Project Manager

Role Overview

• Develop and manage timelines and budgets for post-trial access (PTA) programs supporting investigational products prior to regulatory approval
• Ensure compliance with regulatory requirements and company Policies/SOPs
• Lead cross-functional teams and serve as primary program contact for PTA/Continued Access programs
• Populate PTA templates and tools with program-specific information related to investigational product access decisions and implementation
• Drive development and finalization of core program documents (e.g. PTA Treatment Guidelines, PTA ICF, agreements and contracts)
• Drive decision-making, including selection of appropriate regulatory mechanisms, supply strategy, and safety reporting, in collaboration with cross-functional stakeholders; with support as needed
• Ensure alignment across PTA program decisions, documentation, plans, and implementation
• Provide forecasting and ensure investigational supply strategies are developed and executed, in collaboration with Supply Chain, to facilitate uninterrupted patient access to investigational products
• Manage requests for investigational product access through PTA programs, ensuring timely and compliant processing
• Manage vendor contracting and deliverables in support of PTA/continued access program execution
• Utilize PTA tools, templates, and systems to ensure accurate tracking and reporting of investigational access programs
• Monitor quality, KPIs, and program performance; identify issues and escalate as needed
• Communicate PTA program status, risks, and updates to stakeholders
• Identify risks and implement mitigation strategies specific to investigational product access and program continuity; capture lessons learned and best practices
• Ensure inspection readiness, maintain complete and accurate documentation, and perform quality checks for PTA programs
• Support other PTA/continued access activities and programs, as assigned

Requirements

• BS/BA (or equivalent experience)
• Experience in clinical research or biopharmaceutical operations; including 2+ years leading global, multi-regional PTA programs across the lifecycle, for investigational products prior to regulatory approval; comparable experience leading expanded access/compassionate use programs or significant experience contributing to PTA or EAP may be considered
• General understanding of regulatory frameworks governing pre-approval and continued access to investigational products, ICH GCP, and ethical frameworks of clinical research
• Demonstrated ability to manage mild to moderately complex, multi-region PTA programs involving investigational products with a degree of operational and regulatory complexity, with minimal supervision
• Proven experience collaborating effectively; influencing stakeholders across functions and levels
• Evidence of strong project management skills; including managing competing priorities and solving operational challenges in clinical or investigational program environments
• Successful history of working independently in a global environment
• Experience with automating processes, process mapping and/or certification in Lean or Six Sigma would be considered an advantage, though it is not a mandatory requirement.

Tech Stack

• Google Cloud Platform

Benefits

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways