- Lead and manage a team of Clinical Trial Leads, ensuring smooth completion of studies as per plans, plan resources, recruit talent, establish meaningful development plans, address performance issues and ensure proper issue resolution as appropriate;
- Lead and manage multiple clinical programs through the direct supervision of Clinical Operations Leads / CTLs, and in close collaboration with R&D cross-functional teams, ensuring smooth execution of studies (including budget and contracts review);
- Oversee Strategic Partners/CRO/vendor selection, budget and contract negotiation, and proper supervision of performance for all activities assigned to a Strategic Partner/CRO/vendor for assigned program(s), including escalation of issues to and participation in governance committees when warranted; accountable for operational risk management strategy in collaboration with external partners.
- Establish solid external providers CROs/Vendors selection and oversight, as well as preferred supplier strategy;
- Improve Clinical Operations processes when needed, identify issues and propose solutions and action plans to be implemented by his/her team or by the extended Clinical Operations team, when appropriate, support functional initiatives and processes managed by Clinical Operations Department;
- Provide direction for the development of operational plans including enrollment models and risk management plans, financial planning and management, communication plans, and monitoring plans in collaboration with CRO, be accountable for inspection readiness;
- Provide direction and/or contribute directly to due diligence projects;
- Be accountable for the review and expert clinical operations input into clinical documents related to the drug development process including Investigator Brochures, Investigational New Drug Applications (INDs) and/or Investigational Medicinal Product Dossier (IMPDs), study synopsis protocols, clinical study reports, applicable sections of the New Drug Application (NDA) and/or Marketing Authorization Application (MAA), and updates to IND and NDA documents; provide expert clinical operations input into preparation for key regulatory meetings (e.g. End-of-Phase 2 and 3 Meetings, Request for Scientific Advice Meetings, etc.), as appropriate;
- Collaborate and liaise with R&D functional managers, and/or Core team members as appropriate, champion and nurture cross-functional collaboration, and keep them informed if any issue is highlighted during study team meetings or with external providers;
- Attend and represent Clinical Operations department in some of the Management Meetings (like Development Leadership Team/ DLT or Leadership team/LT, Protocol Review Board/PRB, etc.…) on ad-hoc occasions or to replace the Director of Clinical Operation, when necessary.
- Additional responsibilities as Senior CTL (if applicable/ad hoc):
- Lead multi-disciplinary team (CMC, Drug Supply, Regulatory, Pharmacovigilance, Data Management, Statistics, Clinical Development, …) in the design, start-up, conduct and closure of assigned clinical studies;
- Manage operational aspects of projects including budgeting, study initiation and risk management in close collaboration with all involved R&D functions;
- Select and manage external vendors, such as Contract Research Organizations (CROs), central laboratories, etc.;
- Assist in the identification of investigational sites and perform co-monitoring with CRAs when required;
- Represent clinical operations on multi-function project teams internally and externally; report on study progress;
- Establish study milestones and ensure accurate tracking and reporting of study metrics and timelines, alert in case of deviations or risks, and propose mitigation plans;
- Ensure the delivery of the clinical study according to ICH GCP (E6-R2), local applicable regulations and company’s specific SOPs;
- Provide operational input (and scientific if appropriate) into Protocol synopsis, Study protocol and all other study related documents;
- Design, review and approve of all trial related documentation, and establish trial processes;
- Give operational input (and scientific if appropriate) into Due Diligence activities.
- PhD is a plus or University degree or equivalent in Life Sciences;
- 6-8 years of proven track record of Phase I-III international clinical trials management in the Pharmaceutical Industry, with people management experience. Previous monitoring experience preferred;
- Oncology experience highly preferred;
- Demonstrated excellence in leadership and project/program management, including innovative operations approaches to achieving program goals;
- Deep knowledge and experience on the implementation and use of EDC, IWRS, eTMF, CTMS and any other digital clinical trial systems;
- Solid experience in management of CROs, vendors and consultants, experience in external audits, an asset;
- Strong project management skills, excellent budgeting, planning, and communication skills;
- Entrepreneurial and innovative; taking measured risks; thinking outside the box; challenging the status quo and comfortable with ambiguity:
- Pragmatic and willing to drive and support change, supporting a culture of continual improvement and innovation; promoting knowledge sharing.
- Capable of anticipating obstacles and bottlenecks and acting as a problem solver with a sense of urgency;
- Ability to lead and influence cross-functional teams and external partners;
- Strong negotiation skills;
- Strong scientific and in program strategy involvement, former experience in contributing to protocols and clinical development plans;
- Fluent in English (French and another European language are an asset);
- Ability to travel according to business needs (10-20%).
|Job Category||CLINICAL OPERATIONS|