P2414 -program Operational Lead

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._

For our Clinical Operations organization based at our Headquarters in Lausanne, we are looking for a:
**Program Operational Leader**

Program Operational Leader contributes to the development of the clinical development plan of an assigned program or an indication within an assigned program. POL leads the Clinical Trial Teams taking the accountability for the success of the teams ensuring the creation of robust trial operational executions plans and progress of the clinical trials are on track and that operational risk are identified and mitigated proactively.

**Your responsibilities**:

- Serves as a core member of Core Team and Sub-team(s) representing Global Clinical Operations and contributes to the development of the Clinical Development Plan of the assigned program/indication.
- Conducts program level planning of the assigned program/indication to establish global resource requirements and high-level recruitment strategies.
- Accountable for the operational delivery (including risk management and mitigation) of the assigned program/indication and associated clinical trials and for all related strategic planning, prioritization of activities, within the program.
- Partners with the Medical Director and other Core Team members, actively offers operational insights and options to contribute to the program/indication and clinical trial strategy, with respect to clinical trial design and protocol optimization and timelines planning.
- Leads the Clinical Trial Teams in the execution of clinical trials and oversee the progress and deliverables (including trial budget and spending).
- Provides guidance to Clinical Trial Teams during the development of the trial execution plan, managing trial budgetary issues, resolving trial issues, and implementing appropriate measures.
- Monitors Clinical Trial Teams and CRO/vendor performance through KPIs, and work with the appropriate Development Functional Leaders to optimize Clinical Trial Teams and CRO/vendor performance.
- Point of contact for escalation and resolution of trial related issues. Participates in vendor governance meetings to monitor and address performance issues and escalation/resolution of issues encountered by the Clinical Trial Teams.
- Provides oversight on operational quality and compliance in conjunction with Quality Assurance.
- Supervises Clinical Trial Teams in inspection readiness activities and attend Health Authority inspections to manage and answer/coordinates responses to inspection requests.
- Contributes and provides operational input into the due diligence activities.
- Author/reviewer of Standard Operating Procedures (SOPs) for the conduct of clinical trial and acts as Subject Matter Experts for training or SOPs.
- Participates in Clinical Operations Meetings and/or cross-functional forums to exchange information, best practices, and issues.

**Requirements**:

- Bachelor’s Degree/Master’s Degree/PhD in Science or Healthcare
- 8 years or more years of experience in pharmaceutical drug development with management in a matrix organization
- Experience with FDA or EMEA inspections including sponsor GCP inspections
- Strong team leadership with ability to manage multiple individuals and teams simultaneously
- Strong problem-solving skills with ability to resolve issues with mínimal supervision and understand when to escalate
- Strong interpersonal skills with ability to effectively communicate, interact and work with individuals and teams and to bridge cross-functional stakeholder (business, scientific and technical)
- Performance driven with ability to deliver results and fast in implementation
- Strong knowledge of therapeutic area and fully knowledgeable in area of responsibility serving as source of expertise for others
- Strong knowledge of clinical development processes and understanding roles and responsibilities of Clinical Trial Team members to drive execution of clinical development program
- Strong knowledge in clinical trial forecasting, budgeting, and contracting
- Fluent in English (French and another European language are an asset)

**Benefits**
- International, highly dynamic environment with a long term vision.
- Cross-functional collaboration

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