Director Deputy, Clinical Operations

Job content

Debiopharm is an independent biopharmaceutical company based in Switzerland with an ongoing commitment to research in oncology and bacterial infections in order to improving 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. Bridging the gap between disruptive discovery products and real-world patient reach, we 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.

Here:https://apply.workable.com/debiopharm-group-sa/

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

Director Deputy, Clinical Operations

In this newly created role, you will be 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.

As Director Deputy, you will represent the Clinical Operations function on the R&D Board meeting and will contribute to driving forward the organization.

This position includes the management of Clinical Trial Managers (responsible for leading, planning, and delivering clinical trials (Phases I-III) in Oncology and onco-hematology), 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;
• 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.
• Ad-hoc and as needed, 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, external vendors selection and management, such as Contract Research Organizations (CROs), central laboratories, etc.;
• Assist in the identification of investigational sites and perform co-monitoring with CRAs when required

Requirements:

• PhD in Life Sciences
• Proven people management experience in clinical operations, combined with leadership experience sitting at R&D Board.
• Proven track record of Phase I-III international clinical trials management in the Pharmaceutical Industry or CRO in Oncology, including the Clinical Trial Managers management.
• Solid experience in management of CROs, vendors and consultants, experience in external audits, an asset, including negotiation of contracts & budgets
• Previous monitoring experience 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;
• 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 continuous improvement and innovation; promoting root cause analysis, lessons learnt and 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 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%).

Benefits:

• An international and highly dynamic environment, with a long term vision.
• The opportunity to join a successful company, at the forefront of the most advanced scientific developments in the industry and be exposed to many areas within clinical development and the pharmaceutical industry.
• The possibility to be in a company in which innovation, people and entrepreneurship are the fundamentals of its success.