Lead Modelling Scientist - Pharmacometrics

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Job description

About the Department

The Pharmacometrics department at Novo Nordisk consists of approximately 35 modelling scientists organized in two departments, supporting the entire development portfolio. We are involved from planning and execution of first in human trials to registration and beyond. We maintain a positive and collaborative atmosphere in our everyday work and ensure a healthy work-life balance. This position will be located out of our Lexington, MA facilities.

The Position

As a Pharmacometrics Modelling Specialist, you will play a crucial role within our multidisciplinary project teams, taking charge of pharmacokinetic/pharmacodynamic (PK/PD) modelling plans and analyses across various projects. Your responsibilities will involve contributing significantly to the development of new drugs, encompassing the design, analysis, interpretation, communication, and reporting of pharmacometrics information throughout all phases of clinical drug development. This will include modeling PK data from ongoing clinical programs, conducting exposure-response analysis of efficacy and safety data, simulating new trials, and presenting your findings while guiding the project team.

Relationships

The Modelling specialist reports to the head of the related development area. Internal partners include biostatistics, data science, medical & science, clinical pharmacology, data management, project managers and others across US and Denmark.

External relationships include commercial and academic collaboration partners.

Essential Functions

• Scientific work:
  • Development and Application of Pharmacokinetic and Pharmacodynamic Models: Identify, develop, and apply pharmacokinetic and pharmacodynamic mathematical models for clinical drug projects and possibly regulatory submissions.
  • Simulation and Interpretation: Perform simulations in clinical drug projects, interpret the results of clinical trials, and provide pharmacometric input to the design of trials during outline and protocol development.
  • Innovation and Methodology Improvement: Proactively seek opportunities to introduce new methodologies and processes to enhance efficiency and quality, while looking for ways to save costs and time.
  • Regulatory Document Contribution: Provide pharmacometric input to regulatory documents and submission-related materials, and contribute to the preparation and negotiation of clinical development programs at regulatory meetings.
  • Standardization and Quality Assurance: Ensure relevant standardization within projects on pharmacometric activities, challenge the status quo, and seek out innovative tools or processes to simplify and enhance pharmacometrics impact.
  • Expert Collaboration: Drive various working groups where pharmacometric expertise is required, contribute to the scientific support at congresses, exhibitions, and advisory board meetings, and secure sharing of competency and best practices across the department.
  • Communicate findings and recommendations to diverse audiences, including presentations to internal teams and external partners as well as scientific publications and presentations.
  • Continuous Development: Continuously expand knowledge of key focus areas, provide training and mentoring to colleagues in pharmacometrics, and maintain the scientific state-of-the-art level within the group.
• Collaborative Work
  • Stakeholder Communication: Actively contribute to adequate and timely information of all concerned within and outside the department, establish and maintain professional and social relations, and represent the company in meetings and inspections with regulatory authorities.
  • Cross-functional Collaboration: Collaborate with stakeholders in the Development organization, as well as with research and early development scientists, project management, medical and science management, clinical pharmacology scientists, biostatistics, and other relevant parties.
  • Team Collaboration: Actively participate in cross-functional teams, share learnings, knowledge, and skills, and promote teamwork across functions.
  • Mentoring and Networking: Actively mentor newcomers in the field of pharmacometrics, establish and maintain a network of relationships to drive impact across the organization, and actively raise the level of competency in the team by seeking and sharing domain knowledge.
  • Global Collaboration: Collaborate in virtual global team meetings and drive frequent collaborations with external commercial and academic partners.
  • Driving Best Practices: Drive the implementation of best practices in pharmacometrics, proactively share domain knowledge, and actively seek out and share best practices with an eye on long-term development.
  • Business Impact: Achieve business goals, share learnings, knowledge, and skills, and actively contribute to the development of new methodologies.

Physical Requirements

Up to 20% overnight travel required.

Qualifications

• Master's degree in statistics, engineering, pharmacy, or other relevant scientific discipline required
  • PhD in Pharmacometrics or statistics (or other relevant area) preferred
• Master's Degree with 5+ years' relevant experience, or PhD with 4+ years' relevant experience can be considered
• Relevant experience includes:
• Understanding of pharmacokinetics/pharmacodynamics (PKPD) theory and modelling, statistical methodology, and data interpretation
• Proficiency in R and NONMEM
• Experience working with clinical trial data and clinical drug development
• Possesses a flexible and positive mindset
• Excellent written and oral communication skills, with an emphasis on presentation abilities

Preferred experience includes:

• Experience with health authority interactions and submissions, with an understanding of FDA, EMA, and other regulatory guidelines related to drug development

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-. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.

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