Director, Patient Centered Outcomes

Key responsibilities:

• In collaboration with the Clinical Trial Team (CTT) ensures that endpoints include Clinician Reported Outcomes, Patient Reported Outcomes, Observer Reported Outcomes, and/or Performance Outcomes (including Digital/Wearable technology as appropriate) that validly demonstrate clinically meaningful benefit to patients
• Shapes the PCO components of trial related documents for assigned clinical trial(s) consistent with the Clinical Development Plan (CDP) and for regulatory interactions (e.g., health authority briefing books, submission dossiers, responses to health authorities, and labeling negotiations)
• Interprets analyses of PCO data including patient experience and conceptual models of disease, psychometric validation studies, and meaningful change analyses as well as clinical trial results included in Clinical Study Report(s), publications and internal/external presentations
• Oversees vendor contributions to clinical programs (e.g., qualitative research, in-trial interviews)
• Leads and/or contributes to OnePCO strategies that include joint consideration of patient experience and/or preference data as well as the use of digital/wearables in clinical trials
• Drives the development and strengthening of PCO core expertise through contributions to governance meetings, development of internal training, leadership of process improvement initiatives, and development of best practices
• Engages with external thought leaders (patients, clinicians, academics, health authorities, and vendors) to monitor and shape the external environment with respect to patient centered outcomes research and evolving evidentiary standards (e.g., Innovative Health Initiative, C-Path)
• Promotes capability building by sharing knowledge within OnePCO and across Global Program Teams
• Supports the incorporation of the patient voice in drug development through short- and long-range vision and strategies for PCOs at Novartis

Essential Requirements:

• Advanced degree (Ph.D., M.D., MSc or equivalent) in life sciences/healthcare (or related relevant degree)
• Fluent oral and written English
• Experience in developing PCO measures from conceptualization through negotiation with international health authorities
• 5+ years of experience in clinical research or drug development with a working knowledge of GCP and drug development processes
• Strong communication skills, written and oral
• Proven ability to provide matrix leadership for cross-functional teams and drive alignment
• Ability to manage multiple priorities in rapidly changing environment
• Ability to represent the organization in public forums and health authority discussions

Commitment to Diversity and Inclusion / EEO paragraph

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Benefits and rewards:

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https://www.novartis.com/careers/benefits-rewards

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Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards