Director, PCO Strategy
Director, PCO Strategy
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$ 212000 - 318000
1 Vacancy
Job Description
Band
Level 6Job Description Summary
1 reimagine medicine! The Director Patient Centered Outcomes (PCO) Strategy 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 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.
Job Description
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.
WHAT YOULL 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 employees 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 company with an understanding of drug development 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
- Experience supporting successful PCO-based differentiation to support registration / labeling and access
The pay range for this position at commencement of employment is expected to be between $212000.00 and $318000.00 per year; however while salary ranges are effective from 1/1/24 through 12/31/24 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.
EEO Statement:
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.
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 call 1 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Range
Skills Desired
Cross-Functional Work Cross-Functional Work Customer-Centric Mindset Data Analysis Employee Development External Orientation Finance Go-to-Market Strategies Government Affairs Healthcare Policies Healthcare Sector Understanding Health Economics Health Technology Assessment (HTA) Influencing Skills Innovation Inspirational Leadership Market Access Strategies People Management Pharmacoeconomics Pricing Strategies Process Management Product Launches Real World Evidence (RWE) Regulatory Compliance Reimbursement Strategies 9 moreRequired Experience:
Director
Employment Type
Full-Time
