development of transformative therapies for patients.

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

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

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

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

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

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

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

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

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

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

• Potential to manage multiple direct reports

Required Skills, Experience and Education:

• A PhD, PharmD or equivalent is required. The years of experience are based on clinical development or similar relevant experience.

• Minimum 10+ years experience in clinical development required (Pharma R&D experience outside of a clinical development role also considered pending transferability of skills and responsibilities).

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

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

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

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

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

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

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

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

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

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

• Experience in mentoring other clinical scientists. Experience or clear potential as an effective line manager.

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

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

• Strong written and business presentation skills is required.

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

• Demonstrated strong leadership presence.

• Has demonstrated adaptability and flexibility.

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

Preferred skills:

• Has made significant contributions to clinical development plan conception, conduct and delivery, including successful alignment with scientific governance.

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

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

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

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

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

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

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

  #LI-Hybrid  #LI-SH1

The Opportunity:

We are seeking an experienced clinical science drug developer to serve as Senior Medical Director of Clinical Development in support of Revolution Medicines’ molecule(s) in clinical or late pre-clinical development. In this critical role, you will support various clinical science deliverables and enable effective and efficient execution of the clinical development plan for a molecule(s) within its particular indication(s). The scope of activities spans early-stage clinical research and may extend to studies supporting regulatory submissions including Breakthrough-Therapy-Designation (BTD) or Accelerated Approvals (AA). You will play a vital role in leading the clinical science aspects of the Clinical Development Plan (CDP) strategy, driving the development of transformative therapies for patients.

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

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

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

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

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

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

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

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

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

• Potential to manage multiple direct reports.

Required Skills, Experience and Education:

• MD (oncology training preferred) with 7+ years of experience in clinical development in the pharmaceutical/biotech industry and/or academic/other clinical trial setting; some experience in and understanding of early phase drug development preferred.

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

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

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

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

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

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

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

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

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

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

• Experience in mentoring other clinical scientists. Experience or clear potential as an effective line manager.

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

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

• Strong written and business presentation skills is required.

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

• Demonstrated strong leadership presence.

• Has demonstrated adaptability and flexibility.

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

Preferred skills:

• Has made significant contributions to clinical development plan conception, conduct and delivery, including successful alignment with scientific governance.

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

• Has led or supported clinical development contributions to major regulatory submissions (e.g. IND for First-in-Human studies, EOP2 briefing books (Type C/D); PIP/PSP, label negotiation, Breakthrough Therapy Designation, Accelerated Review is a major plus.

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

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

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

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

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

#LI-Hybrid  #LI-SH1

The Opportunity:

• Provide strategic and operational leadership to scale and globalize the Quality Management System (QMS), establishing a harmonized, flexible framework that supports international growth and regulatory compliance.

• Lead oversight and expansion of core quality systems across global sites, including document control, GxP training, quality events, supplier management, audits, and batch release.

• Partner with regional teams (including Japan, Europe & other global regions) to integrate local regulatory requirements into the global QMS while maintaining global consistency.

• Establish and govern global quality procedures, including policies, SOPs, and standardized processes to ensure compliance and operational efficiency.

• Ensure inspection readiness and lead support for global health authority inspections, regulatory submissions, and product launches.

• Oversee global quality metrics, compliance monitoring, and management review processes; drive proactive identification, escalation, and mitigation of quality risks.

• Provide governance for electronic quality and validated GxP systems (e.g., Veeva Vault Quality), ensuring they effectively support global operations.

• Collaborate cross-functionally to build and sustain a scalable quality infrastructure aligned with organizational growth and global expansion.

• Champion a culture of continuous improvement and quality excellence across the enterprise.

Required Skills, Experience and Education:

• Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, or a related discipline (advanced degree preferred).

• Minimum of 10+ years of experience in Quality within the pharmaceutical or biotechnology industry, including leadership of global quality systems.

• Demonstrated experience establishing, leading, and maintaining a global Quality Management System (QMS) across multiple regions.

• Proven ability to influence and align senior stakeholders and executive leadership on quality strategy and risk-based decision making.

• Deep knowledge of global GxP regulations and experience ensuring compliance across international markets (e.g., FDA, EMA, PMDA).

• Proven track record supporting global regulatory filings, approvals, inspections, and post-market quality obligations.

Preferred Skills:

• Experience building or transforming global QMS in a growing organization.

• Prior interaction with FDA, EMA, PMDA, and other global health authorities.

• Experience supporting commercial product launches and lifecycle management. 

  #LI-Hybrid #LI-JC1

The Opportunity:

The Director, HEOR/RWE is an integral part of the organization, responsible for executing HEOR plans and activities related to Revolution Medicines assets intended for use in lung cancer. This individual will be accountable for generating evidence that demonstrates the value of Revolution Medicines products to healthcare organizations, allowing them to make informed decisions. They will work closely with the Medical Affairs team as well as other cross-functional teams to optimize the Integrated Evidence Plan (IEP) and to deliver evidence supporting the use of Revolution Medicines products. This individual will serve as an HEOR expert internally and also while representing RevMed externally at industry conferences. This is an exceptional opportunity to contribute to the advancement of healthcare by providing evidence that can shape the future of patient care in oncology.

Reporting to the Executive Director of HEOR/RWE Lung, the Director, HEOR/RWE Lung will:

• Execute the product HEOR/RWE strategy to deliver evidence consistent with the medical strategy and IEP.

• Deliver HEOR/RWE tactics with quality and in alignment with agreed upon timing

• Provide HEOR/RWE representation on matrix teams and working groups.

• Work with the HEOR/RWE and Medical Affairs leadership to ensure critical value insights are communicated to key internal teams.

• Provide HEOR evidence which addresses the needs and expectations of key stakeholders such as patients, healthcare providers, payers and Health Technology Assessment (HTA) agencies.

• Effectively present research findings to internal and external stakeholders to improve internal decision making and to promote wider adoption of research findings across external stakeholders.

• Facilitate the communication of the value proposition of Revolution Medicines’ portfolio, allowing key healthcare and formulary professionals to make informed therapeutic decisions.

• Engage and collaborate with external partners including payers, health care providers, thought leaders, patient advocates, and decision-makers to establish/maintain strong partnerships and gather insights into research programs.

• Stay up to date with and add to the advancements in health economics methodologies and best practices; support the build of disease area HEOR/RWE disease area capability, establishing best practices, external visibility, and functional excellence across the medical affairs network.

• Identify and interface with HEOR & RWE experts and organizations, profile data sources and related organizations as they relate to Revolution Medicines’ portfolio and therapeutic areas.

• Closely monitor new trends in health policy and payer environment, assess competitive data gaps and communicate to the organization, to help Revolution Medicines build industry-leading capabilities and be on the cutting edge of evidence-based medicine and HEOR research.

Required Skills, Experience and Education:

• Deep expertise in health economics, outcomes research, patient-reported outcomes or related fields in the biotechnology or pharmaceutical industry.

• Experience in oncology HEOR and RWE development.

• Minimum 5 years of relevant experience with an advanced degree in a relevant field (MD, PhD, PharmD).

• Track record of high impact publications in HEOR/RWE topics.

• Strong written and interpersonal communication skills, with an ability to present complex technical information clearly.

• Demonstrated ability to lead evidence generation initiatives and to communicate with impact internally and externally.

• Knowledge and experience in managed care, integrated delivery networks, formulary decision-making, and payment/access models.

• Ability to establish relationships with experts in real world evidence (RWE) and therapeutic areas of interest.

Preferred Skills:

• 8+ years of relevant experience in the pharmaceutical/biotech industry.

• Experience related to lung cancer. #LI-Hybrid #LI-VN1

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers.  The company’s R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. As a new member of the Revolution Medicines team, you will join other outstanding Revolutionaries in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.

The Opportunity:

As an Associate Director, you will be responsible for the following:

• Lead and/or support development and implementation of GCP systems and inspection readiness.

• Lead and/or support the development and continuous improvement of Clinical Policies/ SOPs/ WIs/ Templates/etc. using knowledge and experience with clinical study management, International Conference on Harmonization (ICH) Guidelines, Good Clinical Practices (GCP) and regulatory requirements.

• SME for Clinical Operations GCP guidance, best industry practices, SOPs, and audit responses.

• Contribute to the development and management of business and compliance metrics to assess and continuously improve RevMed oversight and inspection readiness throughout the clinical trial lifecycle.

• Support Clinical Operations Inspection Readiness activities with clinical study teams; key participation in Mock/Regulatory Authority inspections.

• Contribute to the development and execution of Clinical Operations training programs to deliver RevMed standards, GCP, and regulatory requirements.

• Partner cross-functionally and with QA on quality initiatives, continuous improvement of GCP systems, and internal audits.

• Line management responsibilities including hiring, performance management, career development, and mentorship.

• Participate in other Clinical Operations Activities per the business need.

Required Skills, Experience and Education:

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

• 10+ years direct Clinical Compliance, and/or Clinical Quality Assurance experience in the pharmaceutical or biotech industry. Relevant Clinical Operations experiences may also meet the requirement.

• Strong working knowledge of FDA Regulations, ICH Guidelines, and GCP.

• Demonstrated experience successfully developing and authoring Clinical and cross-functional SOPs ensuring compliance with GCP and regulatory requirements.

• Experience with development and monitoring of oversight activities.

• Knowledge and/or familiarity with Ex-US region(s) e.g. EMA, MHRA, PDMA.

• Ability to perform complex assessments & investigations, draw relevant conclusions, and implement appropriate solutions.

• Strong analytical, negotiation, and persuasion skills.

• Ability to deal with time demands, incomplete information, or unexpected events.

• Outstanding organizational skills with the ability to multi-task and prioritize.

• Excellent interpersonal, verbal, and written communication skills.

• Decision-making skills.

• Comfortable in a fast-paced company environment and able to adjust workload based upon changing priorities.

• Demonstrate proficiency in Microsoft Office Suite (Outlook, MS Word, Excel, PowerPoint); MS Project and/or Smartsheet a plus.

• Travel may be required (~25%).

Preferred Skills:

• Line Management experience.

• Oncology experience, early and/or late stage, strongly preferred.

• RN or Master’s degree in biological sciences or health-related field preferred.

• Strong working knowledge of ex-US regulations and requirements. 

  #LI-Hybrid  #LI-DN1

The Opportunity:

The Director of Regulatory Affairs is accountable for the delivery of regulatory strategy for designated programs at RevMed. They will support programs and drug development teams and ensure delivery of targeted, pragmatic, well-vetted, consistent and actionable regulatory advice. The Director will support policy and process development within regulatory and cross-functionally to define a consistent RevMed approach to regulatory advice and strategy. The Director must have a thorough understanding of and be highly experienced in oncology drug development, applicable regulations, and current health authority thinking, and have strong leadership and relationship-building ability. 

• Provide clear, effective regulatory strategy as the Regulatory Study Lead for global oncology programs.

• Motivate, mentor and develop direct reports to ensure development and performance.

• Ensure late-stage oncology programs are fully resourced and anticipate regulatory needs to deliver on programming milestones.

• Develop robust global regulatory strategies that reflect competitive intelligence, expert input, and align with corporate goals to ensure global success.

• Drive consistency in regulatory approach, ensuring lessons learned across programs are applied broadly.

• Establish highly collaborative and effective relationships with management colleagues in Clinical Research, Clinical Operations, Regulatory Affairs, Medical Writing, Quality and other functions to ensure cross-functional alignment and team effectiveness.

Required Skills, Experience and Education:

• Degree in life sciences, pharmacy, medicine, or related fields with a minimum of 12+ years in the pharmaceutical/biotech industry or relevant work experience and a minimum of 8 years in Regulatory Affairs including regulatory strategy and leadership roles.

• Proven success in developing and delivering global regulatory strategies and submissions.

• Demonstrated success in leading health authority interactions and negotiations.

• Direct experience in oncology drug development including oversight of large, global Phase 3 and platform studies.

• Strong track record in alliance management, coordinating with external development or commercialization partners.

• Skilled at representing Regulatory on cross-functional teams and presenting to senior leadership.

• Excellent communication, planning, and organizational skills with the ability to manage multiple projects and tight deadlines.

Preferred Skills:

• An advanced degree is desirable.

• Experience with dose optimization in oncology.

• Prior NDA experience is highly preferred.

#LI-Hybrid #LI-JC1

The Opportunity:

The Senior Director of Economic Modeling is responsible for defining and executing the economic modeling strategy to produce high quality health economic models & modeling strategies across Rev Meds portfolio.  This is an exceptional opportunity to contribute to the advancement of healthcare by providing evidence that can shape the future of patient care in Oncology.

Key Strategic Responsibilities:

• Lead the development of strategic and operational plans for health economic modeling within Global HEOR & RWE (e.g., early and submission cost-effectiveness / utility models, budget impact models, and country adaptations) while ensuring alignment with Integrated Evidence Plans and appropriate Global stakeholders.

• Partner with Global HEOR & RWE Executive Directors on core health economic modeling plans to support HTA, payer, and other access stakeholder assessments, submissions, negotiations, including associated value/HTA deliverables and publications to meet business and access objectives.

• Provide strategic, methodological and analytical leadership to teams and countries for adaptation of economic models for local HTA submissions

• Lead the development of an approach to monitor, educate and integrate evolving HTA guidelines, payer requirements, and methodologic advancements related to economic modeling.

• Lead the development of robust governance, compliance, and readiness for all economic modeling activities by adhering to processes, guidelines, and project management standards.

• Represent Rev Med in global external working groups regarding modeling standards and innovation (e.g., ISPOR Special Interest groups).

Key Operational Responsibilities:

• Support design and development of economic models from start to finish for products across Rev Meds portfolio.

• Direct statistical analyses of real-world data and clinical trial data (in collaboration with biostatistics) to generate inputs including treatment effects, survival extrapolations, resource use, and health utility estimates.

• Design evidence synthesis, including network meta-analysis (NMA), and matching adjusted indirect comparisons (MAIC) to inform comparative effectiveness.

Required Skills, Experience and Education:

• Advanced degree (Masters or PhD) in health economics, econometrics, biostatistics, mathematics, engineering or related field (DrPH, PharmD).

• Minimum of 15 years with a Masters (or 13+ years with a PhD/PharmD/DrPH) of relevant experience in economic modeling in the pharmaceutical, biotech, or consulting setting.

• Hands on experience in developing cost-effectiveness, budget impact models as well as NMA/MAIC.

• Track record of high impact publications in economic modeling for global access decision-makers.

• Experience supporting HTA submissions and payer evidence generation.

• Strong written and interpersonal communication skills, with an ability to present complex technical information clearly.

• Proven leadership

  • Ability to influence others without direct reporting relationships.

• Comfortable working in a global team across time zones.

Preferred Skills:

• Experience in oncology economic modeling is highly desirable, especially related to gastrointestinal and thoracic malignancies. 

  #LI-Hybrid  #LI-GL1

The Opportunity:

Reporting to the Associate Director, Payroll, the Payroll Manager will be responsible for ensuring accurate, timely and compliant payroll processing from start to finish.  This position is ideal for a payroll leader who thrives in fast-paced, ambiguous, and rapidly growing environments.  The successful candidate will have deep experience in public company environments, understand stock compensation, and be well-versed in SOX compliance, audits, and employment tax. 

Responsibilities:

• Manage full-cycle operations for the US payroll including but not limited to semi-monthly, equity, commission, off-cycle and bonus processing using ADP Workforce Now.

• Support equity compensation processing including RSU, ISO, Non-Qual, and ESPP; ensuring accurate tax treatment and timely reporting.

• Supervise and mentor a team of payroll professionals, providing leadership, development, and training.

• Lead quarter-end and year-end payroll processes, including tax reporting, compliance filings and W-2/equivalent statement delivery.

• Ensure compliance with local payroll, tax, and labor regulations in all jurisdictions.

• Serve as the payroll system expert, overseeing day-to-day system integrations and collaborating with the HR team to maintain data integrity.

• Collaborate with internal stakeholders (HR, Benefits, Compensation, Stock Admin, Tax Team, and Accounting) to optimize end-to-end payroll-related processes and issue resolution.

• Oversee payroll-related audits, compliance checks, and controls (SOX, internal, and external audits).

• Drive continuous improvement and implement solutions to operational challenges, ensuring issues are resolved quickly and effectively.

• Act as the escalation point for complex payroll issues, audits, and employee inquiries.

Required Skills, Experience and Education:

• Bachelor’s degree in Finance, Accounting, Economics, Business or related field.

• 10+ years of progressive payroll experience with 3+ years in a leadership or management role.

• Public company experience with strong understanding of SOX, audit, and compliance.

• Hands-on experience with ADP Workforce Now.

• Ability to work independently, protect and safeguard confidential information, great attention to detail.

• Strong project management skills with the ability to anticipate events, prioritize assignments, deal with interruptions, and meet deadlines in a fast-paced and growth-oriented environment.

• Proven track record of training, coaching and developing high-performing teams.

• Excellent written and verbal communication skills to work with interdepartmental teams.

Preferred Skills:

• Pharmaceutical or biotechnology industry experience.

• International payroll experience is a plus. 

  #LI-Hybrid  #LI-YG1

The Opportunity:

The Senior Director, Real-World Data & Analytics will work with the Executive Director, Head of Epidemiology and VP of HEOR to establish the RWD&A group at RevMed, scaling organizational capabilities and leading the strategy and execution of key RWD&A deliverables for RevMed assets. They will be accountable for working across the clinical development, safety, medical affairs, commercial including analytics and insights, and IT matrix, developing strategies and leading and/or overseeing execution of key projects. Reporting to the Executive Director, Head of Epidemiology & RWD Strategy, they will closely align with the other users of RWD at RevMed, develop ways of working and communication channels to maximize RevMed’s investment in RWD as well as lead the analysis (either directly or leveraging junior team members and vendors) of RWD database and other studies. This is an exceptional opportunity to contribute to the advancement of oncology by leveraging real-world data and analytics that will shape the future of patient care.

• Develop and lead RWD and analytics plans to support portfolio, Medical Affairs, HEOR/RWE, and epidemiology goals.

• Provide subject matter expertise on RWD data sources, their strengths/limitations, and the feasibility of answering key scientific questions using available data.

• Oversee high-quality RWE study design, protocol development, statistical analysis planning, and final reporting in support of regulatory submissions and product value evidence – typical projects include include systematic literature reviews, natural history studies, clinical trial design and optimization, comparative effectiveness and safety, and healthcare resource utilization types of studies, post-approval safety studies leveraging RWD, as well as RWD-related insights such as quick feasibility and information used to inform our fast-moving clinical programs.

• Ensure fit-for-purpose methods are used to provide scientific rigor to non-interventional studies so that they adhere to global regulatory guidance frameworks and are acceptable to other key stakeholders.

• Provide thought leadership in advanced analytic techniques (e.g., causal inference, predictive modeling, AI/ML) that reflect current industry practices.

• Communicate insights and analysis effectively to senior stakeholders, regulatory agencies, payers, and scientific audiences through written reports and presentations.

• Participate in governance, feasibility review, and multidisciplinary project teams, ensuring RWD analytics add meaningful insight at key decision points.

• Build, mentor, and lead a high-performing analytics team with expertise in epidemiology, biostatistics, data science, and RWE methodologies.

• Drive adoption of robust analytics standards and tools that enhance consistency and scalability of RWD efforts across projects including partnership with other functions to establish data ingestion pipelines, and support the establishment of data lakes.

Required Skills, Experience and Education:

• PhD / DSc / DrPH in epidemiology or biostatistics, or a relevant advanced science degree and at least 12 years of experience with RWD analytics and evidence generation in pharma/biotech.

• Demonstrated experience leading complex RWD/RWE projects from concept through delivery, including study design, analysis, and reporting/submission to regulatory agencies.

• Strong expertise with RWD sources (claims, EHR, registries, -omics data, linked datasets) and analytic tools (R/SAS/Python).

• Demonstrated technical knowledge of epidemiologic, biostatistical, and data science methods.

• Knowledge of drug and clinical development process for genomic/targeted medicines.

• Excellent analytic and problem-solving skills.

• Strong interpersonal skills and the ability to work effectively in multidisciplinary teams, including ability to provide oversight to vendors.

Preferred Skills:

• Experience in oncology RWD&A.

• Track record of publications or presentations in RWD&A/epidemiology/data science.

• Experience aligning RWE strategy to regulatory and payer evidence planning, especially around the planning and execution of post-approval safety studies. 

  #LI-Remote #LI-VN1

The Opportunity:

The Senior Director, HEOR/RWE is a leader within the organization, responsible for developing an HEOR/RWE strategy and executing HEOR plans and activities related to Revolution Medicines assets intended for use in pancreatic and colorectal cancer. They will be accountable for demonstrating the value of Revolution Medicines products to healthcare organizations, allowing them to make informed decisions. They will work closely with the Medical Affairs team as well as other cross-functional teams to optimize the Integrated Evidence Plan (IEP) and to deliver evidence supporting the use of Revolution Medicines products. The candidate must also be able to provide input and strategic guidance on the global value of the product as well as have demonstrated success in evidence generation globally. The Senior Director HEOR/RWE will participate with the matrix team across the function to ensure alignment of all activities with the strategic and tactical plans. This individual will serve as an HEOR expert internally and also while representing RevMed externally at industry conferences. This is an exceptional opportunity to contribute to the advancement of healthcare by providing evidence that can shape the future of patient care in oncology. 

Reporting to the Executive Director of HEOR/RWE GI, the Senior Director, HEOR/RWE will:

• Develops and evolves product HEOR/RWE strategy, including integration with development and market access planning.

• Aligns with Medical Affairs and Development leadership to design research and delivers evidence consistent with the medical strategy and IEP.

• Delivers HEOR/RWE tactics with quality and in alignment with agreed upon timing.

• Provides HEOR/RWE leadership on matrix teams and working groups.

• Leads enterprise partnerships with payers, HTA agencies, and global consortia to help shape access strategy, policies, evidence standards, and evidence generation activities.

• Works with the HEOR/RWE and Medical Affairs leadership to ensure critical value insights are communicated to key internal teams.

• Provides HEOR evidence which addresses the needs and expectations of key stakeholders such as patients, healthcare providers, payers and Health Technology Assessment (HTA) agencies.

• Effectively presents research findings to internal and external stakeholders to improve internal decision making and to promote wider adoption of research findings across external stakeholders.

• Facilitates the communication of the value proposition of Revolution Medicines’ portfolio, allowing key healthcare and formulary professionals to make informed therapeutic decisions.

• Engage sand collaborate with external partners including payers, health care providers, thought leaders, patient advocates, and decision-makers to establish/maintain strong partnerships and gather insights into research programs.

• Facilitates and implement real-world research partnership engagements with leading healthcare, academic and payer organizations to co-create value evidence and help drive evidence-based optimal care.

• Stays up to date with and add to the advancements in health economics methodologies and best practices; support the build of disease area HEOR/RWE disease area capability, establishing best practices, external visibility, and functional excellence across the medical affairs network.

• Identifies and interface with HEOR & RWE experts and organizations, profiles data sources and related organizations as they relate to Revolution Medicines’ portfolio and therapeutic areas.

• Closely monitors new trends in health policy and payer environment, assess competitive data gaps and communicate to the organization, to help Revolution Medicines build industry-leading capabilities and be on the cutting edge of evidence-based medicine and HEOR research.

Required Skills, Experience and Education:

• Deep expertise in health economics, outcomes research, patient-reported outcomes or related fields in the biotechnology or pharmaceutical industry.

• Experience in oncology HEOR and RWE development.

• Minimum 10-13 years of relevant experience with an advanced degree in a relevant field (MD, PhD, PharmD).

• Track record of high impact publications in HEOR/RWE topics.

• Proven success influencing payer/HTA strategy and incorporating HEOR considerations into clinical development programs.

• Strong written and interpersonal communication skills, with an ability to present complex technical information clearly.

• Demonstrated ability to lead evidence generation initiatives and to communicate HEOR value to internal senior leadership and external decision-makers.

• Knowledge and experience in managed care, integrated delivery networks, formulary decision-making, and payment/access models.

• Ability to establish relationships with experts in real world evidence (RWE) and therapeutic areas of interest.

Preferred Skills:

• 10+ years of relevant experience in the pharmaceutical/biotech industry.

• Global launch experience.

• Experience related to gastrointestinal oncology. #LI-Hybrid #LI-VN1

The Opportunity:

The Translational Sciences Intern will support the Translational Sciences team in advancing programs that connect preclinical discovery with clinical development. This role provides exposure to how Translational Research integrates molecular biology, pharmacology, biomarker discovery, and clinical data to inform therapeutic development in precision oncology. The intern will gain insight into how translational strategies are developed to understand drug mechanisms, identify biomarkers of response and resistance, and guide clinical trial design. This position is ideal for a student interested in translational cancer research and the interface between laboratory science and clinical application. The role focuses on learning, analysis, and cross-functional collaboration within a multidisciplinary drug development environment.

This role provides the opportunity to learn some or all the following, depending on project assignments and team needs.

• How translational research supports the development of targeted therapies in oncology.

• How biomarker strategies are developed to support clinical trials and precision medicine approaches. • How preclinical data are integrated with clinical observations to understand mechanisms of response and resistance.

• How cross-functional teams across discovery biology, pharmacology, clinical development, and bioinformatics collaborate in drug development.

• How experimental and clinical datasets are analyzed and interpreted to generate translational insights.

• How translational scientists communicate complex scientific findings to multidisciplinary teams.

Required Skills, Experience and Education:

• Strong analytical, critical-thinking, and problem-solving skills.

• Ability to interpret scientific literature and synthesize complex scientific information.

• Strong written and verbal communication skills.

• Interest in oncology, molecular biology, or translational research.

• Organized, detail-oriented, and able to work independently with guidance.

• Professional curiosity and willingness to learn new concepts.

• Pursuing a bachelor’s or master’s degree in a STEM field (e.g., biology, biochemistry, molecular biology, biomedical engineering, or related discipline).

Preferred Skills:

• Coursework or research experience in cancer biology, molecular biology, or pharmacology.

• Familiarity with biomarker concepts or translational research approaches.

• Experience with basic laboratory techniques or biological data analysis.

• Experience preparing scientific presentations or summarizing research findings.

• Interest in precision medicine and targeted cancer therapies. 

  #LI-Hybrid  #LI-AP1

The Opportunity:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Required Skills, Experience and Education:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

• Strong written and business presentation skills is required.

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

• Demonstrated strong leadership presence.

• Has demonstrated adaptability and flexibility.

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

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

Preferred skills:

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

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

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

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

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

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

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

The Opportunity:

The Director of Regulatory Affairs (Global Filing Lead) is accountable for driving preparation & execution of global regulatory NDA/MAA filings for late-stage oncology programs at RevMed. They will manage end-to-end execution of the dossier, ensuring cross-functional coordination and effective communication across Regulatory, Clinical, Biostatistics, CMC, Quality, Translational Medicine and Commercial.  The Director will support drug development teams and ensure delivery of targeted, pragmatic, well-vetted, consistent and actionable regulatory advice. The Director must have a thorough understanding and be highly experienced in oncology drug development, US NDA & global filing regulations, current Health Authority thinking, and have strong leadership & problem-solving ability. 

Reports into Regulatory Affairs, Global Filing & Registration

• High-Impact position to lead cross-functional development & regulatory submission activities for registrational oncology programs in the EU, UK, Japan and internationally.

• Collaborate closely with Program Teams and Global Regulatory Leads to advance effective & consistent regulatory strategies to enable successful filing of approval of New Drug Applications.

• Develop strategic filing plans under expedited regulatory pathways, programs and developing Health Authority initiatives.

• Coordinate dossier filing and sub-team rosters for management endorsement.

• Lead cross-functional MAA kickoff according to global filing plans and framework.

• Maintain & track an integrated filing plan including regulatory timelines, modular MAA deliverables, critical path activities, in concert with Regulatory Program Management.

• Identify, respond to, and proactively mitigate risks to filing timelines or regulatory outcomes and report progress to senior management.

• Drive and/or support modular NDA Sub-teams (e.g., across Clinical, Non-Clinical, Product Label, etc.) to ensure consistent communication, timely data delivery, and issue resolution.

• Lead relevant Health Authority meetings, interactions and query responses and coordinate cross functional team preparation & involvement.

• Motivate, mentor and develop direct reports to ensure development and performance.

Required Skills, Experience and Education:

• Degree in life sciences, pharmacy, medicine, or related fields with a minimum of 12 years in the pharmaceutical/biotech industry or relevant work experience and a minimum of 8 years in Regulatory Affairs including a regulatory strategy role.

• Proven success in executing global NDA/MAAs (preparation, submission & approval).

• Experience filing applications under expedited filing pathways and programs to enable fastest possible regulatory approval.

• Demonstrated ability to lead Health Authority interactions and negotiations.

• In-depth knowledge of CTD structure and management of dossier components.

• Direct experience in oncology drug development including oversight of large, global Phase 3 registrational studies.

• Flexibility to support business needs of dynamic registrational programs.

• Skilled at representing Regulatory on cross-functional teams and presenting to senior leadership.

• Excellent communication, planning, and organizational skills with the ability to manage multiple projects and tight deadlines.

Preferred Skills:

• Prior experience with regulatory filings and strategy in APAC and access consortium countries highly preferred.

• An advanced degree is desirable. 

  #LI-Hybrid #LI-JC1

The Opportunity:

The Director of Regulatory Affairs is accountable for the delivery of regulatory strategy for designated programs at RevMed. They will support programs and drug development teams and ensure delivery of targeted, pragmatic, well-vetted, consistent and actionable regulatory advice. The Director will support policy and process development within regulatory and cross-functionally to define a consistent RevMed approach to regulatory advice and strategy. The Director must have a thorough understanding of and be highly experienced in oncology drug development, applicable regulations, and current health authority thinking, and have strong leadership and relationship-building ability. 

• Provide clear, effective regulatory strategy as the Regulatory Study Lead for global oncology programs.

• Motivate, mentor and develop direct reports to ensure development and performance.

• Ensure late-stage oncology programs are fully resourced and anticipate regulatory needs to deliver on programming milestones.

• Develop robust global regulatory strategies that reflect competitive intelligence, expert input, and align with corporate goals to ensure global success.

• Drive consistency in regulatory approach, ensuring lessons learned across programs are applied broadly.

• Establish highly collaborative and effective relationships with management colleagues in Clinical Research, Clinical Operations, Regulatory Affairs, Medical Writing, Quality and other functions to ensure cross-functional alignment and team effectiveness.

Required Skills, Experience and Education:

• Degree in life sciences, pharmacy, medicine, or related fields with a minimum of 15 years in the pharmaceutical/biotech industry or relevant work experience and a minimum of 8 years in Regulatory Affairs including regulatory strategy and leadership roles.

• Proven success in developing and delivering global regulatory strategies and submissions.

• Demonstrated success in leading health authority interactions and negotiations.

• Direct experience in oncology drug development including oversight of large, global Phase 3 and platform studies.

• Strong track record in alliance management, coordinating with external development or commercialization partners.

• Skilled at representing Regulatory on cross-functional teams and presenting to senior leadership.

• Excellent communication, planning, and organizational skills with the ability to manage multiple projects and tight deadlines.

Preferred Skills:

• An advanced degree is desirable.

• Experience with dose optimization in oncology.

• Prior NDA experience is highly preferred. 

  #LI-Hybrid #LI-JC1

The Opportunity:

This is a unique opportunity for a Clinical Operations Professional who has innate leadership and organizational skills, technical expertise in clinical oncology drug development in an industry setting, and experience in overseeing clinical trials. As an Associate Director, you will be responsible for the Contract Research Organization (CRO) oversight, execution, and management of Revolution Medicines (RevMed) clinical trials.

Responsibilities:

• Adhere to Clinical Standard Operating Procedures (SOP) and Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) Guidelines.

• Global experience in end-to-end execution of different phases of clinical trials.

• Accountable for study delivery goals. Oversee the successful management of all aspects of clinical trials within timelines and designated program budgets.

• Guide assessment, selection, engagement, management, and oversight of appropriate vendors.

• Responsible for making decisions that balance risk/benefit with clear understanding of impact on the study and project; takes action to mitigate risk where appropriate.

• Lead risk management and quality efforts to ensure study compliance and continual inspection readiness. Lead/contribute to ways of working and process improvement initiatives.

• Provide proactive and consistent oversight of CRO and vendor performance Support Clinical Operations Program and / or Indication Lead with key study level status updates, with a particular focus on delivery to corporate and project level objectives.

• Contributions to the strategy and execution of the Clinical Development Plan (CDP) for assigned clinical programs which include timelines, budget, and resource requirements. Ability to identify critical path activities and articulate and mitigate risks to clinical trial conduct.

• Responsible for successful planning and deployment of Clinical Operations staff (potentially including Clinical Program Managers/Clinical Trial Managers/Clinical Trial Assistants, and consultants) for project and non-project related tasks.

• Lead line management responsibilities that include hiring, performance management, career development, and mentorship.

• Manage/oversee CROs and selected study vendors; ensuring all vendors strive to achieve the predetermined program milestones according to budget and timeline, as well as evaluate vendor performance using metrics and KPIs.

• Lead cross functional team meetings and collaborate with other functional groups within the company (e.g., Clinical Development, Regulatory, QA, Finance, Legal, etc.) to achieve clinical study goals.

• Ensure clinical trials maintain an inspection readiness state throughout the lifecycle of the trial.

• Oversee the improvement of processes that will impact clinical trial management and deliverables including contingency plans by maintaining a highly effective Clinical Operations team and building strong relationships with functional leaders.

Required Skills, Experience and Education:

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

• 11+ years direct Clinical Operations experience in the pharmaceutical or biotech industry. Relevant indirect experiences may also meet the requirement.

• Minimum of 5 years of project and first-line management experience.

• Experience in oncology.

• Experience in leading and managing global phase 1-3 clinical trials within designated timelines, resources, and budgets.

• Strong working knowledge of FDA Regulations, ICH Guidelines, and GCP.

• Experience with vendor management and CRO oversight.

• Ability to perform complex analysis, draw relevant conclusions, and implement appropriate solutions.

• Ability to pivot, be solution-oriented with consideration to long-term impact on clinical trials, responsibilities, and inspection-readiness.

• Strong analytical, negotiation, and persuasion skills.

• Ability to deal with time demands, incomplete information, or unexpected events.

• Outstanding organizational skills with the ability to multi-task and prioritize.

• Excellent interpersonal, verbal, and written communication skills.

• Decision-making skills.

• Comfortable in a fast-paced company environment and able to adjust workload based upon changing priorities.

• Demonstrate proficiency in Microsoft Office Suite (Outlook, MS Word, Excel, PowerPoint); MS Project and/or Smartsheet a plus.

• Travel may be required (~25%).

• Demonstrated experience leading in the matrix environment to deliver projects, develop clinical plans and manage change.

• In-depth knowledge of either study management or data management and knowledge of essential global regulatory guidelines and ICH/GCP.

• Proven experience working with investigators, external experts and regulatory agencies and oversight of Contract Research Organizations and third-party vendors including realigning with CRO partners when deliverables are at risk, negotiating solutions and leading After Action Reviews to share lessons learned.

• Excellent project management skills and budget management skills.

Preferred Skills:

• Proven success working with vendor systems/portals (e.g., eTMF, EDC, IRT, CTMS)

• Oncology experience, early and/or late stage, strongly preferred.

• Knowledge and/or familiarity with Ex-US region(s) clinical trial operations

• Experience in working with cooperative group studies and investigator sponsored trials preferred. 

  #LI-Hybrid  #LI-DN1