The Opportunity:

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

Responsibilities:

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

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

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

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

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

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

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

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

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

Required Skills, Experience and Education:

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

• Strong analytical and organizational skills.

• Effective written and verbal communication skills.

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

• Interest in clinical trial operations and process optimization.

Preferred Skills:

• Familiarity with Smartsheet or similar project management tools.

• Prior exposure to clinical research or regulated environments. 

  #LI-Hybrid  #LI-AP1

The Opportunity:

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

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

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

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

• Analyze data health metrics to be shared with stakeholders.

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

• Conduct risk management, contingency, and scenario planning.

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

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

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

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

• Participate in other Clinical Operations activities as appropriate.

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

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

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

• Support junior team members through mentorship.

Required Skills, Experience and Education:

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

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

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

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

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

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

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

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

• Excellent written/verbal communication and interpersonal skills.

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

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

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

• Travel may be required (~25%).

Preferred Skills:

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

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

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

• Some experience mentoring jr staff. 

  #LI-Hybrid  #LI-DN1

The Opportunity:

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

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

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

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

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

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

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

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

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

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

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

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

• Establish standards for maintaining and continuously improving operational knowledge.

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

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

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

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

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

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

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

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

Required Skills, Experience and Education:

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

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

• Minimum of 5 years of line management experience.

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

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

• Experience with leading organizational change efforts.

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

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

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

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

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

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

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

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

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

• Excellent interpersonal, verbal and written communication skills.

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

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

• Decision-making skills.

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

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

• Travel may be required (~25%).

Preferred Skills:

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

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

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

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

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

  #LI-Hybrid  #LI-DN1

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers.  The company’s R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. As a new member of the Revolution Medicines team, you will join other outstanding Revolutionaries in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.

The Opportunity:

As an Associate Director, you will be responsible for the following:

• Lead and/or support development and implementation of GCP systems and inspection readiness.

• Lead and/or support the development and continuous improvement of Clinical Policies/ SOPs/ WIs/ Templates/etc. using knowledge and experience with clinical study management, International Conference on Harmonization (ICH) Guidelines, Good Clinical Practices (GCP) and regulatory requirements.

• SME for Clinical Operations GCP guidance, best industry practices, SOPs, and audit responses.

• Contribute to the development and management of business and compliance metrics to assess and continuously improve RevMed oversight and inspection readiness throughout the clinical trial lifecycle.

• Support Clinical Operations Inspection Readiness activities with clinical study teams; key participation in Mock/Regulatory Authority inspections.

• Contribute to the development and execution of Clinical Operations training programs to deliver RevMed standards, GCP, and regulatory requirements.

• Partner cross-functionally and with QA on quality initiatives, continuous improvement of GCP systems, and internal audits.

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

• Participate in other Clinical Operations Activities per the business need.

Required Skills, Experience and Education:

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

• 10+ years direct Clinical Compliance, and/or Clinical Quality Assurance experience in the pharmaceutical or biotech industry. Relevant Clinical Operations experiences may also meet the requirement.

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

• Demonstrated experience successfully developing and authoring Clinical and cross-functional SOPs ensuring compliance with GCP and regulatory requirements.

• Experience with development and monitoring of oversight activities.

• Knowledge and/or familiarity with Ex-US region(s) e.g. EMA, MHRA, PDMA.

• Ability to perform complex assessments & investigations, draw relevant conclusions, and implement appropriate solutions.

• Strong analytical, negotiation, and persuasion skills.

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

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

• Excellent interpersonal, verbal, and written communication skills.

• Decision-making skills.

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

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

• Travel may be required (~25%).

Preferred Skills:

• Line Management experience.

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

• RN or Master’s degree in biological sciences or health-related field preferred.

• Strong working knowledge of ex-US regulations and requirements. 

  #LI-Hybrid  #LI-DN1

The Opportunity:

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

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

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

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

• Analyze data health metrics to be shared with stakeholders.

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

• Conduct risk management, contingency, and scenario planning.

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

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

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

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

• Participate in other Clinical Operations activities as appropriate.

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

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

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

• Support junior team members through mentorship.

Required Skills, Experience and Education:

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

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

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

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

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

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

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

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

• Excellent written/verbal communication and interpersonal skills.

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

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

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

• Travel may be required (~25%).

Preferred Skills:

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

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

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

• Some experience mentoring jr staff. 

  #LI-Hybrid  #LI-DN1

The Opportunity:

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

Responsibilities:

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

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

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

• Analyze data health metrics to be shared with stakeholders.

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

• Conduct risk management, contingency, and scenario planning.

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

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

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

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

• Demonstrate the ability to lead and manage multiple complex clinical trials within one or multiple programs with limited oversight.

• Independently lead Clinical Study Execution Team (CSETs) and influence relevant stakeholders both internally and externally including management.

• May lead interdepartmental strategic business initiatives as well as spearhead certain SOP development and training.

• May provide input into strategic and operational short- and long-term therapeutic area development, as appropriate, including supporting alignment and communication to other team members upon implementation

• Assists in the hiring, development, and retention of top talent within the team. Coach direct report(s) on their performance, development, and career interests.

• Participate in other Clinical Operations activities as appropriate.

Required Skills, Experience and Education:

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

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

• Minimum of 6 years of cross-functional study management or related leadership experience in life sciences, including multiple years’ experience managing project teams.

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

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

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

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

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

• Excellent written/verbal communication and interpersonal skills.

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

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

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

• Travel may be required (~25%).

Preferred Skills:

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

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

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

• Some experience managing direct reports. 

  #LI-Hybrid  #LI-DN1

The Opportunity:

This is a unique opportunity for a Clinical Operations Professional who has innate leadership and organizational skills, technical expertise in clinical oncology drug development in an industry setting, and experience in overseeing clinical trials. As an Associate Director, you will be responsible for the Contract Research Organization (CRO) oversight, execution, and management of Revolution Medicines (RevMed) clinical trials.

Responsibilities:

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

• Global experience in end-to-end execution of different phases of clinical trials.

• Accountable for study delivery goals. Oversee the successful management of all aspects of clinical trials within timelines and designated program budgets.

• Guide assessment, selection, engagement, management, and oversight of appropriate vendors.

• Responsible for making decisions that balance risk/benefit with clear understanding of impact on the study and project; takes action to mitigate risk where appropriate.

• Lead risk management and quality efforts to ensure study compliance and continual inspection readiness. Lead/contribute to ways of working and process improvement initiatives.

• Provide proactive and consistent oversight of CRO and vendor performance Support Clinical Operations Program and / or Indication Lead with key study level status updates, with a particular focus on delivery to corporate and project level objectives.

• Contributions to the strategy and execution of the Clinical Development Plan (CDP) for assigned clinical programs which include timelines, budget, and resource requirements. Ability to identify critical path activities and articulate and mitigate risks to clinical trial conduct.

• Responsible for successful planning and deployment of Clinical Operations staff (potentially including Clinical Program Managers/Clinical Trial Managers/Clinical Trial Assistants, and consultants) for project and non-project related tasks.

• Lead line management responsibilities that include hiring, performance management, career development, and mentorship.

• Manage/oversee CROs and selected study vendors; ensuring all vendors strive to achieve the predetermined program milestones according to budget and timeline, as well as evaluate vendor performance using metrics and KPIs.

• Lead cross functional team meetings and collaborate with other functional groups within the company (e.g., Clinical Development, Regulatory, QA, Finance, Legal, etc.) to achieve clinical study goals.

• Ensure clinical trials maintain an inspection readiness state throughout the lifecycle of the trial.

• Oversee the improvement of processes that will impact clinical trial management and deliverables including contingency plans by maintaining a highly effective Clinical Operations team and building strong relationships with functional leaders.

Required Skills, Experience and Education:

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

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

• Minimum of 5 years of project and first-line management experience.

• Experience in oncology.

• Experience in leading and managing global phase 1-3 clinical trials within designated timelines, resources, and budgets.

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

• Experience with vendor management and CRO oversight.

• Ability to perform complex analysis, draw relevant conclusions, and implement appropriate solutions.

• Ability to pivot, be solution-oriented with consideration to long-term impact on clinical trials, responsibilities, and inspection-readiness.

• Strong analytical, negotiation, and persuasion skills.

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

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

• Excellent interpersonal, verbal, and written communication skills.

• Decision-making skills.

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

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

• Travel may be required (~25%).

• Demonstrated experience leading in the matrix environment to deliver projects, develop clinical plans and manage change.

• In-depth knowledge of either study management or data management and knowledge of essential global regulatory guidelines and ICH/GCP.

• Proven experience working with investigators, external experts and regulatory agencies and oversight of Contract Research Organizations and third-party vendors including realigning with CRO partners when deliverables are at risk, negotiating solutions and leading After Action Reviews to share lessons learned.

• Excellent project management skills and budget management skills.

Preferred Skills:

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

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

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

• Experience in working with cooperative group studies and investigator sponsored trials preferred. 

  #LI-Hybrid  #LI-DN1

The Opportunity:

This is a unique opportunity as a junior Clinical Trial Assistant in Clinical Operations, initially reporting to the Associate Director/Director Clinical Operations, you will be responsible for acting as a central contact for the clinical study teams and assist with the clinical execution and management to support RevMed clinical trials.

Responsibilities:

• Assisting in the review, distributing, and archiving of study specific documents and reports (plans, training materials, study guides, manuals etc.).

• Assisting with updating and maintaining clinical systems and any reporting tools.

• Support maintenance of the trial master files (TMF) if applicable, or work with CRO to audit and resolve discrepancies.

• Create, maintain, and track information for key study related activities.

• Assisting in the preparation of meeting materials, scheduling meetings, for internal clinical operation team meetings.

• Working with cross functional study teams, and vendors to assist in the coordination of clinical trial activities.

• Support other clinical operations activities as appropriate.

Required Skills, Experience and Education:

• Currently enrolled at an accredited college/university as a rising senior or higher in a Bachelor’s degree in biological sciences or related health related field.

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

• Excellent written and verbal communication and interpersonal skills.

• Demonstrate proficiency in Microsoft Word, Excel and PowerPoint and other software platforms.

• Demonstrated ability to multi-task, prioritize options. 

  #LI-Hybrid  #LI-AP1

The Opportunity:

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

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

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

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

• Analyze data health metrics to be shared with stakeholders.

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

• Conduct risk management, contingency, and scenario planning.

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

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

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

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

• Participate in other Clinical Operations activities as appropriate.

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

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

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

• Support junior team members through mentorship.

Required Skills, Experience and Education:

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

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

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

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

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

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

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

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

• Excellent written/verbal communication and interpersonal skills.

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

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

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

• Travel may be required (~25%).

Preferred Skills:

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

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

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

• Some experience mentoring jr staff. 

  #LI-Hybrid  #LI-DN1

The Opportunity:

This is a unique opportunity for a Clinical Operations Professional. As a Clinical TMF and Systems Manager you will be responsible for acting as a central contact for the Clinical Study Execution Teams (CSETs) for Trial Master File (TMF) management and participating in the development of quality oversight processes for TMF management of RevMed’s clinical trials. Additional responsibilities include the upload, review, and approval of TMF documents, co-authoring and managing TMF documents such as TMF Plan, Index, SOPs, and other guidance documents and ensuring quality management by reporting TMF metrics, periodic checks of adherence to SOPs, and reconciling all outstanding queries and issues (e.g., CAPAs). Support Clinical Operations Management in high-level projects, developing processes, strategies and conducting training for TMF stakeholders. Responsible for overseeing the activities of the TMF Specialist(s) and external vendors, ensuring that study documents are adherent with ICH-GCP guidelines, other regulatory requirements, and internal and external standard operating procedures (SOPs) and that their assigned studies are inspection-ready.

Responsibilities:

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

• Be a primary lead with eTMF and CTMS integration/implementation/maintenance, user training, team advisor and assist in managing oversight for the RevMed clinical trial TMFs and CTMS within timelines and designated program budgets.

• Provide strong support to establish and manage quality oversight of TMF and CTMS, including TMF metrics and KPIs.

• Partner with Clinical Study Execution Teams (CSETs), CROs/vendors and cross-functional team members to align TMF activities, as needed.

• Responsible for vendor and internal implementation and maintenance process for cataloging, filing, retrieving, storing, preserving, and protecting CTMS outputs and TMF records (paper and electronic).

• Develop successful working relationships with service providers (vendors) and CROs on TMF management including review process, ensuring TMF completeness and managing the transfer for TMF records as needed.

• Provides TMF SME audits and inspections support.

• Contributes to and implements TMF planning and strategy development, which may include evaluation of possible options for on and off-site locations.

• Use all available tools to track, analyze, oversee, and report CTMS and TMF health metrics and status to all key stakeholders.

• May be responsible for direct TMF management activities, e.g., for assigned study TMF(s)

• Responsible for contributing to risk management, contingency and scenario planning.

• Analyze and report TMF health metrics by study to be shared with stakeholders.

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

• Actively contribute to the selection and management of eTMF, CTMS and other Clinical System solutions / vendors, including development of Requests for Proposals (RFPs)

• Anticipate obstacles, difficulties, be solution-oriented, proactively provide risk assessment and mitigation strategies to achieve goals.

• Participate in and/or co-lead departmental or interdepartmental strategic business initiatives, as well as contribute to SOP development, implementation, and training.

• Manage staff through mentorship and may supervise TMF specialist(s) or similar as direct reports.

• Assists in the hiring, development, and retention of top talent within the team. Coaches direct report(s) on their performance, development, and career interests.

• Participate in other Clinical Operations activities as appropriate.

Required Skills, Experience and Education:

• RN or bachelor’s or master’s degree desired.

• Minimum of 8+ years working in a pharmaceutical or other highly regulated corporate environment.

• Minimum of 6 years’ experience working in the Records Management field, including 4+ years’ experience using electronic records management systems. Relevant indirect experience may also meet this requirement.

• Strong experience collaborating with the DIA (CDISC) TMF Reference Model.

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

• Strong experience in Trial Master File requirements and set up.

• Strong knowledge of electronic document management systems, document archival systems: (eTMF) and CTMS systems.

• A clear understanding of the clinical development lifecycle and the technologies associated with the activation and management of clinical trials and study sites.

• Ability to successfully oversee study TMFs including development of relevant processes and policies.

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

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

• Excellent written/verbal communication and people skills.

• Strong decision-making skills.

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

• Ability to analyze operational data, contribute with a mindset focused on quality, timeliness and fiscal responsibility, drive decisions, multi-task, prioritize tasks, anticipate challenges, and execute on goals as a member of the Clinical Operations Process and Systems team.

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

• Travel may be required (~25%).

Preferred Skills:

• Has direct experience working with eTMF systems.

• Has familiarity collaborating with vendor systems/portals (e.g., CTMS).

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

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

• Experience managing direct reports(s). 

  #LI-Hybrid  #LI-DN1

The Opportunity:

This is a unique opportunity as a junior Clinical Trial Assistant in Clinical Operations, initially reporting to the Associate Director/Director Clinical Operations, you will be responsible for acting as a central contact for the clinical study teams and assist with the clinical execution and management to support RevMed clinical trials.

• Assisting in the review, distributing, and archiving of study specific documents and reports (plans, training materials, study guides, manuals etc.).

• Assisting with updating and maintaining clinical systems and any reporting tools.

• Support maintenance of the trial master files (TMF) if applicable, or work with CRO to audit and resolve discrepancies.

• Create, maintain, and track information for key study related activities.

• Assisting in the preparation of meeting materials, scheduling meetings, for internal clinical operation team meetings.

• Working with cross functional study teams, and vendors to assist in the coordination of clinical trial activities.

• Support other clinical operations activities as appropriate.

Required Skills, Experience and Education:

• Currently enrolled at an accredited college/university as a rising senior or higher in a Bachelor’s degree in biological sciences or related health related field.

• Demonstrate proficiency in Microsoft Word, Excel and PowerPoint and other software platforms.

Preferred Skills:

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

• Excellent written and verbal communication and interpersonal skills.

• Demonstrated ability to multi-task, prioritize options. 

  #LI-Hybrid  #LI-AP1

The Opportunity:

This is a unique opportunity for a Trial Master File (TMF) Management Professional who has innate leadership and organizational skills, technical expertise in clinical Trial Master File management in an industry setting, and experience in the development and implementation of clinical systems strategy. As Associate Director Clinical TMF Management, you will be a key member of the Clinical Operations Excellence (CORE) team, responsible for the development and oversight of the Trial Master File strategy and standards, in support of Revolution Medicines (RevMed) clinical trials.

Responsibilities:

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

• Serve as a key leader within Clinical Operations Excellence (CORE), a subfunction of Clinical Operations., providing strategic leadership and oversight of TMF activities across the RevMed portfolio.

• Accountable for strategic leadership and continuous improvement of Trial Master File (TMF) activities, ensuring scalable infrastructure and sustained inspection readiness across clinical programs.

• Lead and develop a team of CORE TMF Managers responsible for:

• Administration and operational oversight of the internal RevMed TMF, including management of the eTMF system vendor.

• Partnering with Clinical Study Teams to provide expert guidance and risk-based oversight to support high-quality TMF management.

• Supporting internal and CRO-managed study TMF start-up, ongoing quality oversight, close-out, and migration activities.

• Contributing to inspection readiness strategy and execution.

• Establish and maintain clear TMF governance and role delineation. Clinical study teams retain accountability for their study-specific TMFs; the AD, TMF Management ensures standards, oversight frameworks, tools, and support mechanisms enable consistent quality and compliance.

• Oversee internal and CRO-maintained TMFs to ensure alignment with RevMed standards, the CDISC TMF Reference Model, and global regulatory requirements.

• Develop and advance TMF strategy, processes, standards, SOP development, and quality frameworks to ensure completeness, timeliness, and audit readiness throughout the clinical trial lifecycle.

• Champion innovation in TMF management through implementation of technology-enabled and AI-supported solutions to enhance document quality, reconciliation, reporting, and inspection preparedness.

• Lead TMF-related vendor and CRO oversight, including expectation setting at study start-up, monitoring TMF health metrics and KPIs, proactive risk identification, and timely issue escalation and resolution, budget and resource strategy.

• Establish and monitor TMF performance dashboards and key risk indicators; conduct trend analysis and implement sustainable mitigation strategies to drive operational excellence.

• Identify critical path TMF risks and implement proactive mitigation strategies to protect study timelines, regulatory submissions, and inspection readiness.

• Provides strategic oversight, document strategy support, and remediation leadership as required during audits and regulatory inspections.

• Oversee TMF system strategy and optimization, including vendor management, system enhancements, integrations, and continuous improvement aligned with broader clinical systems strategy.

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

• May manage or participate in implementation, development or management of other clinical systems and system integrations.

• Participate in and/or co-lead departmental or interdepartmental strategic business initiatives.

• Lead TMF training, cross-functional collaboration, and continuous improvement initiatives to strengthen quality, efficiency, scalability, and long-term sustainability.

• Drive line management responsibilities including hiring, performance management, mentorship, succession planning, and development of a high-performing CORE TMF team.

• Contribute TMF expertise to broader Clinical Operations and CORE strategic priorities.

• Participate in other Clinical Operations activities as appropriate.

Required Skills, Experience and Education:

• RN or Bachelor’s or Master’s degree in a science, health-related, or industry-related discipline required. Relevant equivalent experience may be considered.

• 11+ years of progressive experience in pharmaceutical, biotech, or other highly regulated environments.

• Minimum 7–10 years of direct industry experience in TMF/eTMF management, including leadership of TMF strategy, governance, implementation, and oversight within global clinical development programs.

• Minimum 5 years of people management experience, with demonstrated ability to build, lead, and develop high-performing teams.

• Proven experience establishing and advancing TMF strategy, standards, governance models, and inspection readiness frameworks across multiple studies or programs.

• Strong experience overseeing internal and CRO-managed TMFs, including vendor oversight, performance management, risk identification, and issue resolution.

• Demonstrated expertise with the CDISC TMF Reference Model and deep working knowledge of FDA regulations, ICH Guidelines, and GCP.

• Experience supporting regulatory inspections and audits, including preparation strategy, document readiness, and remediation leadership.

• Strong technical expertise in eTMF platforms and clinical systems, including vendor oversight, system optimization, and cross-system integration considerations.

• Experience driving technology-enabled process improvements, including familiarity with or application of AI-enabled tools to enhance TMF quality control, reconciliation, reporting, or inspection preparedness.

• Clear understanding of the clinical development lifecycle and the operational and regulatory interdependencies that impact TMF completeness and compliance.

• Proven ability to develop and implement SOPs, policies, metrics, dashboards, and quality frameworks supporting sustainable TMF oversight.

• Strong analytical and strategic thinking skills, with demonstrated ability to interpret operational data, identify trends, mitigate risk, and implement scalable solutions.

• Demonstrated ability to perform complex analysis, draw sound conclusions, and implement appropriate corrective and preventive actions.

• Experience managing vendor relationships, budgets, timelines, and resource planning within a clinical operations framework.

• Ability to operate effectively in a fast-paced, evolving environment; prioritize competing demands; and maintain focus on long-term inspection readiness and organizational scalability.

• Strong leadership presence with excellent interpersonal, negotiation, and written and verbal communication skills.

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

• Travel may be required (~25%).

Preferred Skills:

• Demonstrated experience leveraging AI-enabled or advanced technology solutions to enhance TMF quality control, document completeness review, reconciliation, reporting, analytics, and inspection readiness.

• Experience contributing to or leading clinical systems strategy initiatives, including eTMF system selection, implementation, optimization, validation support, and cross-functional integration.

• Experience overseeing or supporting record management strategies for Externally Sponsored Research, Expanded Access programs, or other non-traditional study models.

• Familiarity working with other systems/portals (e.g., CTMS, EDC),

• Experience working within or oversight of a Learning Management System (LMS).

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

• Knowledge of global clinical trial operations, including Ex-US regulatory and operational considerations.

• Experience working with Trial Interactive and Veeva systems. 

  #LI-Hybrid  #LI-DN1

The Opportunity:

This is a unique opportunity for an entry-level Clinical Operations Professional. The Clinical Trial Assistant of Clinical Operations, initially reporting to the Director, Clinical Operations, will be responsible for acting as a central contact for the clinical study teams and assist with the clinical execution and management to support RevMed clinical trials.

Specifically, you will be responsible for:

• Assisting in the development, review, distributing, and archiving of study specific documents and reports (plans, training materials, study guides, manuals etc.).

• Assisting with updating and maintaining clinical systems and any reporting tools.

• Set up and maintenance of the trial master files (TMF) if applicable, or work with CRO to audit and resolve discrepancies.

• Create, maintain, and track information for key study related activities.

• Assisting in the preparation of meeting materials, scheduling meetings, and developing agendas, taking meeting minutes for internal clinical operation team meetings.

• Gathering investigator and site information, to support study start-up, maintenance and close out activities.

• Working with cross functional study teams, and vendors to assist in the coordination of clinical trial activities.

• Support other clinical operations activities as appropriate.

Required Skills, Experience and Education:

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

• 1-3-years relevant experience in the pharmaceutical or biotech industry.

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

• Excellent written and verbal communication and people skills.

• Demonstrate proficiency in Microsoft Word, Excel, and PowerPoint.

• Demonstrated ability to multi-task, prioritize options.

• Travel may be required (~25%).

Preferred Skills:

• Experience in working with cooperative group studies and investigator sponsored trials, preferred.

• Experience in clinical operations or clinical research.

• Experience of Global clinical trial operations outside the USA.

• Knowledge of the APAC region. 

  #LI-Hybrid  #LI-DN1

The Opportunity:

This is a unique opportunity for a Clinical Operations Professional who has innate leadership and organizational skills, technical expertise in clinical oncology drug development in an industry setting, and experience in overseeing clinical trials. As an Associate Director, you will be responsible for the Contract Research Organization (CRO) oversight, execution, and management of Revolution Medicines (RevMed) clinical trials.

Responsibilities:

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

• Oversee the successful management of all aspects of clinical trials within timelines and designated program budgets.

• Strategic thought partner on the development, management, and execution of the Clinical Development Plan (CDP) for assigned clinical programs which includes timelines, budget, and resource requirements. Ability to identify critical path activities and articulate and mitigate risks to clinical trial conduct.

• Responsible for successful planning and deployment of Clinical Operations staff (potentially including Clinical Program Managers/Clinical Trial Managers/Clinical Trial Assistants, and consultants) for project and non-project related tasks.

• Lead line management responsibilities that include hiring, performance management, career development, and mentorship.

• Manage/oversee CROs and selected study vendors; ensuring all vendors strive to achieve the predetermined program milestones according to budget and timeline, as well as evaluate vendor performance using metrics and KPIs.

• Lead team meetings and collaborate with other functional groups within the company (e.g., Clinical Development, Regulatory, QA, Finance, Legal, etc.) to achieve clinical study goals.

• Ensure clinical trials maintain an inspection readiness state throughout the lifecycle of the trial.

• Oversee the improvement of processes that will impact clinical trial management and deliverables including contingency plans by maintaining a highly effective Clinical Operations team and building strong relationships with functional leaders.

Required Skills, Experience and Education:

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

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

• Minimum of 5 years of project and first-line management experience.

• Experience in leading and managing global phase 1-3 clinical trials within designated timelines, resources, and budgets.

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

• Experience with vendor management and CRO oversight.

• Ability to perform complex analysis, draw relevant conclusions, and implement appropriate solutions.

• Ability to pivot, be solution-oriented with consideration to long-term impact on clinical trials, responsibilities, and inspection-readiness.

• Strong analytical, negotiation, and persuasion skills.

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

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

• Excellent interpersonal, verbal, and written communication skills.

• Decision-making skills.

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

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

• Travel may be required (~25%).

Preferred Skills:

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

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

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

• Experience in working with cooperative group studies and investigator sponsored trials preferred. #LI-Hybrid  #LI-DN1

The Opportunity:

The Clinical Operations Summer Intern will support a strategic initiative focused on optimizing study-level execution and operational alignment to the Clinical Operations Handbook (V2.0). The intern will conduct a structured review of active clinical studies to assess consistency, tool utilization, and workflow execution from protocol finalization through site activation.

Key Responsibilities

• Select 1–2 active clinical studies for detailed assessment.

• Evaluate use of RAID logs, Study Dashboards, Vendor Oversight Plans, and Startup Timelines.

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

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

• Conduct structured interviews with COLs and CTAs.

• Shadow CSET meetings to observe dashboard and RAID utilization.

• Review Smartsheet tools and Egnyte folder structures.

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

Deliverables

• Current-state workflow maps with annotated pain points.

• Tool consistency matrix across selected studies.

• Prioritized, actionable process improvement recommendations.

• Updated mock dashboard or tracker templates (if applicable).

Impact

• Reduce variability in study-level execution.

• Clarify ownership and functional handoffs.

• Improve dashboard clarity for leadership review.

• Strengthen inspection readiness through documented alignment.

Required Skills, Experience and Education:

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

• Excellent communication skills.

• Interest in clinical trial operations and process optimization.

Preferred Skills:

• Strong analytical and organizational skills.

• Proficiency in Microsoft Office; familiarity with Smartsheet a plus. 

  #LI-Hybrid  #LI-AP1

The Opportunity:

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

Responsibilities:

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

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

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

• Analyze data health metrics to be shared with stakeholders.

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

• Conduct risk management, contingency, and scenario planning.

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

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

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

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

• Demonstrate the ability to lead and manage multiple complex clinical trials within one or multiple programs with limited oversight.

• Independently lead Clinical Study Execution Team (CSETs) and influence relevant stakeholders both internally and externally including management.

• May lead interdepartmental strategic business initiatives as well as spearhead certain SOP development and training.

• May provide input into strategic and operational short- and long-term therapeutic area development, as appropriate, including supporting alignment and communication to other team members upon implementation

• Assists in the hiring, development, and retention of top talent within the team. Coach direct report(s) on their performance, development, and career interests.

• Participate in other Clinical Operations activities as appropriate. 

Required Skills, Experience and Education:

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

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

• Minimum of 6 years of cross-functional study management or related leadership experience in life sciences, including multiple years’ experience managing project teams.

• Experience in Oncology Trials

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

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

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

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

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

• Excellent written/verbal communication and interpersonal skills.

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

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

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

• Travel may be required (~25%).

Preferred Skills:

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

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

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

• Some experience managing direct reports.

#LI-Hybrid  #LI-DN1