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Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in neuroscience and oncology. We actively explore new options for patients including novel compounds, small molecules and biologics, and through cannabinoid science and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries. For more information, please visit www.jazzpharmaceuticals.com and follow [redacted] on Twitter.This Job Description provides a summary of the duties and/or characteristic of work performed and is not inclusive of every detail of the job for every individual assigned to the position. This description will be reviewed periodically and revised as duties and responsibilities change with business demands. Other duties not listed above may be assigned as needed.Brief Description:
The Director of Patient-Centered Outcomes will be responsible for the development and execution of clinical outcome assessment (COA) strategies and tactical plans across the Hematology-Oncology Therapeutic Area globally, in both clinical trials and non-interventional/observational studies. With the evolution of regulator and payer needs, and the evolution of the underlying science of COAs, this is a complex task which requires a creative and solution-oriented leader. Likewise, success in this space requires exceptional stakeholder management and the ability to work with and across functions and regions.Essential Functions
- Lead the development and execution of COA strategies and tactical plans across the Hematology-Oncology Therapeutic Area globally, in both the US and EUR/International regions, in collaboration with cross-functional teams (i.e., Clinical Development Functional Matrix Teams, Brand Teams, Global Medical Affairs TA and HEOR teams, and other groups).
- Collaborate with functional leadership and senior leadership to build awareness about the potential role of COAs in product development, commercial development, indication identification, and other activities.
- Mentor a small-but-growing team, who will lead the execution of many of the identified projects and tactics.
- Actively build trust and lines of communication with internal collaborators in both the US and EUR/International regions: Patient Advocacy, Biostats, Clinical, Medical Affairs, HEOR, Commercial, Market Access, etc.
- Serve as the COA expert in cross-functional discussions involving COA within the context of tight clinical, regulatory, and commercial timelines.
- Work with cross-functional teams to identify COA measurement approaches (using existing or de novo measures) and advise COA endpoint strategies.
- Ensure COA strategy and tactics are integrated with brand plans, molecule evidence generation plans, and value demonstration plans.
- Responsible for the design and execution of rigorous and defensible COA evidence generation initiatives that align with international scientific standards and health authority regulations.
- Define the scope of work for and manage relationships with vendors and KOLs for the timely completion of COA projects, ensuring quality, consistency, and compliance.
- Recognizing that, for products early in development, launch and commercialization may be years into the future, drive early planning for COA tactics.
- Define, establish pathways for, and communicate they ways in which COA data can help support access and reimbursement for assigned clinical programs.
- Identify options, evaluate feasibility, and advise the selection and implementation of innovative digital solutions to capture patient experience data.
- Think globally, ensuring that selected COA instruments and their translations are suitable for inclusion in clinical trials; implement any validation studies required; and prepare COA training and materials for trial investigators.
- Define plans for and oversee the conduct of psychometric analyses, and work with statisticians to advise the inclusion of COAs included in protocols, statistical analysis plans, and clinical study reports.
- Determine the strategy for, lead and/or advise COA-focused communications involving regulatory agencies and payers.
- Develop and present research findings to internal and external stakeholders, including presentations at scientific congresses.
- Represents Jazz in the broader COA community, drives innovative measurement approaches demonstrating leadership in the COA field, and remains current on advances in the COA field.
Required Knowledge, Skills, and Abilities
Required/Preferred Education and Licenses
- At least 10 years of specific experience in COAs and 5+ years of experience in evidence generation/HEOR/RWE/Medical Affairs/Market Access in a pharmaceutical company and/or consultancy is preferred.
- Experience with the psychometric evaluation and selection of COA instruments used in clinical studies is required.
- Working knowledge of relevant regulatory guidance on COAs, and experience in negotiating COA label claims is required.
- Experience with the implementation of digital technologies would be required.
- Experience in Hematology Oncology Therapeutic Area would be preferred.
- Experience mentoring junior personnel and colleagues is required.
- Experience in leading strategically, communicating with impact, and creating a strong, inclusive, energizing culture is required
- Master's or Doctoral degree in a clinical discipline is required.
Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.FOR US-BASED CANDIDATES ONLY
Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the anticipated base pay range is $176,000-$231,000. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate's qualifications, skills, and experience.
At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan.
The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: https://careers.jazzpharma.com/benefits