Clinical Operations Professional
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.
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.