(Associate) Director Bioanalytics, Franchise Lead

il y a 1 mois

Gent, Belgique Argenx Temps plein

For the expansion of the bioanalytical team, argenx is looking for a (Associate) Director Bioanalytics, with profound experience in late-stage drug development of large molecules. The level and title will depend on the experience of the incumbent. He/she will conduct and lead bioanalytical support in all aspects for one of the argenx indication franchises. Argenx operates according to an outsourced model in which key competences responsible for determining the bioanalytical strategy are kept in-house and operations are being outsourced to bioanalytical vendors.

The Bioanalytical experts are responsible for the design of the bioanalytical strategy of their assigned projects, the commission of workpackages to bioanalytical vendors, the oversight and compliant conduct of bioanalytical study phases and the timely delivery of data. They are responsible for the correctness of bioanalytical sections of regulatory documents and the investigator brochure.

The Associate Director/franchise lead will be the key representative of the bioanalytical team in regulatory submissions team meetings, working closely with the senior/principal bioanalytical scientists in the clinical development teams to ensure a harmonized approach within and across franchise(s). He/she will be responsible to oversee the bioanalytical contributions to regulatory documents and serve as a management reviewer and approver. He/she is considered to be an expert bioanalytical scientist with deep understanding of scientific and regulatory requirements of bioanalytical method development and validation. A focus expertise on the fit for purpose characterisation of biomarker assays will be preferred.

The (associate) director Bioanalytics/franchise lead will report into the head of Bioanalytics.

**Responsibilities**:

- Oversees the bioanalytical contributions in the review and writing regulatory documents and performs management review. Collaborate with internal stakeholders such as medical writer and Clinical pharmacology.
- Performs management review and approval of bioanalytical documents
- Review and provide input in clinical trial documents
- Contribute in interactions with regulatory agencies
- Responsible for developing bioanalytical strategies in collaboration with bioanalytical team, project and clinical teams.
- Together with sourcing manager and program manager, responsible for the timely commission and execution of bioanalysis at the bioanalytical vendors. Participate in vendor governance meetings where appropriate
- In collaboration with program manager, ensure correct financial and project planning
- In collaboration with Head of bioanalytics, ensure appropriate resource planning for the franchise(s)
- Takes initiative, follow up and troubleshooting of the methods
- Presenting results and findings at internal multidisciplinary project/clinical teams
- Coach team members

**Profile**:

- Ph.D degree or equivalent by experience
- At least 7 years of industry experience in the field of bioanalytical sciences
- Experience in late-stage drug development including regulatory submissions and interaction with regulatory agencies.
- Experience in managing outsourced activities at external bioanalytical vendors
- Extensive knowledge in drug development spanning from pre-clinical to phase III
- Excellent organizational and communication skills
- Strong emphasis on quality
- Excellent interpersonal skills; enjoys working in multidisciplinary teams
- Strong people management skills
- Proactive and flexible, able to operate in a dynamic surrounding of a fast-growing biotech company

**Offer**:

- A competitive compensation package with extensive benefits
- Exposure to all aspects of pre-clinical and clinical development in the company, but also with external vendors, contract partners and the scientific world
- A work environment in a dynamic, rapidly growing biotech company

  • Associate Scientist Bioanalytics

    il y a 1 mois

    Gent, Belgique Argenx Temps plein

    For the expansion of the Bioanalytical team, argenx is looking for a (Associate) Scientist Bioanalytics, who supports the implementation and execution of the bioanalytical strategies for the non-clinical and/or clinical development programs in tight collaboration with the project teams. **Responsibilities**: - As a bioanalytical study monitor you are...

  • Scientist Bioanalytics

    Il y a 2 mois

    Gent, Belgique Argenx Temps plein

    argenx is a fast-growing clinical-stage biopharmaceutical company developing innovative potential therapies to help improve the lives of people suffering from severe autoimmune diseases. Our global team is committed to living by our values of collaboration, empowerment, humility, innovation and excellence. As we continue to expand our therapeutic franchises,...

  • Franchise Clinical Operations Development Lead

    il y a 1 semaine

    Gent, Belgique MindCapture Temps plein

    FRANCHISE CLINICAL OPERATIONS DEVELOPMENT LEAD - Biotech- GhentWHAT IS OFFERED Franchise 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...

  • Franchise Clinical Operations Development Lead

    Il y a 2 mois

    Gent, 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...

  • Associate Director/director, Regulatory

    Il y a 2 mois

    Gent, Belgique Argenx Temps plein

    For the expansion of our regulatory team, argenx is looking for an Associate Director/Director Regulatory Affairs, argenx, based in Europe, to support the rapid growth needed for successful commercialization. Key Accountabilities and Responsibilities: The Associate Director/Director Regulatory Affairs is a key member of the global regulatory team. This role...

  • Franchise Codl

    il y a 1 mois

    Gent, Belgique Argenx Temps plein

    Franchise Clinical Operations Development Lead ( Franchise CODL) PURPOSE OF THE FUNCTION 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 commercialization. The franchise may involve several assets...

  • Associate Director/director Regulatory Affairs

    Il y a 2 mois

    Gent, Belgique Argenx Temps plein

    For the expansion of our regulatory team, argenx is looking for an Associate Director/Director Regulatory Affairs, based in Europe, to support the rapid growth needed for successful commercialization. The role will report into the Global Head of Regulatory Affairs. Key Accountabilities and Responsibilities: The Associate Director/Director Regulatory Affairs...

  • Franchised Director of Sales

    il y a 2 jours

    Gent, Belgique Marriott International, Inc Temps plein

    **Job Number** 23146550 **Job Category** Sales & Marketing **Location** Ghent Marriott Hotel, Korenlei 10, Ghent, Oost-Vlaanderen, Belgium VIEW ON MAP **Schedule** Full-Time **Located Remotely?** N **Relocation?** Y **Position Type** Management **Additional Information**:This hotel is owned and operated by an independent franchisee, Aimbridge...

  • Associate Director Logistics

    Il y a 2 mois

    Gent, Belgique Coca-Cola Europacific Partners Temps plein

    Ben jij op zoek naar een nieuwe uitdaging bij CCEP? Heb je een microbe voor de logistieke wereld? Dan is onderstaande functie van **Associate Director Logistiek** misschien een unieke opportuniteit voor jou? Als Associate Director Logistiek ben je verantwoordelijk voor de logistieke activiteiten van het Distribution Center te Gent en de Cross-dock & Full...

  • Associate Medical Director Neurology Emea

    il y a 6 jours

    Gent, Belgique Argenx Temps plein

    The EMEA Associate Medical Director Neurology is a medical and scientific expert on argenx’s scientific data, products and trials, and will support and oversee execution of the EMEA Medical Affairs plans for Neurology indications, in very close collaboration with EMEA country medical affairs teams to ensure excellence in execution of medical affairs...

  • Operations Associate

    Il y a 2 mois

    Gent, Belgique Inari Agriculture Temps plein

    **About Inari...** Inari is the SEEDesign company. We embrace the diversity and complexity of nature in every aspect of our business to drive innovation - to push the boundaries of what is possible. Through our unrivaled technology platform, Inari uses predictive design and advanced multiplex gene editing to develop step-change products. We are taking a...

  • Franchised Director of Finance

    Il y a 2 mois

    Gent, Belgique Marriott International, Inc Temps plein

    **Job Number** 23094097 **Job Category** Finance & Accounting **Location** Residence Inn Ghent, Akkerhage 2A, Ghent, Oost-Vlaanderen, Belgium VIEW ON MAP **Schedule** Full-Time **Located Remotely?** N **Relocation?** Y **Position Type** Management **Additional Information**:This hotel is owned and operated by an independent franchisee, Aimbridge...

  • Franchise Hotel

    il y a 2 semaines

    Gent, Belgique Holiday Inn Express Temps plein

    This job posting is for a position at a Hotel owned and operated by an independent franchisee, not by IHG or its affiliates. IHG has no involvement in the hiring or day-to-day employment policies or practices of franchisees_. **About Us** **Who are we?** We are a distinguished hospitality group operating in the heart of Ghent, Belgium, offering two, in...

  • Franchise Hotel

    il y a 4 semaines

    Gent, Belgique Holiday Inn Express Temps plein

    This job posting is for a position at a Hotel owned and operated by an independent franchisee, not by IHG or its affiliates. IHG has no involvement in the hiring or day-to-day employment policies or practices of franchisees_. **About Us** Who are we? We are a distinguished hospitality group operating in the heart of Ghent, Belgium offering in oktober this...

  • Research Associate Bioanalytics

    Il y a 2 mois

    Gent, Belgique Argenx Temps plein

    Work description Your responsibilities include: - Contributing to the development of bioanalytical assays (ELISA, MSD, Gyros platforms) for non-clinical and clinical studies. - Independently planning and conducting experiments, as well as interpreting, reporting, and presenting results. - Offering creative solutions to unforeseen issues as they arise. -...

  • Managing Director

    il y a 2 jours

    Gent, Belgique Fortior Temps plein

    _**Ambitieuze projectontwikkelaar zoekt een managing director met passie voor vastgoed. Word jij getriggerd door de mogelijkheid om de cockpit van de onderneming te betreden en een belangrijke rol te spelen in de verdere groei van onze organisatie? Dan is de functie van managing director bij Fortior iets voor jou!**_ **Wie zijn wij?** Fortior is een...

  • Director Analytical Development

    il y a 6 jours

    Gent, Belgique Ardena Temps plein

    **About us** **Ardena **is a leading contract development organization for the pharmaceutical industry. 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 substance and drug product development, manufacturing,...

  • Associate Scientist

    il y a 5 jours

    Gent, Belgique Exevir Bio Temps plein

    **WE ARE HIRING** **Associate Scientist **THE COMPANY** ExeVir Bio is a young and dynamic pre-clinical stage company, working with a modular platform, developing single-domain antibody-based therapies focused on infectious diseases. ExeVir Bio has set-up a Preclinical Research Laboratory in Gent and we are seeking a highly motivated Associate Scientist...

  • Animation Director

    il y a 2 semaines

    Gent, Belgique Larian Studios Temps plein

    With multiple awards to our name, Larian Studios has proven that we’re dedicated to delivering high-quality role-playing games. As we move on to new projects, the studio that brought you Baldur’s Gate 3 & Divinity: Original Sin 2 is looking for an Animation Director to join the team and help us in crafting the high caliber games our fans have come to...

  • Director of Sales

    il y a 2 jours

    Gent, Belgique LegalFly Temps plein

    **Join LegalFly as our Director of Sales and Lead the Charge!**: LegalFly is on the lookout for a dynamic and visionary Director of Sales to spearhead our Sales department. Are you ready to take the reins and drive our sales team to new heights of success? This is your chance to make a real impact and shape the future of our company! - **Inspire and empower...