About the Department
In Cell Therapy Research and Development, we are focused on developing cellular medicines that have the potential to change the way doctors treat intractable diseases. We develop differentiated cell types derived from pluripotent stem cells - for example cardiomyocytes to treat heart failure, beta islet cells for diabetes, and dopaminergic neurons for Parkinson’s disease. Join a dynamic, innovative and interdisciplinary team focused on non-clinical, clinical and regulatory disciplines that work together to further develop and advance a portfolio of ground-breaking cell therapies and combination product into clinics around the globe.
The Position
This role will contribute to the organization's goals by:
- Preparing and implementing high quality and effective cell therapy clinical development strategies and plans
- Leading the development on early cell therapy clinical study protocols within Cell Therapy R&D
- Developing biomarker strategies across our therapeutic areas
Relationships
Reports to VP, Head of Development – Cell Therapy Translational Research Unit (TRU). This person will interact intensively with members of the Development team in the Cell Therapy TRU (e.g., Non-Clinical and Regulatory) and with its Research, CMC, Device, Innovation, Strategy & Operations departments. Collaboration with the wider Novo Nordisk organization and key external stakeholders will also be necessary to effectively drive our programs forward.
Essential Functions
- Design and outline early cell therapy clinical development strategies, plans and trials, including authoring clinical trial synopses
- Provide high quality clinical development input to relevant documents, such as the Investigator Brochure, regulatory authority meeting packages and submissions, Safety Committee documentation, clinical summaries, risk management plans and other risk assessments, the PDP, and the Target Product Profile
- Develop project specific biomarker strategies
- Evaluate non-clinical and clinical safety, dose-response relations, and pharmacodynamics as relevant, prior to clinical trial initiation
- Provide input to publications and review Clinical Trial Reports
- Present and discuss clinical pharmacology and early clinical development matters at meetings with regulatory authorities /advisory board meetings/internal governance bodies
- Support building and maintaining a network of international investigators in scope for early cell therapy clinical trials
- Lead or being a member of Global Project Teams and/or Clinical Development Team(s)
- Responsible for clinical pharmacology, early clinical development and overall cell therapy development potential assessments of new project opportunities
Physical Requirements
0-10% overnight travel required.
Qualifications
- Advanced Degree in a Scientific discipline, specifically MD, Ph.D. or Pharm.D
- 10+ years Clinical Development experience within biotech/pharma industry
- In depth knowledge of biologics (including combination device-biologic product) development in general and ATMPs specifically, and a clear understanding of the R&D value chain, i.e., the various disciplines and their complex interactions
- Experience developing and executing biomarker strategies
- Experience with strategic and scientific planning aspects of clinical trials and working in cross-functional teams
- Knowledge and hands on experience with cell therapy clinical research and development
- In depth understanding of translation of non-clinical research and development into clinical development
- Experience of interacting with key regulatory authorities e.g., FDA, EMA, PMDA, as well as with external scientific advisors
- Excellent communication and interpersonal skills
- Preferred:
- Experience with clinical development in the cardiovascular therapeutic area
- Experience with design and execution of clinical trials in a surgical setting
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. The base compensation range for this position is $181,660 to $317,910. Base compensation is determined based on a number of factors.
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.