Director, Clinical Operations Project Management
vor 2 Monaten
Location: Root D4, CH, 6039Novocure is a global publicly-traded commercial-stage oncology company developing a profoundly different cancer treatment therapy called tumor treating fields (TTFields) for patients with solid tumors. TTFields therapy is a non-invasive, novel, antimitotic treatment modality which utilizes proprietary technology attempting to slow or reverse tumor progression by inducing tumor cell death. Novocure's commercialized product, Optune, is approved for the treatment of adult patients with glioblastoma (GBM) in the USA, Europe and Israel. Novocure has ongoing or completed clinical trials and is further expanding its efforts into several other solid tumor indications - non-small cell lung cancer, pancreatic cancer, ovarian cancer and other types of solid cancers.
To support our team in Root, Switzerland we are looking for a
**Director, Clinical Operations Project Management**
The Director, Clinical Operations Project Management serves as ‘chief of staff’ to the Vice President, Global Clinical Operations and leads project management of department initiatives to align strategy, create accurate plans and forecasts, identify and respond to risks, and coordinate execution of Clinical Operations objectives. The Director is responsible for overseeing the development and maintenance of Clinical Operations standards and procedures, facilitating organizational alignment and seamless execution within the clinical trial portfolio.
The Director will collaborate with other functional departments, including Regulatory Affairs, Supply Chain, Quality Assurance, Finance, Clinical Affairs, and Clinical Development teams, to coordinate strategies for timely execution of all clinical related activities.
As a member of the R&D team, the Director will provide input to clinical operations strategy, protocol development, target timelines, and budgeting.
**Your responsibilities**:
- Partners with the VP, Global Clinical Operations to oversee the overall department organization, including objective setting, strategy, and prioritization of initiatives
- Guides the Clinical Operations team to enable efficient and high quality execution of global clinical trials, Phases I-IV, for investigational devices
- Ensures compliance with all applicable internal policies and Standard Operating Procedures (SOPs), federal and local regulations, ISO standards, and ICH-GCP guidelines; Ensures inspection readiness of all regulated activities
- Leads the overall internal and external communications of Clinical Operations
- Collaborates with internal and external stakeholders to align strategy and proactively identify key department risks/issues; drives risk response and issue resolution and ensures operational alignment across the clinical trial portfolio
- Collaborates with senior management and other department and functional leadership to improve efficiencies, project outcomes, and quality metrics; maintains a result-focused organization
- Oversees continual process improvement within Clinical Operations; Drives standardization; Leads the prioritization, development, and maintenance of department procedures and tools
- Oversees clinical support functions within Clinical Operations, including Project Management, Clinical Trial Communications, Clinical Data and Systems, Clinical Contracts and Payments, and Learning and Development
- Leads and facilitates routine internal and external cross-functional meetings, including portfolio review meetings; Ensures agendas and team priorities are clear, meetings minutes are distributed, and action items completed
- May manage/support external vendor selection and oversight, including serving as a key member of governance and oversight committees
- Collaborates with the VP, Global Clinical Operations in preparation of comprehensive study recommendations and executive/board meeting presentations
- Develops or coordinates the preparation of project reports and/or summaries on trial/project status
- Supports departmental financial planning, management, and change control; develops corrective fiscal action plans as required
- Supports study-specific quality audits and regulatory authority inspections, acting as a Subject Matter Expert (SME)
- Trains and mentors Clinical Operations personnel, providing leadership, oversight, and motivation; Provides administrative supervision, including performance management, professional development, and goal setting
**Your profile**:
**Qualifications**:
- Bachelor’s degree from an accredited college or university, preferably in Life Sciences required
- Advanced degree preferred
- Minimum of 10 years clinical research industry experience required
- Minimum of 8 years experience in cross-functional trial management in a pharmaceutical, biotechnology, or CRO environment required; device trial management preferred
- Direct Management experience requiredac
- Global trial management experience required
- Oncology experience required
- Personnel managemen
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