The Opportunity:

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

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

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

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

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

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

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

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

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

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

Required Skills, Experience and Education:

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

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

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

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

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

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

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

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

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

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

• Proven ability to manage budgets and timelines effectively.

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

Preferred skills:

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

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

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

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

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

• Direct experience with Phase IV drug development.

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

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

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

  #LI-Hybrid  #LI-GL1

The Opportunity:

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

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

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

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

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

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

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

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

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

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

• Potential to manage multiple direct reports.

Required Skills, Experience and Education:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

• Strong written and business presentation skills is required.

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

• Demonstrated strong leadership presence.

• Has demonstrated adaptability and flexibility.

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

Preferred skills:

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

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

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

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

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

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

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

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

#LI-Hybrid  #LI-SH1

The Opportunity:

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

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

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

System Configuration & Administration

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

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

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

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

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

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

Data Quality & Reporting Support

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

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

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

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

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

Operational Support & Collaboration

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

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

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

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

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

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

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

Compliance & Inspection Readiness

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

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

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

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

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

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

Required Skills, Experience and Education:

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

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

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

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

Core Competencies

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

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

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

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

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

• Foster a structured and efficient work environment.

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

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

Preferred Skills:

• Degree in computer science or related field preferred.

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

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

  #LI-Hybrid  #LI-SH1

The Opportunity:

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

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

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

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

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

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

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

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

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

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

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

• Potential to manage multiple direct reports

Required Skills, Experience and Education:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

• Strong written and business presentation skills is required.

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

• Demonstrated strong leadership presence.

• Has demonstrated adaptability and flexibility.

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

Preferred skills:

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

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

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

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

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

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

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

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

  #LI-Hybrid  #LI-SH1

The Opportunity:

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

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

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

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

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

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

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

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

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

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

• Potential to manage multiple direct reports.

Required Skills, Experience and Education:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

• Strong written and business presentation skills is required.

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

• Demonstrated strong leadership presence.

• Has demonstrated adaptability and flexibility.

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

Preferred skills:

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

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

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

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

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

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

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

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

#LI-Hybrid  #LI-SH1

The Opportunity:

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:

This position will be responsible for the management, development, and oversight of Global Patient Safety operational activities in the execution of safety information collection and reporting for the assigned Revolution Medicines’ clinical programs.

• Participates in the development of Global Patient Safety Operations operational objectives, policies, and procedures.

• Represent Global Patient Safety in different cross functional team meetings.

• Collaborate with other functional groups to achieve clinical program goals.

• Oversee Pharmacovigilance Contract Research Organization (PV CRO) in the execution of safety reporting in clinical studies.

• Manage PV CROs to ensure compliance with required timelines, that potential issues are being communicated, and resolution is achieved in a timely manner.

• Oversee reporting of safety reports to global regulatory authorities, central IRB/ethics committees, investigators to ensure compliance with global regulatory requirements.

• Ensure timely and accurate set up of global safety reporting and safety database in assigned clinical programs.

• Support authoring and updates of clinical trial protocols, informed consent forms, Investigator Brochure (including the Reference Safety Information section), and aggregate reports.

• Support the execution and maintenance Safety Data Exchange Agreements

• /Pharmacovigilance Agreements with business partners.

• Collaborate with other functional groups in SAE reconciliation and SAE query resolution activities.

• Support Global Patient Safety team in other PV activities appropriate to experience and expertise.

• May oversee or be responsible for one or more junior team member(s).

Required Skills, Experience and Education:

• Bachelor’s degree in a healthcare field.

• Minimum of 5 years of relevant experience in pharmacovigilance operational activities.

• Hands-on experience working with CROs/vendors and management of external resources.

• Strong background in safety reporting regulatory compliance and global safety reporting/regulations in clinical trials.

• Able to problem solve, focus on details, multi-task, prioritize options, work independently, anticipate challenges and execute assigned deliverables.

• Ability to analyze situations and data that requires conceptual thinking and in-depth knowledge of organizational objectives.

• Ability to persuade others in sensitive/complex situations while maintaining relationships.

• An innovative team-player with capacity to be effective in a dynamic, continuously improving, and fast-paced company environment.

• Excellent interpersonal skills including ability to work in cross-functional team environments and with external vendors.

• Exercise discretion regarding highly confidential internal and external communications.

Preferred Skills:

• Master’s Degree or higher in a healthcare field.

• 7+ years of relevant experience in pharmacovigilance operational activities.

• Experience working with investigator sponsored trials, extended use programs, and business partnerships. 

  #LI-Hybrid  #LI-SH1

The Opportunity:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Required Skills, Experience and Education:

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

• Minimum 13+ years’ experience in clinical development required (Pharma R&D experience outside of a clinical development role also considered pending transferability of skills and responsibilities).

• Minimum 5 years of experience in late-stage clinical development within the biotech/pharmaceutical industry.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

• Strong written and business presentation skills is required.

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

• Demonstrated strong leadership presence.

• Has demonstrated adaptability and flexibility.

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

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

Preferred skills:

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

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

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

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

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

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

• Has demonstrated courage and conviction in past positions and responsibilities. Demonstrated skills in conflict resolution. #LI-Hybrid  #LI-SH1

The Opportunity:

The Safety Scientist within Global Patient Safety Science is an individual contributor who provides safety science and pharmacovigilance support to all products across the RevMed portfolio, which includes early and late phase development activities. The individual will be responsible for supporting clinical studies, review of clinical trial protocols, supporting updates to IBs, ICFs, and authoring of DSURs. Additional safety related activities will involve medical review of individual case safety reports (ICSRs), safety surveillance of assigned products and active member of cross-functional teams.

The Safety Scientist will develop and maintain an understanding of the safety profile of the assigned product(s). Responsibilities include:

• Proactive medical safety surveillance of ongoing clinical trials for identification of safety

• Conduct ongoing safety data reviews; prepare and present summaries to internal stakeholders.

• Medical review of individual case safety reports, routine review of safety data and pertinent scientific literature articles.

• Identify potential clinical safety issues for ongoing clinical trials based on emerging safety data.

• May perform safety reviews of relevant sections of clinical trial protocols, Investigator’s Brochures (including reference safety information), clinical study reports, informed consent forms, DSURs, and other study related documents, as required.

• Supports authoring or otherwise contributes to the preparation of aggregate safety reports and risk management plans (RMPs).

• Conducts signal detection and evaluation activities for assigned products in collaboration with senior Safety Science team member(s) as part of the continuous benefit-risk evaluation throughout the product lifecycle.

• Establish and maintain collaborative working relationships with all key stakeholders (e.g., clinical study teams, study sites, CROs).

• Consistently comply with all governing laws, regulations, RevMed standard operating procedures (SOPs) and other guidelines.

Required Skills, Experience and Education:

• A relevant postgraduate qualification (e.g., MD, PharmD, PHD/MSc in a Life sciences discipline, or other post-graduate health professional qualifications).

• 1 or more years of drug development experience in the pharmaceutical or related industry.

• Detail-oriented with ability prioritize tasks and function independently as appropriate.

• Strong learning orientation, curiosity, and commitment to science and patients.

• Excellent written and verbal communication skills.

Preferred Skills:

• Understanding of the scientific aspects of safety, PV (including GVP, GCP), and clinical/patient risk management.

• Exposure to Safety Operations and experience with individual case review.

• Knowledge and/or experience with clinical trial management and data review. 

  #LI-Hybrid  #LI-SH1

The Opportunity:

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 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:

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

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

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

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

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

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

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

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

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

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

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

• Potential to manage multiple direct reports.

Required Skills, Experience and Education:

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

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

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

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

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

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

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

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

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

• Proven ability to build and maintain strong relationships and contribute to interactions with external key opinion leaders to optimize clinical programs (e.g. advisory boards, individual engagements, steering committees, etc.). Experience in (or clear ability) investigator engagement to optimize clinical trial conduct. Includes presenting at investigator meetings.

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

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

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

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

• Strong written and business presentation skills is required.

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

• Demonstrated strong leadership presence.

• Has demonstrated adaptability and flexibility.

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

Preferred skills:

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

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

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

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

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

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

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

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

  #LI-Hybrid  #LI-SH1

The Opportunity:

We are seeking an experienced clinical scientist to serve as Associate Director, Clinical Science in support of Revolution Medicines’ late-stage clinical programs.  In this role, you will independently lead defined clinical science workstreams within pivotal and supportive studies and support execution of the registrational clinical development strategy for assigned molecule(s) and indication(s). The Associate Director plays a critical role in ensuring high-quality clinical data review, protocol consistency, and submission-readiness for late-stage programs. This position operates with substantial autonomy within assigned scope and collaborates closely with more senior clinical science team members and the study Medical Director to ensure medically sound and regulatory-aligned execution. Furthermore:

• Independently lead defined clinical science workstreams within pivotal and registration-enabling studies (e.g., endpoint strategy, data review oversight, CSR section ownership, data consistency initiatives).

• Contribute substantially to protocol development, CRF design, ICF updates, and alignment of data standards with downstream regulatory requirements.

• Drive ongoing clinical data review activities, including plausibility review, query trend analysis, and preparation for database lock.

• Accountable for assigned clinical science deliverables supporting regulatory submissions, including CSR sections, briefing package content, and health authority response inputs.

• Support preparation of regulatory documentation and responses to health authority questions.

• Collaborate closely with Biostatistics, Data Management, Medical Writing, Medical Directors, Pharmacovigilance, and Clinical Operations to ensure alignment and submission readiness.

• Participate in study team meetings and represent Clinical Science in sub-team discussions.

• May serve as Clinical Science lead for smaller or supportive studies, based on experience and study complexity.

• Mentor Senior Clinical Scientists and Clinical Scientists as appropriate.

• Proactively identify risks, propose mitigation strategies, and escalate significant issues as appropriate to Directors or Senior Directors.

• Contribute to cross-functional discussions to support eSective and eSicient study execution.

Required Skills, Experience and Education:

• Bachelor’s Degree (life sciences preferred); Advanced Clinical/Science Degree is a plus (e.g., PharmD, PhD, MSN, MPH, etc.).

• 5+ years of clinical development or relevant experience within a pharmaceutical, biotech, or academic clinical research setting; late-stage development experience preferred.

• Demonstrated experience contributing to pivotal or registration-enabling studies.

• Strong knowledge of GCP, ICH, FDA, EMA, and other relevant regulatory guidelines.

• Experience contributing to protocol development, CRF design, and regulatory documentation.

• Strong analytical skills and experience interpreting clinical trial data.

• Proven ability to work eSectively in cross-functional teams and integrate multiple perspectives.

• Excellent written and verbal communication skills.

• Strong organizational skills and ability to manage multiple deliverables.

Preferred Skills:

• Experience contributing to NDA/BLA/MAA submission components.

• Experience supporting health authority interactions.

• Demonstrated ability to lead defined study-level initiatives.

• Experience mentoring junior clinical science staffs.

#LI-Hybrid  #LI-SH1

The Opportunity:

The Senior Safety Scientist within Global Patient Safety Science is an individual contributor who provides safety science and pharmacovigilance support to all products across the RevMed portfolio, which includes early and late phase development activities. The individual will be responsible for safety oversight of clinical studies, review and authoring of clinical trial protocols, IBs, ICFs, and DSURs. Additional safety related activities will involve medical review of individual case safety reports (ICSRs), safety surveillance of assigned products and active member of cross-functional teams.

The Senior Safety Scientist will develop and maintain an understanding of the safety profile of the assigned product(s). Responsibilities include:

• Proactive medical safety surveillance of ongoing clinical trials for identification and management of safety

• Prepare and present safety data summaries to internal and external stakeholders.

• Risk management activities include, but are not limited to medical review of ICSRs, routine review of safety data and pertinent scientific literature articles.

• Acquire and contribute knowledge of relevant drug class and/or competitor safety issues.

• Identify potential clinical safety issues and recommend appropriate risk mitigation measures.

• Involvement in preparation and maintenance of relevant sections of clinical trial protocols, IBs (including the reference safety information section), ICFs, DSURs, RMPs, CCDS, and labelling, as required.

• Perform safety review of clinical protocols, Investigator's Brochure (IB), informed consent form (ICF) and other related documents to ensure alignment with the safety strategy and ensure the appropriateness of risk management strategies and risk communication.

• Accountable for the safety components of study reports (i.e., CSRs), publications, aggregate reports, and other regulatory documents.

• Conducts signal detection and evaluation activities for assigned products for the continuous benefit-risk evaluation throughout the product lifecycle and contributes/leads preparation for escalation to safety governance committees.

• Supports implementation of decisions from the signal evaluation process, including updates to core safety information, Investigator’s Brochure and other key safety documents and deliverables.

• Contributes to input related to regulatory filings, New Drug Applications [NDAs], Biologics License Applications [BLAs]), and responses to safety queries from third parties, such as regulatory agencies.

• Establish and maintain collaborative working relationships with all key stakeholders (study team members, CROs, investigators, study sites, vendors, committees, etc.).

• Consistently comply with all governing laws, regulations, RevMed standard operating procedures (SOPs) and other guidelines.

Required Skills, Experience and Education:

• A relevant postgraduate qualification (e.g., MD, PharmD, PHD/MSc in a Life sciences discipline, or other post-graduate health professional qualifications).

• 3 or more years of drug development experience in the pharmaceutical or related industry with at least 1 year in drug safety.

• Proven success in creating and sustaining strong relationships with internal and external business partners across an organization to create positive partnerships.

• Broad understanding of the scientific aspects of safety, PV (including GVP, GCP), and clinical/patient risk management ​and safety operations.

• Demonstrated ability to lead and influence, with and without authority, in a fast-paced environment.

• Strong presentation skills, effective at summarizing and presenting the key considerations and decision points.

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

• Detail-oriented with ability prioritize tasks and function independently as appropriate.

• Strong organizational skills and an ability to interpret, discuss, and report trial level data effectively and identify trends.

• Excellent written and verbal communication skills. 

  #LI-Hybrid  #LI-SH1

The Opportunity:

This position will be responsible for the management, development, and oversight of Global Patient Safety operational activities in the execution of safety information collection and reporting for the assigned Revolution Medicines’ clinical programs.

• Participates in the development of Global Patient Safety Operations operational objectives, policies, and procedures.

• Represent Global Patient Safety in different cross functional team meetings.

• Collaborate with other functional groups to achieve clinical program goals.

• Oversee Pharmacovigilance Contract Research Organization (PV CRO) in the execution of safety reporting in clinical studies.

• Manage PV CROs to ensure compliance with required timelines, that potential issues are being communicated, and resolution is achieved in a timely manner.

• Oversee reporting of safety reports to global regulatory authorities, central IRB/ethics committees, investigators to ensure compliance with global regulatory requirements.

• Ensure timely and accurate set up of global safety reporting and safety database in assigned clinical programs.

• Support authoring and updates of clinical trial protocols, informed consent forms, Investigator Brochure (including the Reference Safety Information section), and aggregate reports.

• Support the execution and maintenance Safety Data Exchange Agreements

• /Pharmacovigilance Agreements with business partners.

• Collaborate with other functional groups in SAE reconciliation and SAE query resolution activities.

• Support Global Patient Safety team in other PV activities appropriate to experience and expertise.

• May oversee or be responsible for one or more junior team member(s).

Required Skills, Experience and Education:

• Bachelor’s degree in a healthcare field.

• Minimum of 5 years of relevant experience in pharmacovigilance operational activities.

• Hands-on experience working with CROs/vendors and management of external resources.

• Strong background in safety reporting regulatory compliance and global safety reporting/regulations in clinical trials.

• Able to problem solve, focus on details, multi-task, prioritize options, work independently, anticipate challenges and execute assigned deliverables.

• Ability to analyze situations and data that requires conceptual thinking and in-depth knowledge of organizational objectives.

• Ability to persuade others in sensitive/complex situations while maintaining relationships.

• An innovative team-player with capacity to be effective in a dynamic, continuously improving, and fast-paced company environment.

• Excellent interpersonal skills including ability to work in cross-functional team environments and with external vendors.

• Exercise discretion regarding highly confidential internal and external communications.

Preferred Skills:

• Master’s Degree or higher in a healthcare field.

• 7+ years of relevant experience in pharmacovigilance operational activities.

• Experience working with investigator sponsored trials, extended use programs, and business partnerships. 

  #LI-Hybrid  #LI-SH1

The Opportunity:

The Senior Director, Global Patient Safety Science provides safety science and pharmacovigilance support to all products across the RevMed portfolio, which includes early and late phase development activities as a member of the Global Patient Safety team. The individual will be responsible for safety oversight and input into all aspects of study management across the portfolio.  This position may have individual reporting to it depending on the program / portfolio being led. The Senior Director of Safety Science serves as the lead for multiple or large complex strategically important developmental programs. Works closely with the other functions as part of a flexible matrix team to conduct robust safety assessments and safety risk management activities.

The Senior Director, Global Patient Safety Science will develop and maintain an expert understanding of the safety profile of the assigned product(s) as well as an understanding of the relevant strategic context (e.g., disease under study, safety profile of competitors, mechanism of action, etc.) and is accountable for oversight of benefit/risk safety profile of allocated products through the product lifecycle.

Specifically, you will be responsible for:

• Responsible for safety surveillance and risk management activities including, but not limited to medical review of ICSRs, routine review of safety data, and pertinent scientific literature articles. Contribute to the review of assessments for safety signals or in response to Regulatory Authority requests.

• Providing medical safety input into the design and conduct of pharmacoepidemiology and observational studies

• Plan and interpret safety data analyses, prepare and present safety data summaries to internal and external stakeholders.

• Acquire and contribute knowledge of relevant drug class and/or competitor safety issues.

• Lead the development of safety surveillance strategy, identify potential clinical safety issues, and recommend appropriate risk mitigation measures.

• Establish and maintain collaborative working relationships with all key stakeholders (e.g., clinical study teams, safety CROs, business partners) which require expert contribution to the development of the product safety strategy.

• Accountable for risk management activities including preparation and maintenance of relevant sections of clinical trial protocols, IBs (including the reference safety information section), ICFs, DSURs, RMPs, CCDS, and labelling, as required.

• Contribute to regulatory authority submissions (Investigational New Drug applications, New Drug Applications, Marketing Authorization Applications, etc.).

• Developing response strategies in collaboration with safety committee members, providing medical-scientific input to regulatory documents for safety-related requests from health authorities and other external parties.

• Drives risk minimization strategies and takes accountability for the medical-scientific content in the Risk Management Plans, including risk minimization measures, risk minimization action plans and REMS programs, as relevant.

• Accountable for the safety components of study reports (i.e., CSRs), aggregate reports (DSUR, PSUR/PBRER, PADER) and other regulatory documents.

• Participate in internal and external Data Monitoring Committees through review of safety data, insights and leadership and development of DMC Charters.

• Lead representative for Safety Science during Health Authority meetings.

• Reviews publications, including abstracts, manuscripts, and speaker presentations.

• Trains and mentors Safety Scientists.

• Consistently comply with all governing laws, regulations, RevMed standard operating procedures (SOPs) and other guidelines.

Required Skills, Experience and Education:

• 10 or more years of drug development experience in the pharmaceutical or related industry, of which at least 6 years include prior Safety Science experience, which includes performance of medical review, safety surveillance/signal detection, and other related risk management activities.

• A relevant postgraduate qualification (e.g., MD, PharmD, PhD/MSc in a Life sciences discipline, or other post-graduate health professional qualifications).

• Mentor, and lead a high-performing Safety Science team.

• Excellent ability to evaluate, interpret and present scientific data with clarity.

• Proven success in creating and sustaining strong relationships with internal and external business partners across an organization to create positive partnerships.

• Experience with interacting and leading with Regulatory Authorities (i.e. FDA, EMA) at type C, B, pre-BLA/MAA meetings, Advisory Committee meetings, or other scientific advice forums.

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

• Excellent communication, collaboration, and team management abilities.

• Extensive understanding of pharmacovigilance and risk management.

• Strong clinical leadership and experience.

• Outstanding emotional intelligence.

Preferred Skills:

• Demonstrated ability to lead and influence in a global matrix environment.

• 4+ years of experience in Oncology clinical development.

• Proficiency in managing regulatory interactions, BLA/MAA experience.

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

• Excellent influence and collaboration/teamwork capabilities.

• Strong interpersonal and communication (written and verbal) skills. 

  #LI-Hybrid  #LI-SH1