About the Department                                                                                                                                             

The Data Science organization within Novo Nordisk's global Development organization is responsible for clinical data capture, storage, analysis, modeling and simulation as well as the application of artificial intelligence/machine learning.
The team is comprised of approximately 1000 collaborative, diverse and passionate people who have a true sense of pride in their work and are committed to helping others grow and develop their careers. You’ll also have a platform to engage with key stakeholders on a global scale throughout the entire pipeline process. And while changing the future of diabetes and obesity treatment is no easy task, we also recognize the importance of an enjoyable workplace, which is why we’ve cultivated a culture of fun, ingenuity and innovation. And our competitive compensation package and support of a healthy work-life balance all add to a best-in-class employee experience. We are changing lives for a living. Are you ready to make a difference?

The Position

As leaders of the Data Science External Affairs team at Novo Nordisk, we are a dynamic and multi-disciplinary group, consisting of data scientists, technologists, policy experts, strategists, and operational experts. We are dedicated to forging innovative external partnerships that propel our clinical trials and Development organization to new heights. Our collective expertise and vision are focused on the integration of novel and advanced data science capabilities and methodologies, shaping policy strategies, and collaborating with industry stakeholders to drive impact for our patients.

We are seeking an enthusiastic leader to be at the forefront of bridging the gap between advances in data science and the evolving regulatory and policy landscape. As Director, Data Science Policy and Engagement in Novo Nordisk's Development Data Science organization, you will lead external engagements that advance innovative data science methodologies and ensure alignment with global regulations, guidance, and policy. Utilizing your expertise, you will advocate for the acceptance and alignment of innovative data science methodologies with global regulations and guidelines, positioning Novo Nordisk as a leader in the responsible and impactful use of emerging technologies. Your leadership will be instrumental within prioritized data science areas, including real world evidence, artificial intelligence (AI), machine learning, digital health technologies (DHT), decentralized trials, and other opportunities that are transforming the pharmaceutical landscape.

The role requires a thorough understanding of the global regulatory environment and the needs of agencies in the US, EU, and other key markets. It will be critical to understand and communicate how trends in technology and policy will impact our organization with strong collaboration across our Data Science organization, Global Regulatory Affairs, IO, and NAO.

If you are passionate about driving meaningful change in the pharmaceutical industry through innovative data science methodologies, this role offers an exciting opportunity to lead and shape the future of data science policy and engagement at Novo Nordisk. Join us in making a difference and driving impact for patients worldwide.

Relationships

This position reports to the Vice President, Data Science External Affairs in Novo Nordisk’s Data Science Development organization. The Data Science Policy Lead is a key senior expert in the Data Science External Affairs group, leading and coordinating Data Science partnerships across various stakeholders in the value chain.

As Data Science Partnerships is a new function, you will play a key role in helping build this area for both the Data Science team, but also for Global Development and the company more broadly. Therefore, the position will have multiple touchpoints both within Data Science and critical Novo Nordisk stakeholders. The role will also be responsible for identifying external partners to support our studies and business needs.

Essential Functions

  • External Engagement and Alliances: Lead interactions to explore and advance innovative data science methodologies, ensuring alignment and acceptance with global regulations and guidelines. Present at, or support other NN presenters at external workshops, conferences, and meetings, including those with regulators and academia
  • Landscape Analysis and Prioritization: Proactively identify and evaluate opportunities to generate data science methodologies designed to inform both internal and external decision-making processes. Communicate new regulatory requirements, guidelines, and trends within pre-agreed priority focus areas to relevant product/development project teams, regions, and management teams. Anticipate internal and external business challenges and issues and recommend and implement process updates and external strategies to address them
  • Pilot or Collaboration Development: Drive the development and oversee the implementation of pilots and other pioneering approaches to demonstrate the potential impact of data science in informing regulatory decision-making processes
  • Policy Strategic Planning: Collaborate with internal and external stakeholders to shape and influence policy strategies and industry-wide initiatives in data science and healthcare regulation. Provide expert guidance to cross-functional teams on regulatory requirements and implications related to data science initiatives, fostering a culture of collaboration and knowledge sharing
  • Complex Issue and Risk Management: Foresee and address complex issues of high importance to the broader Novo Nordisk (NN) organization and the business. This includes driving the analysis and contextualizing the impact of new regulatory trends and requirements on Novo Nordisk's development strategies
  • External Leadership: Spearhead specific external engagement initiatives aimed at not only supporting but also shaping our team’s vision. Identify and champion initiatives, determining Novo Nordisk's role (observer, participant, or leader) to drive leadership within the industry. Coordinating and communicating with team members and stakeholders, your guidance will play a pivotal role in establishing Novo Nordisk as a prominent leader in pioneering data science methodologies within the realm of healthcare regulation and decision-making processes

Physical Requirements

Ability to travel occasionally – both domestically within US and internationally in Denmark.

Qualifications

  • An advanced degree (Masters or PhD) in a relevant field, such as data science, public policy, or a related field
  • A minimum of 8 years of experience in regulatory affairs, regulatory science, health policy, or a related field
  • Strong understanding of data science methodologies and their application within the healthcare industry
  • Proven history of engaging with regulatory agencies (such as FDA, EMA, etc.) and a comprehensive understanding of the evolving regulatory landscape, particularly in areas such as Real-World Evidence (RWE/D), Artificial Intelligence (AI/ML, GenAI), Quantitative Medicine, Wearable Devices, Digital Solutions, Decentralized Trials, Digital Twins, and Digital Therapeutics, among others.
  • Demonstrated success in navigating complex regulatory environments, facilitating policy change, or evolution.
  • Exceptional communication and collaboration skills, with the ability to cultivate and sustain relationships with external and internal partners, and to effectively present to diverse audiences.
  • Experience in a leadership role within relevant cross-industry partnerships, interest groups, and task forces organized by relevant professional societies.
  • In-depth understanding of industry trends and a willingness to swiftly learn new facets of data science while staying abreast of new capabilities, regulations, and best practices. Genuine enthusiasm to remain current on advancements in data science focus areas.

The base compensation range for this position is $185000 to $215000. 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 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.

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.

Salary

$185,000 - $215,000

Yearly based

Location

Lexington, MA, US

Job Overview
Job Posted:
8 months ago
Job Expires:
Job Type
Full Time

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