Senior Manager, Patient Access Operations

Takeda•USA - MA - Virtual, MA

5d•$116,000 - $182,270•Remote

About The Position

The Senior Manager, Patient Services Operations (Free Goods Programs) is responsible for the strategic and operational oversight of the company’s Free Commercial Goods, Trial, and Product Replacement programs within Patient Services. This role ensures compliant, efficient, and patient‑centric delivery of free product to eligible patients while maintaining rigorous operational controls, regulatory adherence, and strong vendor performance. This position owns end‑to‑end operational execution, serves as the primary operational lead for pharmacy and hub partners, and plays a critical role in balancing patient access, compliance obligations, operational excellence, and financial stewardship.

Requirements

Bachelor’s degree required; advanced degree preferred.
7+ years of experience in patient services operations, specialty pharmacy operations, market access, or hub services.
Demonstrated experience managing Free Goods and/or Patient Assistance Program operations.
Strong understanding of regulatory, quality, and compliance requirements impacting patient support programs.
Proven vendor and contract management experience.
Strong analytical, problem-solving, and communication skills.

Nice To Haves

Experience supporting specialty or neuroscience products.
Prior people-management experience.
Experience with product launches and complex vendor ecosystems.
Operational excellence, Lean, or Six Sigma experience.

Responsibilities

Own day‑to‑day and end‑to‑end operations for Free Commercial Goods programs, including free trials, PAP‑related operations, product replacement, renewals, and discontinuations.
Ensure programs operate in alignment with company policy and applicable legal and regulatory requirements, including government payer exclusions and patient eligibility rules.
Develop, maintain, and enforce SOPs and work instructions governing free goods and PAP operations.
Resolve complex patient, provider, and pharmacy escalations across the free goods and PAP portfolio.
Serve as the primary operational point of contact between the company and dispensing pharmacy partners as well as hub vendors and service partners.
Manage multiple vendor interdependencies across specialty pharmacy, hub, and support partners.
Own operational management of Master Service Agreements (MSAs), Statements of Work (SOWs), SLAs, KPIs, and performance commitments.
Lead annual contract and SOW reviews, including negotiation of free commercial, trial, and PAP services.
Conduct regular business reviews (monthly, quarterly, annual) and verify accuracy of vendor reporting and presentations.
Address service failures, disputes, and performance gaps, issuing corrective action plans as needed.
Monitor and report on KPIs including order accuracy, shipping turnaround times, inventory accuracy, returns processing, cold‑chain compliance, call‑center performance (if applicable), and patient service metrics.
Lead root‑cause analyses and ensure implementation of corrective and preventive actions (CAPAs) when performance trends fall below expectations.
Drive accountability and continuous performance improvement with vendors.
Ensure pharmacy and vendor compliance with FDA regulations, DSCSA requirements, state pharmacy laws, and internal quality standards.
Review, approve, and maintain SOPs related to product handling, storage, dispensing, packaging, and shipping.
Manage quality incidents including temperature excursions, mis‑shipments, product complaints, quarantines, and adverse event reporting workflows.
Lead and participate in recurring quality reviews, call calibrations, scorecard evaluations, and corrective action follow‑up.
Oversee free goods inventory management, including forecasting, replenishment, cycle counts, shrinkage, expiry management, and safety stock levels.
Partner with internal Supply Chain teams and external partners (e.g., Americares) to ensure uninterrupted product availability.
Provide ad‑hoc operational support during low‑stock or stock‑out situations.
Manage supplies ordering, kitting, and troubleshooting when procurement challenges arise.
Oversee quarantine reviews, investigations, approvals, and compliant product destruction or returns.
Review and validate monthly pharmacy and vendor invoices.
Investigate billing discrepancies, overcharges, and cost variances.
Manage purchase order (PO) creation, tracking, reconciliation, and adjustments.
Identify cost‑efficiency opportunities and support savings initiatives without compromising patient service.
Identify workflow inefficiencies across order fulfillment, pharmacy operations, inventory management, and patient services.
Lead or support process improvement initiatives, including technology enhancements and system optimization.
Apply continuous improvement principles to enhance patient experience, reduce cycle times, and improve accuracy.
Oversee data exchange and EDI feeds between internal systems, hub partners, and pharmacy vendors (orders, confirmations, tracking, inventory, and returns).
Validate data accuracy in dashboards and operational reports.
Partner with IT and data teams to resolve system issues and support enhancements.
Support new product launches and indication expansions, including pharmacy onboarding, operational readiness, training, and go‑live support.
Ensure pharmacies and vendors are prepared to support specialty workflows, REMS (if applicable), and evolving program requirements.
Partner with Brand, Patient Services Strategy, and HUB teams to align operational execution with program design.
Ensure vendors maintain appropriate disaster recovery, business continuity, and redundancy plans.
Evaluate data security, product security, and facility controls.
Proactively identify operational risks and implement mitigation strategies.
Collaborate closely with Brand, Patient Services Management, HUB partners, Quality, Compliance, Regulatory, Supply Chain, Finance, Procurement, and IT teams.
Serve as an operational subject‑matter expert for free goods and PAP execution across the organization.