Clincal Development Operations

il y a 1 semaine

Gent, Flandre, Belgique Meet Recruitment Temps plein
110000 EUR 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 paramedical (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 autoimmune clinical trial background is a plus.

  • Clinical Operations Development Lead

    il y a 1 semaine

    Gent, Flandre, Belgique MindCapture Temps plein

    CLINICAL OPERATIONS DEVELOPMENT LEAD Biotech Ghent & remoteWHAT IS OFFEREDThe Clinical Operations Development Lead plays a critical role in ensuring the success of clinical trials and the development of new therapeutic assets, coordinating efforts across various functions and stakeholders to drive effective clinical development strategies.Next to a...

  • Franchise Clinical Operations Development Lead

    il y a 1 semaine

    Gent, Flandre, Belgique MindCapture Temps plein

    FRANCHISE CLINICAL OPERATIONS DEVELOPMENT LEAD Biotech GhentWHAT IS OFFEREDFranchise Clinical Operations Development Lead plays a critical role in overseeing the operational path for all indications within a franchise. Functioning as a line manager, and ensuring consistency to synergy across different indication teams. The Franchise Clinical Operations...

  • Clinical Operations Development Lead

    il y a 1 semaine

    Gent, Flandre, Belgique Argenx Temps plein

    We are currenty looking for a Clinical Operations Development Lead (CODL) to strengthen the Global Clinical Trial Operations team. The Clinical Operations Development Lead is responsible for the oversight of the clinical related activities within a specific therapeutic indication for an asset (CODL) or across all indications for an asset (Xindication CODL)....

  • Clinical Operations Development Lead

    il y a 1 semaine

    Gent, Flandre, 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...

  • Franchise Clinical Operations Development Lead

    il y a 1 semaine

    Gent, Flandre, Belgique Argenx Temps plein

    To strengthen our Global Clinical Trial Operations team, we are currently looking for a Franchise Clinical Operations Development Lead (Franchise CODL).The Franchise CODL is responsible for the strategizing, planning, leading and execution of the operational path for all indications within a franchise from first in human studies through authorization and...

  • Clinical Operations Development Lead

    il y a 1 semaine

    Gent, Flandre, Belgique Argenx Temps plein

    The Clinical Operations Development Lead is responsible for the oversight of the clinical related activities within a specific therapeutic indication for an asset (CODL) or across all indications for an asset (X-indication CODL). Together with the Medical Development Lead (MDL), the CODL co-leads the Clinical Development Team (CDT) and co-owns the Clinical...

  • Clinical Operations Excellence Lead

    il y a 1 semaine

    Gent, Flandre, 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...

  • Operations Expert

    il y a 1 semaine

    Gent, Flandre, Belgique Page Personnel Temps plein

    Added 08/03/202- Do you want to change lives everyday? You don't mind working in shifts and during the weekends?About Our Client:Our client is on a mission to revolutionize healthcare by combatting life-threatening diseases with groundbreaking biotechnology. Situated in the vibrant heart of New Jersey, their global influence extends far and wide as they...

  • Operations Associate

    il y a 1 semaine

    Gent, Flandre, Belgique OTIV Temps plein

    Who we areOTIV is a Ghent-based company leading the autonomous revolution in rail. We are on a mission to increase safety and efficiency of railway operations by teaching rail vehicles to drive autonomously. By making trains more efficient and safer, we actively contribute to a modal shift and a greener future. We bring this vision to life by a unique focus...

  • Business Development Manager

    il y a 1 semaine

    Gent, Flandre, Belgique Resillion Temps plein

    Ben jij een gedreven business development specialist met vooral een passie voor het creëren van waardevolle klantrelaties? Je zal nieuwe klanten aanbrengen die nood hebben aan een partner (Resillion) om hun software feilloos te kunnen ontwerpen en uitbrengen voor klanten. Je zal dus in de niche van Quality Assurance voor software alsook Cyber Security aan...

  • Car-t Operations Supervisor

    il y a 1 semaine

    Gent, Flandre, Belgique Legend Biotech EU Temps plein

    Company InformationLegend 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 OVERVIEWThe CAR-T Operations Supervisor is...

  • Business Development Manager

    il y a 1 semaine

    Gent, Flandre, Belgique DFDS AS Temps plein

    Business Development Manager:DFDS operates 3 shortsea routes and 30 weekly intermodal connections (rail, barge) out of Belgium. Ghent, where DFDS Belgium also operates a multimodal terminal, operates 6 sailings per week to/from Gothenburg. Once per week Brevik in Norway is also called. In Zeebrugge DFDS operates 4 sailings per week to/from Gothenburg and 1...

  • Car-t Operations Expert

    il y a 1 semaine

    Gent, Flandre, Belgique MindCapture Temps plein

    CAR-T OPERATIONS EXPERT Biotech GhentABOUT THE COMPANYJoin 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, and...

  • Operations Technician

    il y a 1 semaine

    Gent, Flandre, Belgique Legend Biotech EU Temps plein

    Company InformationLegend 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 OverviewAs CAR-T Operations Technician, you...

  • eCommerce Operation Lead

    il y a 1 semaine

    Gent, Flandre, Belgique Pandora Temps plein

    eCommerce Operations Lead (m/f/d) – Gent WE DELIVER • WE DREAM • WE CARE • WE DARE We are looking for a candidate that is as eager to drive and actively takes responsibility of the fulfillment operations, leading the Operations team on-site. The primary responsibility of the eCommerce Operations Team Lead is to run, guide and support day-to-day...

  • eCommerce Operation Lead

    il y a 2 semaines

    Gent, Flandre, Belgique Pandora Temps plein

    eCommerce Operations Lead (m/f/d) – Gent WE DELIVER • WE DREAM • WE CARE • WE DARE We are looking for a candidate that is as eager to drive and actively takes responsibility of the fulfillment operations, leading the Operations team on-site. The primary responsibility of the eCommerce Operations Team Lead is to run, guide and support day-to-day...

  • People Operations Specialist

    il y a 1 semaine

    Gent, Flandre, 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 region....

  • Marketing Operations Manager Benelux, Scandinavia

    il y a 1 semaine

    Gent, Flandre, Belgique Trouw Nutrition Temps plein

    Excited to take charge of marketing initiatives across Benelux, France, and Scandinavia? Join our team as Marketing Operations ManagerAbout the jobAs 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 objectives. Your...

  • Ecommerce Operation Lead

    il y a 1 semaine

    Gent, Flandre, Belgique Pandora Jewelry Temps plein

    eCommerce Operations Lead (M/F/d) - GentWE DELIVER - WE DREAM - WE CARE - WE DAREThe primary responsibility of the eCommerce Operations Team Lead is to run, guide and support day-to-day operations of the newly established e-Commerce fulfillment center in Gent to ensure great customer experience for our Pandora customers.WE DELIVER - Let's deliver...

  • Senior Manufacturing and Operations Lead

    il y a 1 semaine

    Gent, Flandre, Belgique MindCapture Temps plein

    SENIOR MANUFACTURING AND OPERATIONS LEAD IVD & Medical devices GhentWHAT IS OFFEREDTogether with the team of experts, you will work on the development of the first invisible Continuous Glucose Monitor, which will improve the life of so many people living with Diabetes.You will be part of a fast growing and very international team with plenty of development...