Nonclinical Project Director - Global Drug Discovery
Novo Nordisk
- Lexington, MA
- Permanent
- Full-time
- Manage the nonclinical development of siRNA research and development projects in Novo Nordisk’s core business areas from lead candidate selection to submission and approval
- Lead nonclinical project teams working with siRNA molecules and be an integrated member of the overall global project teams in research and development
- Coordination of all nonclinical activities, such as toxicology, safety pharmacology, bioanalysis and DMPK, to ensure optimal project progress during the project lifespan
- Ensure timely and adequate nonclinical deliveries and safety documentation for clinical trial applications, regulatory interactions, and market registration to global regulatory authorities (e.g. IB, pre-IND, IND/CTA and NDA/MAA)
- Participate in development and optimize our siRNA nonclinical development strategy
- Provide regular updates to internal stakeholders/project teams on the progress of nonclinical activities
- Support evaluations of external opportunities
- 0-10% overnight travel required.
- Advanced degree or PhD within the life sciences (DVM, MD, Pharmacist, Biology), or a related discipline
- 10+ years professional experience working with nonclinical development and nonclinical project management in the pharma industry or biotech
- Prior experience with oligonucleotides would be an advantage
- Experience in communication with health authorities and in preparing regulatory filings, such as IB/IND/CTA/IMPD/NDA
- Excellent communication skills, able to work in a complex and interdisciplinary organization, and having the personal power to influence and to retain focus
- Ability to navigate in a fast-paced and project-driven environment with changing deliverables and timelines
- Capability to manage several projects simultaneously