Project Manager – Post Trial Access

This is a fully remote position, open to applicants in Poland.

📋 Description

• Overseeing and coordinating project activities to ensure timely delivery, adherence to budgetary constraints, and compliance with the highest quality standards.

• Managing project and program delivery, addressing challenges, and enhancing team capabilities.

• Creating and overseeing timelines and budgets for post-trial access (PTA) programs that support investigational products before they receive regulatory approval.

• Leading cross-functional teams and acting as the main point of contact for PTA/Continued Access programs.

• Filling PTA templates and tools with program-specific details related to decisions and implementation for investigational product access.

• Steering the development and completion of essential program documents (e.g., PTA Treatment Guidelines, PTA Informed Consent Form, agreements, and contracts).

• Facilitating decision-making processes, including the selection of suitable regulatory mechanisms, supply strategies, and safety reporting, in cooperation with cross-functional stakeholders, providing support as necessary.

• Ensuring coherence across PTA program decisions, documentation, plans, and execution.

• Offering forecasts and ensuring the establishment and execution of investigational supply strategies, in collaboration with the Supply Chain, to enable seamless patient access to investigational products.

• Overseeing vendor contracts and deliverables to support the execution of PTA/continued access programs.

⛳️ Requirements

• Experience in clinical research or biopharmaceutical operations; including over 2 years of leading global, multi-regional PTA programs throughout the lifecycle for investigational products prior to regulatory approval; relevant experience in leading expanded access/compassionate use programs or significant contributions to PTA or Expanded Access Programs (EAP) may be considered.

• Fundamental understanding of regulatory frameworks that govern pre-approval and continued access to investigational products, ICH GCP, and the ethical standards of clinical research.

• Proven ability to manage moderately complex, multi-regional PTA programs involving investigational products with a level of operational and regulatory complexity, with little supervision.

• Demonstrated experience in effective collaboration and influencing stakeholders across various functions and levels.

• Strong project management skills evidenced by the ability to manage competing priorities and resolve operational challenges in clinical or investigational program settings.

• A successful track record of working independently in a global context.

• Familiarity with process automation, process mapping, and/or certifications in Lean or Six Sigma would be advantageous, though not mandatory.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellness programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life insurance and disability coverage.

• Employee assistance programs and wellness resources.

• Opportunities for learning and development through structured training and career pathways.