P2318 - Associate Director Clinical Operations

vor 2 Wochen

Lausanne, Schweiz Debiopharm Vollzeit

**_Debiopharm_**_ is an independent biopharmaceutical company based in Switzerland with an ongoing commitment to research in oncology and infectious diseases in order to improve patient outcomes and quality of life. Our main activities include drug development, drug manufacturing and digital health investment. Debiopharm International SA aims to develop innovative therapies that target high unmet medical needs. Our unique “development only” business model allows us to act as a bridge between disruptive discovery products and patient access in international markets. We first identify high-potential compounds for in-licensing, clinically demonstrate their safety and efficacy and then select large pharmaceutical commercialization partners to maximize patient access globally._
- At Debiopharm you will be at the forefront of the fight against cancer and infectious diseases, and you will have the opportunity to work on new innovative medicines for patients. Efficiency is our mode of action, saving lives our collective target._

For our Clinical Operations organization based at our Headquarters in Lausanne, we are looking for a

**Associate Director, Clinical Operations**
In this newly created role, you will responsible for planning, directing and evaluating all clinical activities for an assigned number of programs, with a focus on balancing efficient performance with high-quality (reliable and quality data) services according to the protocol, SOPs, applicable regulations and principles of Good Clinical Practice, in close collaboration with all R&D functions.
This position includes the management of our Clinical Trial Managers (responsible for leading, planning, and delivering clinical trials (Phases I-III) in Oncology and onco-haematology), and the drive of department initiatives on CRO Selection and Management, Operational Excellence and Process Improvement.
**Your responsibilities will be but not limited to**:

- Lead and manage a team of Clinical Trial Managers, 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 Managers / CTMs, 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 CTM (if applicable/ad hoc):

- Lead multi-disciplinary team (CMC, Drug Supply, Regulatory, Pharmacovigilance, Data Management, Statistics, Clinical Development,) in the design, start-up, condu

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