Executive Director, Clinical Operations, Europe

Revolution Medicines•Redwood City, CA

About The Position

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 Revolution Medicines expands their global footprint and evolves as an organisation, the Company is seeking an Executive Director, Clinical Operations who will play a critical role in driving the implementation and execution of the R&D strategic vision in the Europe region. The incumbent will be responsible for implementing clinical trial strategy and management of all clinical studies in close collaboration with the Clinical Development Sciences functions and cross functional partners. Expected to support clinical growth, the individual will also be responsible for overseeing the operating activities in drug development spanning across all human trial activities from Phase 1 trials through Phase 3 and beyond. Given the broad area of responsibility, this role requires a thorough knowledge of all aspects of biopharmaceutical drug development. The incumbent will utilise their excellent understanding of pharmaceutical business operations and apply state-of-the-art practices to drug development and clinical trial processes, ensuring good clinical practices and ethical, patient-centric trial conduct to produce high-quality results. The goal is to safeguard and augment the efficiency of RevMed’s clinical operations to facilitate the delivery of a rapidly growing pipeline, accelerating parallel drug developments, leading to the long-term success of the company. Areas of specific responsibility and attention will include the following:

Requirements

Considering the operating model of Revolution Medicines, a deep understanding of CRO processes and workings will be critical to managing their largely outsourced trials.
On a leadership front, the incumbent should be a big-picture executive who is apt at bringing strategy to an operations-centric organisation.
They bring a well-rounded personality with strong executive presence and stature and a collaborative management style to bring people together and strive towards the organizational aim of developing and delivering functional cures to effectively combat cancer and infectious diseases.
The Executive Director of Clinical Operations, Europe is expected to be a strategic networker, who can foster relationships with internal and external partners and potentially translate discussions into business opportunities, keeping a relationship framework in mind and identifying win-win scenarios for each party involved.
A MSc/PhD or MD with significant experience in Clinical Operations (BSc 19+ years, MSc 17+ years, PhD/PharmD 15+ years).
Strong leadership skills and proven biopharmaceutical industry experience in leading clinical operations and development for preferably both early and mid- late stage therapeutic programs.
Therapeutic area knowledge of and experience of working on oncology clinical development programs.
Track record of managing clinical operations for a product from pre-clinical through all clinical phases and product launches.
Solid track record of working with CROs or for CROs will be beneficial.
Deep understanding of clinical development, from Phase I-IV and LCM programs.
Has helped to define and execute global R&D strategies.
Demonstrated leadership in a clinical operations role, effective organizational skills, and excellent verbal and written communication.
Provide oversight of review and approval (as required by the scope of work) for regulatory processes, monitoring and quality assurance of investigative sites for the studies.
Experience developing, implementing, and leading a broad range of clinical trials both in the U.S. and ex-U.S., building clinical operations infrastructure, including SOPs, and managing vendors.
Excellent working knowledge of FDA, EMA & ICH/GCP regulations and guidelines.
Ability to work in a team environment, meet deadlines, and prioritize and balance work from multiple individuals.
Entrepreneurial experience with drive and a bias for action to successfully manage multiple project deadlines in a hands-on manner, within a fast-paced work environment.
Comfortable at leading through others.
Experience working in a collaborative, matrix-based organisation.
Ability to influence externally through representation on scientific, regulatory or government bodies.
Able to operate with a high degree of independence, can make decisions and enjoys responsibility and accountability.
An excellent networker and effective leader who inspires trust and confidence in others.
A passionate, curious, entrepreneurial, resourceful, energetic self-starter who is capable of shifting between collaboration and coaching.
Strategic and analytical, with a real appreciation for the risk/benefit of a biotech enterprise.
Of unquestionable integrity with the highest ethical standards.

Responsibilities

Build a Clinical Operations organization to successfully plan and conduct multiple clinical trials in the early to the late stage to achieve corporate objectives.
Contribute to the design of clinical trial strategy and management of all clinical studies in close collaboration with Research, Clinical Development, Regulatory, Biomarkers, and Project & Portfolio Management.
Manage the operational and logistical tasks of clinical development to ensure efficient execution of trials within established budgets and timelines, ensuring all activities occur in compliance with the appropriate regulations.
Coordinate the efforts of internal and external resources to ensure fast patient recruitment, optimal trial site selection, trial plan optimization and execution of trials with a focus on quality.
As required for a specific trial/project communicate with countries, CROs and vendors regarding trial updates, trial-specific procedures, and enrollment and quality issues.
Create and implement SOPs for clinical trials and related activities.
Implement process improvements, in conjunction with trial team in response to trial or project needs or team/CRO feedback.
Work with trial sites to ensure expedient patient recruitment in conjunction with CRO.
Build, retain, and provide leadership and mentorship to clinical operations team.
Provide input to the development of trial processes and documents, problem identification and resolution and corrective action plans as needed for assigned trials.
Support team members and vendors to improve their efficiency and effectiveness at prioritizing work, identifying, and solving trial-specific issues and improving performance as evidenced by the work produced, audit results and QC measures.
Provide updates and status reports to senior management on a regular basis.
Implement process improvements, in conjunction with trial teams in response to trial or project needs, client and team feedback and quality audits.
Monitor and provide oversight on CRO performance according to functional metrics and protocol amendments.
Maintain a positive, results-oriented work environment by building partnerships, modelling teamwork, motivating team members, and communicating to the study team in an open, balanced, and objective manner.
Ensure compliance with all applicable regulations.
Ability to travel domestically and internationally as required (up to 30%).