REVOLUTION Medicines
Senior Clinical Program Manager, Clinical Operations
REVOLUTION Medicines, Redwood City, California, United States, 94061
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 professionals in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.
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.
Adhere to Clinical Standard Operating Procedures (SOP), Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) GuidelinesBe a team leader, providing guidance and oversight for the successful management of all aspects of clinical trials within timelines and designated program budgetsPartner with cross-functional teams to manage, adjust, and revise project timelines and budgets as neededAnalyze data health metrics to be shared with stakeholdersActively 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 processConduct risk management, contingency, and scenario planningSupervise, communicate project status/issues, and problem solve to ensure project team goals are metParticipate in the development of all study-related documentation, including study protocolsActively 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 stakeholdersDemonstrate the ability to lead and manage multiple complex clinical trials within one or multiple programs with limited oversightIndependently lead Clinical Study Execution Team (CSETs) and influence relevant stakeholders both internally and externally including managementMay lead interdepartmental strategic business initiatives as well as spearhead certain SOP development and trainingMay 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 implementationAssists 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 in biological sciences or health-related field required10+ 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 teamsStrong working knowledge of FDA Regulations, ICH Guidelines, and GCPProven 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 resourcesThrives 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 environmentBe solution-oriented by anticipating obstacles and difficulties, and proactively providing risk assessment and mitigation strategies to achieve project goalsExcellent written/verbal communication and interpersonal skillsHigh sense of priority and commitment to excellence in the successful execution of deliverablesAbility 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 teamDemonstrate proficiency in Microsoft Office Suite (Outlook, MS Word, Excel, PowerPoint); MS Project and/or Smartsheet a plusTravel may be required (~25%)Preferred Skills, Experience and Education:
Familiarity working with vendor systems/portals (e.g., eTMF, EDC, IRT, CTMS)Oncology experience, early and/or late stage, strongly preferredKnowledge and/or familiarity with Ex-US region(s) clinical trial operationsSome experience managing direct reports.
The base salary range for this full-time position is $150,000 to $190,000 for candidates based at our headquarters in Redwood City, CA. The range displayed on each job posting is intended to be the minimum and maximum salary for the position in Redwood City and will be adjusted for the local market a candidate is based. Our salary ranges are determined by role, level, and location. Individual pay is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.
Please note that base salary is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities.
Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, medical condition, and veteran status.
Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact privacy@revmed.com.
#LI-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.
Adhere to Clinical Standard Operating Procedures (SOP), Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) GuidelinesBe a team leader, providing guidance and oversight for the successful management of all aspects of clinical trials within timelines and designated program budgetsPartner with cross-functional teams to manage, adjust, and revise project timelines and budgets as neededAnalyze data health metrics to be shared with stakeholdersActively 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 processConduct risk management, contingency, and scenario planningSupervise, communicate project status/issues, and problem solve to ensure project team goals are metParticipate in the development of all study-related documentation, including study protocolsActively 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 stakeholdersDemonstrate the ability to lead and manage multiple complex clinical trials within one or multiple programs with limited oversightIndependently lead Clinical Study Execution Team (CSETs) and influence relevant stakeholders both internally and externally including managementMay lead interdepartmental strategic business initiatives as well as spearhead certain SOP development and trainingMay 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 implementationAssists 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 in biological sciences or health-related field required10+ 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 teamsStrong working knowledge of FDA Regulations, ICH Guidelines, and GCPProven 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 resourcesThrives 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 environmentBe solution-oriented by anticipating obstacles and difficulties, and proactively providing risk assessment and mitigation strategies to achieve project goalsExcellent written/verbal communication and interpersonal skillsHigh sense of priority and commitment to excellence in the successful execution of deliverablesAbility 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 teamDemonstrate proficiency in Microsoft Office Suite (Outlook, MS Word, Excel, PowerPoint); MS Project and/or Smartsheet a plusTravel may be required (~25%)Preferred Skills, Experience and Education:
Familiarity working with vendor systems/portals (e.g., eTMF, EDC, IRT, CTMS)Oncology experience, early and/or late stage, strongly preferredKnowledge and/or familiarity with Ex-US region(s) clinical trial operationsSome experience managing direct reports.
The base salary range for this full-time position is $150,000 to $190,000 for candidates based at our headquarters in Redwood City, CA. The range displayed on each job posting is intended to be the minimum and maximum salary for the position in Redwood City and will be adjusted for the local market a candidate is based. Our salary ranges are determined by role, level, and location. Individual pay is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.
Please note that base salary is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities.
Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, medical condition, and veteran status.
Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact privacy@revmed.com.
#LI-Hybrid #LI-DN1