Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines, the next frontier in innovative drug design aimed at improving treatment options for patients with cancer and inflammatory diseases. Powered by a fully AI-integrated discovery engine capable of tackling any protein class, and coupled with unparalleled ligase expertise, Nurix’s dedicated team has built a formidable advantage in translating the science of targeted protein degradation into clinical advancements. Nurix aims to establish degrader-based treatments at the forefront of patient care, writing medicine’s next chapter with a new script to outmatch disease.

Job Summary:

As a key member of the cross-functional Development Team responsible for providing regulatory writing expertise and leadership to formulate the writing strategy for key regulatory documents for submission. The Sr. Director, Head of Regulatory & Medical Writing will be responsible for providing guidance to the medical and or regulatory writing group (contractors and internal writers) assigned to deliverables and ensuring appropriate work allocation and document preparation.; will also provide review and substantive editing of documents to ensure delivery of high-quality documents. This individual will work effectively with many other functional groups, including with Clinical Scientist(s), Medical Monitors, Regulatory and other functions as applicable, and collaborate with clinical medical writing as applicable to ensure scientific excellence in the execution of clinical trials. The Head of Regulatory Writing will build a medical writing group internally when appropriate.

Reporting to the SVP, Head of Regulatory Affairs, this role will be responsible for the regulatory writing & medical writing deliverables of assigned project(s), in accordance with the agreed timelines and quality standards.

Responsibilities:

• Ensure appropriate allocation of internal and external resources needed for all regulatory writing deliverables.
• Hire and manage medical writers internally and manage external medical writing contractors.
• Forecasting and maintaining budget for the regulatory writing team.
• Assess efficiencies, help identify areas of improvement and initiate improvement processes.
• Coordinate, author and edit documents used to support clinical trial conduct and reporting including but not limited to:
• Clinical study protocols and clinical protocol amendments (in partnership with Clinical Science/Clinical Development)
• Clinical study reports
• Investigator’s brochures and annual updates
• IND submissions and annual reports
• Lay-person summary
• Integrated summary reports
• Clinical, Nonclinical and Multidisciplinary Information Amendments
• NDA, BLA, MAA, (e)CTD submissions
• Risk Management Plans
• Health Authority responses
• Briefing Documents, ODDs, BTDs/PRIME, FTD etc
• Participate in relevant subteam(s) and ensure effective planning and management of timelines for all components of assigned documents across all projects.
• Participate in document strategy sessions, including messaging, document flow, logic, and consistency for assigned projects.
• Support and develop deliverables required for global transparency and disclosure requirements (e.g., plain language lay summary, applicable redactions to regulatory documents subject to EU posting regulations and results for EU CTR).Partner with Biometrics in developing standard TFLs and in text tables for deliverables as applicable
• Maintain and support developing and reviewing standard processes and templates.
• Review and edit documents as required.
• Work effectively and lead in cross-functional working groups.

Qualifications:

• Candidates must have a BS with 15+ years, or MS or other advanced science degree (e.g.: RN, NP, MSN, PharmD, PhD, MD) with 10+ years of experience in oncology clinical research experience as a clinical or regulatory medical writer within the pharmaceutical/biotech industry.
• Prior experience leading a regulatory writing group
• Experience writing/leading the writing of critical clinical documents in major regulatory filings (NDA, BLA, MAA).
• Proficiency in the use and understanding of computer software e.g. word processing, graphics, reference manager, document management systems.
• Familiarity with all phases of drug development processes (discovery to market), clinical study protocol design, CTA/IND submissions, investigator’s brochures and clinical study data collection and results reporting.
• Advanced knowledge of routine document content preparation, including the use of style guides, medical dictionaries, and regulatory guidance documents and templates.
• Experience writing, at a minimum, protocols (Phase 1-3, in oncology), investigator’s brochures, clinical study reports, Health Authority briefing packages, and Health Authority responses. Experience with Pediatric Investigational Plans (PIPs) is preferred.
• Advanced understanding/knowledge of regulatory requirements and drug development processes, Good Clinical Practice (GCP), regulatory requirements and guidelines associated with regulatory documents (e.g., protocols, investigator brochures, and clinical study reports).
• Ability to interpret and summarize complex tabular and graphical data presentations.
• Strong organization, documentation and communication skills with an ability to multitask.
• Adaptable / flexible, willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism.
• Detailed knowledge of GCP, ICH Guidelines and current US FDA regulations.

Nurix Therapeutics, Inc. is committed to protecting and respecting your privacy and personal information, including information collected by Nurix when you apply for a job with Nurix or in the course of your employment with Nurix. By applying for a position at Nurix, you agree to our collection and use of personal information as described in our Privacy Policy (https://www.nurixtx.com/privacy-policy/).

Position Title:  

Associate Director, Regulatory Affairs (Strategy, Hematology Oncology)

Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines, the next frontier in innovative drug design aimed at improving treatment options for patients with cancer and inflammatory diseases. Powered by a fully AI-integrated discovery engine capable of tackling any protein class, and coupled with unparalleled ligase expertise, Nurix’s dedicated team has built a formidable advantage in translating the science of targeted protein degradation into clinical advancements. Nurix aims to establish degrader-based treatments at the forefront of patient care, writing medicine’s next chapter with a new script to outmatch disease.

Job Summary:

Nurix Therapeutics, Inc. is seeking a Manager/Sr. Manager/Associate Director, Regulatory Affairs (Strategy, Hematology Oncology) to join the Regulatory team.  The successful candidate will be a core member of the Regulatory team and will be responsible for helping build and execute on global regulatory strategy, objectives, policies and programs pertaining to development and future marketing of products for guiding and executing upon regulatory strategy of compliant, high quality, nonclinical and clinical submissions and interactions in support of early development, registration and life cycle management activities. This includes supporting regulatory activities to enable clinical development plans and studies, working cross-functionally across the organization.

Responsibilities:

• Provides regulatory strategic direction and support for assigned global development programs/development program activities
• Assists Sr. Regulatory Affairs staff with their development program activities and deliverables
• Designs and implements regulatory strategies with Regulatory Affairs staff to obtain and maintain product investigative and marketing applications for assigned programs, as well as their life cycle management
• Acts as regulatory representative on early and/or late phase clinical studies, ensuring compliant execution of trials
• Strong competency in understanding regulatory requirements and emerging regulatory landscapes associated with US and global regulatory authorities
• Experienced in responding to inquiries from global regulatory authorities as well as the preparation and conduct of meetings with global regulatory authorities
• Assist in the preparation and maintenance of Annual Reports, Development Safety Update Reports (DSURs), Investigator’s Brochures and other documents required for INDs, CTAs, NDAs and other related regulatory development and marketing applications
• Assist in the cataloging and maintenance of regulatory application submissions
• Conduct research and stay up-to-date on regulatory requirements and changes
• Collaborate with cross-functional teams to ensure product compliance throughout the development lifecycle
• Monitor and assess regulatory risks and develop mitigation strategies
• Oversee quality assurance processes to ensure compliance with regulatory standards
• Review SOPs pertaining to Regulatory
• Works strategically with all regulatory functions to develop detailed, actionable submission plans, tracks major submission deliverables, and ensures consistent management submission documents, health authority communications, and all other regulatory information supporting Nurix’s investigational and marketing applications
• Plays an essential part in defining requirements for, implementing, and supporting future systems and tools to be employed by Nurix in the areas of document management, submission content planning, and regulatory information management
• Tracks the status of major deliverables for regulatory submissions (e.g., study reports, summary documents, labeling) along with their dependencies
• Develops and maintains submission plan templates to ensure Nurix regulatory submissions are consistently planned and executed across programs
• Participates in cross-functional process initiatives impacting regulatory submission processes and systems
• Manages consultants and contractors as needed

Experience and Skills:

• Bachelor's degree in life-sciences or related scientific discipline; advanced degree preferred Manager:
• Must have minimum of 8 years in Regulatory affairs strategy
• Strong demonstration of knowledge of drug development, FDA, EMA and ICH guidelines and regulations
• Experience providing hands-on support for planning clinical trial and marketing applications to health authorities including but not limited to FDA, EMA
• Ability to read, analyze and interpret scientific and technical information, as well as regulatory
• Ability to understand and explain detailed regulatory affairs and compliance programs and/or to effectively present information to senior regulatory management, other departments or external
• Ability to comply with changing regulatory
• Proven track record of supporting Regulatory affairs in the planning and execution of major filings and ongoing maintenance of clinical trial and marketing applications
• Strong project management and critical thinking skills
• Experience applying project management techniques and tools (e.g., MS Project, Smartsheet, Excel trackers) to the planning and execution of regulatory submissions
• Excellent organizational and communication skills, both written and verbal
• Ability to work independently as well as part of a team environment
• Positive attitude, energetic and proactive
• Proven ability to manage multiple projects, identify and resolve regulatory issues
• Strong interpersonal skills and the ability to effectively work with others

Nurix Therapeutics, Inc. is committed to protecting and respecting your privacy and personal information, including information collected by Nurix when you apply for a job with Nurix or in the course of your employment with Nurix. By applying for a position at Nurix, you agree to our collection and use of personal information as described in our Privacy Policy (https://www.nurixtx.com/privacy-policy/).

Summary:

A hands-on role providing both strategic and operational activities. This role develops and executes multi-product global regulatory CMC strategies for investigational products and leads the preparation and filing of regulatory CMC submissions. Manages interactions with Health Authorities for CMC topics. Provides regulatory CMC guidance to various cross-functional teams and ensures all applicable global regulatory requirements are considered and incorporated into product development. Conducts routine regulatory surveillance and communicates new/changing regulations.  

Essential Functions:

• Leads the preparation and review of CMC sections of global regulatory submissions, as well as the interactions and responses with regulatory agencies
• Member of technical development teams which require experienced interpretation of applicable EMA/FDA/ICH/Global regulations to ensure CMC compliance
• Defines CMC content (data and documentation) requirements for regulatory submissions and compiles/reviews this content for conformance with established requirements
• Provides CMC regulatory guidance to cross-functional teams and key stakeholders
• Manages regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations throughout development
• Leads projects with cross-functional teams and acts as the primary regulatory CMC contact for assigned products and projects
• Represents company in Health Authority meetings and leads or supports CMC preparation activities for meetings with Health Authorities on CMC related matters
• Stays abreast of current and evolving regulatory CMC requirements, applies this knowledge to assigned projects, and shares knowledge and experience with others to support their development
• Participates in the design, development and implementation of department strategies, providing recommendations in area of expertise

Requirements:

Bachelor’s Degree in a scientific discipline (e.g. Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices). Minimum 10 years of experience working in vaccine or biotech industry, or in a related field, or the equivalent combination of education and experience. Other combinations of education and/or experience may be considered.

• Prior experience preparing/authoring CMC DS sections:
• BLA highly preferred.
• Post-approval supplements/variations highly preferred.
• INDs/IMPDs.
• Prior development or manufacturing experience is a plus.
• Computer software skills (LIMS, SAP, TrackWise, Veeva will be used).
• Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency.
• Excellent interpersonal skills to communicate difficult concepts.

• Strategic thinking and strong problem-solving skills
• Collaborates and communicates in an open, clear, complete, timely, and consistent manner
• Strong sense of planning and prioritization, and the ability to work with all levels of management
• Advanced knowledge in regulatory (FDA, EMA, Health Canada and ICH) guidelines

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

Role Overview

We are seeking a Sr. Technical Product Manager to lead the strategy and execution of data product, AI/ML system, AI-powered tooling, and automation initiatives across the go-to-market and operational teams embedded within Natera’s core business units (i.e., Oncology, Women’s Health, Organ Health), including Sales, Marketing, and Medical stakeholders. 

This role focuses on building, scaling, and leveraging platforms and products that power decision intelligence and activity orchestration across these domains. You will work in close collaboration with ‘S&M + GM’ leaders while building through centralized Data & AI organization platforms, standards, and governance. You will own the full product lifecycle from discovery through production, ensuring solutions are adopted, trusted, and deliver measurable business impact. In doing so, you will work hands-on as an empowered builder of AI and software solutions to improve workflow efficiency, productivity, and quality for the teams you support.

This is a technical product role requiring fluency in data systems, modern data platforms, ML, and AI implementation patterns (and the ability and drive to build with them directly), combined with strong experience and stakeholder intuition across Sales, Marketing, Medical, and related functions.

This role sits at the intersection of business impact and technical depth, with deep visibility into commercial performance and executive decision-making. You will have direct ownership of high-impact initiatives fueling overall organizational success.

What You’ll Do

Strategy & Roadmap

• Define and own the Data & AI product strategy and roadmap for the S&M + GM pod by deeply partnering with business leaders to proactively identify high-impact opportunities, shape problem definitions, and drive aligned priorities
• Translate ambiguous business problems (e.g., churn risk, campaign performance, clinical profile segmentation, next-best-action orchestration) into clear product direction and measurable outcomes
• Own the line between ‘what the business needs’ and ‘what gets built’ end-to-end

Discovery, Experimentation, & Requirements

• Develop deep context on the domain so you can proactively propose solutions rather than field requests
• Be hands-on with data: query datasets, review schemas, and validate assumptions through analysis
• Lead end-to-end product discovery with interviews, workflow mapping, data assessments, ROI modeling, etc.
• Define clear product requirements (PRDs, user stories, acceptance criteria) and success metrics
• Design and run experiments to validate product performance and measure causal impact
• Establish leading indicators and KPIs for proactive product and process health assessments

Delivery, Data, & ML Lifecycle

• Partner with data and AI/ML engineering resources to deliver scalable products and capabilities
• Guide development of robust data pipelines and unified data models (360° views across key entities)
• Own the end-to-end ML lifecycle: feature definition, evaluation, deployment, monitoring, drift detection, and retraining
• Ensure training–serving consistency, model versioning, and clear deployment decision gates
• Establish strong observability across data pipelines and models (data quality, latency, reliability, cost)

AI Productization & Hands-On Building

• Define and implement AI product patterns, including agentic workflows and tool/function-calling integrations
• Build process automations and internal tools that improve workflow efficiency, productivity, and output quality for the teams you support
• Establish evaluation frameworks for LLM-powered features (faithfulness, relevance, safety, cost, latency)
• Implement prompt strategies, guardrails, and continuous evaluation pipelines

Governance, Compliance, & Data Quality

• Ensure products meet regulatory and compliance requirements
• Champion data quality, lineage, and reliability through data contracts and observability standards
• Maintain strong documentation practices (e.g., model cards, dataset documentation, audit trails)
• Partner with governance teams (Security, Legal, Compliance, AI Governance) to operationalize AI responsibly

Adoption, Change Management, & Impact

• Launch products with supporting enablement activities to ensure solutions are embedded in workflows with confidence
• Partner with stakeholders to integrate products into proactive, day-to-day decision-making
• Monitor product usage, performance, and business outcomes to iterate based on data and feedback
• Quantify and communicate impact (e.g., revenue lift, cost reduction, cycle time improvements, forecasting accuracy)
• Influence across Sales, Marketing, Medical, and GM stakeholders through delivery, not authority

Qualifications

Required

• 7+ years of relevant experience (e.g., product management, applied AI/ML engineering, technical founder, forward-deployed engineering), including 3+ years building data products, AI/ML systems, or related platforms
• Demonstrated domain fluency in Sales, Marketing, Field Medical, and/or related commercial/GTM functions 
• Strong understanding of sales funnel, marketing funnel, medical affairs funnel, and related funnels to relate product ideas to the overall opportunity landscape
• Familiarity with key domain-relevant tooling (e.g., Salesforce) and associated data 
• Strong technical capability (e.g., comfortable scripting, performing EDA, with AI-aided application development)
• Hands-on experience shipping LLM-powered features or automations (e.g., prompting, RAG, tool/function calling, agentic orchestration, evals)
• ML/MLOps literacy (evaluation metrics, experimentation, feature stores, CI/CD, monitoring, drift)
• Familiarity with modern data stacks (e.g., Snowflake, dbt, AWS/SageMaker, Airflow/Dagster)
• Strong stakeholder leadership and communication skills, with the ability to work across technical and business teams
• Experience working in regulated environments (e.g., healthcare, life sciences, fintech)

Preferred

• Experience in healthcare, diagnostics, life sciences, and/or digital health
• Familiarity with healthcare data domains and systems
• Experience with vendor evaluation, platform selection, or external AI tooling ecosystems
• Advanced degree in a technical and/or business discipline

What Success Looks Like

• Production-grade data and AI products are deployed and embedded in day-to-day decision-making workflows
• Process automations and internal tools you build are reducing manual effort and improving output quality across the teams you support
• Measurable improvements seen in key business metrics (e.g., increased sales efficiency, better campaign performance)
• Reliable, high-quality data foundations connect patient, clinical, financial, and commercial insights end-to-end
• AI systems are continuously monitored, evaluated, and improved with measurable business impact
• Stakeholders trust and adopt implemented solutions across both corporate and business-unit teams
• Internal teams have transparent access to the function’s roadmap, trust in delivery against it, and visibility into the evaluation logic that prioritizes initiatives based on their impact to organizational goals

Senior Manager, Government & Industry Affairs Operations

VGW is an interactive entertainment company, harnessing technology and creativity to deliver world-class, free-to-play online social games.

We have an exciting opportunity to join our Government & Industry Affairs team in the United States and are currently looking for a Senior Manager, Government & Industry Affairs Operations to join the team. 

This is a newly created role that will play an important part in helping VGW coordinate and execute its government affairs activity across the US. You will be responsible for bringing structure, discipline, and clear operating rhythm to a complex, multi state lobbying network, ensuring our external partners are well coordinated, accountable, and aligned to business priorities.

You will work closely with Government Affairs, Legal, Marketing, and external lobbying partners to ensure activity is well planned, compliant, and clearly tracked.

We’re open to candidates based anywhere in the US, and this role can be performed remotely. We do not currently have a US office, but occasional in person office attendance may be required if that changes in future.

The salary range  for this role is USD $200,000 - $230,000 per year.

Key responsibilities will include:

• Managing the day to day operations of VGW’s external lobbying contractors, ensuring activity is clearly understood, tracked, and delivered.
• Supporting compliance across VGW’s lobbying activity, including oversight of relevant registrations, disclosures, and state and federal requirements.
• Establishing a single source of truth for legislative tracking, reporting, and key activity across the lobbying network.
• Building dashboards, reporting frameworks, and quarterly operating reviews tied to clear KPIs for lobbying firms.
• Developing detailed execution plans and ensuring strong cross functional alignment across Government Affairs, Legal, Marketing, and other relevant teams.
• Driving accountability with external partners, including performance tracking, budget oversight, resource allocation, and renewal decisions.

What you will bring to the role:

• 8 plus years of experience in government affairs, public policy, lobbying operations, regulatory affairs, or a related field.
• Experience supporting lobbying or government affairs activity in fast moving, high growth, or highly regulated industries.
• Strong multi state coordination skills, with the ability to manage a complex network of external partners, priorities, and deadlines.
• A highly organised and operationally focused approach, with a track record of creating structure where it does not already exist.
• Strong vendor and contract management experience, including the ability to drive accountability and assess performance.
• The ability to read complex regulatory, legislative, or legal materials and translate the practical impact clearly for non technical audiences.
• Experience building tracking, documentation, reporting, or operating systems from scratch and ensuring they are adopted successfully.

About VGW

VGW is an interactive entertainment company, harnessing technology and creativity to deliver world-class, free-to-play online social games.

Our high-quality, acclaimed brands include Chumba Casino, Global Poker and LuckyLand Slots, which are enjoyed by millions of players in North America.

Our games are based on a freemium model, meaning they are available to play at no cost, but include optional in-game purchases to enhance gameplay. We also offer sweepstakes promotions where players can collect free entries for the chance to win real-world prizes.

At VGW, one of our core values is “our players come first”. This means always striving to deliver a safe, responsible and positive player experience.

Why VGW?

At VGW, we’re more than just a team. We’re a diverse and inclusive group of individuals, each playing a vital role in our success.

Our core values are clear and strong; we win together, do what’s right, put our players first and are powered by passion.

We believe in our people and are committed to creating an environment where everyone feels welcome, inspired, and supported. We recognise that life is more than just work - that’s why we’re all about flexibility so you can strike a healthy balance between your personal life and career. We’re also here to champion your growth in your current role and future aspirations, providing opportunities for learning and career advancement. And to top it off, we back this all up with competitive compensation, perks and benefits.  

But it’s not all business. We inject fun into the workplace, celebrate together and create lasting memories, from a mix of in-person and online events, to social gatherings and much more.

It’s our combined skills, ideas and visions that drive us forward. Join us on this exciting journey, and together, we’ll achieve remarkable things. 

If you want to join a team that does things differently, apply today - we look forward to seeing what you can bring to our team.

Find out more at www.vgw.co

#LI-JG1

#LI-Remote

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:

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

About the Role >>> Submission Content Manager, Regulatory Operations 

The Submission Content Manager plays a critical role within Regulatory Operations by preparing regulatory submission documents for final publishing and delivery to global health authorities. This position ensures that all documents meet technical, formatting, and eCTD (Electronic Common Technical Document) requirements prior to formal submission. The role partners closely with Regulatory Affairs, Medical Writing, CMC, Nonclinical, and Clinical teams to ensure high-quality, compliant, and timely regulatory submissions (e.g., INDs, NDAs, MAAs, amendments). 

The ideal candidate has strong attention to detail, experience with document management and eCTD standards, and the ability to manage multiple concurrent submission activities in a fast-paced environment. 

This role is based out of either our Cambridge, Ma or San Francisco, Ca office and may require up to 15% travel. 

Your work will primarily encompass: 

Document Preparation & Formatting 

• Prepare and format submission-ready documents, including applying PDF standards, bookmarks, hyperlinks, headers/footers, and accessibility elements
• Ensure all documents meet technical standards (e.g., PDF/A compliance, OCR/searchability, file size limits)
• Verify that tracked changes, comments, draft watermarks, and metadata are removed before pre-publishing
• Serve as a subject-matter expert for the Starting Point templates and provide training, guidance, and support to cross-functional teams on how to use these templates effectively

 Submission Assembly Support 

• Assist Regulatory Operations staff in assembling and preparing eCTD sequences for publishing
• Coordinate with submission teams to confirm final document versions and readiness for publishing
• Track and document issues, risks, and deviations, escalating as appropriate
• Work closely with Regulatory Affairs, Medical Writing, CMC, Quality, and Clinical teams to ensure submission accuracy and completeness

Quality Control & Compliance 

• Perform technical QC checks on documents prior to publishing, ensuring formatting, structure, and completeness
• Develop publishing standards and guidelines in coordination with Regulatory Operations and Medical Writing 
• Ensure all pre-publishing activities comply with company SOPs, regulatory guidelines, and eCTD specifications

Ideal Candidate Profile >>>  

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

Knowledge: 

• Bachelor’s degree is required 
• Knowledge and experience of eCTD submissions 
• Knowledge and experience with enterprise document management systems, preferably Veeva RIM 
• Knowledge and understanding of global industry standards, guidelines, and validation concepts, including eCTD format and registration tracking 
• Experience with StartingPoint eCTD templates or equivalent 

 Experience: 

• Minimum 3+ years pharmaceutical industry experience in Regulatory Affairs, Regulatory Operations or Medical Writing
• Demonstrated leadership skills while working in a fast paced and changing environment
• Experience in building and submission of NDA and life-cycle management is highly desirable

Attributes: 

• Displays strong proactive acumen and inclusive way of engagement to drive decision making, turnaround time improvement and effective ways of working 
• Influences the cross-functional team to adapt fit-for purpose solutions to meet the expected timelines 
• Ability to understand, analyze and develop recommendations from multiple complex sources such as scientific and operational perspectives  
• Excellent written and verbal communication skills 
• Excellent negotiation and organizational skills 

The base pay range for this position is expected to be $145,000 - $155,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits. 

#LI-CK1

The Vision

At Okta, growth is our mandate, but a secure foundation is the prerequisite. In the Public Sector, this foundation is the bedrock of national security and citizen trust. As we scale, our focus is evolving beyond the "renewal transaction" toward a holistic strategy of Strategic Retention. We aren't just renewing contracts; we are securing the identity infrastructure of the US Federal Government and State & Local (SLED) agencies.

The Role

We are looking for a high-impact sales leader and strategic architect to lead our Public Sector Renewals team. As the Director, you are the steward of Okta’s largest and most complex public-interest partnerships.

In this role, you will lead a team of high-performing, individual contributor Renewals Managers. You will act as their coach, mentor, and lead strategist, navigating the unique procurement, regulatory, and budgetary landscapes of the Public Sector. You will be responsible for turning territory-level data into actionable retention playbooks, ensuring your team acts with precision, integrity, and long-term vision.

Core Responsibilities

1. Strategic Retention & Territory Architecture

• Segment Leadership: Own the retention strategy and execution for Okta’s Public Sector business, covering both US Federal and SLED markets.
• High-Value Deal Strategy: Act as the lead executive and strategic advisor for the segment’s most complex, high-stakes agreements, including those exceeding $5M+ in ARR.
• Predictive Intelligence: Move beyond basic forecasting to develop a deep, programmatic understanding of territory health, identifying risks early and designing "Path to Green" strategies that ensure long-term account stability.
• Retention Architect: Design and implement modern renewal playbooks that account for the unique cycles of public sector procurement, ensuring that our approach is proactive rather than reactive.

2. Leadership & Team Evolution

• The Leader as Coach: Manage and mentor a team of individual contributors, assisting them in navigating high-pressure negotiations and complex customer environments.
• Cultural Architect: Foster a culture of high accountability, integrity, and relentless customer focus. You will be responsible for recruiting, hiring, and developing the next generation of Public Sector renewal talent.
• Field Advocacy: Act as the voice of the Public Sector within the broader Renewals organization, ensuring that global processes are optimized for the nuances of government customers.

3. Diplomatic Power & Cross-Functional Partnership

• Sales Alignment: Partner as a peer to Public Sector Sales Leadership to ensure a unified strategy for account growth and retention.
• Government Affairs & Compliance: Collaborate closely with Government Affairs and Legal teams to stay ahead of regulatory shifts (e.g., FedRAMP) and procurement hurdles that impact our ability to retain and grow.
• Customer Success & Product Feedback: Drive a tight feedback loop with Customer Success and Product teams, ensuring that the "ground-level" reality of our government customers informs our long-term product and service roadmap.

Qualifications

• Experience: 10+ years in Renewals, Sales, or Account Management within the SaaS industry, with a minimum of 3-5 years in a high-performing leadership role.
• Public Sector Mastery: A proven track record of navigating US Federal and SLED procurement cycles, including experience with large-scale, $5M+ license agreements.
• Strategic Translator: The ability to take complex data sets and translate them into simple, winning tactics for the field.
• Negotiation Excellence: Expert-level negotiation skills with the ability to tactfully close high-value deals with a high degree of integrity and independence.
• Diplomatic Influence: Exceptional ability to partner cross-functionally with Sales, Customer Success, Product, and Government Affairs to drive collective outcomes.

Measures of Success

• Net Retention & ARR Growth: Achieve or exceed team goals for renewal rates and total ARR stabilization within the Public Sector.
• Operational Excellence: Maintain a highly accurate and predictable forecast for the segment.
• Talent Development: High engagement and performance scores from your team of Renewals Managers.

Cross-Functional Impact: Successful implementation of new retention playbooks that bridge the gap between Sales and Renewals.

#LI-Hybrd

#P25154_3426080

We are seeking a highly skilled and experienced Director of Health Economics and Outcomes Research (HEOR) with a strong focus on Oncology to join our team. The ideal candidate will play a critical role in leading and shaping the global HEOR and evidence strategy across both pipeline and launched oncology products to inform regulatory decision making and drive market access, reimbursement, and lifecycle value management globally.

This position involves working cross-functionally with Medical Affairs, Market Access, and Clinical Development to ensure alignment between evidence generation and strategic objectives. This role offers the opportunity to drive scientific leadership and innovation, developing new methodologies and evidence strategies to enhance the understanding of the value of oncology treatments and advance the organization’s mission of delivering life-changing therapies to patients worldwide.

Responsibilities:

• Execute integrated global HEOR strategies across pipeline and marketed oncology products, ensuring alignment with regulatory, market access, and reimbursement requirements across key geographies
• Contribute to and drive execution of end-to-end evidence generation plans across the product lifecycle, integrating clinical, economic, and real-world evidence to support value demonstration and access
• Execute and oversee the development of ex-US value Dossiers, ensuring alignment with clinical, economic, and epidemiologic evidence to support payer and HTA requirements
• Oversee the design and execution of real-world and observational studies (e.g., retrospective studies, prospective cohorts, registries) to generate evidence on effectiveness, safety, treatment patterns, and healthcare resource utilization
• Lead the development and adaptation of cost-effectiveness and budget impact models, ensuring alignment with global and local market access strategies and payer expectations
• Lead the design and execution of indirect treatment comparisons, external control analyses, and other comparative effectiveness approaches, ensuring methodological rigor and alignment with HTA expectations
• Oversee the development of systematic literature reviews and evidence syntheses to support HTA submissions, modeling inputs, and broader evidence strategies
• Provide strategic input into HTA submissions and payer engagement, ensuring that evidence packages address key uncertainties and support favorable reimbursement outcomes in global markets
• Drive innovation by advancing methodological approaches in health economics, epidemiology, and outcomes research, including novel frameworks to support value demonstration
• Identify and leverage appropriate real-world data sources (e.g., EHR, claims, registries) and establish external partnerships to support timely and high-quality evidence generation
• Develop and deliver clear, data-driven insights to internal leadership and external stakeholders, supporting alignment on the value proposition of oncology therapies
• Demonstrate strong leadership across cross-functional and cross-regional teams, fostering collaboration and driving high-quality, timely execution
• Uphold Corcept’s Key Principles by driving Collaboration, Embracing Possibility, Following the Data, and Leading by Doing, ensuring all initiatives align with the company’s ethics and patient-first mission

Preferred Skills, Qualifications and Technical Proficiencies:

• Proficiency in advanced statistical and modeling techniques for economic evaluation (e.g., Markov models, decision trees, cohort simulations)
• In-depth knowledge and ability to apply knowledge of US and global healthcare systems, global HTA requirements, and clinical development, to identify evidence gaps and formulate evidence generation and communication strategies
• Generate peer-reviewed publications to communicate study findings in scientific channels in alignment with the product publication strategy and the overall HEOR evidence generation strategy
• Expertise in the preparation and delivery of high-quality, evidence-based health economic reports and presentations to stakeholders at various levels (internal teams, HTA bodies, payers)
• Strong project management skills, with the ability to manage multiple priorities and deadlines
• Excellent communication and presentation skills

Preferred Education and Experience:

• Advanced degree (PhD, MSc, or equivalent) in health economics, public health, health policy, statistics, or a related field. A focus on oncology is highly desirable
• 10+ years of experience in HEOR, with a strong background in oncology
• Demonstrated ability to lead cross-functional initiatives and influence senior stakeholders
• Proven experience in global HEOR strategy, HTA submissions, and payer engagement
• Strong expertise in health economic modeling, RWE, and comparative effectiveness research
• Demonstrated expertise in indirect treatment comparisons, real-world evidence generation, and observational study designs (e.g., registries)
• Strong understanding of US & EU healthcare systems, reimbursement pathways, and payer requirements
• Strong communication and presentation skills, with the ability to translate complex data into actionable insights
• 15% with travel as required

The pay range that the Company reasonably expects to pay for this position is $209,100 - $276,800; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.

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

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

Follows guidance from the senior leader to deliver and implement customer training and support. Performs virtual and onsite visits for imaging site support. Denver, Los Angeles, or Dallas based. 

Responsibilities

• Communicates with imaging partners to increase efficiency and quality of performed scans through education of CCTA best practices for: patient preparation, acquisition, reconstruction, and heart rate control;
• Performs virtual and onsite support events with our imaging partners;
• Organizes and leads training events
• Attends or reviews recording/AI Companion notes for all assigned meetings;
• Reports and documents all related concerns and recommended process improvements to imaging sites and leadership;
• Demonstrates Cleerly software;
• Collaborates with other departments and CT vendors to standardize best practices for image quality and workflow efficiency.
• In person (25% - 50% required travel);
• Travel within the US and International;
• In virtual meetings (50% - 75%);

Required Competencies

• ARRT (CT) required;
• Minimum level of education is an associate degree in radiologic technology or equivalent;
• 2+ years Coronary CTA experience;
• Basic Computer Software Knowledge.

Soft Skills            

• Communication: Clear, concise communication to convey plans and initiatives to team members and stakeholders;
• Critical thinking: evaluate various planning scenarios, anticipate challenges;
• Adaptability: adjust plans in response to unexpected developments;
• Coachability - willingness to Learn;
• Collaboration: cross-functional projects;

The base salary range for this role varies by location and is aligned to market benchmarks.

• Candidates located in higher-cost labor markets, including California, Washington, New York, New Jersey, Connecticut, Massachusetts, and Washington, DC represent the middle to high end of the range, while candidates located in all other U.S. locations represent the low to middle end of the range.
• Final compensation is determined based on location, experience, skills, and internal equity.

This role is eligible for a 10% target annual bonus, resulting in the following base salary and Total Target Compensation (TTC) ranges:

• Base Salary: $103,000 - $108,000
• TTC: $113,300 - $118,800

*Total Target Compensation (TTC): Total Cash Compensation (including base pay, variable pay, commission, bonuses, etc.) Additionally, stock options, paid benefits, and employee perks are part of your total rewards.

About Zipline 

Do you want to change the world? Zipline is on a mission to transform the way goods move. Our aim is to solve the world’s most urgent and complex access challenges by building, manufacturing and operating the first instant delivery and logistics system that serves all humans equally, wherever they are. From powering Rwanda’s national blood delivery network and Ghana’s COVID-19 vaccine distribution, to providing on-demand home delivery for Walmart, to enabling healthcare providers to bring care directly to U.S. homes, we are transforming the way things move for businesses, governments and consumers. The technology is complex but the idea is simple: a teleportation service that delivers what you need, when you need it. Through our technology that includes robotics and autonomy, we are decarbonizing delivery, decreasing road congestion, and reducing fossil fuel consumption and air pollution, while providing equitable access to billions of people and building a more resilient global supply chain. 

About the Role:

As the Regional Construction Manager you will own and drive all aspects of project construction to establish Zipline’s ground infrastructure in the region. This includes managing the entire process from contractor evaluation, contracting and bid evaluation, design review in partnership with our engineering teams, through to full scope site construction management and project competition  and oversight in partnership with our Service Operations and Superintendent teams. You’ll work closely with the broader Deployment and Construction team, Real Estate and Government Affairs teams, Finance, Legal, and Engineering to build strong relationships with key stakeholders and secure the necessary approvals to expand our network.

You will lead negotiations, manage external vendors, and ensure project timelines are met, all while maintaining alignment with Zipline’s strategic goals. Zipline’s Community Engagement and Legal teams will support you in fostering local partnerships and navigating jurisdictional processes to fast-track approvals.

WHAT YOU’LL DO

• Manage construction projects, site infrastructure installments, construction contractors, and additional real estate development projects ensuring schedule and cost targets are met or beaten.
• Develop and lead pre-construction strategies to streamline entitlements and permits for our ground infrastructure.
• Build and maintain strong relationships with City Managers, staff, and City Council members and inspectors to facilitate smooth approvals and permit completion from Planning and Zoning commissions and AHJ’s. 
• Collaborate closely with jurisdictions, land use counsel, and our Legal team to create pathways for drone delivery in evolving regulatory landscapes.
• Work with customer real estate teams to seamlessly integrate Zipline systems into both existing and newly designed infrastructure.
• Source and foster relationships with external stakeholders, including local jurisdictions, utilities, and contractors.
• Identify and mitigate risks associated with pre-construction and construction phases.
• Engage with partners’ Real Estate and Government Affairs teams to ensure alignment on expectations and timelines.
• Source and manage general contractors and subcontractors across various trades (construction, assembly, electrical) during bid, pre-construction, construction and site commissioning project phases. 

WHAT YOU’LL BRING

• Bachelor’s degree in Civil, Real Estate Development, Finance, Business Administration, Urban Planning, Architecture, Construction Management, or a related field 
• 6+  years of experience in real estate development or construction.
• Proven ability to manage entitlements and permits for infrastructure projects in collaboration with customers’ Real Estate and Construction teams.
• Strong communication skills with the ability to align internal stakeholders on project requirements and provide leadership with regular updates on challenges, risks, and opportunities.
• 4+ years of experience working with external design teams (Architectural, Structural, Civil, MEPs) on commercial real estate or construction projects.
• Familiarity with working alongside Authorities Having Jurisdiction (AHJs) to navigate permitting and inspection processes.
• Familiarity with construction software such as Bluebeam, Procore, and similar tools.
• Ability to travel frequently 75%+ with a near term focus in West Coast Region, an travel to our head offices in California and other domestic states, and possible international travel to support expansion projects.
• Must be eligible to work in the U.S.

What Else You Need To Know

Zipline is an equal opportunity employer and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws or our own sensibilities.

We value diversity at Zipline and welcome applications from those who are traditionally underrepresented in tech. If you like the sound of this position but are not sure if you are the perfect fit, please apply!

If you’d like to learn more about Zipline and our teams, feel free to check out our Instagram, one of our Reddit AMA’s, or our website!

About the Role

As the Associate Regional Construction Manager you be a key stakeholder in driving all aspects of project construction to establish Zipline’s ground infrastructure in the region. This includes supporting the entire process from contractor evaluation, contracting and bid evaluation, design review in partnership with our engineering teams, through to full scope site construction management and project competition  and oversight in partnership with our Service Operations and Superintendent teams. You’ll work as a lead to the Construction Management team in region and with the broader Deployment team, Real Estate and Government Affairs teams, Finance, Legal, and Engineering to build strong relationships with key stakeholders and secure the necessary approvals to expand our network.

You will lead negotiations, manage external vendors, and ensure project timelines are met, all while maintaining alignment with Zipline’s strategic goals. Zipline’s Community Engagement and Legal teams will support you in fostering local partnerships and navigating jurisdictional processes to fast-track approvals.

This role is well suited to an early career Construction Manager looking to take on more scope, responsibility and ownership across the entire project lifecycle - if you are looking to do more, see more and own more this is the job for you!

What You'll Do

• Support construction projects, site infrastructure installments, construction contractors, and additional real estate development projects ensuring schedule and cost targets are met or beaten.
• Develop and lead improvements to construction methods and processes.
• Develop and lead pre-construction strategies to streamline entitlements and permits for our ground infrastructure.
• Build and maintain strong relationships with City Managers, staff, and City Council members and inspectors to facilitate smooth approvals and permit completion from Planning and Zoning commissions and AHJ’s. 
• Collaborate closely with jurisdictions, land use counsel, and our Legal team to create pathways for drone delivery in evolving regulatory landscapes.
• Work with customer real estate teams to seamlessly integrate Zipline systems into both existing and newly designed infrastructure.
• Source and foster relationships with external stakeholders, including local jurisdictions, utilities, and contractors.
• Identify and mitigate risks associated with pre-construction and construction phases.
• Engage with partners’ Real Estate and Government Affairs teams to ensure alignment on expectations and timelines.
• Source and manage general contractors and subcontractors across various trades (construction, assembly, electrical) during bid, pre-construction, construction and site commissioning project phases. 

What You'll Bring

• Bachelor’s degree in Engineering (Civil, Mechanical, Structural), Real Estate Development, Finance, Business Administration, Urban Planning, Architecture, Construction Management, or a related field 
• 3+  years of experience in real estate development or construction.
• Strong communication skills with the ability to align internal stakeholders on project requirements and provide leadership with regular updates on challenges, risks, and opportunities.
• Familiarity with construction software such as Bluebeam, Procore, and similar tools.
• Ability to travel frequently 75%+ with a near term focus in West Coast Region, and travel to our head offices in California and other domestic states, and possible international travel to support expansion projects.
• Must be eligible to work in the U.S.

What Else You Need To Know

Zipline is an equal opportunity employer and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws or our own sensibilities.

We value diversity at Zipline and welcome applications from those who are traditionally underrepresented in tech. If you like the sound of this position but are not sure if you are the perfect fit, please apply!

If you’d like to learn more about Zipline and our teams, feel free to check out our Instagram, one of our Reddit AMA’s, or our website!

About the Role >>> Senior Director, Global Regulatory Strategy 

As the Senior Director, Global Regulatory Strategy reporting to the Senior Vice President of Regulatory Affairs, your main responsibilities will include the following:  

• Leading the development and execution of innovative regulatory strategies supporting Olema products  
• Representing Regulatory Affairs on cross-functional teams as the subject matter expert and providing regulatory guidance and oversight to the global project teams
• Providing strategic and tactical guidance and leading the development of regulatory submissions (INDs, CTx, briefing documents, IB, NDA, BLA, IMPD etc.)  

This role is based either out of our Boston, MA or San Francisco, CA office and will require domestic and international travel up to 20%. 

Your work will primarily encompass:  

• Develop innovative global regulatory strategies for the Olema portfolio of products, in clinical development and life-cycle management, as needed  
• Represent Regulatory Affairs as the SME across cross-functional teams and provide regulatory guidance/oversight to the global project teams, Study Execution Teams, and the Executive Committee  
• Stay abreast of the regulatory landscape and regulatory requirements impacting drugs, biologics and devices (e.g., companion diagnostics)  
• Be accountable for, provide both strategic and tactical guidance and lead the development of regulatory submissions (INDs, CTX, briefing documents, IB, NDA, BLA, DSUR, IMPD etc.)  
• Represent Olema with global Health Authorities and lead Agency interactions to achieve company objectives  
• Proactively identify gaps and develop risk mitigation strategies for regulatory submissions in alignment with the team(s) and management 
• Ensure Olema’s regulatory activities are robust and in compliance with Health Authority (HA) regulatory requirements  
• Coordinate and maintain all HA reporting schedules in collaboration of cross-functional teams  
• Serve as the point of contact with external parties and vendors supporting regulatory activities (e.g., CROs, contractors etc)   
• Participate in and contribute to cross-functional and departmental objectives  
• Maintain flexibility to adapt and accommodate additional duties as assigned  

And will also include the following:  

• Lead the development of Regulatory Affairs department policies, SOPs, and work instructions  
• Provide Regulatory guidance and leadership to cross-functional teams on software implementation for Regulatory dossiers (e.g., Veeva)  
• Keep the Leadership and the organization fully informed of the regulatory landscape, including HA initiatives, policies and their potential impact on Olema’s programs  
• Lead the global Regulatory team(s) and ensure execution of the regulatory strategies to achieve company objectives  
• Mentor and develop colleagues in the Regulatory department   

Ideal Candidate Profile  >>> Innovative Experienced Regulatory Strategy Leader  

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

Knowledge:  

• Bachelor’s degree in a scientific discipline  
• Advanced degree in scientific discipline Masters, Pharm D or PhD is preferred   

Experience:  

• 12 years’ experience in Regulatory Affairs in Pharma/Biotech  
• Minimum of 3 years direct leadership experience  
• Strong negotiation skills with health authorities (viz., FDA, EMA, Health Canada, etc.) as well as submissions  
• Experience with leading the NDA/BLA or Marketing Applications is desirable.) 
• Experience in Oncology Therapeutic area is required 
• Experience with development and execution of regulatory strategies in Oncology TA is required  
• Ability to work in a fast-paced environment in a hands-on fashion  
• Excellent oral, written, and presentation skills  
• Strong organizational skills  

Attributes:  

• Self-starter  
• Flexible and proactive, with the ability to manage multiple projects and successfully adapt to changing business needs and priorities

The base pay range for this position is expected to be $270,000 - $290,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits. 

#LI-MK1

Position Title:   Director, Regulatory Affairs (Strategy, Immunology and Inflammation)

Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines, the next frontier in innovative drug design aimed at improving treatment options for patients with cancer and inflammatory diseases. Powered by a fully AI-integrated discovery engine capable of tackling any protein class, and coupled with unparalleled ligase expertise, Nurix’s dedicated team has built a formidable advantage in translating the science of targeted protein degradation into clinical advancements. Nurix aims to establish degrader-based treatments at the forefront of patient care, writing medicine’s next chapter with a new script to outmatch disease.

Nurix Therapeutics, Inc. is seeking a Director, Regulatory Affairs (Strategy, I&I) to join the Regulatory team.  The successful candidate will be a core member of the Regulatory team and will serve as the global regulatory lead (GRL) for the immunology and inflation therapeutic area. This role will be responsible for developing the global regulatory strategy in collaboration with key internal stakeholders, as well as tactical implementation of that strategy guiding and executing compliant, high quality, nonclinical and clinical submissions and interactions in support of early development, registration and life cycle management activities.  This position works cross-functionally with regulatory affairs and clinical development organizations to facilitate the completion of regulatory filing documentation according to company timelines. It also ensures adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as required. This position is on site in the Brisbane, CA office.

Responsibilities:

• Develop and implement competitive and effective global clinical & nonclinical regulatory strategies for various immunology and inflammation indications and identify potential risks and mitigation strategies associated with proposed strategies
• Work in close collaboration with the SVP, Head of Regulatory Affairs and the development team leader and other cross-functional colleagues, including CROs to deliver sound, efficient development strategies and operational plans
• Represent Regulatory Affairs on assigned cross-functional development teams.
• Lead and manage the development and preparation of high-quality global submissions (including IND, CTAs, NDAs, and MAAs) for early and late-stage programs in collaboration with the regulatory and project teams to support and accelerate clinical development and regulatory approval, as applicable
• Lead communication with global Health Authorities (HA), such as FDA and EMA, including, planning and preparing for formal meetings with regulatory agencies and interpreting HA feedback from these interactions.
• Develops and executes, or oversees global regulatory strategy for long-term planning, including the potential to accommodate expedited development needs
• Anticipate issues and guide cross-functional teams on risk mitigation strategies for any development challenges Provides insight and guidance on the implementation of current regulations and assesses regulatory risk based on precedence
• Ensure adherence to current regulations associated with regulatory activities
• Works strategically with all regulatory functions to develop detailed, actionable submission plans, tracks major submission deliverables, and ensures consistent management submission documents, health authority communications, and all other regulatory information supporting Nurix’s investigational and marketing applications
• Plays an essential part in defining requirements for, implementing, and supporting future systems and tools to be employed by Nurix in the areas of document management, submission content planning, and regulatory information management
• Tracks the status of major deliverables for regulatory submissions (e.g., study reports, summary documents, labeling) along with their dependencies
• Develops and maintains submission plan templates to ensure Nurix regulatory submissions are consistently planned and executed across programs
• Participates in cross-functional process initiatives impacting regulatory submission processes and systems
• Manages consultants and contractors as needed

Requirements

• Bachelor's degree in life-sciences or related scientific discipline; advanced degree preferred Manager:
• Must have minimum of 12 years in Regulatory affairs strategy with significant experience in the immunology and inflammation therapeutic area
• Strong demonstration of knowledge of drug development, FDA, EMA and ICH guidelines and regulations
• Experience providing hands-on support for planning clinical trial and marketing applications to health authorities including but not limited to FDA, EMA
• Proven track record of supporting Regulatory affairs in the planning and execution of major filings and ongoing maintenance of clinical trial and marketing applications
• Strong project management and critical thinking skills
• Experience applying project management techniques and tools (e.g., MS Project, Smartsheet, Excel trackers) to the planning and execution of regulatory submissions
• Excellent organizational and communication skills, both written and verbal
• Ability to work independently as well as part of a team environment
• Positive attitude, energetic and proactive
• Proven ability to manage multiple projects, identify and resolve regulatory issues
• Strong interpersonal skills and the ability to effectively work with others

Salary Range:  220K – 254K plus bonus and equity.

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

Company Overview

Tango Therapeutics is a biotechnology company dedicated to discovering novel drug targets and delivering the next generation of precision medicine for the treatment of cancer.

Using an approach that starts and ends with patients, Tango leverages the genetic principle of synthetic lethality to discover and develop therapies that take aim at critical targets in cancer.

This includes expanding the universe of precision oncology targets into novel areas such as tumor suppressor gene loss and their contribution to the ability of cancer cells to evade immune cell killing.

The Tango labs and offices are located at 201 Brookline Avenue, in the Fenway area of Boston, Massachusetts.

Summary 

The Senior MSL is a U.S. field-based role within Medical Affairs, reporting to the Executive Director, Medical Affairs. This role will be a core member of Tango’s growing field medical team during a critical phase of development.

The Senior MSL will be responsible for high‑quality scientific exchange, trial execution support, medical education, and insight generation across priority solid tumor indications, with an initial focus on pancreatic cancer (PDAC), non-small cell lung cancer (NSCLC), and our evolving pipeline programs.

This role is ideal for an individual who wants to operate at the intersection of clinical development, external scientific engagement, and launch readiness in a late-emerging biotech environment, where individual impact is high and scientific accountability matters.

Your role

      Primary Focus: Solid tumors (pancreatic cancer (PDAC), non-small cell lung cancer (NSCLC)

      Scientific Exchange & External Engagement

What You Bring

      Education & Experience

• 8 years of relevant experience with a bachelor’s degree, 6 years with a master’s degree, or 3 years with an advanced scientific or medical degree (e.g., PharmD, PhD, MD) Candidates with advanced clinical degrees (e.g., NP, PA) and significant oncology Medical Science Liaison experience will also be considered.
• Experience in PDAC, GI malignancies, or NSCLC strongly preferred
• Prior experience supporting clinical-stage or pre-launch oncology assets highly valued

      Skills & Attributes

• Strong scientific acumen with the ability to engage deeply on complex biology and emerging clinical data
• Demonstrated strength in insight generation, synthesis, and communication
• Comfortable operating in a fast-moving, high-accountability biotech environment
• Excellent collaboration skills across matrixed teams
• Strong understanding of U.S. clinical research and healthcare environments

      Compliance & Technical Requirements

• Working knowledge of FDA, OIG, ICH, GCP, PhRMA Code, and applicable compliance standards
• Commitment to compliant, ethical scientific exchange
• Proficiency in standard business and field tools (CRM, MS Office, virtual engagement platforms)

Work Environment

• Field-based role in California, with residence required within assigned territory
• ~ 50% domestic travel expected, with significant time spent with external scientific partners

Why Join Tango Medical Affairs?

• Be part of a Medical Affairs team built for a transition from mid-stage to late-stage development
• Contribute directly to trial success, data readiness, and future regulatory and commercialization pathways
• Expand and establish Tango as a credible clinical scientific leader in precision oncology
• Work in a lean, collaborative environment where your scientific judgment and execution matter

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

#LI-Remote

Summary:

Vaxcyte is seeking a Director, Health Economics & Outcomes Research (HEOR) to establish and lead the company’s health economic strategy across the vaccine lifecycle, with initial focus on adult pneumococcal programs. This strategic leadership role will be responsible for developing and executing global health economic models to support payer value propositions, immunization policy engagement, reimbursement strategy, and external stakeholder communications.

This role will focus specifically on health economic modeling and payer value strategy. Observational real-world evidence and epidemiology studies will be led by the Epidemiology & Real-World Evidence function. The Director, HEOR will work in close collaboration with RWE and Epidemiology colleagues to ensure economic models are grounded in robust disease burden, vaccine effectiveness, and coverage assumptions.

As Vaxcyte advances toward commercialization, this role will partner closely with Market Access colleagues, who will lead pricing and contracting strategy. The Director, HEOR will provide the analytic foundation and economic evidence required to inform pricing strategy, payer engagement, and health technology assessment discussions.

Essential Functions:

Health Economic Strategy & Leadership

• Develop and lead Vaxcyte’s HEOR strategy across early development, launch planning, and lifecycle management.
• Define the economic evidence generation plan required to support payer access and policy recommendations.
• Ensure health economic considerations are incorporated early into development planning.

Health Economic Modeling

• Lead development of cost-effectiveness, budget impact, and population health models for adult and pediatric vaccine programs.
• Design and oversee decision-analytic models (e.g., Markov models, microsimulation models, dynamic transmission models as appropriate).
• Establish modeling assumptions grounded in epidemiologic, clinical, and real-world data.
• Ensure all models are scientifically rigorous, transparent, and defensible in policy and payer environments.

Value Communication & Policy Support

• Translate health economic findings into clear, compelling value narratives for internal leadership and external stakeholders.
• Support development of global value dossiers, AMCP dossiers, and materials for payer engagement.
• Contribute to peer-reviewed publications and scientific congress presentations.

Cross-Functional Partnership

• Partner closely with Epidemiology & RWE to integrate disease burden and vaccine effectiveness assumptions into economic models.
• Collaborate with Clinical Development, Regulatory, Medical Affairs, and Market Access teams to align value strategy.
• Support consistent, aligned value messaging across stakeholders.

Capability Building

• Establish best practices and governance processes for health economic modeling.
• Build and manage external modeling partnerships.
• Mentor future HEOR team members as the function expands.

Requirements: 

PhD in Health Economics, Health Services Research, Public Health, Epidemiology, or related quantitative field with 8+ years of relevant industry experience required OR Master’s degree (e.g., MPH, MSc, MBA) with 12+ years of relevant industry experience in health economic modeling.

• Demonstrated experience leading cost-effectiveness and budget impact models.
• Deep expertise in decision-analytic modeling methodologies.
• Experience supporting payer submissions or health technology assessments.
• Strong cross-functional leadership and communication skills.

Summary:

The Quality Control Operations function is an executive role within a matrixed global vaccine organization, responsible for the implementation of Vaxcyte analytical strategies at our CDMO’s and CRO’s. This role is the single point of contact for our CDMO’s and CRO’s to ensure they deliver the quality, accuracy, and compliance of testing and analytical services.  Working closely with the analytical technical lead and other functions within Analytics, Process Development, Analytical and Manufacturing Science and Technology, Quality Assurance, Manufacturing, and Regulatory Affairs, this role provides leadership and oversight for implementation of analytical strategies at the CDMO / external lab supporting analytical readiness and deliverables. The role is accountable that testing and release at our CDMO & CRO is performed in a timely and compliant manner to ensure secure and uninterrupted supply of Vaxcyte’s innovative therapies.

Essential Functions:

• Implement and maintain analytical strategies for process-related, release and stability testing for our programs at our CDMO/contract labs and ensure they are aligned with the CDMO's goals and objectives as well as comply with relevant regulations and industry standards.
• Implement, and maintain robust quality control systems that encompass sampling, testing, documentation, and release procedures.
• Ensure on-time performance for QC testing at our CDMO’s or contract laboratories related to raw materials, intermediates, and drug substance.
• Ensure that contracted QC laboratories are equipped with appropriate instrumentation and equipment, maintained according to regulatory requirements, and calibrated regularly to ensure accuracy and reliability of test results.
• In partnership with analytical technical lead and analytical science and technology as well as the contract laboratories, oversee method validation and transfer activities between contract laboratories.
• Assure that appropriate systems for data management, including secure storage, retrieval, and retention of QC data and documentation are in place. Ensure that all testing activities are well-documented and comply with Good Documentation Practices (GDP).
• Review and approval of analytical data, test reports, and certificates of analysis (CoAs) generated by contract laboratories to verify accuracy, completeness, and compliance with specifications for both release and stability testing.
• Lead and support investigations and deviations, out-of-specification (OOS), out-of-trend (OOT), out-of-expectation (OOE) results, laboratory incidents, and customer complaints related to contract laboratory testing, collaborating with contract laboratories and internal stakeholders to implement corrective and preventive actions (CAPAs).
• Provide technical support for product related regulatory documents and inspections by Health Authorities.
• Writing, review and approval of documents related to Quality Control to ensure compliance with applicable regulatory and industry standards.

Requirements: 

Bachelor of Science with 10+ years of relevant experience in the biotechnology/pharmaceutical industry specifically in Quality Control. Other combinations of education and/or experience may be considered.

• Experience in Pneumococcal vaccines is a plus.
• Excellent experience in managing CDMOs and/or contract laboratories.
• Comprehensive knowledge in cGMP and experience in multi-national regulations.
• Excellent communication, negotiation, and relationship-building skills, with the ability to collaborate effectively with internal and external stakeholders.
• Strong analytical and problem-solving abilities, with a focus on data-driven decision-making and continuous improvement.
• Strong teamwork and interpersonal skills.
• Relentless focus and passion around process improvements (efficiency and automation).
• Experience with digital tools for data management, document review workflows.
• Level of Supervision: General Supervision
• The role will perform a variety of routine work within established policies and procedures. It is expected that the role receives rather high-level project information instead of detailed instructions on a weekly basis and general instructions on new projects and assignments.

The Oncology MSL role is an exciting opportunity to work at a well-established pharmaceutical company that is poised to have a first in class oncology product in a platform extending across multiple therapeutic areas. This role is a chance to join a high performing team that is well-respected in the cross-functional Oncology Business Unit. This will cover the West Territory.

The MSL will represent Corcept to the highest ethical and professional standards and in accordance with guidelines, directions, and policies.

Responsibilities:

• Engage in clinically meaningful scientific discussions with thought leaders in gynecological oncology and other malignancies to enhance their knowledge of Corcept and the role of cortisol modulation in oncology
• Proactively communicate and educate health care professionals on disease states where cortisol modulation may play a role. Provide responsive support when appropriate requests are made. Engage in scientific exchange on Corcept’s non-clinical and clinical trial data as well as the clinical development plan
• Develop and maintain strong working relationships with thought leaders, patient advocacy organizations, and oncology associations (like GOG and ASCO as well as regional organizations) within the oncology community
• Capture, analyze, and communicate insights and intelligence from the medical and scientific community in a compliant manner to help inform decisions by Corcept. Communications will clearly and effectively frame insights in a usable manner
• Support company-sponsored clinical trials, investigator-initiated studies (IIS), scientific communications, publications, clinical and scientific education, advisory boards, and congresses
• Maintain the highest standards of scientific, clinical, and technical expertise in relevant therapeutic area(s)
• Demonstrates teamwork and collaboration within Medical Affairs (MA) as well as cross-functionally with Clinical Development, Clinical Operations, Market Access, Marketing, Commercial, Data Analytics, etc. Exchanges ideas and knowledge compliantly among Oncology functions
• Travel required – approximately 50-60% of the time

Preferred Skills, Qualifications and Technical Proficiencies:

• Demonstrates strong scientific oncology acumen: therapeutic landscapes, NCCN guidelines, clinical trial data, oncology cooperative groups, NCI/NCCN cancer centers, etc.
• Exemplifies the following core competencies: intellectual curiosity, managing change, teamwork and collaboration, communication, achieving results, decision-making, and clinical and scientific expertise
• Demonstrates strong business acumen: has working knowledge of the multi-disciplinary functions involved in a company's drug development process, e.g., research, development, clinical operations, biostatistics, regulatory, commercial, etc.
• Exhibits excellent project management skills: can prioritize multiple tasks and goals and ensure the timely, on-target, and within-budget accomplishment of projects
• Identifies resources to accomplish priorities and works with the MA team to ensure resources are available
• Understands change management and demonstrates adaptability in priorities, goals, and territory
• Has proven effective interpersonal and communication skills
• Provide feedback to the MA trainer and MA Senior Director to ensure an atmosphere of quality improvement and excellence
• Demonstrates strong experience with PowerPoint, Word, and Excel; must be able to create and edit content with minimal assistance and an eye for accuracy and detail
• Experienced with Veeva CRM (or other CRM) and Veeva Vault, as well as SharePoint and/or BOX is preferred
• Must maintain a driving record in accordance with Corcept vehicle policy

Preferred Education and Experience:

• PhD, advanced degree in medical science (MD, PharmD, MSN, PA, NP) required
• 1-3+ years MSL experience; 2+ years in oncology

 _#LI-Remote

The pay range that the Company reasonably expects to pay for this position is $206,370 – $242,820; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.

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

Summary:

We are seeking a Vice President of Marketing to lead our marketing strategy as we prepare to become a U.S. commercial vaccine company within the next 18 months. This role is critical to shaping our U.S. launch, building the marketing foundation for a first commercial product, and positioning the company for future global expansion.

The ideal candidate brings deep vaccine marketing experience, a strong understanding of the U.S. immunization landscape, and a proven track record of leading pre-launch and launch activities in a highly regulated environment. This leader will balance strategic vision with hands-on execution, building capabilities, teams, and processes appropriate for a first commercial launch. This individual should have demonstrated experience driving commercial demand across target audiences—including healthcare providers, consumers/patients, payers, and public health stakeholders—with a particular emphasis on consumer engagement strategies that build disease awareness and motivate vaccination behavior.

Essential Functions:

U.S. Launch & Commercial Strategy

• Lead the development and execution of the U.S. marketing strategy for our initial vaccine launch, including disease awareness, brand positioning, and go-to-market planning.
• Develop differentiated value propositions grounded in clinical data, public health impact, and real-world evidence.
• Partner closely with the Chief Commercial Officer to align marketing strategy with overall commercial, sales, and market access plans.

Vaccine & Immunization Expertise

• Apply deep understanding of the U.S. vaccine ecosystem, including immunization schedules, CDC/ACIP considerations, public health stakeholders, and provider types.
• Design marketing strategies that address the unique dynamics of vaccine adoption, including site-of-care complexity, and public trust.
• Collaborate with Medical Affairs and Regulatory to ensure compliant, scientifically sound communications.
• Partner with Government Affairs and Policy teams to ensure marketing strategies account for evolving immunization policy, public funding mechanisms, and advocacy stakeholder dynamics.
• Collaborate with HEOR and Market Access to develop evidence-based value narratives and payer-facing materials that support formulary positioning and access.

Brand & Portfolio Marketing

• Establish the company’s commercial brand and narrative as we transition from a development-stage biotech to a commercial organization.
• Lead brand development, messaging, and omnichannel promotional strategy across HCP, payer, and patient audiences.
• Design and execute integrated omnichannel engagement strategies spanning personal promotion, digital channels, and non-personal promotion to optimize customer reach, frequency, and impact across the vaccine adoption journey.
• Develop digital-first engagement models for hard-to-reach HCP segments, including pharmacists and public health practitioners critical in vaccine delivery.
• Develop and execute consumer/patient engagement strategies—including disease awareness campaigns, direct-to-consumer (DTC) advertising, and health literacy initiatives—that drive vaccination demand at the population level.
• Build multi-audience demand generation strategies that create a pull-through effect across HCPs, consumers, payers, employers, and public health decision-makers to maximize vaccine adoption.
• Partner with Patient Advocacy organizations and community health stakeholders to inform patient-centric messaging and overcome barriers to vaccination, including vaccine hesitancy and health equity gaps.
• Develop lifecycle and indication expansion strategies to support future growth and pipeline advancement.

Market Insights & Analytics

• Lead market research, customer insights, and competitive intelligence to inform launch readiness and ongoing optimization.
• Define KPIs and performance metrics to measure marketing effectiveness and launch success.
• Leverage data analytics and AI-powered tools to enhance competitive intelligence, identify prescriber behavior patterns, and inform real-time marketing optimization decisions.

Team, Infrastructure & Capability Building

• Build and lead a high-performing marketing organization, scaling the team and capabilities over time.
• Establish agency partnerships and external vendors to support launch execution. Build and manage a high-performing agency roster with clear scopes of work, performance metrics, and governance structures that drive accountability and cost efficiency.
• Implement marketing processes, governance, and operating models consistent with U.S. commercial and regulatory requirements.
• Implement marketing operations infrastructure including project management systems, digital asset management (DAM), and content supply chain processes designed for scale and speed-to-market.
• Own the marketing budget, ensuring disciplined resource allocation across brand, digital, and promotional investments with clear ROI measurement and launch investment frameworks.

Future Global Expansion

• Design U.S. marketing strategies with future global scalability in mind.
• Partner cross-functionally to support early planning for potential international expansion, including global brand frameworks and knowledge transfer.

Digital Innovation & AI-Enabled Marketing

• Champion the integration of AI and emerging technologies into marketing workflows to improve quality, speed, cost efficiency, and decision-making across the marketing organization.
• Evaluate and deploy AI-powered tools for content creation, personalization, competitive intelligence, and customer engagement—ensuring all applications comply with regulatory and MLR requirements.
• Leverage generative AI to accelerate content development cycles, enable omnichannel personalization at scale, and streamline the Medical-Legal-Regulatory (MLR) review process.
• Establish an AI-informed marketing operations model that uses predictive analytics to optimize targeting, message sequencing, and media mix allocation.
• Identify opportunities to use AI and automation to reduce agency costs, accelerate time-to-market for promotional materials, and improve ROI across marketing investments.
• Partner with IT, Data Science, and Commercial Operations to build a connected, data-driven marketing ecosystem from the ground up.

Requirements: 

• Bachelor’s degree required; advanced degree (MBA, MS, PhD) preferred with 15+ years of progressive marketing experience in biotech or pharmaceuticals.
• Other combinations of education and/or experience may be considered
• Significant experience in vaccine marketing, including U.S. launch experience.
• Demonstrated success leading pre-launch and first-launch marketing efforts.

Preferred Qualifications:

• Experience building a marketing organization in a pre-commercial or first-launch biotech environment.
• Track record of leading omnichannel marketing strategies integrating digital, non-personal, and field-based promotion.
• Experience managing complex agency rosters and marketing vendor ecosystems across creative, media, digital, and analytics functions.
• Familiarity with AI/ML applications in marketing, including content generation, customer segmentation, predictive analytics, and campaign optimization.
• Demonstrated fluency in marketing analytics, including KPI frameworks, attribution modeling, and data-driven optimization.
• Experience with MLR processes and demonstrated ability to partner effectively with Medical and Legal/Regulatory in a compliant promotional environment.
• Strong executive presence with the ability to influence C-suite stakeholders and represent the marketing function on cross-functional leadership teams.
• Proven experience driving commercial demand generation across both HCP and consumer/patient audiences in a regulated healthcare environment, including DTC, disease education, or unbranded awareness campaigns.
• Public health marketing or disease awareness campaign experience preferred

The Associate Director, Supply Chain (Logistics) will lead Corcept’s global logistics operations from early-phase development through commercial distribution. This role is responsible for the compliant, efficient, and timely movement of research samples, APIs, drug substance (DS), drug product (DP), and finished goods across a global CDMO network within a GDP-regulated environment.

The position requires deep expertise in managing complex, small-scale and large-scale international shipments, while navigating customs, VAT, and tariff requirements. This position is highly cross-functional role supporting R&D, Manufacturing, Clinical, and Commercial teams ensuring timely, accurate and compliant material transfers.

This is a hybrid role typically requiring on-site presence at 3 days per week. This position may require ~10–15% travel.

Responsibilities:

• Lead logistics strategy and execution, ensuring compliance with GDP and all applicable global regulations
• Ensure compliant import/export processes for a broad range of materials, from research samples to commercial products, and manage VAT implications for cross-border shipments
• Prepare and submit documentation for customs clearance, ensuring compliance with regulations and obtaining appropriate licenses or permits
• Liaise with government agencies and customs authorities to resolve issues
• Oversee tariff classification (HS codes), duty optimization, and correct valuation methodologies
• Lead vendor selection, qualification, and ongoing performance management for logistics providers
• Support qualification of shipping lanes and packaging systems
• Oversee temperature monitoring, excursion management, deviations and CAPAs
• Support onboarding of new partners by establishing logistics processes and compliance frameworks, as required
• Provide logistics input into planning processes, including supply planning and network strategy
• Develop SOPs and governance models for global logistics and material transfers
• Partner with R&D, Clinical Operations and Supply, Manufacturing, Quality, Regulatory Affairs, and Finance
• Drive continuous improvement in service, compliance, and cost
• Monitor and report KPIs for contract service providers

Preferred Skills, Qualifications and Technical Proficiencies:

• Strong knowledge of GDP and global distribution requirements
• Strong knowledge of customs laws and regulations
• Deep understanding of international shipping documentation, Incoterms, customs clearance, VAT, and tariffs
• Ability to operate independently in an ambiguous, fast-changing environment
• Effective communication and ability to influence across global teams
• Excellent problem-solving skills in time sensitive, high-risk scenarios

Preferred Education and Experience:

• Bachelor’s degree in supply chain management, logistics, life sciences, or equivalent experience
• 8+ years industry experience in global logistics within biotech, pharmaceuticals or life sciences
• Experience supporting clinical and commercial logistics operations
• Possession of a valid customs broker license preferred

The pay range that the Company reasonably expects to pay for this headquarters-based position is $180,900 – $212,800; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.

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

About the role

Reporting to the General Counsel, the Senior Counsel, Privacy & AI Governance will lead Applied Intuition’s global privacy and AI governance efforts and serve as a key legal partner to Product, Engineering, Data Science, Security, and Go-to-Market. You will own the company’s privacy program end-to-end, advise on GDPR, CCPA/CPRA, cross-border data transfers, and privacy impact assessments, and help build the policies, frameworks, and processes needed to support responsible AI development and deployment, including compliance with the EU AI Act and other emerging requirements. You will also partner closely with Regulatory Affairs, outside counsel, regulators, and standards bodies, while building the data governance infrastructure needed to scale the business.

At Applied Intuition, you will:

• Own and operationalize the global privacy program across the company

• Lead AI governance strategy, policy development, and implementation

• Advise Product, Engineering, Data Science, Security, and Go-to-Market teams on privacy, data protection, and responsible AI issues

• Conduct privacy and AI impact assessments and support regulatory compliance efforts worldwide

• Advise on cross-border data transfers, SCCs, adequacy frameworks, and other transfer mechanisms

• Manage engagement with data protection authorities, outside counsel, regulators, and standards bodies

• Build and maintain data mapping, records of processing activities, consent frameworks, and vendor privacy diligence processes

• Support commercial transactions and product launches requiring privacy review

We’re looking for someone who has:

• 8+ years of law firm and/or in-house experience, with substantial privacy and data protection focus

• Deep experience advising on GDPR and CCPA/CPRA compliance programs

• Experience with data processing agreements and cross-border data transfer mechanisms, including SCCs and adequacy frameworks

• Experience with AI regulatory requirements, including the EU AI Act or similar emerging frameworks

• Experience advising on machine learning data use, training data governance, algorithmic bias and fairness, and transparency obligations

• Experience in a technology company in-house role, or in a dedicated privacy and data security practice at a law firm

• J.D. from an accredited law school and active membership in at least one state bar

Nice to have:

• CIPP/E, CIPP/US, or equivalent privacy certification

• Experience with autonomous systems, sensor data, and the privacy implications of physical AI

• Experience spanning both law firm and in-house practice

Compensation at Applied Intuition for eligible roles includes base salary, equity, and benefits. Base salary is a single component of the total compensation package, which may also include equity in the form of options and/or restricted stock units, comprehensive health, dental, vision, life and disability insurance coverage, 401k retirement benefits with employer match, learning and wellness stipends, and paid time off. Note that benefits are subject to change and may vary based on jurisdiction of employment.

Applied Intuition pay ranges reflect the minimum and maximum intended target base salary for new hire salaries for the position. The actual base salary offered to a successful candidate will additionally be influenced by a variety of factors including experience, credentials & certifications, educational attainment, skill level requirements, interview performance, and the level and scope of the position.

Please reference the job posting’s subtitle for where this position will be located. For pay transparency purposes, the base salary range for this full-time position in the location listed is: $180,000 - $325,000 USD annually.

Job Title: Executive Medical Director, Clinical Development         

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

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

Key Responsibilities:

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

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

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

Qualifications:

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

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

Compensation:

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

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

About You and The Role 

As a Development & Permitting Project Manager, you will be responsible for driving the expansion of our network - defining how autonomous aerial logistics integrates into the built environment at scale. You are the single-threaded owner of development outcomes from site identification through entitlements, permitting and approvals across multiple metros, often simultaneously and under real deadlines.

We are looking for someone who takes ownership seriously - someone organized, highly detail-oriented, and consistent in follow-through. You are a self-starter who can operate independently, make decisions with incomplete information, and drive outcomes without constant direction. The work will be ambiguous at times; the expectation is that you bring structure and clarity to it.

This role sits at the intersection of site acquisition, real estate development, land use, aviation, and regulatory strategy. You will work closely with government affairs and legal land use to unlock jurisdictions that have never approved infrastructure like ours before. The playbook is being written - and you will help create it. Success requires sound judgment, persistence, and the ability to move projects forward in environments that are ambiguous, slow-moving, or resistant.

You will partner closely with engineering and operations to solve technical and site-specific challenges and ensure projects are executable - not just approvable. You should be comfortable going deep on drawings, constraints, and tradeoffs while still maintaining forward momentum.

This is an in-person position based out of our regional office in metro. Candidates must be local to the area and bring existing, credible relationships with AHJs and permitting authorities. This is not a role where you build your network from scratch.

What You'll Do

• Real Estate Search & Site Development:
• Support site selection, feasibility, and risk assessment end-to-end, ensuring alignment with zoning, land use, and aviation constraints.
• Identify risks early and drive mitigation plans across permitting, environmental, and infrastructure considerations before they impact timelines.
• Partner with engineering to translate site constraints into clear design requirements and ensure permit-ready drawings.
• Land Use Approvals & City Permitting:
• Build and maintain strong working relationships with planners, zoning officials, and building departments to move projects forward efficiently.
• Lead permitting efforts across multiple metros, including navigating novel regulatory pathways for drone operations.
• Partner with government affairs to navigate and, where necessary, help shape regulatory approaches.
• Represent Zipline in public forums (Planning & Zoning, City Council), communicating clearly and effectively to secure approvals.
• Ensure all submittals are complete, accurate, and aligned with jurisdictional requirements - high attention to detail is critical.
• Actively manage permitting timelines by engaging directly with departments, resolving issues, and escalating when appropriate.
• Pre-Construction:
• Support the building permit process from submission through approval, ensuring accuracy, completeness, and timeliness.
• Work with external consultants to produce high-quality, compliant drawings and documentation.
• Support contractor engagement and scope definition to ensure a smooth transition to the construction team.
• Cross-Functional Coordination:
  • Collaborate with site acquisition, engineering, regulatory, legal land use and operations teams to ensure alignment across development and execution.
  • Surface risks early and propose practical solutions to keep projects moving.
  • Provide clear input on permitting and policy considerations during site selection and deal review.

What You'll Bring

• Bachelor’s degree in Engineering (Civil, Mechanical, Industrial, Electrical, Others), Real Estate, Development, or Construction Management.
• 5+ years of experience in Real Estate Development, Permitting, Urban Planning, Civil Engineering, and/or Public-Private Project Development, with a track record of delivering projects from concept through approvals.
  • Bonus: Professional Engineering (Civil) License in the State of Texas, Florida, Arizona, Georgia or California and ability to stamp drawings.
• Strong understanding of zoning laws, building codes, and regulatory processes, with the ability to navigate them independently.
• Proven experience managing entitlements, permitting, and development projects in coordination with real estate and construction teams.
• Proficiency in tools such as Smartsheet and Bluebeam (Revit / AutoCAD a plus), with the ability to review and interpret drawings.
• Ability to work effectively with government officials, permitting agencies, and community stakeholders to secure approvals.
  • Bonus: Experience in aviation, logistics, or other highly regulated infrastructure environments.
• Strong communication skills, including experience presenting in public meetings or similar forums.
• Established local relationships with AHJs and permitting authorities that can be leveraged immediately.
• Willingness to travel up to 50% across the state to support expansion efforts.
• Must be eligible to work in the US.

What Else You Need to Know   

Your Impact

You will design and lead the strategy that unlocks scalable procurement and partner-driven growth across our US Public Sector business. By building and optimizing our state and cooperative contract portfolio, activating high-impact commercial partnerships, and proactively clearing procurement hurdles for new products, you will remove friction from the buying process, expand market access and accelerate revenue growth. This role sits at the intersection of Sales, Legal, Product, Finance, and Government Affairs — translating go-to-market priorities into executable contracting and commercialization frameworks that drive measurable growth.

What You’ll Do

Location: This role is based out of our San Francisco, CA office and follows a hybrid schedule. We rely on in-person collaboration and ask that team members work onsite Tuesdays through Fridays, with the flexibility to work remotely on Mondays, unless there is an approved workplace accommodation. We believe that connection fuels innovation, and our in-office culture is designed to foster meaningful teamwork, mentorship, and shared success.
Reports to: Senior Director, Strategy & Enablement
Direct Reports: None

State & Cooperative Contract Strategy

• Develop and execute a forward-looking state and cooperative contract strategy aligned to go-to-market priorities; anticipate procurement needs 12–18 months in advance and establish required vehicles ahead of revenue timelines.
• Establish, expand, and renew statewide and cooperative contracts to include new products, services, and pricing models that support growth objectives.
• Lead negotiations for new and expanded contracts, aligning Legal, Sales, Finance, and external stakeholders to secure favorable commercial and operational terms.
• Own strategic relationships with cooperative purchasing organizations and evaluate new vehicles based on revenue potential and market coverage.
• Track contract utilization and performance, identifying opportunities to optimize scope, usability, and adoption across priority markets.

Commercial Partner Strategy & Activation

• Operationalize new commercial partnerships identified by Corporate Development by designing the revenue activation plan and establishing repeatable pathways to secure the first deals on Axon paper.
• Identify priority accounts and use cases where partner products strengthen Axon’s solution; align Sales, Product, Marketing, and the partner on positioning, pricing, and enablement readiness.
• Build scalable procurement and contracting frameworks that allow Axon to compliantly resell partner products within public sector constraints, tracking early performance and refining activation strategy based on results.

New Product Growth Enablement

• Proactively identify and remove procurement, contracting, and regulatory barriers that could delay adoption of new products in state and local markets.
• Ensure state-specific requirements and contract inclusion strategies are understood early and addressed in alignment with launch revenue timelines.
• Translate complex procurement considerations into actionable guidance for Sales and Enablement teams.

What You Bring

• 7+ years of experience in public sector strategy, government contracting, channel/partner strategy, business development, or sales operations within a complex, multi-stakeholder environment.
• Demonstrated success designing and executing strategies that expanded market access and accelerated revenue growth.
• Experience operationalizing commercial partnerships or resell models, translating partnership agreements into executable revenue plans.
• Comfortable balancing legal, financial, and commercial considerations in negotiations.
• Proven ability to influence senior stakeholders and drive cross-functional alignment without direct authority.
• Experience supporting new product launches or commercialization strategies within regulated or procurement-constrained markets.
• Analytical mindset with ability to assess performance metrics, identify friction points, and refine strategy based on data.
• Strategic thinker with a bias for action and a track record of delivering complex, long-horizon initiatives to completion.
• Deep understanding of public sector procurement, including statewide master contracts and cooperative purchasing organizations is a plus.
• Experience in Government Technology, SaaS, or Public Safety Technology preferred.

Benefits that Benefit You

• Competitive salary and 401k with employer match
• Discretionary paid time off
• Paid parental leave for all
• Medical, Dental, Vision plans
• Fitness Programs
• Emotional & Mental Wellness support
• Learning & Development programs
• And yes, we have snacks in our offices

Benefits listed herein may vary depending on the nature of your employment and the location where you work

Position Summary

We are seeking a detail-oriented and experienced Senior QA/Verification Specialist to join our team. In this role, you will be responsible for ensuring the quality, reliability, and regulatory compliance of our software products. You will design and execute comprehensive test cases, and develop FDA-compliant documentation in support of our product submissions and quality management system. 

Duties and Responsibilities

• Plan, design, and execute functional, integration, regression, and system-level software tests across multiple product releases. 
• Author and maintain detailed software test cases, test plans, and test reports in accordance with internal standards and regulatory requirements. 
• Review, and maintain FDA-required software documentation, including Software Requirements Specifications (SRS), Software Design Specifications (SDS), Hazard Analysis, Traceability Matrices, and Verification & Validation (V&V) protocols and reports. 
• Ensure documentation aligns with FDA guidance, including 21 CFR Part 11, 21 CFR Part 820, IEC 62304, and relevant ISO standards. 
• Collaborate with software developers, product managers, and regulatory affairs teams to define acceptance criteria and quality benchmarks. 
• Identify, document, and track software defects through resolution using issue tracking tools. 
• Participate in design reviews and risk analysis activities. 
• Support internal audits, external audits, and FDA inspections by ensuring documentation is accurate, complete, and audit-ready. 
• Contribute to continuous improvement of QA processes, tools, and documentation templates. 

Qualifications

• Bachelor's degree in Science or Engineering. 
• 6+ years of experience in quality assurance, preferably in a regulated industry (medical device, pharmaceutical, or life sciences). 
• Demonstrated experience writing and executing test cases and test plans. 
• Hands-on experience maintaining FDA regulatory documentation (e.g., 510(k)). 
• Understanding of FDA guidance documents, such as:  
  • Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
• Familiarity with risk management frameworks such as ISO 14971. 
• Proficiency with defect tracking and project management tools. 
• Strong written communication skills with meticulous attention to detail. 

The base salary range for this full-time position is $120,000 - $140,000 + bonus + equity + benefits. Our salary ranges are determined by work location, job-related skills, experience, and relevant education or training. The ranges displayed on each job posting reflect the minimum and maximum target for new hire salaries but are subject to change if the leveling of the role is adjusted. Your recruiter can share more about the specific salary range during the hiring process. 

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:

We are seeking a highly motivated and scientifically rigorous Director of Biostatistics to our Medical Analytics and Exploratory Data Science Biostatistics group. This role will provide strategic and hands-on statistical leadership for exploratory data analyses, scientific publications, real-world evidence (RWE), post-marketing research, and health economics and outcomes research (HEOR) initiatives. The successful candidate will serve as a key statistical leader and individual contributor, partnering closely with cross-functional teams to generate high-quality evidence that advances our oncology pipeline and supports medical and scientific strategy.

• Provide statistical leadership for exploratory data analyses using existing clinical trial data, real world data studies, post-marketing research, and HEOR projects.

• Serve as a primary statistical contact for assigned projects, working collaboratively with clinical development, medical affairs, safety, statistical programming, regulatory affairs and commercial.

• Lead the design, analysis, and interpretation of complex statistical models, including survival analysis, machine learning, and casual inference methodologies.

• Contribute to and implement policies, standards, and procedures to ensure consistency and quality in statistical practices.

• Manage relationships with external partners, such as contract research organizations (CROs), ensuring adherence to timelines, budgets, and quality standards.

• Mentor and provide technical guidance to junior statisticians, fostering scientific rigor, innovation, and professional growth.

• Contribute to regulatory and payers/HTA agencies interactions, scientific publications, abstracts, and internal decision-making through clear and effective communication of statistical results.

Required Skills, Experience and Education:

• Ph.D. or M.S. in Statistics/Biostatistics, a minimum of 8 years (for Ph.D.) and 12 years (for M.S.) of experience in biotech/pharma industry as a statistician.

• Solid knowledge of statistical methodologies for oncology, including survival analysis and causal inference.

• Hands-on experience in exploratory analysis of oncology trials.

• Proven ability to independently lead statistical aspects of complex, cross-functional projects.

• Strong understanding of regulatory requirements related to biostatistical activities and clinical trials.

• Excellent verbal and written communication skills are required.

• Excellent interpersonal and project management skills are essential.

• Proficiency in SAS and/or R.

Preferred Skills:

• Knowledge of RWD and health economics and outcomes research (HEOR) in oncology is a plus.

• Familiarity with machine learning or advanced modeling approaches applied to biomedical or observational data. 

  #LI-Hybrid  #LI-SH1

The Opportunity:

The Director, Global Regulatory Affairs Project Management is an integral part of the global Regulatory Affairs organization and is responsible for translating global regulatory strategies into actionable execution plans.  This role applies advanced project management expertise and operational leadership to guide cross-functional teams, supporting planned and ongoing drug marketing applications across RevMed programs.  The role partners closely with Global Regulatory Science and Global Filing and Registration and contributes to the broader Global Regulatory Affairs function at RevMed.  This position reports to the Senior Director, Global Regulatory Affairs Project Management.

The ideal candidate will have an in-depth understanding of oncology drug development and demonstrated hands-on regulatory project management experience supporting early- and late-stage registrational programs, including the execution of global new drug marketing applications, in alignment with corporate objectives. 

Core Responsibilities:

• Project manage regulatory submissions from initiation through submission, supporting the definition of scope, timelines, prioritization, resource needs, and key deliverables.

• Develop, maintain, and track comprehensive submission timelines for INDs / CTAs, NDAs / MAAs, amendments, agency interactions, and other key global regulatory activities.

• Partner with Global and Regional Regulatory Science Leads to advance global regulatory strategies for assigned molecules across indications.

• Facilitate Global Regulatory Teams and meetings to ensure coordinated development and execution of high-quality, timely global regulatory deliverables at the study level.

• Partner with Global Filing Leads on planning, resourcing, and execution of new drug marketing applications for global agency submissions, interactions, and approvals.

• Drive the operational planning, coordination, and tracking of new drug marketing application submission activities across cross-functional Filing Teams (including Regulatory, Medical Writing, Nonclinical, Clinical, Safety, Biostatistics, CMC / Pharmaceutical Development and Manufacturing, etc. and external consultants), supporting the Global Filing Lead’s strategic vision.

• Coordinate with global partners to maintain consistent regulatory program plans, ensuring alignment, compliance, and continuity across regions.

• Proactively identify operational risks, gaps, and bottlenecks; propose and implement solutions, including process improvements and outsourcing strategies, as appropriate.

• Build and maintain submission dashboards; communicate status, risks, and mitigation strategies to senior management and key stakeholders.

• Support the development, implementation, and continuous improvement of global regulatory project management processes, templates, tools, dashboards, analytics, and best practices.

• Champion innovation and operational excellence, identifying opportunities to streamline regulatory project management and enhance submission preparation efficiency and scalability.

Required Skills, Experience and Education:

• Bachelor’s degree in a life sciences or related discipline; advanced degree preferred.

• 15+ years of pharma / biotech industry experience, including 8-10 years of regulatory project management experience. Hands-on U.S. drug marketing application experience required.

• Strong working knowledge of global regulatory regulations, guidelines, and submission pathways; familiarity with nonclinical, clinical, and CMC (bio)pharmaceutical development.

• In-depth knowledge of CTD structure and dossier component management, including coordination across cross-functional filing team contributors and senior leadership.

• Exceptional project management skills with proven ability to manage multiple complex programs under compressed timelines in a fast-paced, cross-functional environment that values both speed and quality.

• Excellent communication and interpersonal skills, with demonstrated ability to influence, manage group dynamics, and balance functional, team, and leadership objectives.

• Ability to think both strategically and tactically and present recommendations to senior leadership and key stakeholders.

• High proficiency with project management tools including Smartsheet and Microsoft Project, and familiarity with WBS management, timeline development, and critical path analysis; experience with OnePager, Office Timeline, and Veeva RIM is a plus.

Preferred Skills:

• Experience supporting global regulatory filings including Japan, Canada, and EU / UK submissions.

• Oncology drug development experience.

• Experience with complex oncology clinical trial designs (e.g., combination studies, multi-cohort expansions, basket or umbrella master protocols). 

  #LI-Hybrid #LI-JC1

The Opportunity:

The Senior Director, Pipeline & Product Communications will lead the strategy, development, and execution of integrated communications across the company’s pipeline and product candidate portfolio. This role is accountable for shaping how Revolution Medicines’ pipeline and product narratives are understood by external stakeholders, including scientific and medical audiences, patients and advocates, media, and the broader healthcare ecosystem.

Reporting to the Head of Communications, this leader will serve as a trusted strategic advisor to cross-functional partners across R&D, Medical Affairs, Regulatory, Commercial, Market Access, Patient Advocacy, Legal, and Investor Relations. The role requires deep expertise across the full product lifecycle, from early clinical development through regulatory milestones and launch readiness, and the ability to translate complex science into clear, differentiated, and credible narratives.

This is a high-impact leadership role for a communications professional who thrives at the intersection of science, strategy, people leadership, and reputation management. Key Responsibilities include but not limited to:

• Own and lead the integrated pipeline and product communications strategy across all stages of development, ensuring clear differentiation, scientific credibility, and alignment with corporate and business priorities.

• Direct communications for major clinical and regulatory milestones, including data readouts, congress presentations, trial initiations, filings, approvals, and pre-launch milestones, in close partnership with R&D, Medical Affairs, Regulatory, and Legal.

• Serve as the senior communications advisor for launch readiness, shaping pre-launch and launch narratives across earned media, disease education, patient engagement, and stakeholder communications, with clear linkage to future commercial strategy.

• Lead disease awareness and patient advocacy communications, ensuring responsible education, strong patient advocacy group partnerships, and integration of patient voice into pipeline and product storytelling.

• Provide strategic counsel on value, access, and product-related issues, anticipating reputational risk and leading communications response to safety updates, competitive dynamics, and external scrutiny.

• Drive scientific and medical thought leadership, positioning Revolution Medicines and its leaders as credible voices through publications, congress presence, executive visibility, and media engagement.

• Build and lead a high-performing pipeline and product communications team, setting direction, developing talent, and ensuring consistent, high-quality execution.

• Oversee agency partners and measurement frameworks, using insights to evaluate impact, optimize performance, and scale communications effectiveness.

Required Skills, Experience and Education:

The successful candidate will be a seasoned communications leader with a proven track record of building and leading integrated pipeline and product communications strategies in complex, science-driven organizations.

• 15+ years of experience in biotech or pharmaceutical communications, including deep experience in pipeline and product communications in-house and/or at a leading agency.

• Bachelor’s degree required in Communications or similar; advanced degree preferred

• Demonstrated success supporting clinical development, regulatory milestones, and product launches, ideally in precision oncology or a similarly complex therapeutic area.

• Proven people management experience, including leading teams and developing talent.

• Strong leadership presence with the ability to influence senior stakeholders and lead cross-functional initiatives.

• Deep understanding of the U.S. healthcare environment, including regulatory policy, R&D, pricing, and access.

• Exceptional storytelling and writing skills, with the ability to translate complex science for diverse audiences.

• Demonstrated experience managing sensitive issues and high-profile communications.

• Track record of building relationships with top-tier scientific, medical, and industry media.

Preferred Skills:

• Deep familiarity with precision oncology, including competitive landscapes, combination strategies, and evolving standards of care.

• Proven success leading communications for major regulatory milestones, including FDA approvals, advisory committee meetings, and high-stakes data readouts.

• Strong issues-management experience relating to global trial access and expanded access.

• Track record of coordinating with corporate patient advocacy and patient advocacy organizations and integrating patient voice into pipeline and product storytelling.

• History of leading large-scale disease education or awareness campaigns that shift understanding of disease complexity or heterogeneity.

• Background spanning both product and corporate communications, enabling integrated decision-making across asset narratives and enterprise reputation. 

  #LI-Hybrid  #LI-YG1

The Opportunity:

The Associate Director, Regulatory Operations Systems role contributes to the development, implementation, and governance of regulatory operation systems. This role serves as the subject matter expert for RIM, regulatory operation infrastructure, driving submission excellence, process optimization, compliance readiness, and system innovation across the Regulatory organization in line with global regulatory expectations and Global Regulatory Affairs (GRA) technology roadmap. Core responsibilities include driving RIM and other RO systems projects across the business, guiding the team through challenges and aligning with the overall business strategy and business development.

• Support and lead activities related to regulatory operation infrastructure and system maintenance, guiding the team through challenges and aligning with the overall business strategy.

• Contributes to the development, implementation, and governance of RIM and publishing system.

• Provides independent leadership and direction on regulatory specifications for RIM systems, working closely with cross-functional teams to achieve shared goals.

• Promotes regulatory information quality, reporting, and development and monitoring of KPIs and metrics to ensure quality.

• Monitor regulatory metadata quality and consistency across the system; identify, investigate, and drive remediation of data quality issues.

• Manages and oversees vendor(s) in relation to RIM supported activities and information management projects, ensuring compliance with regulatory standards while fostering strong partnerships.

• Support inspection readiness activities by ensuring regulatory correspondence and submissions are complete, traceable, and readily retrievable.

• Partner cross-functionally with Regulatory Affairs, Quality, IT, and other stakeholders to continuously improve regulatory archiving and information management processes.

• Contribute to the development and maintenance of SOPs, work instructions, and best practices related to regulatory operations and RIM.

Required Skills, Experience and Education:

• Bachelor’s degree required; advanced degree preferred.

• Minimum of 7–10 years of experience in Regulatory Affairs, Regulatory Operations, Regulatory Information Management, or related functions within the pharmaceutical or biotechnology industry.

• Demonstrated hands-on experience with Veeva Vault RIM, including regulatory document management, metadata usage, and records lifecycle management.

• Strong working knowledge of global regulatory submissions and health authority correspondence processes.

• Proven ability to apply metadata practices in a regulated environment.

• Experience supporting inspection readiness and responding to regulatory or business-critical document requests.

• Strong attention to detail, organizational skills, and ability to manage work independently in a fast-paced environment.

• Excellent written and verbal communication skills, including the ability to train and guide cross-functional stakeholders.

Preferred Skills:

• Prior experience with regulatory submission publishing processes; hands-on publishing experience a plus.

• Experience supporting regulatory due diligence activities for business development, licensing, or mergers and acquisitions.

• Extensive experience in global drug development regulations, regulatory submissions, lifecycle management, and information management processes.

• Experience working in emerging or mid-size biotechnology organizations.

• Experience contributing to process improvement initiatives related to regulatory systems or information management.

• Experience managing vendors and contracts, including overseeing project deliverables and ensuring compliance.

• Ability to work effectively in a matrix structure and complex environments, demonstrating leadership, problem-solving, and flexibility.

  #LI-Hybrid  #LI-SH1

The Opportunity:

We are seeking a highly capable Associate Director of Biostatistics to join our Medical Analytics and Exploratory Data Science Biostatistics group within our Biostatistics organization. This role will play a critical part in the design, analysis, and interpretation of exploratory data analyses, scientific publications, real-world evidence (RWE), post-marketing research, and health economics and outcomes research (HEOR) studies. The successful candidate will serve as a key statistical contributor and emerging leader, partnering closely with cross-functional teams to deliver high-quality, data-driven insights that support scientific understanding and evidence generation.

• Lead statistical design, analysis, and interpretation for exploratory data analyses using existing clinical trial data, real world data studies, post-marketing research, and HEOR projects.

• Partner closely with other subfunctions within quantitative sciences and with cross-functional teams, including clinical development, medical affairs, safety, statistical programming, regulatory affairs and commercial, to execute evidence generation plans.

• Apply appropriate statistical methodologies, including survival analysis, machine learning, and casual inference approaches, to address complex scientific and medical questions in oncology.

• Contribute to the development of analysis plans, technical specifications, and interpretation of results under general direction from senior statistical leadership.

• Support cross-functional evidence generation planning by providing statistical input into study design, feasibility, and analysis strategies.

• Review and oversee statistical deliverables produced by internal programmers or external vendors/contractors to ensure scientific quality and consistency with standards.

• Contribute to and implement policies, standards, and procedures to ensure consistency and quality in statistical practices.

• Assist with the preparation of scientific communications, including abstracts, manuscripts, posters, and internal presentations.

Required Skills, Experience and Education:

• Ph.D. or M.S. in Statistics/Biostatistics, a minimum of 5 years (for Ph.D.) and 8 years (for M.S.) of experience in biotech/pharma industry as a statistician.

• Solid knowledge of statistical methodologies for oncology, including survival analysis and causal inference.

• Hands-on experience in exploratory analysis of oncology trials.

• Ability to work independently and within a team.

• Ability to independently execute statistical analyses for moderately complex projects with guidance from senior statisticians.

• Familiar with regulatory requirements related to biostatistical activities and clinical trials.

• Strong verbal and written communication skills are required.

• Strong interpersonal and project management skills are essential.

• Proficiency in SAS and/or R.

Preferred Skills:

• Knowledge of RWD and health economics and outcomes research (HEOR) in oncology is a plus.

• Familiarity with machine learning or advanced modeling approaches applied to biomedical or observational data. 

  #LI-Hybrid  #LI-SH1

The Opportunity:

The Associate Director, Global Regulatory Affairs Project Management is an integral part of the global Regulatory Affairs organization and is responsible for translating global regulatory strategies into actionable execution plans.  This role applies advanced project management expertise and operational leadership to guide cross-functional teams, supporting planned and ongoing drug marketing applications across RevMed programs.  The role partners closely with Global Regulatory Science and Global Filing and Registration and contributes to the broader Global Regulatory Affairs function at RevMed.  This position reports to the Senior Director, Global Regulatory Affairs Project Management.

The ideal candidate will have an in-depth understanding of oncology drug development and demonstrated hands-on regulatory project management experience supporting early- and late-stage registrational programs, including the execution of global new drug marketing applications, in alignment with corporate objectives. 

Core Responsibilities:

• Project manages regulatory submissions from initiation through submission, supporting the definition of scope, timelines, prioritization, resource needs, and key deliverables.

• Develop, maintain, and track comprehensive submission timelines for INDs / CTAs, NDAs / MAAs, amendments, agency interactions, and other key global regulatory activities.

• Partner with Global and Regional Regulatory Science Leads to advance global regulatory strategies for assigned molecules across indications.

• Facilitate Global Regulatory Teams and meetings to ensure coordinated development and execution of high-quality, timely global regulatory deliverables at the study level

• Partner with Global Filing Leads on planning, resourcing, and execution of new drug marketing applications for global agency submissions, interactions, and approvals.

• Drive the operational planning, coordination, and tracking of new drug marketing application submission activities across cross-functional Filing Teams (including Regulatory, Medical Writing, Nonclinical, Clinical, Safety, Biostatistics, CMC / Pharmaceutical Development and Manufacturing, etc. and external consultants), supporting the Global Filing Lead’s strategic vision.

• Coordinate with global partners to maintain consistent regulatory program plans, ensuring alignment, compliance, and continuity across regions.

• Proactively identify operational risks, gaps, and bottlenecks; propose and implement solutions, including process improvements and outsourcing strategies, as appropriate.

• Build and maintain submission dashboards; communicate status, risks, and mitigation strategies to senior management and key stakeholders.

• Support the development, implementation, and continuous improvement of global regulatory project management processes, templates, tools, dashboards, analytics, and best practices.

• Champion innovation and operational excellence, identifying opportunities to streamline regulatory project management and enhance submission preparation efficiency and scalability.

Required Skills, Experience and Education:

• Bachelor’s degree in life sciences or related discipline; advanced degree preferred.

• 12+ years of pharma / biotech industry experience, including 6-8+ years of regulatory project management experience. Hands-on U.S. drug marketing application experience required.

• Strong working knowledge of global regulatory regulations, guidelines, and submission pathways; familiarity with nonclinical, clinical, and CMC (bio)pharmaceutical development.

• In-depth knowledge of CTD structure and dossier component management, including coordination across cross-functional filing team contributors and senior leadership.

• Exceptional project management skills with proven ability to manage multiple complex programs under compressed timelines in a fast-paced, cross-functional environment that values both speed and quality.

• Excellent communication and interpersonal skills, with demonstrated ability to influence, manage group dynamics, and balance functional, team, and leadership objectives.

• Ability to think both strategically and tactically and present recommendations to senior leadership and key stakeholders.

• High proficiency with project management tools including Smartsheet and Microsoft Project, and familiarity with WBS management, timeline development, and critical path analysis; experience with OnePager, Office Timeline, and Veeva RIM is a plus.

Preferred Skills:

• Experience supporting global regulatory filings including Japan, Canada, and EU / UK submissions.

• Oncology drug development experience.

• Experience with complex oncology clinical trial designs (e.g., combination studies, multi-cohort expansions, basket or umbrella master protocols). 

  #LI-Hybrid #LI-JC1

The Opportunity:

Revolution Medicines is seeking a Senior Manager, Commercial Regulatory Affairs to partner closely with the cross-functional teams to ensure that all promotional and medical communication strategies are compliant with applicable regulations, industry standards, and internal policies. This role will help enable successful product commercialization while upholding regulatory integrity and scientific accuracy.

As part of the Regulatory Affairs function, the Senior Manager will work under supervision to provide strategic regulatory advice on advertising/promotion and medical materials to the US organization for assigned products in accordance with business goals and objectives, FDA regulations/guidances, pharma guidelines, and company policy.

The position can be based at our Redwood City, CA site in a hybrid work schedule (preferred) or remote-based with quarterly and as needed travel.

Required Skills, Experience and Education:

• Serves as a primary or secondary regulatory advertising and promotion reviewer for assigned products on MLR teams with oversight.

• Manage regulatory submissions of promotional materials as required (e.g., FDA Form 2253) and interact with health authority stakeholders when applicable.

• Interpret evolving regulatory requirements and enforcement trends to proactively guide commercial strategy and risk assessments.

• Train and advise cross-functional teams on commercial regulatory compliance, MLR process and best practices.

• Monitors US regulatory promotional environment by reviewing regulatory promotional guidelines, untitled and warning letters to pharmaceutical/biotech companies published by OPDP or APLB, and by attendance of major FDLI, DIA and other industry meetings.

• Ensures that changes in US Prescribing Information are reflected in current promotion and advertising.

• Participate in the development and maintenance of MLR operational objectives, policies, and procedures.

• Bachelor's Degree in a relevant field with 10 years relevant experience.

• 5-7 years of relevant promotional regulatory affairs experience in the biotech or pharmaceutical industry for the US market.

• Strong understanding of FDA regulatory requirements governing promotional activities and experience managing promotional submissions and reviews.

• Strong, current understanding of scientific exchange and pre-approval discussions; ability to unpack and deploy these concepts in practice.

• Track record of influencing cross-functional decisions and operating with sound regulatory judgment.

• Excellent communication skills and ability to work collaboratively across teams.

• Collaborative and solution-oriented mindset and approach.

• Exemplary compliance ethics and high concern for standards.

Preferred Skills:

• Advanced degree in a relevant field.

• Experience in oncology therapeutic areas.

• Experience with product launches. 

  #LI-Hybrid #LI-JC1

The Opportunity:

The Senior Manager of Regulatory Affairs will provide project teams with regulatory advice, manage and coordinate various Regulatory Affairs activities within and between departments, and obtain and maintain National Health Authority approvals for investigational products. The position may also undertake regulatory intelligence and research supporting company decision-making.

• Manage planning, preparation, coordination, and submission of regulatory documents to global National Health Authorities. Such submissions may include Clinical, Preclinical, or CMC content.

• Correspond and collaborate with RevMed colleagues and departments to achieve alignment.

• Function as a Regulatory Affairs subject matter expert member of cross-functional teams, including study teams and submission teams.

• Perform regulatory research to inform business strategy. Assess and communicate risks.

• Assure that there are no significant interruptions to the business due to regulatory compliance issues.

• Collaborates across the organization at all levels, across functional groups, and with executive management.

• Develop regulatory strategies to inform associated budgets, tools and specialized support. necessary for efficient operations.

Required Skills, Experience and Education:

• Bachelor's Degree in a relevant field and at least 5 years of direct Regulatory experience.

• Strong working knowledge of US FDA Pharmaceutical regulations and guidance.

• Proven track record of successful submissions within a regulatory environment.

• Exceptionally strong team player with excellent interpersonal and communication skills.

• Detail-oriented with strong organizational skills and high-quality standards.

Preferred Skills:

• Knowledge of EU EMA Pharmaceutical regulations and guidance preferred.

• Direct experience with IND/NDA filings. 

  #LI-Hybrid  #LI-SH1

The Opportunity:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Required Skills, Experience and Education:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

• Strong written and business presentation skills is required.

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

• Demonstrated strong leadership presence.

• Has demonstrated adaptability and flexibility.

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

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

Preferred skills:

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

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

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

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

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

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

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

  #LI-Hybrid  #LI-SH1

The Opportunity:

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

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

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

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

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

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

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

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

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

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

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

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

Required Skills, Experience and Education:

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

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

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

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

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

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

• Have a strong attention to detail.

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

  #LI-Hybrid #LI-CT1

The Opportunity:

• Support regulatory review activities related to site activation across clinical studies.

• Manage Regulatory Affairs contracts and invoices; maintain and update internal RA tracking tools.

• Archive regulatory documents in accordance with internal procedures and maintain the regulatory query tracker.

• Support regulatory submission workflows in Veeva.

• Co-host Regulatory Sub-Team meetings, including agenda preparation and documentation of action items.

• Participate in RAxROxMW workshops and Regulatory Strategy Forums.

• Conduct weekly one-on-one meetings with the RA Manager to review priorities and progress.

• Build and maintain working knowledge of FDA regulations, guidances, and applicable regulatory requirements.

Required Skills, Experience and Education:

• Currently pursuing a bachelor's degree/MS/PhD in life science, pharmacy, regulatory science, or relevant fields.

• Basic understanding of drug development.

• Attention to detail and organizational skills.

• Must have good verbal and written communication skills.

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

Preferred Skills:

• Familiarity with FDA regulations or global regulatory guidance.

• Prior experience in biotech/pharma or clinical research. 

  #LI-Hybrid  #LI-AP1

The Opportunity:

The Senior Corporate Counsel, Contracts (Clinical Development) will support the Company’s clinical research and development activities by drafting, negotiating, and advising on a broad range of clinical and research-related agreements. This role partners closely with Clinical Development, Clinical Operations, Biometrics, Medical Affairs, Procurement, and Legal and Compliance teams to enable efficient and compliant execution of clinical programs.

The ideal candidate has strong experience with clinical trial agreements and related contracts in a biotech or pharmaceutical setting, excellent judgment, and the ability to manage multiple priorities in a fast-paced environment. Key responsibilities include:

• Draft, review, and negotiate a wide range of clinical development agreements, including:

• Clinical Trial Agreements (CTAs).

• Site agreements and amendments.

• CRO, SMO, and vendor agreements.

• Consulting agreements for investigators and key opinion leaders.

• Data sharing, biometrics, and lab services agreements.

• Advise internal stakeholders on legal, regulatory, and risk considerations related to clinical development activities.

• Support contracting strategy and process improvements to streamline clinical contracting workflows.

• Partner with Clinical Operations and Legal colleagues to identify and mitigate contractual and operational risks.

• Ensure agreements align with applicable laws, regulations, and company policies (e.g., GCP, FDA/EMA requirements, applicable data privacy laws, anti-kickback, transparency).

• Manage multiple agreements simultaneously while meeting clinical timelines.

• Support audits, inspections, and internal reviews related to clinical contracts.

• Stay current on evolving legal and regulatory developments affecting clinical research.

Required Skills, Experience and Education:

• Juris Doctor (JD) from an accredited law school.

• Active license to practice law and in good standing.

• 10+ years of relevant legal experience, with a strong focus on clinical development or life sciences contracts.

• Demonstrated experience negotiating CTAs and CRO agreements in a biotech, pharmaceutical, or law firm setting.

• Strong understanding of clinical trial operations and regulatory frameworks.

• Excellent drafting, negotiation, and communication skills.

• Ability to work independently and collaboratively with cross-functional teams.

• Strong organizational skills and attention to detail.

• In-house experience at a biotech or pharmaceutical company.

• Experience supporting global or multi-region clinical trials.

• Familiarity with contracting tools and CLM systems.

• Experience working in a fast-growing or development-stage company.

#LI-Hybrid  #LI-YG1

The Opportunity:

• Support the Quality Assurance (QA) team in maintaining compliance with internal procedures, regulatory requirements, and quality standards.

• Assist with the review, organization, and maintenance of quality documentation, including SOPs, training records, and quality records.

• Participate in quality system activities such as deviations, CAPAs, change controls, and document control processes.

• Collaborate cross-functionally with Manufacturing, R&D, and other teams to support quality initiatives and continuous improvement efforts.

• Gain hands-on experience in a regulated biotech/pharmaceutical environment while developing a foundational understanding of GMP and quality systems.

Required Skills, Experience and Education:

• Currently pursuing a Bachelor’s or Master’s degree in Life Sciences, Engineering, Chemistry, Biology, Biotechnology, or a related field.

• Strong attention to detail with the ability to follow written procedures and maintain accurate records.

• Basic understanding of quality principles or regulated environments (academic coursework acceptable).

• Proficiency with Microsoft Office (Word, Excel, PowerPoint); ability to learn electronic quality management systems (eQMS).

• Strong written and verbal communication skills.

• Ability to work independently as well as collaboratively in a team environment.

Preferred Skills:

• Prior internship, coursework, or laboratory experience in GMP, GxP, QA, QC, or manufacturing environments.

• Familiarity with FDA regulations, ICH guidelines, or ISO standards.

• Experience with document control systems, quality databases, or data analysis tools.

• Demonstrated interest in quality assurance, regulatory affairs, or compliance-focused career paths. 

  #LI-Hybrid  #LI-AP1

The Opportunity:

We are seeking an experienced oncology drug-development leader to serve as Global Development Lead (GDL) for one of Revolution Medicines’ most advanced clinical programs. This is a senior, program-accountable leadership role with end-to-end ownership of clinical development strategy and execution for a late-stage asset, including pivotal studies, regulatory engagement, and long-range planning.

The GDL functions as the single point of clinical accountability for the assigned program, setting direction, driving alignment across functions, and representing the program at internal governance bodies and externally with investigators, key opinion leaders, and global health authorities. This position sits at the Executive Director level within Clinical Development and carries program-level accountability and authority typically associated with the most senior clinical leaders in the organization.

In addition to program ownership, the GDL serves as a senior clinical advisor to development leadership, contributing perspective to cross-program and enterprise-level development discussions as appropriate.

Responsibilities

Program & Clinical Strategy

• Own and lead the global clinical development strategy for the assigned program, integrating scientific, clinical, regulatory, biomarker, and commercial considerations.

• Partner closely with the Project Team Leader (PTL) or Lifecycle Team Leader (LCL) to ensure that clinical development strategy, positions and decision-making are fully represented and integrated within lifecycle planning and decision-making for the molecule, with clear alignment on roles, decision rights and accountability.

• Develop and maintain the Target Product Profile (TPP), Clinical Development Plan (CDP), risk assessments, scenario analyses, and long-range program roadmap.

• Present strategic recommendations to internal governance bodies (e.g., DRG, SMT, PRG, ePRG) and drive high-quality, timely program decision-making.

• Ensure strategy reflects deep disease-area insight, emerging science, competitive intelligence, and evolving regulatory expectations.

Execution & Oversight

• Accountable for the design, execution, and delivery of pivotal and registration-enabling studies (Phase 2/3), including protocol strategy, enrollment and geographic planning, patient safety oversight, and data interpretation.

• Ensure alignment and harmonization across related studies within the program and across regions to support coherent regulatory and lifecycle objectives.

• Provide senior clinical leadership across functions to anticipate risk, resolve complex issues, and ensure delivery of critical milestones, leveraging matrixed teams rather than direct operational control.

• Guide preparation of regulatory briefing materials and serve as the senior clinical representative in global health authority interactions.

Scientific & Medical Leadership

• Serve as the program’s senior medical authority, providing deep expertise in pancreatic and colorectal cancers.

• Translate scientific, translational, and biomarker insights into actionable clinical strategy.

• Engage key opinion leaders, investigators, advisory boards, and external experts to refine development strategy and strengthen scientific and clinical positioning.

Cross-Functional & Enterprise Leadership

• Serve as the clinical and strategic leader for the assigned program, with clear accountability for clinical direction and integrated decision-making across functions.

• Lead a high-performing, cross-functional Global Development Team, in close partnership with the PTL or LCL, ensuring clarity of direction, strong collaboration, and accountability for outcomes.

• Demonstrate the ability to lead through both influence and authority in situations where program priorities cut across functions, senior leaders, and organizational boundaries.

• Partner with Medical Affairs and Commercial colleagues to ensure alignment between clinical strategy and future market needs.

• Act as a visible senior leader within Clinical Development, modeling enterprise mindset and contributing to broader discussions on development strategy, standards, and best practices beyond the assigned program.

People Leadership & Organizational Impact

• Assume leadership of an established, multidisciplinary Clinical Development Team, including multiple senior direct reports, with immediate accountability for alignment, performance, and delivery across the program.

• Rapidly assess team capabilities, clarify roles and decision rights, and establish operating cadence to ensure seamless execution during critical late-stage development phases.

• Demonstrated ability to step into complex, high-visibility leadership situations and effectively lead teams through transition, inflection points, or accelerated timelines.

• Mentor senior clinical development staff and contribute to capability-building across the broader organization.

• Model Revolution Medicines’ values of scientific rigor, transparency, inclusiveness, and commitment to patients.

• Contribute to the evolution of development processes, tools, and governance practices that enhance efficiency, quality, and scalability across the portfolio.

Required Skills, Experience & Education:

Medical & Scientific Qualifications

• MD (or international equivalent) with board certification in Medical Oncology or Hematology/Oncology; adult solid tumor focus strongly preferred.

• Recognized expertise in NSCLC developed through academic clinical leadership and/or substantial industry experience.

Clinical Development Leadership

• Depth of experience typically gained at least 13 years in oncology clinical development, or a combination of senior academic clinical leadership and relevant industry roles.

• (Academic leadership may be counted when directly related to oncology trials and patient care.)

• Demonstrated leadership of global, late-stage development programs, including design and execution of pivotal Phase 2/3 studies.

• Experience owning or leading global regulatory strategy, including direct involvement in multiple interactions with global health authorities.

• Experience contributing to or leading regulatory submissions (NDA/BLA/MAA); multiple submissions strongly preferred.

Enterprise Leadership & Influence

• Proven ability to align and influence senior stakeholders across a highly matrixed organization.

• Exceptional ability to communicate complex scientific and clinical concepts clearly to executives, cross-functional partners, and external experts.

• Demonstrated skill in navigating conflict, establishing role clarity, and building durable cross-functional trust.

• Demonstrated commitment to developing people and building strong, resilient teams.

Other

• Excellent written and verbal communication skills.

• Ability to travel approximately 25–30% (domestic and international).

• San Francisco Bay Area preferred, but hybrid acceptable.

Preferred Skills:

• Prior academic appointment in medical oncology with leadership of clinical trials.

• Experience integrating translational and biomarker strategies into late-stage clinical development.

• Publication record supporting disease-area credibility.

• Experience supporting commercialization planning or launch readiness.

• Exposure to cross-program or portfolio-level development strategy and governance.

#LI-Hybrid  #LI-GL1

The Opportunity:

We are seeking an experienced oncology drug-development leader to serve as Global Development Lead (GDL) for one of Revolution Medicines’ most advanced clinical programs. This is a senior, program-accountable leadership role with end-to-end ownership of clinical development strategy and execution for a late-stage asset, including pivotal studies, regulatory engagement, and long-range planning.

The GDL functions as the single point of clinical accountability for the assigned program, setting direction, driving alignment across functions, and representing the program at internal governance bodies and externally with investigators, key opinion leaders, and global health authorities. This position sits at the Executive Director level within Clinical Development and carries program-level accountability and authority typically associated with the most senior clinical leaders in the organization.

In addition to program ownership, the GDL serves as a senior clinical advisor to development leadership, contributing perspective to cross-program and enterprise-level development discussions as appropriate.

Responsibilities

Program & Clinical Strategy

• Own and lead the global clinical development strategy for the assigned program, integrating scientific, clinical, regulatory, biomarker, and commercial considerations.

• Partner closely with the Project Team Leader (PTL) or Lifecycle Team Leader (LCL) to ensure that clinical development strategy, positions and decision-making are fully represented and integrated within lifecycle planning and decision-making for the molecule, with clear alignment on roles, decision rights and accountability.

• Develop and maintain the Target Product Profile (TPP), Clinical Development Plan (CDP), risk assessments, scenario analyses, and long-range program roadmap.

• Present strategic recommendations to internal governance bodies (e.g., DRG, SMT, PRG, ePRG) and drive high-quality, timely program decision-making.

• Ensure strategy reflects deep disease-area insight, emerging science, competitive intelligence, and evolving regulatory expectations.

Execution & Oversight

• Accountable for the design, execution, and delivery of pivotal and registration-enabling studies (Phase 2/3), including protocol strategy, enrollment and geographic planning, patient safety oversight, and data interpretation.

• Ensure alignment and harmonization across related studies within the program and across regions to support coherent regulatory and lifecycle objectives.

• Provide senior clinical leadership across functions to anticipate risk, resolve complex issues, and ensure delivery of critical milestones, leveraging matrixed teams rather than direct operational control.

• Guide preparation of regulatory briefing materials and serve as the senior clinical representative in global health authority interactions.

Scientific & Medical Leadership

• Serve as the program’s senior medical authority, providing deep expertise in pancreatic and colorectal cancers.

• Translate scientific, translational, and biomarker insights into actionable clinical strategy.

• Engage key opinion leaders, investigators, advisory boards, and external experts to refine development strategy and strengthen scientific and clinical positioning.

Cross-Functional & Enterprise Leadership

• Serve as the clinical and strategic leader for the assigned program, with clear accountability for clinical direction and integrated decision-making across functions.

• Lead a high-performing, cross-functional Global Development Team, in close partnership with the PTL or LCL, ensuring clarity of direction, strong collaboration, and accountability for outcomes.

• Demonstrate the ability to lead through both influence and authority in situations where program priorities cut across functions, senior leaders, and organizational boundaries.

• Partner with Medical Affairs and Commercial colleagues to ensure alignment between clinical strategy and future market needs.

• Act as a visible senior leader within Clinical Development, modeling enterprise mindset and contributing to broader discussions on development strategy, standards, and best practices beyond the assigned program.

People Leadership & Organizational Impact

• Assume leadership of an established, multidisciplinary Clinical Development Team, including multiple senior direct reports, with immediate accountability for alignment, performance, and delivery across the program.

• Rapidly assess team capabilities, clarify roles and decision rights, and establish operating cadence to ensure seamless execution during critical late-stage development phases.

• Demonstrated ability to step into complex, high-visibility leadership situations and effectively lead teams through transition, inflection points, or accelerated timelines.

• Mentor senior clinical development staff and contribute to capability-building across the broader organization.

• Model Revolution Medicines’ values of scientific rigor, transparency, inclusiveness, and commitment to patients.

• Contribute to the evolution of development processes, tools, and governance practices that enhance efficiency, quality, and scalability across the portfolio.

Required Skills, Experience & Education:

Medical & Scientific Qualifications

• MD (or international equivalent) with board certification in Medical Oncology or Hematology/Oncology; adult solid tumor focus strongly preferred.

• Recognized expertise in pancreatic and colorectal cancers developed through academic clinical leadership and/or substantial industry experience.

Clinical Development Leadership

• Depth of experience typically gained at least 13 years in oncology clinical development, or a combination of senior academic clinical leadership and relevant industry roles.

• (Academic leadership may be counted when directly related to oncology trials and patient care.)

• Demonstrated leadership of global, late-stage development programs, including design and execution of pivotal Phase 2/3 studies.

• Experience owning or leading global regulatory strategy, including direct involvement in multiple interactions with global health authorities.

• Experience contributing to or leading regulatory submissions (NDA/BLA/MAA); multiple submissions strongly preferred.

Enterprise Leadership & Influence

• Proven ability to align and influence senior stakeholders across a highly matrixed organization.

• Exceptional ability to communicate complex scientific and clinical concepts clearly to executives, cross-functional partners, and external experts.

• Demonstrated skill in navigating conflict, establishing role clarity, and building durable cross-functional trust.

• Demonstrated commitment to developing people and building strong, resilient teams.

Other

• Excellent written and verbal communication skills.

• Ability to travel approximately 25–30% (domestic and international).

• San Francisco Bay Area preferred, but hybrid acceptable.

Preferred Skills:

• Prior academic appointment in medical oncology with leadership of clinical trials.

• Experience integrating translational and biomarker strategies into late-stage clinical development.

• Publication record supporting disease-area credibility.

• Experience supporting commercialization planning or launch readiness.

• Exposure to cross-program or portfolio-level development strategy and governance.

#LI-Hybrid  #LI-GL1

The Opportunity:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Required Skills, Experience and Education:

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

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

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

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

• Proven track record of leadership in global pharmacovigilance environments.

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

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

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

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

• Demonstrated technical expertise in QA/QC.

• Outstanding emotional intelligence.

• Proven ability to lead and develop people.

Preferred Skills:

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

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

• Proficiency in managing regulatory inspections and interactions.

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

• Excellent influence and collaboration/teamwork capabilities. 

  #LI-Hybrid  #LI-GL1

The Opportunity:

• Provide management and leadership of one or more therapeutic areas for late-stage oncology programs.

• Oversee the development of global regulatory therapeutic area and product strategies to drive product development, global registration, , and effective regulatory agency interactions.

• Provide regulatory expertise and guidance to therapeutic area commercialization teams and other governance bodies.

• Foster the career development of staff within the therapeutic area and contribute to departmental leadership activities.

• Ensure alignment and consistency across programs within a therapeutic area based on regulatory intel, research, and competitive landscape.

Primary Responsibilities:

• Direct the development of global regulatory strategy from registrational studies to marketing application across one or more therapeutic areas.

• Lead and mentor GRLs/Study Leads in the development of global regulatory strategies, in partnership with regional regulatory leads, including precedence, risk management and contingency planning.

• Partner with regional regulatory leads to incorporate regional regulatory, scientific, clinical, and market insights into integrated disease area and product strategies.

• Communicate to management aligned global regulatory strategy and plans for a therapeutic area to support portfolio and life cycle management.

• Conduct management review and approval of key documents for regulatory submissions and governance communications.

• Contribute to the target product profile and evaluation of probability of regulatory success.

• Monitor, assess and communicate to staff impact of relevant global regulations, guidance, and current regulatory environment.

• Advise on global health authority interactions and participate on core regulatory and cross-functional teams to ensure effective agency interactions.

• Provide managerial leadership & direction to staff within the therapeutic area, allowing appropriate prioritization of resources to achieve corporate goals.

• Provide coaching, mentoring, and development of staff, ensuring staff are compliant with Revolution Medicine’s corporate and departmental policies and procedures.

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.

• Prior marketing application filing experience. Demonstrated success in obtaining health authority approvals.

• Demonstrated ability in leading teams, establishing organizational direction, and championing continuous improvements.

• Direct experience with global oncology drug development.

• Experienced in representing Regulatory on cross functional teams and presenting to senior management. Proven ability to anticipate challenges and future risks and mitigate against potential strategic issues.

• Excellent planning and organizational skills and the ability to work simultaneously on multiple projects with tight timelines.

Preferred Skills:

• An advanced degree is desirable.

• Experience with combination studies, multiple expansion cohort, global registrational studies, basket or umbrella and master protocols highly preferred. 

  #LI-Hybrid  #LI-SH1

The Opportunity:

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

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

Key Responsibilities:

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

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

  • Preformulation and formulation development.

  • Manufacturing process development.

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

  • Process validation and commercial manufacturing support.

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

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

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

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

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

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

Required Skills, Experience and Education:

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

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

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

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

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

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

• Experience contributing to CMC regulatory filings is desirable.

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

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

Preferred Skills:

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

  #LI-Hybrid #LI-CT1

The Opportunity:

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

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

Responsibilities:

Global CMC Regulatory Strategy

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

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

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

Health Authority Engagement

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

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

Regulatory Submissions & Lifecycle Management

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

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

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

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

Cross-Functional Collaboration

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

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

Team Development & Leadership

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

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

Required Skills, Experience and Education:

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

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

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

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

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

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

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

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

Preferred Skills:

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

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

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

  #LI-Hybrid  #LI-GL1

The Opportunity:

We are seeking a Scientific Writer with strong nonclinical regulatory experience to support the authoring and integration of nonclinical content for U.S. and global regulatory submissions. This role focuses on developing and integrating nonclinical content beyond INDs and NDAs, including briefing documents, Investigator Brochures, responses to health authority questions, and other submission-related materials across the U.S., Europe, and Asia.

As a strategic scientific integrator, this individual will translate complex RAS biology and translational pharmacology into clear, compelling regulatory narratives that reflect RevMed’s deep mechanistic understanding of RAS signaling and frontier targets. The role partners closely with nonclinical subject matter experts (SMEs) in pharmacology, toxicology, and DMPK, as well as Regulatory Affairs, Regulatory Operations, and Medical Writers, to ensure nonclinical strategy and content are scientifically rigorous, aligned, and submission-ready.

The Scientific Writer will leverage structured source documents, document management systems, and emerging AI-enabled tools to improve efficiency, consistency, and scalability of nonclinical regulatory writing. This role requires strong organizational skills and the ability to manage multiple programs and cross-functional inputs simultaneously in a fast-paced, scientifically rigorous environment.

Key Responsibilities

• Author, integrate, and edit nonclinical sections of regulatory documents across multiple submission types, including INDs, NDAs, briefing documents, amendments, and response to health authority requests.

• Safeguard and articulate the scientific rationale underlying RevMed’s RAS(ON) and companion inhibitor programs across regulatory communications.

• Develop clear, hypothesis-driven regulatory narratives that integrate pharmacology, toxicology, and DMPK data, and engage as a critical scientific thought partner to these functions to strengthen mechanistic coherence, regulatory positioning, and alignment with global regulatory expectations (FDA, EMA, and select Asian agencies).

• Collaborate closely with project Medical Writers to ensure nonclinical sections are delivered in alignment with overall timelines and coordinated with related document sections.

• Ensure scientific consistency across programs to preserve and extend RevMed’s reputation for rigor and mechanistic depth.

• Manage multiple regulatory writing efforts in parallel, balancing priorities across programs and functions in a fast-paced environment.

• Utilize Regulatory information management systems (e.g., Veeva) and AI-enabled writing tools to support authoring, review, and lifecycle management of regulatory documents.

• Contribute to templates, guidance, and best practices for global nonclinical regulatory documentation.

• Drive continuous improvement of nonclinical authoring standards, templates, and knowledge management systems.

• Capture and institutionalize lessons learned from prior submissions to improve quality, consistency, and efficiency across programs and regions.

Required Skills, Experience and Education:

• Advanced degree (PhD preferred; MS considered) in a relevant nonclinical scientific discipline.

• Demonstrated experience authoring or substantially contributing to nonclinical sections of regulatory submissions across multiple document types.

• Strong working knowledge of pharmacology, toxicology, and DMPK and their integration into regulatory narratives.

• Demonstrated ability to synthesize complex mechanistic datasets into coherent, hypothesis-driven regulatory narratives.

• Comfortable engaging deeply in data discussions with subject matter experts and operating in a culture of scientific debate and rigorous review.

• Familiarity with range of regulatory expectations including those beyond the U.S. such as European and/or Asian health authorities.

• Proven ability to manage multiple projects concurrently and work effectively across functions.

• Excellent written communication skills, attention to detail, and a collaborative, solutions-oriented mindset.

Preferred Skills:

• Industry experience as a Scientific or Medical Writer.

• Experience supporting global regulatory submissions (FDA, EMA, etc.).

• Proficiency with Veeva or similar Regulatory information management systems platforms.

• Experience leveraging AI-enabled tools for scientific or regulatory writing.

• Comfortable operating in a dynamic, evolving research and development environment. #LI-Hybrid  #LI-LN1