Job Information
Novo Nordisk Director - Clinical Trial Simulations in Lexington, Massachusetts
About the Department
Are you prepared to be a game-changer in drug development? Do you possess the leadership and the technical expertise to refine clinical drug development through the power of clinical trial simulations? If so, we invite you to join our dynamic Pharmacometrics team at Novo Nordisk. The Pharmacometrics (PMX) department supports the entire Novo Nordisk development portfolio with model-based analyses, from the strategic planning and execution of first-in-human trials to regulatory submissions.
By being patient-focused, with a clear purpose of driving change to defeat diabetes and other serious chronic diseases, we have achieved a market leading position, and we continuously develop our expertise to stay ahead – both as a company and as individuals. Working here mean joining a team of highly qualified, ambitious colleagues with a passion to bring better treatments to the people who need them. We strive for always keeping our positive and collaborative atmosphere in our daily work.
The Position
The director will drive the implementation of pharmacometrics concepts across the Novo Nordisk pipeline. Pharmacometrics aids in streamlining drug development by guiding decision-makers in the design of clinical trials. It helps determine optimal dosing regimens, assess the likelihood of trial success, and identify potential issues early in the development process. This leads to more efficient resource allocation and faster development timelines. One of the critical applications of pharmacometrics is in trial design and optimization. Through model-based simulations, this director will be responsible for clinical trial simulations will be available for all projects to explore different dosing strategies, trial durations, and patient populations before conducting expensive and time-consuming clinical trials. This not only reduces the cost of drug development but also enhances the likelihood of trial success. Furthermore, the Director will actively coach more junior colleagues in both professional development and project execution, setting technical direction and influencing the progression of initiatives across team boundaries. The Director is perceived as an expert across the SVP area, anticipates internal and/or external business challenges and issues, and drives innovation in their field of expertise. Solves unique and complex problems that have a broad impact on project and business performance.
Relationships
The Director in ‘Clinical Trial Simulations’ reports to the relevant Vice President (VP) of Pharmacometrics in the global Data Science function. Internal partners include other team leaders in the specific Pharmacometrics area, as well as more broadly in Data Science. Furthermore, key partners and stake holders include global clinical, medical and biological experts, colleagues in IT, and other experts across US and Denmark.
External relationships include relationships with commercial and academic collaboration partners.
Essential Functions
Leadership, being able to motive and develop people to make a difference in drug development
Communication expertise to convey message
Connect all dots in the pharmacokinetic/pharmacodynamic storyline throughout the development process
Optimize trial design in close interaction with the medical/statistics/clinical Pharmacology
End-to-end thinking to optimize drug development
Automations procedures, and how to best utilize new concepts like ML or AI to automate procedures within the area of pharmacometrics
Regulatory interactions and submissions to authorities across the globe
Pharmacokinetic and pharmacodynamic modelling and physiologically based extensions
Therapy area understanding, including disease progression and the implementation of these concepts in drug development
Virtual and avatar patient setup for simulations and how to deploy these concepts in drug development
Physical Requirements
Up to 20% overnight travel.
Development of People
Ensure that reporting personnel have individual development plans (IDP), with annual goals and measurements that are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those priorities, and they understand their level of accountability for results and the measurement process.
Ensure that the IDP forms include completed learning and aspiration plans and are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility.
Manage the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way.
Qualifications
Bachelor’s degree required. Master’s degree or PhD preferred. Degree within related scientific discipline with training in modelling and simulation preferred
11 years of relevant experience, at least 5 years of experience in pharmaceutical, biotech or healthcare industry in relevant area. Advanced degree may be substituted for experience when deemed appropriate
Other Relevant experience including:
Proficient in modelling and simulation (PKPD), with demonstrated experience in clinical trial simulations and a comprehensive understanding of regulatory requirements and industry best practices in this area
Robust management background with a strategic and analytical mindset
Extensive experience in regulatory interactions and a deep understanding of regulatory requirements
Demonstrated leadership skills, with the ability to inspire and motivate a team. Skilled in establishing clear objectives and efficiently prioritizing tasks
Self-driven, resilient, and dedicated to upholding high personal integrity. Excellent communication and collaboration skills, with the ability to work effectively with cross-functional teams; proven ability to create and delivery presentations
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.