Director, Patient Centered Outcomes

330350BR
Jan 19, 2022
USA

Job Description

Job Purpose

Over 108,000. That’s how many US patients our oncology products touched in 2018. And while we’re proud of that, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?

We believe the answers are found when curious, courageous and collaborative people like you are empowered to ask new questions, make bolder decisions and take smarter risks.

The Director, Patient Centered Outcomes partners with product franchises, Regulatory, Development, Patient engagement, Medical teams, and key countries to develop and communicate of PCO/PRO endpoint measurement strategy that provides evidence on the impact of disease and treatment on patients and supports product value to regulators. HTA/Payers health care providers and patients.

Lead and partner in execution of PCO/PRO endpoint measurement strategy including instrument development, selection, validation, writing/reviewing relevant section of clinical development plans, study protocols, statistical analysis plans, briefing packages, clinical study reports and regulatory labeling interactions. Ensure these reflect the needs from key partners, including regulators, payers, health care professionals and patients (as needed)

Develop and implement strategies that enable implementation and execution of PCO endpoint measurements in our development programs including, educating/ training the relevant functions, developing guidance on use of critical instruments, activating digital enablers and developing relevant processes that meet or exceed regulator and payer evidentiary standards

Serve as an in-house expert that assists/leads the development and updating of quality standards of strategic frameworks for PRO/PCO instrument selection/creation/design/validation/analysis plans in order to deliver consistent quality evidence globally.

Please note this position will be located in HQ East Hanover, New Jersey and only local candidates will be considered

Responsibilities:

PCO Strategy Development:
• Develop PRO strategy for assigned clinical programs in collaboration with the Franchise HEOR and access leads and cross-functional teams.
• Understand and communicate how PRO data can help support access and reimbursement for assigned clinical programs.
• Work with clinical development teams to identify appropriate trial endpoints and/or to understand when new measures should be developed.

PCO Executional Excellence:
• Assess literature and existing PRO/PCO, conduct gap analyses and expert interviews to advise measurement strategy
• Identify and select/recommend appropriate PRO/PCO measures, lead development of PROs/modify existing PROs, including patient concept elicitation, cognitive debriefing, psychometric validation, developing, assessing, using, interpreting, and disseminating Patient Reported Outcomes (PROs) measures
• Ensure PRO/PCOs are appropriately implemented in clinical studies, including reviewing relevant clinical protocol sections and conducting training at Investigator Meetings
• Provide technical expertise in the analysis, reporting and dissemination of PRO data. Present scientific work in peer-reviewed journals and at professional meetings. Produce PRO evidence dossiers for regulatory submissions (e.g. FDA, EMA)
• Advise on and contribute to PRO/PCO sections of regulatory documents, including briefing documents and submissions. Assist in interaction with regulatory agencies (e.g. FDA, EMA) regarding PRO/PCO endpoints
• Deliver end-to-end strategic and tactical plans in partnership with Global Access/Product Leads, and countries. Work collaboratively with internal (i.e. CTS) and external partners to complete aligned and prioritized projects

Functional Excellence:
• Ensure ground breaking methodologies are applied in day-to-day research, working in collaboration with the Franchise HEOR
• Maintain awareness of scientific and regulatory developments within PCO/PRO area and communicate information internally
• Collaborate with other divisions, the Pharma/ Oncology RWE COE PRO/PCO functions and Group to define align and share best practices in PRO/PCO measurement strategy
• Commission thoughtful and agenda setting pieces of work, working with a range of partners including think tanks and academic researchers to enable progressive approaches to PRO/PCO measurement strategies

Diversity & Inclusion / EEO

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

Minimum Requirements

What you’ll bring to the role:

• Education: Bachelor's Degree is required, preferably in Medicine, Natural or Pharmaceutical Sciences. An advanced degree in science and/or business preferred (MD, Pharm. D., PhD., MBA Psychology, Economics, Epidemiology or Statistics, Public Health or related discipline) and experience conducting PCO research

Required Experience:

• Minimum 10 years of PRO experience in the pharmaceutical or related industries (e.g., consulting).
• Experience with pharmaceutical or biotechnology drug development process.
• Awareness of healthcare markets and regulatory and reimbursement decision making, especially in relation to the global use of PRO data.
• Experience with managing PRO development and validation projects.
• Demonstrated skills to develop/recommend strategies for the appropriate utilization of non-intervention studies (NISs) across clinical, medical, and commercial disciplines to address key PRO/PCO scientific and business questions.
• Understanding of the evolving use of PRO research concepts and methodologies.
• Must have ability to prioritize and understand key stakeholders and identify gaps in evidence and value.
• Proven track record to collaborate, operate and influence cross-functionally and cross-culturally
• Strong analytical, critical thinking and project management skills

What you’ll receive:
Competitive salary, annual bonus, long term incentive for select levels, health insurance, paid vacation/holidays, flexible working arrangements, employee recognition program.

Why consider Novartis?
769 million. That’s how many lives our products touched in 2020. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?

We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.

We are Novartis. Join us and help us reimagine medicine.

Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network

Accessibility and reasonable accommodations
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] call (877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
ONCOLOGY
ONCOLOGY BU
USA
East Hanover, NJ
Switzerland
Market Access
Full Time
Regular
No
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330350BR

Director, Patient Centered Outcomes

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