Associate Director, Clinical Operations

A leading pharmaceutical client is searching for an Associate Director, Clinical Operations to join their team in London. The company specialises in various therapy areas including oncology, neurology and gastroenterology, and employs several thousand across the globe.

Job Responsibilties:

• A highly specialized individual contributor or functional manager with advanced knowledge and expertise in a professional discipline
• Leads execution of key business objectives or projects within the department
• Involved in developing, modifying, and executing company policies that affect immediate operations and may also have company-wide effect
• Decisions can impact overall business goals
• Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors
• Analyses gaps in current work processes and recommends enhancements
• Consistently exercises judgment and discretion within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results
• Internal - contacts are typically other professionals and internal customers
• External - contacts are with peers in other biopharma firms, federal officials, external customers, vendors, regulatory authorities
• Influences, advises and interprets on relevant issues
• May supervise a team of professionals, or may lead teams within a project setting
• Typically reports to the group head, department head or above
• Objectives typically require longer term perspective to determine success
• Has primary accountability for operational program level time, cost and quality deliverables (e.g., as global compound lead or global indication lead)
• Monitors overall program timelines using clinical trial management tools and systems
• Prepares teams and documentation to ensure inspection readiness
• Facilitates interactions within study teams to resolve operational issues
• Manages coordination with data management for data review and query resolution
• Directs the adherence to ICH/ GCP guidelines, local regulatory requirements and SOPs/ SWPs
• Proactively assesses risks and develops and implements creative solutions
• Applies judgment to escalate issues to Unit leadership
• Comprehensively assesses options to address study issues
• Manages CROs for successful conduct of the clinical trial and assesses contractual deliverables
• Supports the timely development and / or review of all study related documents (e.g., PCS, Protocol, CRF etc.) and operational feasibility assessments
• Supports the activities of CDP development and reviews quality of data from studies prior to submission

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Matthew Pike on +44 207 4400 639 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.