Franchise Clinical Operations Development Lead
Il y a 6 mois
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 commercialization. The franchise may involve several assets.
The Franchise CODL functions as the line manager for all the Clinical Operations Development Leads (CODLs) assigned to indications within the specific franchise.
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.
The role reports to the Global Head of Trial Operations.
Roles & Responsibilities:
- 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.
- Operationalise 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 Operartions 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 TrialOps 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’ cultural pillars.
- Act as line manager for the CODLs and leader within the Trial Ops team:
- On-boarding
- Ensuring that assigned staff are trained
- Goal setting and review
- Mentoring 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.
Skills & Competencies:
- 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, i
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