Senior Program Manager, Expanded Access Operations

As a Senior Program Manager, Expanded Access Operations at myTomorrows, your primary responsibilities will include managing the full spectrum of Expanded Access Programs (EAP). You will act as the main point of contact for Biopharma clients and internal stakeholders, ensuring that operational processes are followed meticulously. Your role will involve overseeing program execution, maintaining comprehensive documentation, creating detailed timelines, addressing operational challenges, and continuously improving our EAP processes while ensuring client and patient satisfaction.

To qualify for the Senior Program Manager, Expanded Access Operations role at myTomorrows, you should ideally have a university degree in Life Sciences or Healthcare. A minimum of 5 years of experience within the pharmaceutical industry or CROs is essential. Familiarity with Expanded Access Programs is a plus, alongside strong relationship-building skills, an eye for detail, and excellent communication skills in English.

At myTomorrows, we prioritize patient and client satisfaction in our Expanded Access Programs by fostering strong communication and ongoing relationships with all stakeholders involved. The Senior Program Manager is tasked with maintaining oversight, delivering timely updates, managing expectations, and addressing any issues that arise promptly. Our structured approach, combined with our commitment to transparency and accountability, allows us to achieve high standards of service that ultimately benefit both patients and clients.

A typical workday for a Senior Program Manager, Expanded Access Operations at myTomorrows includes collaborating with cross-functional teams, ensuring all aspects of Expanded Access Programs run smoothly. You will spend time responding to client inquiries, updating stakeholders on program progress, and developing solutions to operational challenges. You’ll also analyze data to identify areas for improvement and may lead meetings to discuss strategies for continuous growth and success.

As a Senior Program Manager in Expanded Access Operations at myTomorrows, you will find numerous growth opportunities due to our fast-paced and innovative environment. You will be encouraged to develop your skills further through a dedicated learning and development budget, participate in knowledge-sharing sessions, and potentially take on larger responsibilities or leadership roles as the company expands. The dynamic nature of our organization means you will always have the chance to enhance your career path.

To keep stakeholders informed about the progress of an Expanded Access Program, I focus on establishing a regular communication schedule to share updates. This may involve weekly reports that highlight key milestones, deliverables, and any issues that need addressing. I also leverage project management tools to maintain transparency and create a collaborative environment where stakeholders can access relevant information in real-time.

When faced with unforeseen challenges during an Expanded Access Program, I prioritize quickly assessing the situation to understand the impact. I then convene relevant team members to brainstorm potential solutions, balancing urgency with thoroughness. Open communication with clients is also essential, as I keep them informed and involve them in the problem-solving process whenever appropriate, striving for a resolution that maintains trust and satisfaction.

In my previous role, I identified excessive approval times as a bottleneck in our Expanded Access Program process. I spearheaded the introduction of a new digital workflow system that allowed simultaneous approvals across departments rather than sequential ones. The result was a 30% reduction in time from program initiation to patient treatment, significantly enhancing our organizational efficiency and client satisfaction.

Data analysis is crucial to my approach as a Senior Program Manager. I utilize data to measure program performance, identify trends, and derive insights that inform decision-making. By analyzing patient access metrics and feedback, I can pinpoint areas for improvement and align our strategies with stakeholders' needs, ultimately driving better outcomes in our Expanded Access Programs.

Building trust with Biopharma clients starts with open and consistent communication. I ensure that I actively listen to their needs and maintain transparency about the program’s progress and any challenges. Regular check-ins and updates allow them to feel involved in the process. Additionally, I deliver on promises and demonstrate our commitment to patient-centric outcomes, reinforcing our partnership on every level.

My experience with risk management in Expanded Access Programs involves proactively identifying potential risks and developing mitigation strategies. I conduct regular risk assessments, analyzing both internal processes and external factors that could impact program performance. By collaborating with cross-functional teams, I ensure that we can quickly adapt our approach should any issues arise, minimizing disruptions and ensuring patient access remains smooth.

In a fast-paced environment, I prioritize tasks based on urgency and impact. I begin each week by assessing deadlines and aligning them with overarching project goals. Utilizing project management tools, I track tasks and milestones, adjusting my priorities as needed to accommodate new responsibilities while ensuring that the most critical actions receive attention first.

To ensure high-quality documentation in Expanded Access Programs, I implement standardized templates and checklists for documentation requirements. I also conduct regular training sessions for team members to clarify expectations. Additionally, I incorporate peer reviews of critical documents to enhance accuracy and maintain compliance, fully supporting client and regulatory requirements.

My motivation to work in Expanded Access Operations stems from the profound impact that timely treatment access can have on patients’ lives. I am driven by the opportunity to bridge gaps in the healthcare system and advocate for patient rights. Witnessing the positive outcomes of my work fuels my passion and commitment to contributing to this critical field.

To ensure that my team remains aligned with the overall objectives of the Expanded Access Program, I start by clearly communicating our goals and expectations. Regular team meetings allow us to discuss progress, address challenges, and share feedback. I also emphasize the importance of each member's role in achieving success, promoting a culture of accountability and collaboration within the team.