Senior Director Medical Affairs, Global Managed Access Programs, Strategy & Operations

Who We Are:

Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in Prader-Willi syndrome, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For more than three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X, Facebook and YouTube. (*in collaboration with AbbVie)

At Neurocrine, strong leadership drives both business results and team success. We look for leaders who think strategically, anticipate what’s ahead and set clear direction, while building and empowering high-performing teams. Successful leaders foster an environment where people are motivated to do their best work and deliver meaningful, measurable impact through sound decision-making and accountability.



About the Role:

The Senior Director, Global Managed Access Programs, Strategy & Operations will provide strategic and operational leadership for the development and execution of Neurocrine's global Managed Access Programs (MAP) (eg, early access, post-trial access, name patient sales, etc.), enabling appropriate access to Neurocrine medicines for patients in countries where traditional commercial access is not yet available or is not planned.

This individual will serve as the enterprise leader for managed access strategy and execution, bringing together Medical Affairs, Lifecycle Management, Market Access, Commercial, Regulatory Affairs, Pharmacovigilance, Quality, Technical Operations/Supply Chain, Legal, Compliance, Finance and other partners to determine where and how MAP should be implemented across the Neurocrine portfolio.

The Senior Director will be accountable for translating asset and lifecycle strategy into scalable, compliant and operationally executable access pathways across countries. The Senior Director will support managed access planning across the product lifecycle (eg, Early/Expanded Access Programs, Single/Named Patient Access, cohort programs, Post-Trial Access, and other pre- and post-approval access pathways, as appropriate). The role will lead the selection, oversight and governance of external partners responsible for program administration, regulatory coordination, distribution and other access services, while ensuring Neurocrine maintains appropriate strategic oversight, decision-making and accountability.

This role requires deep expertise in the complex regulatory, operational, supply and access considerations associated with providing medicines outside traditional commercial channels. The successful candidate will combine strategic thinking with strong operational leadership and will be able to navigate highly matrixed, time-sensitive situations where patient need, regulatory requirements, supply considerations and long-term asset strategy intersect.

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Your Contributions (include, but are not limited to):

Global Managed Access Program Strategy

• Develop and lead Neurocrine's global strategy and operating model for MAP across commercial and development-stage assets, in alignment with overall asset, lifecycle and geographic expansion strategies

• Establish scalable processes, governance, and operational capabilities while recognizing that managed access strategies should be tailored to the specific needs of each asset, patient population, geography, and stage of development

• Partner with Medical Affairs, Lifecycle Management, Commercial, Market Access, Regulatory and other functions to assess when an MAP is appropriate and define the objectives, geographic scope, timing, eligibility framework and operating model for each program

• Lead country and regional prioritization and feasibility assessments, considering unmet medical need, regulatory pathways, anticipated patient demand, local treatment availability, commercial launch plans, pricing and reimbursement timelines, supply requirements and operational complexity

• Ensure MAP planning is incorporated proactively into asset lifecycle and launch planning rather than managed solely in response to individual patient requests

• Develop strategies that allow Neurocrine to responsibly address immediate patient need while preserving flexibility as regulatory approval, reimbursement, commercial footprint and broader access strategies evolve

Program Design & Operational Execution

• Lead the end-to-end design and operationalization of MAPs, establishing clear implementation plans, timelines, decision points, accountabilities and escalation pathways
• Lead or facilitate cross-functional MAP working groups to develop program-specific access strategies including exit and transition strategy
• Establish scalable processes for physician requests, patient eligibility assessment, program enrollment, product ordering and fulfillment, program renewals and discontinuation or transition
• Partner with Regulatory Affairs to understand and navigate country-specific requirements for unlicensed or investigational medicine access, importation, labeling, documentation and regulatory submissions
• Partner closely with Technical Operations and Supply Chain to develop demand forecasts, assess supply feasibility, establish appropriate distribution models and ensure reliable product availability
• Ensure appropriate integration of Pharmacovigilance, Quality, product complaint management, data privacy and other compliance requirements into each program
• Anticipate operational risks and emerging patient access issues and establish mitigation and contingency plans to ensure continuity of treatment wherever appropriate

External Partner & Vendor Leadership

• Lead the strategy, selection and governance of external MAP partners, distributors and other service providers
• Establish clear roles, responsibilities, service-level expectations, decision rights, escalation pathways and performance metrics with external partners
• Maintain senior-level relationships with key strategic vendors and hold partners accountable for program quality, responsiveness, regulatory compliance, patient and HCP experience, and operational performance
• Assess the external access landscape and recommend new capabilities, partnerships, technologies or operating models that improve Neurocrine's ability to provide compliant and efficient patient access globally

Cross-Functional Governance

• Establish and lead cross-functional governance for MAP, ensuring appropriate representation and decision-making across Medical Affairs, Lifecycle Management, Regulatory, Market Access, Commercial, Supply Chain, Quality, Pharmacovigilance, Legal, Compliance and Finance
• Define enterprise policies, standards, SOPs, decision frameworks and governance processes for NPP initiation, operation, expansion and discontinuation
• Establish clear processes for assessing new country or patient access requests, including defined decision criteria and escalation pathways for complex or time-sensitive situations
• Serve as the internal subject matter expert for MAP and advise senior leadership and asset teams on global access options, risks, trade-offs and recommendations
• Build organizational understanding of MAP requirements and provide education and training to cross-functional teams on appropriate processes, roles and responsibilities

Access, Pricing & Lifecycle Integration

• Partner with Market Access, Finance and Commercial teams to evaluate appropriate models for funded, reimbursed, for-charge or other permitted access pathways based on local regulatory and market requirements
• Ensure program strategy considers potential implications for future pricing, reimbursement, HTA, commercial launch and geographic expansion decisions
• Develop transition strategies as products move from early access or unlicensed access to approved and reimbursed commercial access, with particular attention to continuity of treatment for patients already receiving therapy
• Develop strategies for countries where Neurocrine may not establish a traditional commercial presence but where a sustainable mechanism for ongoing patient access may be appropriate

Performance, Insights & Continuous Improvement

• Establish program KPIs and dashboards that provide leadership with visibility into patient demand, geography, time to access, program performance, supply requirements, costs, vendor performance and emerging risks
• Lead program budget development, forecasting and ongoing financial oversight
• Analyze program trends and access barriers to identify opportunities to improve patient access, operational efficiency and long-term portfolio planning
• In partnership with Medical Affairs, HEOR, Regulatory and other appropriate functions, evaluate opportunities for compliant collection and use of data generated through access programs where scientifically appropriate and permitted by local regulations
• Monitor the evolving global regulatory and policy environment for Named Patient, Expanded Access, Compassionate Use and other Managed Access pathways and recommend changes to Neurocrine's strategy and operating model
• Drive continuous improvement and harmonization of processes across programs and geographies as Neurocrine's global portfolio and footprint expand

Requirements:

• BS/BA degree in life sciences, pharmacy, public health, business or a related discipline and 15+ years of relevant pharmaceutical/biotechnology industry experience, including substantial direct experience with managed access (eg, Named Patient, Early Access, Expanded Access, Compassionate Use or comparable global patient access programs; OR
• Master's degree or other relevant advanced degree and 13+ years of similar experience
• Significant demonstrated experience designing and executing global Managed Access Programs within a pharmaceutical or biotechnology company strongly preferred
• Experience working with global third-party access providers, specialty distributors and/or partners such as Managed Access Program service organizations required
• Experience with rare diseases, specialty medicines and/or populations with significant unmet medical need strongly preferred
• Experience supporting programs across multiple international markets, particularly Europe and other markets outside the United States, required
• Experience with both pre-approval and post-approval/non-launch access models preferred
• Deep knowledge of the global Managed Access environment, including country-specific regulatory pathways, operational requirements and compliance considerations
• Strong understanding of the pharmaceutical clinical development and product lifecycle and the relationship between patient access programs, regulatory approval, medical strategy, pricing and reimbursement, commercial launch and long-term lifecycle strategy
• Working knowledge of pharmaceutical supply chain, distribution, import/export requirements, product labeling, quality, pharmacovigilance and data privacy considerations associated with global access programs
• Demonstrated ability to develop strategy and translate it into clear governance, processes and operational execution
• Strong vendor-management capabilities, including partner selection, contracting, governance, performance management and issue escalation
• Excellent analytical and problem-solving capabilities with the ability to make thoughtful decisions in situations involving significant complexity, ambiguity and urgency
• Demonstrated ability to lead highly matrixed cross-functional teams and drive alignment and accountability without direct authority
• Strong executive presence and outstanding written, verbal and presentation skills, with the ability to communicate complex access issues and recommendations to senior leadership
• Ability to balance immediate patient needs with regulatory, operational, financial and long-term business considerations while maintaining a strong commitment to ethical and compliant decision-making
• Highly proactive and comfortable operating at both the strategic and detailed operational levels in a rapidly evolving organization
• Ability to establish new organizational capabilities, develop scalable ways of working and continuously improve processes as the portfolio grows
• Fluency in English required; additional European language capability is beneficial
• Ability to travel internationally as required

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Neurocrine Biosciences is an EEO/Disability/Vets employer.

We are committed to building a workplace of belonging, respect, and empowerment, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don’t line up to exactly what we have outlined in the job description.