The Program Portfolio Manager - Expanded Access (EAP) is responsible for overseeing the planning, execution, and management of expanded access and compassionate use programs. This role involves close collaboration with internal cross-functional teams and external stakeholders to provide access to drugs for eligible patients outside of clinical trials. The role will have line management responsibility of a team of Program Managers/ Program Associates who will manage day to day actions for the programs. Excellent client interaction and relationship building is paramount. The role encourages continuous improvement of processes and ways of working to share with the wider EAP team.
Responsibilities:
Program Oversight:
* Manage all aspects of EAPs, ensuring program design and execution align with company goals and regulatory guidelines.
* Monitor the program's lifecycle, from initiation to closure, to meet timelines and deliverables.
* Provide strategic direction and oversight for multiple EAP projects in parallel.
Stakeholder Management:
* Serve as the primary point of contact for clients, healthcare providers, and internal teams regarding EAP-related activities.
* Coordinate with pharmaceutical partners to align expectations, timelines, and goals.
Operational Leadership:
* Lead cross-functional teams, regulatory, quality, and logistics, to execute EAPs effectively.
* Develop workflows to manage patient requests, eligibility screening, drug supply, and reporting.
Strategic Planning:
* Design innovative solutions for managing patient access in line with the company's therapeutic focus and market strategy.
* Evaluate emerging trends and implement program improvements for optimal outcomes.
Training and Development:
* Train internal teams and external stakeholders on EAP processes, policies, and regulatory requirements.
* Mentor and support junior staff involved in program management.
Continuous Improvement:
* Work as part of the EAP team to identify, update and roll out best ways of working, including updates to internal processes, writing of SOPs and training material.
Line Management:
* Line management of team members, offering support, guidance and mentorship.
* Responsible for managing weekly one-to-one meetings and end of year meetings with direct reports, including objective setting and management reviews.
Qualifications:
* Bachelor's degree in life sciences, healthcare management, or a related field; advanced degree preferred.
* Minimum of 5-7 years of experience in project or program management, preferably within the pharmaceutical or healthcare industry.
* Knowledge of regulatory frameworks governing expanded access or compassionate use programs.
* Demonstrated experience managing multiple complex projects simultaneously.
* Strong communication and interpersonal skills to engage with internal teams and external clients.
* Proficiency in project management tools and software.
Key Competencies:
* Strong organizational and problem-solving abilities.
* Adaptability to work in a fast-paced, global environment.
* Leadership and decision-making skills.
* Analytical mindset with attention to detail.
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