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Laatst bijgewerkt: 4 dagen geleden
Director Clinical Program Management

Director Clinical Program Management

Meet RecruitmentGhent Belgium
€ 110.000,00 per jaar
Director Clinical Program Management.A leading, innovative European Biotech committed to bringing life changing treatments to those suffering severe and life-threatening auto-immune illnesses throu...Laat meer zienLaatst bijgewerkt: 30+ dagen geleden
  • Gesponsord
TrustBuilder - Project Manager

TrustBuilder - Project Manager

TrustBuilderGhent, Belgium
Project Manager is a pivotal position entails overseeing several projects (customer experience, service delivery managers, internal communication,. Reporting to the Senior Vice President Operations ...Laat meer zienLaatst bijgewerkt: 4 dagen geleden
Strategic Accountleader / Business Development Manager Industry

Strategic Accountleader / Business Development Manager Industry

ArcadisGent, Oost-Vlaanderen, Belgium
Arcadis is een toonaangevende internationale organisatie die ontwerp-, engineering- en adviesdiensten levert voor een duurzame gebouwde en natuurlijke omgeving. Iedereen speelt hierbij een belangrij...Laat meer zienLaatst bijgewerkt: 30+ dagen geleden
  • Gesponsord
Supply Chain Manager Safety Jogger

Supply Chain Manager Safety Jogger

CortinaGhent, BE
The organization is active in the development, production and distribution of shoes, Personal Protective Equipment (PPE under the label . With a yearly turnover of more than 200 mio the company is i...Laat meer zienLaatst bijgewerkt: 30+ dagen geleden
Lead Accountant

Lead Accountant

Findhu - Joana MarquesGhent, Belgium
Our client has a team of highly skilled professionals who contribute to the company's success and growth.To further strengthen its finance department, we are seeking a Lead Accountant who will over...Laat meer zienLaatst bijgewerkt: 11 dagen geleden
Country Manager Italia

Country Manager Italia

CeresRecruitmentGent, Oost-Vlaanderen, BE
Op afstand
Home Office, travelling in the assigned working area.European Foliar Nutrition specialist providing for more than 4 decades reliable and innovative plant nutrition solutions helping farmers and gro...Laat meer zienLaatst bijgewerkt: 30+ dagen geleden
Strategic BI / Data Analyst

Strategic BI / Data Analyst

EmpHireGhent, VBR, be
Belgium (2 days per week on-site).Join a leading multinational FMCG producer committed to innovation and sustainability.Our products are sold globally, and we are dedicated to meeting the evolving ...Laat meer zienLaatst bijgewerkt: 13 dagen geleden
Revenue Enablement Manager, Programs

Revenue Enablement Manager, Programs

ShowpadGhent
Revenue Enablement Manager, Programs .This role is available for hybrid work from either our Ghent Chicago or London offices. As the Revenue Enablement Manager, Programs, you will play a pivota...Laat meer zienLaatst bijgewerkt: 30+ dagen geleden
Director Formulation Development & Production

Director Formulation Development & Production

ArdenaGhent
Vast
We assist pharmaceutical companies, from virtual biotech to big pharma, in bringing their valued molecule(s) to the clinic and market. We provide a comprehensive and integrated portfolio of drug sub...Laat meer zienLaatst bijgewerkt: 30+ dagen geleden
Junior Consultant Transfer Pricing

Junior Consultant Transfer Pricing

Moore GlobalGent, BE
Moore is een grote werkgever met het karakter van een kleine organisatie : korte lijnen, snelle beslissingen, no-nonsense cultuur en veel ondernemerszin. Wij bieden medewerkers zinvol werk in een bed...Laat meer zienLaatst bijgewerkt: 30+ dagen geleden
Director of Corporate Finance

Director of Corporate Finance

ArgenxGent
Fulltime
At argenx, we are committed to pioneering the discovery, development, and commercialization of innovative immunology therapies to transform the lives of patients worldwide.Our dynamic team operates...Laat meer zienLaatst bijgewerkt: 30+ dagen geleden
Lead Technieker

Lead Technieker

Forum JobsGent
Regio : Oost-Vlaanderen Gemeente : Gent Contract : Interim job met optie vast werk Arbeidsovereenkomst : Voltijds Job statuut : Arbeider Tijdsregeling : Dagwerk. Onze klant is op zoek naar een technieker ...Laat meer zienLaatst bijgewerkt: 30+ dagen geleden
Operations Lead

Operations Lead

OTIVGhent, Flanders, BE
Quick Apply
OTIV is a Ghent-based company leading the autonomous revolution in rail.We are on a mission to increase safety and efficiency in railway operations by teaching rail vehicles to drive autonomously.B...Laat meer zienLaatst bijgewerkt: 30+ dagen geleden
Strategic Marketing Manager - Test & Measurement

Strategic Marketing Manager - Test & Measurement

nVentGhent, BE
Fulltime
We’re looking for people who put their innovation to work to advance our success – and their own.WHAT YOU WILL EXPERIENCE IN THIS POSITION : . THIS IS A REMOTE POSITION, CAN BE BASED IN DIFFERENT COUN...Laat meer zienLaatst bijgewerkt: 30+ dagen geleden
Lead Stabiliteitsingenieur

Lead Stabiliteitsingenieur

ENGIEGhent, BE
Tractebel is een wereldwijd actief engineering- en consultancybedrijf dat geïntegreerde oplossingen biedt voor duurzame energieprojecten en de gebouwde omgeving. Door strategie, ontwerp, engineering...Laat meer zienLaatst bijgewerkt: 30+ dagen geleden
CEO

CEO

Hudson BeneluxGent, Vlaanderen
Build and execute the business transformation plan.You are ultimately responsible for realizing the strategic objectives and ambitious results of the organization. You represent the organization in ...Laat meer zienLaatst bijgewerkt: 30+ dagen geleden
Sales Manager

Sales Manager

FluvesGhent, Flanders, Belgium
Quick Apply
Founded in 2014 and integrated into the Virya Energy portfolio in 2021, Fluves has rapidly established itself as a leader in monitoring water and energy distribution systems.Operating in over 15 co...Laat meer zienLaatst bijgewerkt: 30+ dagen geleden
Sales and pricing administrator - internationale topwerkgever Gent

Sales and pricing administrator - internationale topwerkgever Gent

Manpower BEGent
Manpower Office People is specialist in het rekruteren van bedienden.We gaan telkens voluit voor de 'perfect match' tussen werkgever en sollicitant. Welcome to a world of opportunity.Samen met onze ...Laat meer zienLaatst bijgewerkt: 30+ dagen geleden
Head of PMO

Head of PMO

Viroclinics BiosciencesGhent, Vlaams Gewest, Belgium
Join Our Team as Head of PMO (Project Management Office).Are you an experienced leader who can build and lead high-performing teams? Do you thrive in dynamic environments and possess a talent for s...Laat meer zienLaatst bijgewerkt: 30+ dagen geleden
Lead E&I Engineer

Lead E&I Engineer

WorleyGhent, Flanders, Belgium
Quick Apply
Antwerpen en Gent, en is aanwezig op klantlocaties.We werken aan nationale en internationale projecten.Onze projecten vereisen de inzet van multidisciplinaire technische teams en bieden kansen om t...Laat meer zienLaatst bijgewerkt: 30+ dagen geleden
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Director Clinical Program Management

Director Clinical Program Management

Meet RecruitmentGhent Belgium
30+ dagen geleden
Salaris
€ 110.000,00 per jaar
Functieomschrijving

Director Clinical Program Management

143940 Posted : 03th May 2024

  • 110000 EUR - 110000 EUR
  • Ghent, Belgium
  • Permanent

A leading, innovative European Biotech committed to bringing life changing treatments to those suffering severe and life-threatening auto-immune illnesses through the development of their cutting-edge portfolio of antibody products.

Position Overview :

If successful you will be tasked with overseeing all Clinical related activities within a specific Therapeutic Indication for your assigned asset. Working closely with your colleagues in the Medical & Scientific teams through the concept and execution of the Clinical Development plan as well as the end-to-end oversight of all operational activities including leadership of the Clinical Development Team.

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 colleagues, 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 ., through input to different regulatory authorities (., 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

    • Competencies and Qualifications :

  • Minimum of 10 years of leading experience in Clinical Development including oversight of complex Clinical Development programs / portfolios within a Biotech or Pharma setting
  • Hands on experience in the leadership of cross functional Clinical Development Teams as well as line management (Clinical Managers)
  • Bachelor’s degree or University degree – medical or para-medical (Biology, Biomedical Sciences, Pharmacy, Veterinary or equivalent by experience. PhD degree is a plus.
  • Rare disease and / or auto-immune clinical trial background is a plus.

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