Sr. Associate Director, Experimental Medicine - Clinical Trial Leader

Duties & Responsibilities

Trial Preparation:

• Accountable for the accurate planning and operational feasibility of trial timelines; and oversight of trial preparation to ensure trial team members are aligned and on track.
• Supports development of trial level documents owned by other functions (e.g., Statistics, Data Management, Study Physician, Medical Writing, Site Monitoring).
• Verifies and provides input into the country allocation and oversees trial feasibility.
• Accountable for development and implementation of trial level engagement plans, recruitment planning and risk mitigation.
• Leads development of core trial and patient facing documents.
• Integrates patient/site level feedback during document development and ensures trials are designed with a focus on patient value.
• Ensures activities are frontloaded where possible at the trial level and cascaded to country level to facilitate efficiencies as well as to ensure and leverage speed.
• Oversees outsourcing of vendor services in conjunction with other functions.
• Supports identification of vendors, vendor selection and development of vendor scope of work.
• Works with functional partners to ensure that all required trial processes are in place to meet trial delivery milestones (e.g., clinical quality monitoring, safety monitoring and reporting, investigational medicinal product, trial budget, site monitoring).
• Aligns and supports team members in timely responses to questions from Regulatory Authority/Ethics Committee and other external stakeholders.
• Provides/supports provision of appropriate study-specific and standardized non-trial specific trial team training, internal and external partners.

Trial Conduct:

• Maintains oversight during clinical trial conduct including adherence to GCP and all global and local regulatory requirements; compliance with SOPs and continuous risk monitoring/mitigation.
• In collaboration with other functions, ensures budget oversight, including support of regular clinical quality monitoring, SMC/DMC management and safety reporting.
• Prepares and implements amendments of core documents including training material updates/retraining as needed.
• Supports authority/ethics responses to requests as applicable.
• Maintains oversight of outsourcing of vendor services (including central lab) in conjunction with other functions.
• Monitors progress of patient recruitment and accrual of endpoints and proactively updates and actions contingencies throughout trial conduct.
• For early clinical trials, co-ordinates and harmonizes Innovation Unit tasks in a trial (e.g., biomarker sampling, genomics, sub-studies).

Trial Closeout and Reporting:

• In collaboration with other functions, ensures timely cleaning and delivery of clinical trial data. Coordinates and supports Trial Medical Writer in providing the CTR.
• Responsible for timely, complete, and compliant archiving of all relevant global documents in the TMF, including all required documents from vendors.
• Supports results/documents disclosure of global registries.
• May support publication of trial data.

Description

Experimental Medicine - Cardiometabolic, Renal and Metabolism (ExpMed - CRM) is currently seeking a talented and innovative Senior Associate Director, Clinical Trial Leader to support our ExpMed team to join our Ridgefield, CT facility. ExpMed - CRM is a new and dynamic organization responsible for the strategic and operational execution of programs in the CRM field from start of development (SoD) to proof of concept (PoC).

The (Senior) Associate Director, Clinical Trial Leader (AD, CTL) is accountable for the set-up, execution and delivery of their assigned trial(s) and contribute to delivery of BI’s pipeline through accurate planning and efficient execution of trials that bring speed & value to participating subjects and sites. 

The SR AD, CTL provides leadership and direction to the trial team (core and extended team members) and is accountable for the overall success and delivery of their assigned clinical trial. The incumbent is responsible for steering and directing clinical trial activities, including patient and site engagement activities, direct communication, and interaction with multiple internal and external stakeholders (e.g., investigative sites) and team members on a global, multi-country or regional basis. 

The SR AD, CTL is responsible for managing the planning, implementation, and tracking of the clinical trial process as well as risk mitigation. The SR AD, CTL serves as a proactive member of the clinical delivery team, liaising closely with the Clinical Trial Managers (“CTM”) on all study-related issues. As leader of the Trial Team, the SR AD, CTL com