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Laatst bijgewerkt: 16 uren 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
Director Formulation Development and Production

Director Formulation Development and Production

ArdenaGhent
As a leading contract development and manufacturing organization (CDMO) within the pharmaceutical industry,.Our commitment extends to providing a comprehensive and integrated portfolio covering dru...Laat meer zienLaatst bijgewerkt: 24 dagen geleden
Medical Secretary (deel- of voltijds)

Medical Secretary (deel- of voltijds)

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Binnen Ringphone zijn wij omwille van onze blijvende groei op zoek naar gemotiveerde medewerkers.Ben je op zoek naar een omgeving waar je helpt meebouwen aan de efficiëntie binnen die medische were...Laat meer zienLaatst bijgewerkt: 30+ dagen geleden
Zet je sales skills in de spotlights!

Zet je sales skills in de spotlights!

RekruutGhent, Flanders, .BE
Quick Apply
REKRUUT brings you the best and most diverse vacancies at start-ups and scale-ups.From new kids on the block to booming young companies. Wanted profiles? From sales to IT and from junior level to C ...Laat meer zienLaatst bijgewerkt: 28 dagen geleden
Postdoctoral researcher - Hoofd en Huid (26510)

Postdoctoral researcher - Hoofd en Huid (26510)

Ghent UniversityGhent, Belgium
Apply before 31 / 10 / 2023 (DD / MM / YYYY) 23 : 59 (Brussels Time).Faculty of Medicine and Health Sciences.Department : GE34 - Hoofd en Huid. Type of employment : Contract of limited duration .Term of assignm...Laat meer zienLaatst bijgewerkt: 30+ dagen geleden
  • Gesponsord
Cfo

Cfo

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BeNeLux Key Account and Business Development Manager with strong entrepreneurship skills

BeNeLux Key Account and Business Development Manager with strong entrepreneurship skills

3HRGhent, Flanders, BE
Our client is a fast-growing company active in various Life Science Industries like Pharmaceutical, Biotechnology, Medical Devices, with expertise in Commissioning, Qualification & Validation, Qual...Laat meer zienLaatst bijgewerkt: 30+ dagen geleden
  • Gesponsord
Director Clinical Program Management

Director Clinical Program Management

TN BelgiumGent, Oost-Vlaanderen, Belgium
Social network you want to login / join with : .Director Clinical Program Management, Ghent.Director Clinical Program Management. A leading, innovative European Biotech committed to bringing life-changi...Laat meer zienLaatst bijgewerkt: 14 dagen geleden
  • Gesponsord
Director Formulation Development and Production

Director Formulation Development and Production

Ardena CareersGent, Oost-Vlaanderen, Belgium
As a leading contract development and manufacturing organization (CDMO) within the pharmaceutical industry,.Our commitment extends to providing a comprehensive and integrated portfolio covering dru...Laat meer zienLaatst bijgewerkt: 21 dagen geleden
BeNeLux Key Account and Business Development Manager with strong entrepreneurship skills

BeNeLux Key Account and Business Development Manager with strong entrepreneurship skills

Genius PeopleGhent
Our client is a fast-growing company active in various Life Science Industries like Pharmaceutical, Biotechnology, Medical Devices, with expertise in Commissioning, Qualification & Validation, Qual...Laat meer zienLaatst bijgewerkt: 30+ dagen geleden
Quality Assurance Manager

Quality Assurance Manager

Viroclinics BiosciencesGhent, Vlaams Gewest, Belgium
Quality Assurance (QA) Manager.Cerba Research processes covering the clinical laboratory and diagnostic solutions part of clinical trial protocols, in close collaboration with the Scientific and Pr...Laat meer zienLaatst bijgewerkt: 30+ dagen geleden
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Technological Expert Teaching & Learning

Technological Expert Teaching & Learning

The Institute of Tropical Medicine (ITM)Ghent, BE
Department of Biomedical Sciences - Education Coordination.The Institute of Tropical Medicine (ITM) in Antwerp is a leading institution dedicated to the advancement and dissemination of scientific ...Laat meer zienLaatst bijgewerkt: 30+ dagen geleden
Accountmanager Levensverzekeringen (Medical)

Accountmanager Levensverzekeringen (Medical)

hays-beGent
Accountmanager Levensverzekeringen (Medical).Gent | Accountmanager Levensverzekeringen | Medische sector | Expertenrol | Commercieel | 1095445Vanuit de divisie. Accountmanager Levensverzekeringen.Be...Laat meer zienLaatst bijgewerkt: 30+ dagen geleden
Medical Asset Lead

Medical Asset Lead

ArgenxGent
Provides strategic medical direction, advice and oversight in the Asset Strategy Team in close collaboration with the other members of this cross functional team, in order to maximize the potential...Laat meer zienLaatst bijgewerkt: 30+ dagen geleden
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Principal Medical Writer

Principal Medical Writer

PharmiwebGhent, BE
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(Praktijk)lector Digitale en Data Skills

(Praktijk)lector Digitale en Data Skills

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  • Gesponsord
Technicien matériel médical - Sous-officier (Bachelier)

Technicien matériel médical - Sous-officier (Bachelier)

Defensie - La DéfenseGhent, BE
€ 2.043,00 per maand
À la Défense, nous transformons vos talents en de véritables compétences.Nous prévoyons le nécessaire pour votre développement personnel. Grâce aux nombreuses opportunités de développement personnel...Laat meer zienLaatst bijgewerkt: 2 dagen geleden
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  • Nieuw!
Junior Medical Science Liaison Women’s Health

Junior Medical Science Liaison Women’s Health

TheramexGhent, BE
Key Duties and Responsibilities.Engagement with Healthcare Professionals (HCPs) .Actively engage with HCPs to provide medical and scientific information, ensuring a deep understanding of therapeuti...Laat meer zienLaatst bijgewerkt: 16 uren geleden
Center for Medical Biotechnology (CMB) PhD program

Center for Medical Biotechnology (CMB) PhD program

VIBGhent
VIB is an entrepreneurial non-profit research institute, with a clear focus on groundbreaking strategic basic research in life sciences and operates in close partnership with the five universities ...Laat meer zienLaatst bijgewerkt: 30+ dagen geleden
Software Engineer

Software Engineer

DedalusBEL, Gent
Do you want a job with a purpose?.And do you want to make healthcare safer, better and more reliable?.You engineer software for our next generation of CIS (Clinical Information Systems) and EPR (El...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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