Category Manager - Expanded Access Programs (Hybrid)

Alphanumeric•Waltham, MA

22h•Hybrid

About The Position

This role will provide operational leadership and oversight for oncology Expanded Access Programs (EAP) and Compassionate Use (CU) programs, ensuring patients have access to investigational therapies while maintaining compliance with regulatory requirements, company policies, and industry standards. Partner with internal stakeholders to provide operational leadership for oncology Expanded Access and Compassionate Use programs. Develop and execute program strategies related to geographic footprint, drug supply, regulatory coordination, physician engagement, safety reporting, and overall program management. Oversee the selection, onboarding, and management of vendors supporting access programs. Establish operational processes that ensure rapid and effective responses to physician requests regarding patient access to EAP/CU programs. Monitor program utilization and provide regular status updates, metrics, and insights to key stakeholders. Collaborate cross-functionally with Global Medical Affairs, Clinical Operations, Supply Chain, Regulatory Affairs, Pharmacovigilance, Local Operating Companies (LOCs), physicians, and external partners. Support program planning, implementation, and continuous improvement initiatives. Ensure all program activities are conducted in compliance with applicable regulations, company policies, and Standard Operating Procedures (SOPs). Identify operational risks and implement mitigation strategies to ensure successful program execution. Build and maintain strong working relationships across internal and external stakeholder groups.

Requirements

Bachelor's degree in Life Sciences, Business, Healthcare Administration, Supply Chain, or a related field.
Experience supporting Expanded Access Programs (EAP), Compassionate Use Programs (CU), Medical Affairs, Clinical Operations, Patient Access, or related pharmaceutical programs.
Strong project management and operational leadership skills.
Experience managing external vendors and service providers.
Knowledge of pharmaceutical regulatory requirements and compliance standards.
Excellent communication, stakeholder management, and relationship-building skills.
Ability to manage multiple priorities in a fast-paced, highly collaborative environment.
Strong analytical, organizational, and problem-solving abilities.

Nice To Haves

Oncology experience within the pharmaceutical or biotechnology industry.
Experience working with global cross-functional teams.
Familiarity with safety reporting, drug supply management, and regulatory coordination processes.

Responsibilities

Provide operational leadership and oversight for oncology Expanded Access Programs (EAP) and Compassionate Use (CU) programs.
Develop and execute program strategies related to geographic footprint, drug supply, regulatory coordination, physician engagement, safety reporting, and overall program management.
Oversee the selection, onboarding, and management of vendors supporting access programs.
Establish operational processes that ensure rapid and effective responses to physician requests regarding patient access to EAP/CU programs.
Monitor program utilization and provide regular status updates, metrics, and insights to key stakeholders.
Collaborate cross-functionally with Global Medical Affairs, Clinical Operations, Supply Chain, Regulatory Affairs, Pharmacovigilance, Local Operating Companies (LOCs), physicians, and external partners.
Support program planning, implementation, and continuous improvement initiatives.
Ensure all program activities are conducted in compliance with applicable regulations, company policies, and Standard Operating Procedures (SOPs).
Identify operational risks and implement mitigation strategies to ensure successful program execution.
Build and maintain strong working relationships across internal and external stakeholder groups.