Manager/Sr. Manager, Patient Supply Operations

About the role

The Manager/Sr. Manager, Patient Supply Operations plays a crucial role in supporting hands-on execution of global patient supply activities for early clinical Cell and Gene Therapy programs. This role is accountable for operational readiness of investigational product supply from IND through First-In-Human and early Phase studies, in alignment with regulatory requirements.

Responsibilities

• Own and execute global patient supply for early-phase programs, aligned with clinical development plans and evolving protocol requirements as per program strategy.
• Operationalize bulk vs. per-patient distribution strategies, safety stock policies, and contingency plans.
• Support Label design for primary and secondary packaging for the drug products in compliance with regional requirements.
• Manage end-to-end global shipments including preparation of shipping documentation and coordination with couriers and custom brokers.
• Lead and execute import/export processes, including establishment and oversight of Importer of Record (IOR) and Exporter of Record (EOR) models.
• Support country start-up activities, particularly in ex-US regions (EU, APAC, LATAM).
• Oversee cold-chain logistics (LN2 and -80°C), including lane qualification and performance monitoring.
• Partner with Quality to ensure QP release processes are operationally executable, and documented.
• Develop collaboration, influencing, and negotiation skills to work effectively with internal cross-functional groups and external suppliers to meet the aggressive clinical study timeline and patient needs.

Requirements

• BS or MS Degree in Supply Chain, Pharmacy or equivalent discipline is required. Advanced technical training and experience preferred.
• 8+ years of experience in clinical supply chain, patient supply, or GMP operations within a sponsor or CRO environment.
• Demonstrated strategic ownership of early-phase (FIH, Phase I) patient supply programs.
• Direct experience supporting allogeneic and/or in-vivo therapies, including complex cold-chain and non-patient-specific supply model is preferred.
• Proven expertise managing global clinical shipments. Experience with GMP, cell therapy logistics is highly desirable.
• Experience with temperature-controlled shipments, logistics, and E-Systems is highly desirable.
• Development of collaboration, influencing, and negotiation skills to work effectively with internal cross-functional groups and external suppliers to meet the aggressive clinical study timeline and patient needs.
• Collaborative, team-oriented mindset with strong verbal and written communication skills.
• Ability to communicate clearly and effectively with all levels of the organization.
• Understanding of escalation processes and requirements.
• Good written and verbal skills.
• Ability to work hands on, independently and successfully prioritize and manage multiple tasks simultaneously, integrate cross-functional issues and balance competing priorities effectively.

Qualifications

• BS or MS Degree in Supply Chain, Pharmacy or equivalent discipline is required. Advanced technical training and experience preferred.
• 8+ years of experience in clinical supply chain, patient supply, or GMP operations within a sponsor or CRO environment.
• Demonstrated strategic ownership of early-phase (FIH, Phase I) patient supply programs.
• Direct experience supporting allogeneic and/or in-vivo therapies, including complex cold-chain and non-patient-specific supply model is preferred.
• Proven expertise managing global clinical shipments. Experience with GMP, cell therapy logistics is highly desirable.
• Experience with temperature-controlled shipments, logistics, and E-Systems is highly desirable.
• Development of collaboration, influencing, and negotiation skills to work effectively with internal cross-functional groups and external suppliers to meet the aggressive clinical study timeline and patient needs.
• Collaborative, team-oriented mindset with strong verbal and written communication skills.
• Ability to communicate clearly and effectively with all levels of the organization.
• Understanding of escalation processes and requirements.
• Good written and verbal skills.
• Ability to work hands on, independently and successfully prioritize and manage multiple tasks simultaneously, integrate cross-functional issues and balance competing priorities effectively.

Skills

• Strategic thinking and problem-solving skills.
• Strong organizational and project management skills.
• Excellent communication and interpersonal skills.
• Ability to work independently and collaboratively.
• Knowledge of GMP regulations and standards.
• Experience with cold-chain logistics and temperature-controlled shipments.
• Proficiency in relevant software tools (e.g., SAP, IRT).

Benefits

• Medical, dental, and vision insurance.
• 401(k) retirement plan with a company match that vests fully on day one.
• Eight (8) weeks of paid parental leave after just three (3) months of employment.
• Paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays.
• Voluntary benefits such as flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans like pet, critical illness, accident, and hospital indemnity insurance.
• Voluntary commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs.

Pay

• Base pay range: $110,706 - $167,099 USD

Schedule

• Full time

Location

Somerset, New Jersey, United States