(Associate) Director Bioanalytics, Franchise Lead
il y a 1 mois
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
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