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

  • 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...

  • Program Advisor

    vor 4 Wochen

    Lausanne, Schweiz IMD Vollzeit

    Contract Type: Open-ended- Location: Lausanne, CH**About IMD** The Institute for Management Development (IMD) is an independent academic institution with Swiss roots and global reach, founded more than 75 years ago by business leaders for business leaders. Since its creation, IMD has been a pioneering force in developing leaders who transform organizations...

  • Global Clinical Development Lead

    vor 1 Monat

    Lausanne, Schweiz Nestle Operational Services Worldwide SA Vollzeit

    **Position Snapshot** Location: Nestlé Health Science Lausanne, Switzerland Company: Nestlé Health Science Act. Rate: Full-Time Act. Rate 100% Type of contract: Permanent contract **What we offer at Nestlé** Flexible work policies in terms of core hours and working from home. Please talk to us during the recruitment process about what flexibility could...

  • P2407 - Global Project Leader - Oncology

    Vor 4 Tagen

    Lausanne, Schweiz Debiopharm Vollzeit

    Debiopharm is privately-owned Swiss biopharmaceutical company commitmented to research in oncology and infectious diseases in order to improve patient outcomes and quality of life. Debiopharm International SA aims to develop innovative therapies via our unique “development only” business model, acting as a bridge between disruptive discovery products and...

  • Future Leaders

    vor 1 Monat

    Lausanne, Schweiz EPFL Vollzeit

    EPFL, the Swiss Federal Institute of Technology in Lausanne, is one of the most dynamic university campuses in Europe and ranks among the top 20 universities worldwide. The EPFL employs more than 6,000 people supporting the three main missions of the institutions: education, research and innovation. The EPFL campus offers an exceptional working environment...

  • P2407 - Global Project Leader - Oncology

    Vor 5 Tagen

    Lausanne, Schweiz Debiopharm Vollzeit

    Debiopharm is privately-owned Swiss biopharmaceutical company commitmented to research in oncology and infectious diseases in order to improve patient outcomes and quality of life. Debiopharm International SA aims to develop innovative therapies via our unique “development only” business model, acting as a bridge between disruptive discovery products and...

  • Graduate Program

    vor 1 Monat

    Lausanne, Schweiz Colas Vollzeit

    Spécialisé dans la construction et l’entretien d’infrastructures routière Colas Suisse fait partie du groupe Colas international, leader mondial de la route. Colas Suisse regroupe plusieurs centres travaux, carrières, postes d’enrobés et bureaux d’études. Chaque jour 700 collaborateurs mettent leur savoir-faire au service de nos clients dans...

  • Graduate Program

    vor 1 Monat

    Lausanne, Schweiz Colas Vollzeit

    Spécialisé dans la construction et l’entretien d’infrastructures routière Colas Suisse fait partie du groupe Colas international, leader mondial de la route. Colas Suisse regroupe plusieurs centres travaux, carrières, postes d’enrobés et bureaux d’études. Chaque jour 700 collaborateurs mettent leur savoir-faire au service de nos clients dans...

  • EMBA Program Coordination Intern

    vor 2 Wochen

    Lausanne, Schweiz IMD Vollzeit

    About IMD Founded by business executives for business executives, the International Institute for Management Development (IMD) is an independent academic institute with campuses in Lausanne and Singapore as well as a Management Development Hub in Shenzhen. We strive to be the trusted learning partner of choice for ambitious individuals and organizations...

  • MBA Program Coordinator Intern

    vor 1 Monat

    Lausanne, Schweiz IMD Vollzeit

    About IMD Founded by business executives for business executives, the International Institute for Management Development (IMD) is an independent academic institute with campuses in Lausanne and Singapore as well as a Management Development Hub in Shenzen. We strive to be the trusted learning partner of choice for ambitious individuals and organizations...

  • Operations Internship Program

    vor 1 Monat

    Lausanne, Waadt, Schweiz Batmaid SA Vollzeit

    Are you passionate about making a positive impact in the world? Do you want to work for a company that values collaboration, innovation, and community? Batmaid is seeking talented and ambitious people to join our Internship Program and help us achieve our objective of Fighting the Black MarketHere at Batgroup our objective is to become the global leader...

  • Operations Internship Program

    vor 1 Monat

    Lausanne, Schweiz Batgroup Vollzeit

    Are you passionate about making a positive impact in the world? Do you want to work for a company that values collaboration, innovation, and community? Batmaid is seeking talented and ambitious people to join our Internship Program and help us achieve our objective of Fighting the Black Market!Here at Batgroup our objective is to become the global leader...

  • Audit & Capa Lead

    vor 17 Stunden

    Lausanne, Schweiz CK Group Vollzeit

    **Salary**:Competitive - **REF Number**:00054965 - **Consultant**:Kajenthi Chelliah - **Contact**:0041800106106 - **Date Published**:12.01.2023 - **Sector**: - **Location**:Lausanne, - **Discipline**: CK QLS are recruiting for an Audit & CAPA Lead to join a biopharmaceutical company based in Switzerland on an 8 months contract. The Audit & CAPA Lead’s...

  • Customer Care Enhancement

    Vor 4 Tagen

    Lausanne, Schweiz Philip Morris International Vollzeit

    Be a part of a revolutionary change! At PMI, we’ve chosen to do something incredible! We’re totally transforming our business and building our future on one clear purpose - to deliver a smoke-free future. With huge change, comes huge opportunity. So, wherever you join us, you’ll enjoy the freedom dream up and deliver, better, brighter solutions and...

  • Digital Transformation

    Vor 5 Tagen

    Lausanne, Schweiz Medair Vollzeit

    Role & Responsibilities Provide input for the International Programmes Department (IP) to the development of new digital systems to improve finances, budgeting, reporting, resource planning and supply chain management. This includes collecting input from staff based at GSO and also from all country programmes. This position is the key link between the...

  • Global Clinical Development Lead

    vor 1 Monat

    Lausanne, Waadt, Schweiz Nestlé Suisse S.A. Vollzeit

    Global Clinical Development Lead - Drug Develop Rare Diseases / IEMGlobal Clinical Development Lead - Drug Develop Rare Diseases / IEMPosition Snapshot Location: Nestlé Health Science Lausanne, Switzerland Company: Nestlé Health Science Act. Rate: Full-Time Act. Rate 100% Type of contract: Permanent contract What we offer at Nestlé Flexible work...

  • Clinical Operations Director

    vor 1 Monat

    Lausanne, Schweiz LHH Vollzeit

    **Clinical Operations Director** As **Clinical Operations Director, you will be **responsible for the strategic and tactical operational planning and execution of R&D sponsored clinical programs for all corporate sponsored programs for Phase I - Phase IV Missions: Plan, drive and monitor program related activities throughout the lifecycle of the project...

  • Marketing Analytics and Insights Lead

    vor 1 Tag

    Lausanne, Schweiz IMD Vollzeit

    Contract Type: Open-ended- Location: Lausanne, CH**About IMD** The Institute for Management Development (IMD) is an independent academic institution with Swiss roots and global reach, founded 75 years ago by business leaders for business leaders. Since its creation, IMD has been a pioneering force in developing leaders who transform organizations and...

  • Graduate Program

    vor 1 Monat

    Lausanne, Schweiz KPMG Vollzeit

    Use your analytical skills to put the pieces of the global mobility puzzle together, with the support of a young and dynamic team! In this 24 months Graduate Program you will discover different areas of our global mobility practice and develop your skills in Swiss tax compliance, payroll, equity and more. Lausanne October 2023 100 % Your contribution to...

  • Lead Patent Counsel

    vor 4 Wochen

    Lausanne, Schweiz Nestle Operational Services Worldwide SA Vollzeit

    **Position Snapshot** Location: Lausanne and Orbe, Switzerland Company: Nestlé, R&D Legal Department Act. Rate: Full-Time Act. Rate 100% Type of contact: Permanent contract **What we offer at Nestlé** Flexible work policies in terms of core hours and working from home. Please talk to us during the recruitment process about what flexibility could look...