Job Description Summary Primary Location: Barcelona, Spain Working model: This location has a hybrid working model (12 days per month in the office).
Note: Novartis is not able to offer relocation support for this role.
About this role: Leading Managed Access Programs (MAP) and Post Study Drug Supply (PSDS) operations activities with precision and efficiency, our Associate Director, Managed and Post Trial Access Operations makes a substantial contribution to enable access to Novartis products for patients with an unmet medical need.
You will be working within a highly collaborative, global team.
Job Description Major accountabilities: Responsible for planning, execution and management of Managed Access Program (MAP) and Post Study Drug Supply (PSDS) operations activities with high quality, adequate resources, timely and cost-efficiently for assigned area/product.
Lead and oversee implementation, progress, close out activities of assigned MAP and PSDS activities and monitor compliance for reporting.
Accountable for forecasting and managing drug supply for activity and for activity budget planning, approval, and oversight.
Accountable for accuracy of MAP and PSDS information in relevant systems.
Point of contact for MAP and PSDS operational activities for assigned area/product.
Partner to global and local Medical, Finance, Supply, Quality Assurance, Ethics, Risk & Compliance and other relevant teams to ensure timely, efficient and quality planning and execution of MAP and PSDS activities.
Support process simplification and knowledge sharing with a quality and compliance mindset and drive operational excellence and performance.
Enable a collaborative and empowered organization that can navigate in a matrix environment and adjust quickly to business needs.
Work Experience and skills: Advanced scientific, life science/healthcare degree required.
At least 5 years technical, operational, or managerial experience in planning, executing and reporting Managed or Post Trial Access or clinical trials in a Pharma company or Contract Research Organization.
Experience in Medical Affairs preferred.
Experience in working in matrix organizations and international multidisciplinary teams.
Experience in multiple clinical indications preferred.
Previous experience leading several MAPs/PTA/trials in parallel.
Skills required: Project management expertise.
Strong understanding of clinical development activities and functions/roles/responsibilities.
Advanced understanding of business processes.
Thorough knowledge of Good Clinical Practice and global drug development process.
Demonstrated innovation in operational processes and issues resolutions.
Strong interpersonal, problem-solving, negotiation, communication and conflict management/resolution skills.
Languages: Fluent English both spoken and written.
Skills Desired: Agility, Clinical Practices, Cross-Functional Collaboration, Data Analysis, Drug Development, Employee Development, Healthcare Sector Understanding, Health Sciences, Influencing Skills, Innovation, Inspirational Leadership, Integrated Evidence Generation, Medical Affairs, Medical Communication, Medical Education, Patient Care, People Management, Pharmaceutics, Priority Disease Areas Expertise, Product Launches, Product Strategy, Real World Evidence (RWE), Regulatory Compliance, Research Methodologies.
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