An opportunity has arisen for a permanent position, working within the Development team at BenevolentAI. The successful candidate will work in close collaboration with the Chief Medical Officer, BenevolentAI Bio Development Scientists, and external contractors, to contribute to the clinical evaluation of new drug candidates through strategic input and operational excellence in management of multinational clinical studies from phase I till MAA/NDA.
The Associate Director – Clinical Programme Leader role is the primary point of contact for the operational execution of assigned project(s) and is accountable for delivery, through management and oversight of internal and external partners.
Suited towards individuals with a proven strong experience in project management of Clinical Development Programme (Phases I, II and/or III clinical drug development) and setting-up Clinical Development strategies from early stages. Must be self-motivated, driven and proactive with strong organizational skills and able to work with limited supervision. Ability to perform in a small dynamic company environment with an ability to work flexibly and independently.
• Provide input on Clinical Development Strategies from the selection of a Pre-Clinical Candidate up to MAA/NDA.
• Closely collaborate with Chief Medical Officer on defining the Clinical Development Strategies, including the assessment of the required studies and their design.
• Responsible for budget and timeline forecasting, reporting and management on a compound and project level.
• Provide Internal Sponsor reports of progress of each study project including site activation, patient enrolment, costs and issue resolution.
• Oversee the overall clinical development plan and operational management clinical programme for assigned compound.
• Select and oversee performance of CROs, and other third-party vendors, including co-monitoring, to ensure delivery of quality data on time, compliance with study protocol, and regulatory and safety compliance.
• Confidently identify, assess and manage CMC, pre-clinical and/or bioanalytical activities as required through third parties (CMOs).
• Manage regulatory vendors and provide input in IND submission dossier, Orphan application dossier, Scientific Advice/Protocol Assistance (PA)/EoP1 briefing document, EoP2 briefing document and other key strategic regulatory activities.
• Lead the development of protocol synopses and study protocols. Ensure all stakeholders (internal and external) contribute key elements in a timely fashion.
• Lead the development and review of the Investigator Brochure, including Risk/Benefit section and its implementation in all applicable study-related documents.
• Development and maintenance of good visibility/motivating relationships with KOLs, investigators and study site staff.
• Ensure projects are carried out according to the study protocol, SOPs, and ICH/GCP regulations and study- specific manuals and procedures.
• As required, set-up scientific advisory boards and build and maintain a network of Key Opinion Leaders.
• Review Clinical Study Reports, Statistical Analysis Plans, Mock Tables, Listings and Figures, DSMB charters and ensure consistency across all the studies within assigned compound development.
• Be actively involved in external communication (posters, abstracts, publication or presentation) of clinical results towards external parties and maintain oversight of consistent reporting of clinical data, including co-authorship on any clinical abstracts, papers, etc.
• Initiate and/or participate in Process Improvement initiatives across the organization.
• Ensure compliance with Good Clinical Practices (GCPs), Good Manufacturing Practices (GMP), ICH, internal Standard Operating Procedures (SOPs), and other relevant corporate, regulatory, or legal requirements.
• Oversee of investigational product (IP) supply, and CRO accountability and reconciliation process of material.
• Development and application of best practices and oversight of Root Cause Analysis, ensuring Corrective Actions and Preventive Actions for affiliate level GCP risks and issues are effectively implemented, in order to mitigate impact in key areas. Identify trends, develop strategies to reduce risk and support the Quality Management System.
• Input and support of Due Diligence and Business Development activities as required.
Competitive salary, depending on experience, annual bonus, share options and comprehensive benefits.
If this challenge and opportunity excites you, please email your CV and a covering letter to firstname.lastname@example.org