Director - Patient Centered Outcomes Research - Remote - Novo Nordisk

Plainsboro, NJ

About the Job

About the Department

The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that keeps us all marching to the same beat is our patient-centered focus. At Novo Nordisk, you will help patients around the world. As their needs evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We’re changing lives for a living. Are you ready to make a difference?

The Position

The Director, Patient Centered Outcomes Research, is responsible for the design and execution of strategically focused and innovative patient experience data (PED) evidence to support optimization of access & reimbursement, clinical practice, product development and registration. The Director serves as a visible PED champion and subject matter expert within the US organization to execute PED strategy initiatives, which ultimately drive a patient-centric culture and adoption/uptake of standards and best practices for PED throughout the US organization.

Relationships

The Director-Patient Centered Outcomes Research reports directly to a Senior Director within the CDSE RWE team. This is a US affiliate role focused on executing on US PED strategy which encompasses innovative research aligned with overall asset strategy in collaboration with a wide number of NNI stakeholders across not only within Clinical Data Strategy and Evidence (CDSE) but more broadly within Clinical, Medical and Regulatory (CMR), Market Access and Public Affairs (MAPA), as well as collaborating where appropriate with therapeutically aligned global counterparts in Medical Science, Patient Focused Drug Development, Data Science and Global Evidence and Pricing Access. In addition, the Director will represent Novo Nordisk externally and assume a leadership role in collaborations with external partners on generating PED (eg, industry consortiums, key opinion leaders, research organizations, patient advocacy groups).

Essential Functions

Leads management of projects to ensure timely execution of PED research to characterize patient outcomes, identify patient preferences and unmet needs, inform patient-focused measurement strategies, and contribute to develop and validate innovative patient-relevant outcomes measures and endpoints to differentiate Novo Nordisk’s portfolio and meet business and US needs

Leverages novel digital health technology such as sensor/wearable data capture instruments to inform identification and/or evaluation of symptoms, function, health-related quality of life, or other patient-centric concept of clinical benefit

Ensures the scientific quality and integrity of patient focused research through development of rigorous qualitative and quantitative study research proposals, protocols, analysis plans and reports

Serves as internal PED SME on technical specialty areas to identify new methodologies and advancements in the field (e.g., psychometric methods and results interpretation, clinical outcomes assessment (COA) methods, regulatory requirements to obtain COAs on labels, industry trends)

Ensures scientific integrity of PED research through serving as expert reviewer on study designs, protocols, results and scientific communications (eg, qualitative or quantitative method review)

Facilitates integration of the US PED strategy into clinical development programs, post-authorization and commercial research activities and support/lead development, validation, and implementation of COAs measures for randomized controlled trials (RCTs) / observational studies that satisfy US business needs

Contributes to strategy and development of content for US regulatory submissions regarding PED and patient-relevant endpoints and participates in US regulatory discussions and negotiations to optimize registration approval, product labeling & CFL promotion decisions

Develops and maintains stakeholder relationships to ensure optimal utility of PED within NNI, championing the concept of patient-focused decision making through these relationships

Develops scientific communication plan including submission and presentation of research in peer-reviewed journals and at medical / methodological congresses

Communicates study results and the approaches used to reach these to internal stakeholders, customers and scientific community, using an appropriate level and detail of terminology for the audience

Engages with external thought leaders and representatives to shape the external environment with respect to patient centered outcomes research

Actively participates in knowledge sharing including coaching, and mentoring junior colleagues

Responsible for continuous development of own skills according to personal development plan

Physical Requirements

10-20% overnight travel required.

Qualifications

Bachelor’s Degree and at least 12 years of related experience; Master’s Degree and at least 8 years of related experience; or a PhD is required.

Degree in a relevant field such as health services research, health outcomes research, epidemiology, pharmacy administration, public health, economics, statistics or decision sciences, psychometrics, or similar is preferred.

Related experience: preferably pharmaceutical industry or consulting experience in PED research such as clinical outcome assessment / patient reported outcome development, validation, or implementation

Experience with medical product development and trial design is preferred

Demonstrated ability in generating patient insights about disease and treatment to support clinical development, post-authorization, and commercial research activities across the lifecycle of drug development with consideration for US stakeholder needs

Demonstrated prior research accomplishment (e.g., publications in peer-reviewed journals and presentations at scientific conferences)

Excellent leadership, strong communication and critical thinking skills with keen knowledge of patient focused research

Excellent process and project management skills required including the ability to manage a significant volume of projects with exercise of good triage and judgment skills

Excellent presentation skills, strong business acumen and a team player

Strong strategic thinking skills

The base compensation range for this position is $235,000 to $260,000. Base compensation is determined based on a number of factors. This position is also eligible for a company bonus based on individual and company performance.

Novo Nordisk offers long-term incentive compensation and or company vehicles depending on the position's level or other company factors.

Employees are also eligible to participate in Company employee benefit programs including medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance program; tuition reimbursement program; and voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance. The Company also offers time off pursuant to its sick time policy, flex-able vacation policy, and parental leave policy.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

The job posting is anticipated to close on January 30, 2025. The Company may however extend this time-period, in which case the posting will remain available on our careers website at www.novonordisk-us/careers.com.

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.

Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.

Source : Novo Nordisk