Address
Form of workAbout 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 nonclinical, 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
These positions will make substantial contributions to the organization's objectives by:
- Driving nonclinical development activities in the Cell Therapy R&D portfolio (strategic planning, experimental design, execution, analysis and reporting)
- Providing expert advice on Cell Therapy non-clinical development matters within Cell Therapy R&D
- Planning and conducting the first Safety Committee Meeting to support First Human Dose
- Representing the non-clinical function as a member of Global Project Teams, Clinical Development Teams, Product Systems Development Teams and Formulation teams
This position may also be located in our Lexington, MA locationWe will also consider candidates at the Sr. title commensurate with required qualifications/experience
Relationships
Reports to VP, Head of Development – Cell Therapy TRU.
This person will interact intensively with members of the Development team in the Cell Therapy TRU (e.g., Clinical Pharmacology/Science, Regulatory and Medical) and with its Research, CMC, Device, Innovation, Strategy & Operations departments of the departments. Collaboration with the wider Novo Nordisk organization and key external stakeholders will also be necessary to effectively drive our programs forward.
Essential Functions
- Prepare and implement Cell Therapy nonclinical development strategies and plans, ensuring that the Nonclinical Project gates and key deliverables are met
- Ensure timely nonclinical input to IBs, IMPD/INDs, PSUR/DSUR and other relevant documents, including responses to health authorities, material for advisory boards or investigator meetings
- Prepare input, and guide external collaborators on the execution of nonclinical studies
- Monitor, and review results from nonclinical studies
- Responsible for the nonclinical Common Technical Document (CTD) deliverables
- Manage and follow-up on nonclinical parts of project budgets
- Responsible for nonclinical input to the Target Product Profiles (TPP) and Product Development Plans (PDP)
- Provide high quality nonclinical safety assessments for Cell Therapy drug development
- Present and discuss Cell Therapy nonclinical development matters at meetings with regulatory authorities, advisory boards and internal governance bodies
Physical Requirements
Up to 10% overnight travel required.
Qualifications
- Minimum of doctorate degree (PhD, DVM, or MD) ; Master’s degree with substantial additional industry experience may also be considered
- 10+ years’ relevant experience, relevant experience includes:
- Experience managing the toxicology function within a biotech or pharmaceutical company.
- Proficiency in strategizing, conceptualizing, executing, evaluating, and documenting nonclinical studies pivotal for IND submission. These studies encompass biodistribution, toxicity, tumorigenicity, and efficacy assessments.
- Comprehensive understanding and practical application of Cell Therapy nonclinical protocols and fundamental research methodologies.
- Adeptness in navigating the external prerequisites for nonclinical Cell Therapy, encompassing GLP compliance and pertinent regulatory guidelines.
- Extensive engagement with key regulatory authorities such as FDA, EMA, and PMDA, showcasing a nuanced familiarity with regulatory interactions.
- Demonstrated expertise in leading cross-functional, international teams and adeptly managing multinational collaborative efforts.
Preferred:
- Experience or with neurosurgical, cardiovascular or general surgery procedures
- Experience with device or combination product 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. 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.
