Vandria is recruiting a Clinical Operations Manager to support our clinical program.
Vandria is a biopharmaceutical company that develops best-in-class small molecule mitophagy inducers to treat age-related and chronic diseases in the fields of muscle- and CNS diseases with large unmet medical need.
Vandria is planning to initiate phase I trials for its lead CNS candidate in Q1-Q2 of 2024.
This position offers the chance to join a young company at an exciting time in its journey and to work with a dynamic, diverse, and motivated team.
In this role, you will be responsible for co-planning, directing, and evaluating all clinical activities for Vandria’s early-stage clinical programs according to the protocol, SOPs, applicable regulations and principles of Good Clinical Practice, in close collaboration with all R&D functions. You will report to the Chief Medical Officer of Vandria.
Your responsibilities will include but are not limited to:
- Lead the overall initiation, coordination, implementation, and management of international clinical trials at different stages.
- Lead and manage our early-stage clinical programs through the direct supervision of external vendors, and in close collaboration with R&D cross-functional teams, ensuring smooth execution of studies (including budget and contracts review).
- Manage and coordinate external vendors, such as Contract Research Organizations (CROs), central laboratories, trial sites etc. You may be involved in the selection process, depending on the study status.
- Monitor vendor and CROs performance and ensure continuous oversight.
- Manage operational and technical aspects of projects including budgeting, timelines, and risk management.
- Improve Clinical Operations processes when needed, identify issues, and propose solutions and action plans to be implemented.
- Plan for and provide input into clinical documents related to the clinical trial applications such as Investigator Brochures, Investigational Medicinal Product Dossier (IMPDs), study synopsis protocols, clinical study reports, etc.
- Anticipate potential issues and risks within the clinical program, create contingency plans and drive solution implementation.
- 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. Quality is of utmost importance to Vandria.
Candidate profile:
- PhD is a plus or University degree or equivalent in Life Sciences.
- Several years of proven track record of Phase I-III clinical trials management in the Pharmaceutical Industry.
- Knowledge and experience on the implementation and use of EDC, IWRS, eTMF, CTMS and any other digital clinical trial systems.
- Solid experience in the management of CROs, vendors and consultants, experience in external audits would be an asset.
- Experience in pharmacokinetic studies (e.g. DDI, ADME) is 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.
- 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%).
- Possibility to work from home with weekly visit to the office (Lausanne).
Application:
info@vandria.com with your CV and motivation letter under the title “Clinical Operations Manager”.