As part of the Center of Excellence (CoE) for Patient-Centered Outcomes (PCOs) in the Advanced Methods and CoEs Group and in coordination with the Head of PCO, leads cross-functional patient-centered Clinical Outcome Assessment knowledge and activities in different Novartis functions in specific Development Units (DUs).
Enhances and drives alignment of activities among DUs and Global Program Teams to elevate PCO activities to a level of industry leadership, maintaining overall accountability for Company’s deliverables in the area.
When required, represents Novartis externally in Industry Associations, Public Private relevant projects (e.g. IMI and IHI) and participates in discussions with Health Authorities and Payers.
Interacts with Global Program Heads, Global Program Clinical Heads, HE&OR, and Global Program Regulatory directors to influence program strategies.
About the Role
This hybrid role will report to Head - PCO Center of Excellence
Major accountabilities:
Leads multidisciplinary teams of senior functional experts focusing on facilitating and monitoring the development and implementation of PCOs strategy in individual GPTs.
- Accountable for the functional excellence in PCO development and implementation across the organization.
- Accountable for PCO planning content in development programs and ensuring quality inputs for regulatory and market access purposes.
- Drives capability building for the Clinical Development and Global Medical Affairs community encompassing all major aspects in developing PCOs, leveraging cross-functional exchange of expertise within Value & Access, Patient Engagement, Digital Endpoints Capability Center, and external experts.
- Participates in and leads projects on behalf of the PCO Alignment Forum (Patient Engagement, Digital Endpoints Capability Center, Clinical Development PCO, and V&A PRO groups).
Contributes to the establishment of short- and long-range vision and strategy for PCOs development and implementation.
- Leverages knowledge, experience, and understanding of external stakeholders and internal goals and capabilities to develop a compelling and innovative vision for PCO for individual programs/brands.
- Ensures cross-functional and cross-divisional alignment.
- Drives and/or anticipates internal and external changes reflecting relevant regulatory requirements to maintain constant, state-of-the-art output in the area.
- Maximizes efficiency by identifying existing resources and COA instruments to meet program timelines.
- Collaborates with Global Program Teams to secure individual program internal buy-in.
- Supports Biomedical Research in developing an overall strategy for early-stage implementation of PCOs.
Represents Novartis externally in Industry Associations, Health Authority, and Payer discussions concerning PCOs and impact on individual products.
- Supports individual program teams in their interaction with HAs and Payers concerning PCOs.
- Represents Novartis at Industry Associations and public initiatives where PCOs is a topic (e.g., IHI, NIH partnership projects).
- MD (desirable) or MSc/PhD in relevant field.
- At least 5 years relevant experience in Pharma or consultancy.
- Good knowledge of the drug development process spanning from research to commercialization with emphasis on projects requiring PROs or COAs in their development.
- Ability to lead without formal authority.
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GB16 (FCRS = GB016) Novartis Pharmaceuticals UK Ltd.
Alternative Location 1: Basel (City), Switzerland.
Functional Area: Research & Development.
Job Type: Full time.
Employment Type: Regular.
Shift Work: No.
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.