Clincal Development Operations

Il y a 6 mois


Gent, Belgique Meet Recruitment Temps plein

110000 EUR - 110000 EUR
- Ghent, Belgium
- Permanent

**About**:
Our client is a leading, innovative biotechnology company dedicated to developing cutting-edge antibody products to transform patients' with autoimmune disease lives. They are at the forefront of the immunology space, pioneering groundbreaking treatments for various diseases. Their mission is to revolutionize healthcare, and we're looking for a talented Clinical Operations Development Lead to join their dynamic team.

**Position Overview**:
We are looking to identify an experienced and highly motivated Clinical Operation/Development Lead to strengthen the Global Clinical Trial Operations team. In this key role, you will be responsible for co-leading the Clinical Development Team and co-owning the Clinical Development plan alongside the Medical Development Lead.

**Key Responsibilities**:
**Strategic Input & Accountability**: All clinical related aspects within the assigned therapeutic indication/program and in line with the agreed timelines, budget and quality standards and as outlined in the applicable Standard Operation Procedures (SOPs) and Work Instructions (WIs).

**Clinical Development Plan**: Ensure it describes the clinical development strategy, comprising effective and where possible innovative trial designs and is consistent with the target product profile. Ensures it is endorsed by the Asset Strategy Team and the Development Management Committee and is executed within agreed timelines and budget.

**Lead Responsibility**: Alongside Medical Development Lead, acts as primary point of contact for all clinical related activities for a given indication or across asset indications ).

**Risk Assessment**: Conduct risk assessments and proactively address Clinical Development Trial -related timeline, budget, and milestone challenges and issues.

**Cross-functional Collaboration**: Collaborate closely with various departments, including R&D, manufacturing, quality, and clinical teams, to ensure regulatory alignment throughout the product lifecycle.

**Health Authority Interactions**: After completion of the Clinical Phase III program, Clinical Operations Development Lead and Medical Development Lead, in close collaboration with the CDT members, continue to be involved in the clinical related activities e.g., through input to different regulatory authorities (e.g., FDA, EMA, PMDA, MHRA).

**Project Management**: Lead and manage regulatory CMC projects, ensuring timelines and objectives are met.

**Budgeting**: Contribute to timeline and resource requirements and provides input to the financial CDT planning

**Team Leadership**: As a Leader, sets expectations, communicates in a transparent, clear way and energises and motivates the team members as well as the respective Clinical Trial Managers to work towards achieving the clinical goals in line with the business goals and cultural pillars.
If applicable, acts as line manager of CTMs and/or CTAs:

- On-boarding of new direct reports
- Ensuring that assigned staff are trained
- Goal setting and review
- Mentoring and enabling the growth and development of assigned staff
- Supports ClinOps and Global Company initiatives as applicable.

**Competencies and Qualifications**:

- The Clinical Development Operations Lead excels in leadership and establishing good and effective internal and external working relationships and communication, embedding the company values.
- Global Strategic Drug Development experience and understanding.
- Proven Clinical Operations experience in a relevant global leadership position in the pharmaceutical/biotech industry.
- Bachelor’s degree or University degree - medical or para-medical (Biology, Biomedical Sciences, Pharmacy, Veterinary etc.) or equivalent by experience. PhD degree is a plus.
- Minimum of 10 years of leading experience in Clinical Development (monitoring, local and global/international trial management).
- Experience in working in an outsourced model, including overseeing CROs and vendors.
- Rare disease and/or auto-immune clinical trial background is a plus.



  • Gent, Belgique Argenx Temps plein

    For the expansion of our Global Clinical Trial Operations team, argenx is looking for a Clinical Operations Development Lead. Key Accountabilities/Responsibilities: The Clinical Operations Development Lead (CODL) is responsible for the oversight of the clinical related activities within a specific therapeutic indication for an asset (CODL) or across all...


  • Gent, Belgique Argenx Temps plein

    Due to the exponential growth of argenx worldwide, we are currently looking for several _Clinical Operations Development Leads (CODL) _to strengthen the Global Clinical Trial Operations team. Ideally, location would be based in Belgium._ - The Clinical Operations Development Lead is responsible for the oversight of the clinical related activities within a...


  • Gent, Belgique Argenx Temps plein

    ROLES AND RESPONSIBILITIES: - Ensure oversight of the adequacy of processes in Global Clinical Operations. Ensure regulatory requirements and commitments are reflected in the procedural documents - Identify and drive continuous improvement of processes and systems within Global Clinical Operations organization - Ensure quality risk management principles are...


  • Gent, Belgique Argenx Temps plein

    This position reports into the Head Clinical Operations Excellence. We want to fill in the position in Europe or the United States. Roles & Responsibilities - Ensure oversight of the adequacy of processes in Global Clinical Operations. Ensure regulatory requirements and commitments are reflected in the procedural documents. - Identify and drive continuous...

  • Compass Java Development

    Il y a 7 mois


    Gent, Belgique Halian Temps plein

    I am currently seeking a skilled and dynamic Java Developer for my client. This is a unique opportunity to contribute to the development of future-proof, scalable information systems in a company committed to innovation and excellence. **_Responsibilities: _** - Develop advanced, scalable information systems. - Evaluate operational feasibility through...

  • Sales Operations Manager

    Il y a 6 mois


    Gent, Belgique Otamiser Holdings BV Temps plein

    **About us**: **bout You**: We are seeking a proactive and results-driven Sales Operations Manager to join our growing team at Otamiser. You should thrive in a fast-paced environment and have a passion for optimizing sales processes and driving business growth. This role is pivotal in ensuring operational efficiency and effectiveness across our sales...

  • Car-t Operations Expert

    Il y a 6 mois


    Gent, Belgique MindCapture Temps plein

    CAR-T OPERATIONS EXPERT - Biotech- GhentABOUT THE COMPANY Join a global biotechnology company committed to treating and ultimately curing life-threatening diseases. They are at the forefront of developing advanced cell therapies utilizing diverse technology platforms. These include autologous and allogeneic chimeric antigen receptor T-cell, T-cell receptor,...

  • Operations Technician

    Il y a 6 mois


    Gent, Belgique Legend Biotech EU Temps plein

    **Company Information** Legend Biotech entered into a global collaboration agreement with Janssen Biotech, Inc. to develop, manufacture and commercialize ciltacabtagene autoleucel (cilta-cel). Through our strategic partnership, we look to advance the promise of an immunotherapy in the treatment of multiple myeloma. **Role Overview** As CAR-T Operations...


  • Gent, Belgique Trouw Nutrition Temps plein

    Excited to take charge of marketing initiatives across Benelux, France, and Scandinavia? Join our team as Marketing Operations Manager! **About the job** As the Marketing Operations Manager you will collaborate closely with local sales teams and the ECA Marketing Operations team to develop and execute marketing strategies aligned with our business...

  • Partner Development Lead

    Il y a 3 mois


    Gent, Belgique Sofico Temps plein

    Overview Location Gent, East Flanders, Belgium Department Partner Management About the Job Imagine unlocking new horizons for the Miles Enterprise Suite as you step into the exciting role of Partner Development Lead at Sofico. Help define Sofico’s future by personally guiding partners in becoming integrators and fostering dynamic alignments. Join us at the...

  • Director of Operations

    il y a 4 semaines


    Gent, Belgique Techwolf Temps plein

    **TechWolf is on a hyper-growth journey and our recent $43 million Series B fundraise has just supercharged that!** We’re expanding fast, and as we scale globally, we need an Operations leader to build the central tech and operations backbone that will ensure smooth and efficient operations across the business. As we enter this next phase of growth, the...


  • Gent, Belgique Robovision Temps plein

    Robovision, a leading AI Platform, is in hyper-growth. With an award-winning platform operating in over 40 countries, we are globally recognized as an AI-vision leader. We have enabled groundbreaking innovations in healthcare, agriculture, retail and manufacturing. Our AI platform empowers users to intuitively adapt vision intelligence within smart...


  • Gent, Belgique EPAM Systems Temps plein

    **ABOUT THE ROLE**: We are looking to make a new addition to our people team and hire a People Operations Specialist in Ghent who will play a key role in supporting EPAM continued growth through people programs, processes, policies and practices that enable EPAM to attract, develop, engage, leverage and retain talent in highly competitive markets in the...


  • Gent, Belgique Legend Biotech EU Temps plein

    **Company Information** Legend Biotech entered into a global collaboration agreement with Janssen Biotech, Inc. to develop, manufacture and commercialize ciltacabtagene autoleucel (cilta-cel). Through our strategic partnership, we look to advance the promise of an immunotherapy in the treatment of multiple myeloma. **Role Overview** The Warehouse...


  • Gent, Belgique Showpad Temps plein

    **People Operations Manager EMEA** **Location Qualifications** London (Hybrid) Ghent (Hybrid) **Position Overview** The EMEA People Operations Manager plays a crucial role in the success of our organization. You will help ensure that our people operations run smoothly throughout the employee lifecycle, from onboarding through exit. This role requires a...

  • Director of Operations

    il y a 3 semaines


    Gent, Belgique Techwolf Temps plein

    TechWolf is on a hyper-growth journey and our recent $43 million Series B fundraise has just supercharged that! We’re expanding fast, and as we scale globally, we need an Operations leader to build the central tech and operations backbone that will ensure smooth and efficient operations across the business. As we enter this next phase of growth, the...

  • Operation Specialist Planet B

    il y a 3 semaines


    Gent, Belgique WONDR care Temps plein

    Operation Specialist **Operation specialist: Sustainable Innovation** At Planet B, we are transforming the FMCG sector with sustainable and innovative products. Our brands, such as Bambooze, WONDR care, and Klaaar, stand for well-being, sustainability, and impact. To support our growth and mission, we are looking for an enthusiastic Operations Specialist...

  • Director of Operations

    il y a 4 semaines


    Gent, Belgique TechWolf BV Temps plein

    **TechWolf is on a hyper-growth journey and our recent $43 million Series B fundraise has just supercharged that!** We’re expanding fast, and as we scale globally, we need an Operations leader to build the central tech and operations backbone that will ensure smooth and efficient operations across the business. As we enter this next phase of growth, the...

  • Director of Operations

    il y a 3 semaines


    Gent, Belgique Techwolf Temps plein

    **TechWolf is on a hyper-growth journey and our recent $43 million Series B fundraise has just supercharged that! **We’re expanding fast, and as we scale globally, we need an Operations leader to build the central tech and operations backbone that will ensure smooth and efficient operations across the business. As we enter this next phase of growth, the...

  • Director of Operations

    il y a 3 semaines


    Gent, Belgique Techwolf Temps plein

    TechWolf is on a hyper-growth journey and our recent $43 million Series B fundraise has just supercharged that! We’re expanding fast, and as we scale globally, we need an Operations leader to build the central tech and operations backbone that will ensure smooth and efficient operations across the business. As we enter this next phase of growth, the...