Clinical Operations Development Lead
Il y a 2 mois
We are currenty looking for a Clinical Operations Development Lead (CODL) to strengthen the Global Clinical Trial Operations team.
- The Clinical Operations Development Lead is responsible for the oversight of the clinical related activities within a specific therapeutic indication for an asset (CODL) or across all indications for an asset (X-indication CODL). Together with the Medical Development Lead (MDL), the CODL co-leads the Clinical Development Team (CDT) and co-owns the Clinical Development Plan (CDP).
- As ad-hoc member of the Asset Strategy Team (AST), works with the MDL and the Project Manager (PM) to ensure that all relevant information from all functions within the AST and CDT are brought to the table. A CDT kicks off as soon as preparations start for a First in Human (FIH) study (in the case of the first indication for a given compound) or when first clinical related discussions start for a new indication.
- To build a strong CDT, the CODL works with the respective functional heads to assign CDT representatives from the involved functional areas. During the start of the clinical related activities for a new asset, the AST meetings and the CDT meetings may be combined.
- The Target Product Profile (TPP), created by the AST (with input from the CDT), is used as the basis for the CDP. The CDT is responsible for the clinical development strategy, ensuring creation of the CDP and execution once endorsed by the AST. As co-leader, the CODL drives the execution of the clinical program in collaboration with the CDT members and according to what is in the CDP.
- Likewise, the CODL and PM partner to ensure that risks and mitigations are discussed in the team, reflected in the applicable risk registries, and translated into timely plan adjustment and action.
- The CODL and the MDL keep the oversight and are the primary contact person for the CDT and all CDP related activities for a given indication (CODL) or across asset indications (X-indication CODL). These include the trial related activities as well as the clinical development strategy across the lifecycle of a compound, starting with the preparation of the FIH clinical trial throughout registration and post-approval clinical development activities. Hence, after completion of the Clinical Phase III program, CODL and MDL, in close collaboration with the CDT members, continue to be involved in the clinical related activities e.g., through input to different regulatory authorities (e.g., FDA, EMA, PMDA, MHRA).
- The CODL and MDL ensure the cross-functional optimization of solutions integrating contributions on complex matters and take accountability for decisions taken, each from their discipline’s perspective.
- The actual trials are conducted within the Clinical Trial teams (CTT) led by the Clinical Trial Managers (CTMs) and the Trial Physicians (TPs).
- Dependent on the program (phase and number of clinical trials), the CODL may also act as a CTM for 1 or more selected trials.
- The CODL function may include line management of Clinical Trial Manager(s) (CTMs) and/or Clinical Trial Associate(s) (CTAs).
- Roles & Responsibilities:
- Provides strategic input and is accountable for 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).
- Creates the CDP in collaboration with the MDL, PM and other CDT representatives, ensures the CDP describes the clinical development strategy, comprising effective and where possible innovative trial designs and is consistent with the TPP. Ensures the CDP is endorsed by the AST and the Development Management Committee (DMC) and is executed within agreed timelines and budget.
- Together with the MDL acts as primary point of contact for all clinical related activities for a given indication (CODL) or across asset indications (X-indication CODL).
- With the MDL, leads the CDT meetings, hereby supported by the PM who ensures an agenda is in place prior to the meeting, chairs during the meeting, makes sure outcome/actions/conclusions are agreed upon (where the CODL and MDL can focus on the (strategic) content of the discussions) and minutes are in place.
- Provides input to the Objectives, Goals, Strategies and Measures (OGSM), and ensures that clinical trials are executed according to the CDP and those OGSMs, following the argenx procedures and processes and conducted in compliance with ICH-GCP and other applicable legislation.
- In collaboration with the other CDT members, identifies risks of missing team goals, timelines or spend expectations, ensures that these are reflected in applicable risk registries and drives their mitigation. Works with the PM to decide which risks and issues are to be put under the attention of the asset Project Leader (PL) and the DMC. Pro-actively provides solutions and oversees implementation and follow-
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