- Oversee the CODLs who provide strategic input and are accountable for all clinical related aspects within the assigned therapeutic indication/program, in line with the agreed timelines, budget and quality standards and as outlined in the applicable Standard Operation Procedures (SOPs) and Work Instructions (WIs).
- Oversee the Clinical development Plan (CDP) creation for all indications within the franchise. The CDP is co-created by the CODL and the Medical Development Lead (MDL), with support from the Project Manager (PM) and other Clinical Development Team (CDT) representatives. The indication CDP describes the clinical development strategy, includes effective and, where possible, innovative trial designs and is consistent with the TPP. The CDP is endorsed by the AST and the Development Management Committee (DMC) and is executed within agreed timelines and budget
- The Franchise CODL can temporarily take on the role of an CODL for an indication within the franchise Please refer to the Job Description of the CODL for further details on the CODL role.
- Acts as senior point of contact for all clinical related activities for a given Franchise across asset indications. Collaborate with the asset teams as applicable.
- Focus on risks and mitigations on the franchise level. Ensures that the Global Head of Trial Operations is informed in case an identified issue/risk could have an impact on/may also occur in, the other therapeutic indications/programs / franchises. Involve the X-indication CODL, AST and PM as needed.
- Operationalize knowhow and synergies at the franchise level, ensure knowhow is shared with different indication teams.
- Ensure optimal implementation of lessons learnt within and across the franchises.
- Provides input to the relevant Objectives, Goals, Strategies and Measures (OGSMs), and ensures that clinical trials are executed according to the CDPs and those OGSMs, following the argenx procedures and processes and conducted in compliance with ICH-GCP and other applicable legislation.
- As needed, participates in the Clinical Research Organization (CRO) and vendor selection and management process. Supports CDTs and Clinical Trial Teams (CTTs) with issue resolution where required in collaboration with the CODL and alliance vendor manager, if relevant.
- Acts as a point of escalation for resolution of trial management and operational issues within the franchise indications.
- Reviews and provides input to the overarching clinical program/indication documents such as Investigator Brochure (IB), Pediatric Investigation Plan (PIP), FDA/PMDA/EMA and other regulatory critical documents.
- Oversees the Indication and clinical trial budgets and timelines in collaboration with the CODLs and the Clinical Trial Managers (CTMs).
- Oversees the resource requirements for Trial Operations within the franchise and ensures the needed resources are onboarded timely and efficiently.
- Oversees audit/inspection readiness of the assigned program/trials. Support audits and inspections.
- Supports continuous improvement processes and consistency. Collaborates with the knowledge hubs with the Trial Ops team.
- As seasoned Leader, sets expectations, communicates in a transparent, clear way and energizes and motivates the CODLs and the CTMs to work towards achieving the clinical goals in line with the OGSM and argenx's cultural pillars.
- Act as line manager for the CODLs and leader within the Trial Ops team:Interviewing candidatesOn-boardingEnsuring that assigned staff are trainedGoal setting and reviewMentoring and enabling the growth and development of assigned staff
- Supports ClinOps and Global Company initiatives as applicable.
- Collaborate on the franchise level with stakeholders outside of Clinical and R&D, eg Corporate Development, Science, Patient Advocacy Group (PAG), Medical Affairs and others.
- The Franchise CODL excels in leadership and establishing good and effective internal and external working relationships and communication, embedding the argenx values.
- Proven track record in relevant leadership positions, including line management, within Clinical Operations in the pharmaceutical/biotech industries.
- Proven knowledge of planning and execution of clinical development plans and clinical trials.
- Experience in building and leading a team with a variety of skill sets.
- Build bridges between people, functions and regions.
- Pro-active problem solver - demonstrated ability to identify and resolve issues, identify and mitigate risks, able to handle conflicts.
- Strong organizational skills, able to manage multiple and varied tasks and prioritize workload with attention to the holistic/ helicopter view but also able to dive into the details when needed.
- Excellent written and verbal communication skills, acting globally in a culturally diverse dynamic team.
- Strong verbal and written English communication skills (primary fluency or full professional proficiency).
- Thorough knowledge of ICH GCP guidelines and other applicable regulatory requirements and guidelines.
- Bachelor's degree or University degree – medical or para-medical (Biology, Biomedical Sciences, Pharmacy, Veterinary etc.) or equivalent by experience. PhD degree is a plus.
- Minimum of 12 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.
- Strategy as well as execution for clinical development.
- Change and risk management.
- Budget financial acumen.
- Rare disease and/or auto-immune clinical trial background relevant to the franchise.
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Franchise Codl
1 week geleden
Argenx Gent, BelgiëFranchise 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 ...
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Franchise Clinical Operations Development Lead
3 weken geleden
Argenx Gent, BelgiëTo 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 indic ...
Franchise CODL - Ghent, België - Argenx
Beschrijving
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 and/or may cover specific development phases across all assets/indications (teams specifically focusing on ph I or ph IV trials).
The Franchise CODL functions as the line manager for all the Clinical Operations Development Leads (CODLs) assigned to indications within the specific franchise or development phase specific teams.
The Franchise CODL will function as a clinical strategic operational voice for the franchise, both internally and externally. This seasoned professional will excel in leadership, people management and organizational skills.
ROLES AND RESPONSIBILITIES
SKILLS AND COMPETENCIES
EDUCATION, EXPERIENCE and QUALIFICATIONS