Senior Manager - Clinical Research Equity (Plainsboro, NJ or Remote) at 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
Supports the North America Clinical Development (NACD) Clinical Research Equity (CRE) strategy integrating diversity and health equity systematically in clinical trial planning and execution.
This role will create an equity & inclusion experience for underserved and underrepresented patients, sites, and serve as a CRE advocate for NACD. They will actively work to understand patient barriers, advocate for inclusive trial design, collaborate with private and public sector to establish common understanding of industry trends and enable diverse enrollment at the site level. They will serve as an advocate for patient and site awareness, education, knowledge, and inclusion in our clinical portfolio.
Relationship
This role reports into the Director of Clinical Research Equity supporting the strategy across NACD.
This role will partner with other internal and external stakeholders. Internally, they may partner with the Local and Global Clinical Operations, regulatory affairs, medical affairs, legal, communications, compliance, etc. Externally, this role may regularly interact with patients, sites, advocates, caregivers, and key partners.
No direct reports, strong cross functional relationships across NACD, NAO, and NN.
Essential Functions
- Oversight of trial- or program-level diversity plan development within one or more of NNI’s therapeutic areas as well as supporting execution of plan with trial- or TA-specific initiatives
- In collaboration with the Director, support the implementation of the CRE strategy to fulfill and adapt to the needs of patients, sites, and caregivers
- With Director, serve as NACD SME on clinical trial diversity for local and global forums, initiatives, and communications
- Identify and develop partnerships in alignment with NN global strategy (e.g., patient advocacy groups, community organizations, professional associations, etc.) to gain insight into patient barriers and drive diversity into trials
- Develop consistent process for including diverse patient voice in the planning and execution of clinical trials
- Engage with diverse communities to understand their cultural, linguistic, and healthcare needs and barriers; work to address these issues through collaborative initiatives
- Develop and/or promote health education and awareness programs
- Advocate for policies and practices that promote health equity and address SDOH, working with policymakers and community leaders to effect change
- Develop resources and/or support training for NN staff and/or healthcare professionals on disparities, health equity, cultural competence, implicit bias, and inclusive patient care
- Conduct research on cultural health disparities in healthcare outcomes among different cultural groups and use findings to inform improvement initiatives
- Ensure that health-related materials, such as informed consent forms, patient instructions, and educational resources, are written in plain language that is easily understood by the target audience
- Collaborate with stakeholders to build sustainable investigator and site relationships and to ensure sites have resources and support to drive diverse recruitment
- Collaborate with stakeholders to identify, evaluate, and develop emerging research centers with diverse patient populations
- Together with site feedback and internal stakeholders, advocate for the needs of diverse patient populations involved in clinical trials
- Analyze trial participant demographics and outcomes to assess the diversity of trial populations, inform strategies for improvement, and ensure compliance with regulatory requirements
Physical Requirements
10-20% overnight travel required; May be required to work company holidays and weekends. The incumbent can work in our Plainsboro, NJ facility or remotely from anywhere within the United States.
Qualifications
- Bachelor’s degree is required. Advanced degree preferred
- Minimum of 9 years of progressively responsible, relevant clinical operations/development experience required. Related experience in clinical trial diversity preferred
- Maintains a deep understanding of industry trends and best practices in clinical trial diversity to drive informed decision-making with management
- Experience in ICH-GCP principles, regulatory requirements, and compliance requirements and the application of those to trial design, planning & conduct of clinical trials
- Highly motivated self-starter with a willingness to assume responsibility, take ownership for their work, intelligently challenge the status quo, and drive initiatives from idea to completion
- Demonstrated analytical skills, critical thinking, and creative problem-solving to resolve complex issues
- Strong relationship building and experience communicating with site staff including Key Opinion Leaders (KOLs) and patient/community organizations
- Advanced capability in Excel, PowerPoint and Word required
- Strong communication (written and verbal), meeting efficiency, time management, and cross-functional collaboration skills required. Presentation skills required
- Leadership skills with the ability to develop and communicate a vision and engage people in that vision
- Understanding of a metrics-driven organization required
The base compensation range for this position is $150 to $180 K. 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.
The job posting is anticipated to close on November13th, 2024. The Company may however extend this time-period, in which case the posting will remain available on our career’s website at www.novonordisk-us/careers.com.
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
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.