Director, Patient Centered Outcomes Strategy

1 purpose...to reimagine medicine! The Director, Patient Centered Outcomes (PCO) Strategy - Remote partners with the Global Therapeutic Areas (TAs), Health Economics & Outcomes Research (HEOR) professionals, Global Drug Development (GDD), Novartis Institutes for Biomedical Research (NIBR), Regions, and prioritized countries, to co-create a PCO strategy that enables measurement of patient centered outcomes, improved product labeling, and development of a robust payer value proposition to improve access for prioritized Novartis IM assets.
This role partners in developing and completing the PCO endpoint measurement strategy, including instrument selection, novel instrument design, validation, writing/reviewing relevant sections of clinical development plans, study protocols, statistical analysis plans, study reports, regulatory briefing packages and evidence dossiers. The Director of PCO Strategy - Remote serves as an in-house authority that builds and implements standards, roadmaps, and systems for development, delivery and communication of PCO / Patient Reported Outcome (PRO) endpoints that meet or exceed Health Technology Assessment Bodies (HTAs) and regulatory standards. Additionally, they will provide advice to advance PRO/PCO capabilities and embed patient centricity in the wider organization.
YOUR KEY RESPONSIBILITIES:
Your responsibilities include, but are not limited to:

• Partners with TAs, HEOR, GDD, and regulatory to formulate, articulate and deliver a compelling and robust PRO/PCO measurement strategy

• Supports development, delivery, and communication of PCO/PRO endpoint for select IM assets in partnership with Global TAs, HEOR, regulatory, drug development and medical

• Leads the development of PRO/PCO endpoints for inclusion in clinical, non-interventional studies and real-world studies for select assets.

• Builds scientific case for labelling claims based on PRO/PCO endpoints as needed and produce and/or provide advice on PRO evidence dossiers for regulatory filings.

• Assists in scientific discussions and interactions with regulatory agencies and HTA bodies for PRO/PCO endpoints by preparing appropriate briefing documents and dossier.

• Drives operational efficiency of PRO/PCO strategy execution by embracing existing infrastructure and quality standards and completing projects with assigned budget

• Serves as a subject matter expert and advises on strategies for implementing digital platform for electronic PRO

• Recommends and as needed drives research collaboration/ partnerships with external stakeholders (academic institutions, HTA agencies, regulatory agencies) to help monitor and shape evolving evidentiary standards for PCO/PRO endpoints and ensures awareness of these changes for Novartis IM.

The pay range for this position at commencement of employment is expected to be between $201,600 and $302,400/year; however, while salary ranges are effective from 1/1/23 through 12/31/23, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

WHAT YOU'LL BRING TO THE ROLE:
Essential:

• The ideal location for this role is East Hanover, NJ but remote work may be possible (there may be some restrictions based on legal entity). Please note that this role would not provide relocation as a result. If associate is remote, all home office expenses and any travel/lodging to specific East Hanover, NJ site for periodic live meetings will be at the employee’s expense. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager. This position will require 10% travel. This position may also be located in the UK, Ireland or Spain.

• 8+ years of experience at pharmaceutical companies with at least 3 years in a PRO specific role

• Advanced Degree

• Experience in evaluating and developing PRO/PCO instruments for inclusion in clinical studies that meet regulatory agency standards for label claims

• In-depth understanding of key patient centered outcomes measurement systems – e.g., FACIT, EORTC, NCCN, PRO-CTCAE, EuroQoL, Quality Metric Short-Form measures etc.

PREFERRED

• Ph.D., M.D., MBA, RPh or equivalent

• Strong external interfaces and network: KOLs, clinical research & scientific groups, payers, and policy and regulatory organizations

• Experience in conducting psychometric evaluation of PCO measures, patient concept elicitation studies, cognitive debriefing, electronic PCO and designing patient preference studies

• Significant (3+ years) and recent US in-market experience: includes working in the US market with the local US customers, the FDA, etc.

#TRANSFORMINGFORGROWTH
Why Novartis?
236 million lives were touched by Novartis medicines in 2022, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could achieve here at Novartis!
COMMITMENT TO DIVERSITY & INCLUSION:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
ACCESSIBILITY AND REASONABLE ACCOMMODATION
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 +1 (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.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network.

ONCOLOGY

ONCOLOGY BU

USA

East Hanover, NJ

Novartis Corporation

Market Access

Full Time

Regular

No

No