Location: East Hanover,NJ, USA
Summary
In partnership with Director PE TA drives systematic collaboration with the patient community and internal stakeholders to achieve strategic PE objectives and priorities by informing R&D programs that create value for patients, healthcare systems and Novartis. Implements and executes the PE Strategy in line with the Novartis Patient Focused Drug Development approach and the Decision Point Framework across the clinical development continuum for priority disease areas. The role reports to the Director PE TA and works closely with PE Science team, and Clinical Development and Development Unit teams within the assigned disease area(s). Partners internally with Early Patient Insights team in Biomedical Research, and US and International Comms & Patient Advocacy teams in Corporate Affairs. Partners externally with patient organizations, patient experts, patient advocates, patients, and caregivers.
About the Role
Major accountabilities:
* Contribute to the Patient Engagement Strategy, implementing decision point framework, in line with patient focused drug development across priority disease areas.
* Execute patient engagement priorities in alignment with the clinical development priorities, developing and implementing relevant activities.
* Strategically collaborate cross-functionally to bring in critical patient insights and patient experience data to inform clinical development plans and key decisions across the RDC continuum.
* Implement regulatory and policy/access patient engagement strategies in disease areas.
* Contribute to innovative approaches to partnering with patient groups/forums, including multi-stakeholder forums in areas of strategic alignment.
* Identify with patient groups integrated campaigns/initiatives to address patient needs and drive leadership in clinical development.
* Ensure seamless collaboration and effective knowledge sharing with PE Science, BR PIE team and Patient Advocacy team within the relevant disease area.
* Ensure compliant execution of funding and engagement activities that support clinical development plans.
* Secure financial resources to support execution of planned PE activities.
* Develop and maintain strategic partnerships with global, US, and international patient advocacy organizations to deepen Novartis understanding of patient community landscape, patient goals, needs and priorities in the disease area.
* Ensure product profiles are co-created with patients and meet their needs.
* Integrate patient perspectives into clinical trials design and clinical trial execution.
* Act as C-ISRC reviewer for relevant clinical trial concept sheet and protocol reviews.
* Expected travel up to 20%
Requirements:
* Master's degree in a relevant field such as life sciences, business administration, or equivalent.
* At least 7-10 years of experience in global pharma and/or non-profit health organization with at least 3-5 years in an external-facing function, i.e. medical affairs, patient engagement, patient advocacy, access. Knowledge of product development lifecycle.
* Critical thinker and with ability to navigate uncertainty without major supervision
* Fluent oral and written English; Other relevant languages are an advantage.
* Ability to truly collaborate across functions and markets: serve-partner-co-create.
* Strong track record of delivery focus for time and quality in Patient Engagement projects
* Credibility as peer expert with external stakeholders
* Agile mindset & ability to lead in an agile organization across Disease Areas
* Firm working knowledge of GCP, and clinical methodology, protocol designs, management and regulatory requirements for clinical studies designated for review by regulatory authorities.
* Proven change agent
* Expert knowledge in Pharma Product lifecycle.
* Understanding of patient insights, experience data and their creation
* Understanding of the R&D process and of clinical trial execution.
* Understanding of Patient-Focused Drug Development (PFDD) principles.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together?