Leading and coordinate project activities, ensuring that projects are delivered on time, within budget, and to the highest quality standards
Coordinating project and programme management delivery, resolving issues, and developing team capability
Developing and managing timelines and budgets for post-trial access (PTA) programs supporting investigational products prior to regulatory approval
Leading cross-functional teams and serving as primary program contact for PTA/Continued Access programs
Populating PTA templates and tools with program-specific information related to investigational product access decisions and implementation
Driving development and finalization of core program documents (e.g. PTA Treatment Guidelines, PTA ICF, agreements and contracts)
Driving decision-making, including selection of appropriate regulatory mechanisms, supply strategy, and safety reporting, in collaboration with cross-functional stakeholders; with support as needed
Ensuring alignment across PTA program decisions, documentation, plans, and implementation
Providing forecasting and ensuring investigational supply strategies are developed and executed, in collaboration with Supply Chain, to facilitate uninterrupted patient access to investigational products
Managing vendor contracting and deliverables in support of PTA/continued access program execution

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

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

Project Manager – Post Trial Access

Key skills