At Roche, we believe it's urgent to deliver medical solutions right now - even as we develop innovations for the future. We are passionate about transforming patients' lives and we are fearless in both decision and action. We also believe that good business means a better world.
That is why we come to work each day. We commit ourselves to scientific rigour, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow.
You are a key leader role within Early Development (pRED) Clinical Operations and the critical interface between pRED Clinical Operations and the Oncology Discovery and Translational Areas (DTAs). You are accountable for the strategic operational planning, implementation and delivery of the entire clinical portfolio within the Oncology DTA up to Life Cycle Investment Point; typically Clinical Proof of Concept.
In partnership with key Oncology stakeholders, you define and implement the clinical operations strategy for the early development oncology portfolio and are accountable for the delivery of all studies in accordance with current Standard Operating Procedures (SOPs) and ICH GCP guidelines.
You actively uses strategic understanding and operational delivery expertise to define and enable flexible and innovative operational strategies to impact clinical trial management and acts as a cross functional liaison to ensure portfolio and study plans align with business development strategies.
In order to deliver the portfolio, you are responsible for line management of Clinical Program Leaders (CPLs) and Study Leader Team Leads (SLTLs), and you are expected to build strong working relationship with many internal and external stakeholders. In some instances, you may be required to assume program delivery responsibilities.
Your main responsibilities are to:
Provide the key strategic interface between Oncology DTA and the Clinical Program Execution roles in pRED Clinical Operations.
Be accountable for delivery of Oncology programs with respect to quality, timelines, budget and ensure resources from the sub-functions of study management are available to the DTA.
Define the clinical operations sourcing strategy for Oncology trials and accountable for the placement of programs/studies.
Partner with internal and external stakeholders (i.e. Oncology DTA Head, Business Operations Management, Global Procurement, CROs, etc.) to remove obstacles, mitigate risks, ensure alignment on operational strategy and execution.
Make key operational strategic decisions and provide technical review on behalf of Clinical Operations as a core member of the relevant Oncology DTA Portfolio Committees which drives the strategic direction for the portfolio, and of the Development Review Committee (DRC), which provides critical technical reviews of project team clinical development plans.
Play a critical role in contributing to the design of pRED Oncology Clinical Development Plans and clinical protocols to enable flexible and innovative development of operational strategies with appropriate scenario planning, including forecasting of timelines, resources and budget as well as program level feasibility assessment.
Leader within Clinical Operations, driving the continuous development and innovation of the Clinical Operations function and beyond including in the definition of functional strategies, integration of digital solutions, deployment of budget and resources and support of the development of processes and systems tailored to the early development setting.
Provide specialized operational support to internal and external stakeholders and maintain relevant knowledge of business, regulatory, and therapeutic advances that may impact life cycle planning or ongoing operational strategies.
Line manage Clinical Programme Leaders and Study Lead Team Leaders: leading assessments/evaluations on topics that relate to study management and study leadership, talent management and development of the Study Leader group, change management, communication for leadership teams.
Displays the Roche leadership commitments and exhibits leadership competencies in key creative behaviours that are critical to complementing what we do as we deliver value to pRED. The key competiencies are focused being a leader who is Visionary, and Architect, a Coach and a Catalyst.
Who you are:
With at least 10 years' experience in clinical research experience, you have a proven track record in project or portfolio leadership roles across multiple global programs in a pharma, biotech, or CRO setting.
A Life Sciences degree with extensive post-graduate experience in clinical and drug development in the therapeutic area of interest is an asset.
You have strong knowledge and experience of clinical drug development across the value chain within and beyond oncology, with particular focus on early development.
Experience in the management of a Global Clinical Operations Team, as it relates to systems/processes, staff recruitment, resource management and talent management is highly desired.
You have a proven ability to understand and critically assess oncology global clinical development plans, protocol design, resource needs, global budgets and timelines for multiple programs across multiple oncology indications.
You have direct line management experience as well as demonstrated senior leadership, influencing, communication and strategic project management skills.
Willingness to travel internationally and work across cultures is necessary along with the ability to take on broader leadership responsibilities as necessary.
Are you ready to apply? We want someone who thinks beyond the job offered - someone who knows that this position can be a rare springboard to many other opportunities at Roche.
Roche embraces diversity and equal opportunity in a serious way. We are committed to building a team that represents a variety of backgrounds, perspectives, and skills. The more inclusive we are, the better our work will be.
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Roche is an equal opportunity employer.
Research & Development, Research & Development > Clinical Operations