Director - Clinical Trial Simulations

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 Nordis