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Director of Bus Ops Pharma Site Contracts

Executive Management
Dublin City Centre
Jill Madden
Permanent
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Job Reference: JO-2005-65175_1588759315

Summary:

An amazing career opportunity has arisen for an industry leader to manage Site Contracts in the clinical trials space with a network of specialist partners globally, for a world class Biopharma company expanding their operation in Dublin.



The key leadership role is responsible for the strategy, planning, oversight, and delivery of Site Contracts and function across the clinical drug development cycle. The successful candidate will have deep expertise in global program design, people management and development, direct vendor oversight the management of Functional Service Providers (FSPs) involved in the contracting process, and project management skills in the biotech or pharmaceutical industries. A strong foundation in operations, site contract lifecycle including payments, pricing (FMV) and project management with the ability to resolve complex issues associated with domestic (US) and international (rest of world) site contracts with support from the Clinical Legal department is critical for success in this role.



Responsibilities


· Delivery Excellence


· Leads or manages a functional team within Development Business Operations department.


· Manages the day-to-day activities of multiple areas in complex clinical contracts and finance processes.


· Demonstrates understanding of regulatory and legal issues pertinent to clinical development (Contracts)


· Develops strategy for and provides oversight of activities necessary for the development and execution of site contract for studies.


· Focuses on site contracting, fair market value (FMV) compliance of site contracts, and financial accountability as it relates to FSP management


· Leads the escalations related to the site contracting and budget negotiations in terms of risk management, leading issue resolution at the operational and senior executive levels


· Manages contract activities for multiple clinical development programs, ensuring that there is adequate staff with the skills to complete contracts accurately, consistently, and in a timely manner.


· Demonstrates understanding of regulatory and legal issues pertinent to clinical development (Contracts)


· Demonstrates a basic understanding of the regulatory implications of contracts as related to clinical research - Good Clinical Practices (GCPs)


· Utilizes prior experience in the development of, or reporting on, portfolio level KPI's, and subsequently uses these to drive performance goals and improvements, as necessary



Requirements:


· 10 + years of experience with a MS in a relevant discipline, MBA preferred, ideally in a global site environment


· Familiarity with various Regulatory and industry trends on compliance level activity (i.e. - ICH GCP E6 R2, etc.) and experience with interfacing with internal regulatory compliance and quality functions to drive site contracts and budget (FMV)


· Demonstrated leadership skills while working in fast paced and changing environment



Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.


Fastnet - The Talent Group
'Not Just Placers.........Partners'


The Life Science Specialists


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