Associate Director, Clinical Operations Enablement & Knowledge Systems
Redwood City, CA - USA
Job Summary
Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The companys R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The companys RAS(ON) inhibitors daraxonrasib (RMC-6236) a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291) a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805) a RAS(ON) G12D-selective inhibitor; and RMC-5127 a RAS(ON) G12V-selective inhibitor are currently in clinical development. 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 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 ecosystemincluding how information is structured accessed and appliedto 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 Bachelors degree in biological sciences or health-related field required.
11 years direct Clinical Operations experience in the pharmaceutical or biotech industry Relevant indirect experiences may also meet the requirement.
Minimum of 5 years of line management experience.
Strong working knowledge of FDA Regulations ICH Guidelines and GCP.
Demonstrated experience successfully developing and authoring Clinical Operations and cross-functional handbooks guidances or process templates in support of clinical operations or clinical study team management.
Experience with leading organizational change efforts.
Minimum of 6 years of cross-functional study management or related leadership experience in life sciences.
Demonstrated experience building or scaling learning programs knowledge systems or operational frameworks within Clinical Operations.
Experience translating complex clinical workflows into practical tools guidance or training materials.
Strong systems thinking and ability to design scalable user-friendly solutions.
Experience in selection and management of external resources (e.g. CROs vendors contractors).
Thrives in a collaborative team setting that demonstrates flexibility required to maintain a fast pace and is driven by a desire to deploy innovative approaches and technologies in a high-energy environment.
Be solution-oriented by anticipating obstacles and difficulties and proactively providing risk assessment and mitigation strategies to achieve project goals.
Ability to deal with time demands incomplete information or unexpected events.
Outstanding organizational skills with the ability to multi-task and prioritize.
Excellent interpersonal verbal and written communication skills.
High sense of priority and commitment to excellence in the successful execution of deliverables.
Ability to contribute with a mind on quality diligence timeliness and fiscal responsibility make and drive decisions multi-task prioritize tasks anticipate challenges and execute on goals as a member of the Clinical Operations Excellence team.
Decision-making skills.
Comfortable in a fast-paced company environment and able to adjust workload based upon changing priorities.
Demonstrate proficiency in Microsoft Office Suite (Outlook MS Word Excel PowerPoint); MS Project and/or Smartsheet a plus.
Travel may be required (25%).
Preferred Skills:
Experience deploying AI-enabled solutions to support Clinical Operations activities.
Familiarity working with in-house or vendor systems/portals (e.g. eTMF EDC IRT CTMS).
Oncology experience early and/or late stage strongly preferred.
Experience in start-up management and close-out of clinical trials including authoring clinical study and regulatory documentation.
Knowledge and/or familiarity with Ex-US region(s) clinical trial operations.
#LI-Hybrid #LI-DN1
The base pay salary range for this full-time position for candidates working onsite at our headquarters in Redwood City CA is listed below. The range displayed on each job posting is intended to be the base pay salary range for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our base pay salary ranges are determined by role level and location. Individual base pay salary is determined by multiple factors including job-related skills experience market dynamics and relevant education or training.
Please note that base pay salary range 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 ourCCPA additional information please contact.
Base Pay Salary Range
$186000 - $233000 USD
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Please note that Revolution Medicines does not extend unsolicited employment offers and will never ask candidates to provide financial information purchase equipment or pay fees as part of the hiring process. All legitimate communication from Revolution Medicines will come from an official @ email address.
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Required Experience:
Director
About Company
We are aware of recent recruitment scams in which individuals or organizations falsely represent themselves as being affiliated with Revolution Medicines. These scams may appear as false job advertisements or unsolicited contacts through communication or chat platforms, email, phone, ... View more