Nonclinical Project Director - Global Drug Development

About the Department

Our US Research & Development (R&D) hub, located in the Greater Boston area, brings together the best talent to drive life science innovation, from early research through late-stage clinical development.

By combining the speed and agility of biotech with the quality, resources, and stability of a large pharmaceutical company, our US R&D hub will benefit from the best of both worlds to develop new medicines that meet the needs of patients.

Global Discovery and Development Sciences (GDDS) Boston, part of the US R&D hub, is building a new siRNA Nonclinical Development department with cross-functional scientific expertise, including toxicology, safety pharmacology, PKPD, ADME, outsourcing management, and non-clinical project management.

The department manage the nonclinical development process from lead candidate selection to submission and registration of new siRNA-based therapies within our core business areas, including diabetes, obesity, cardiovascular disease, metabolic dysfunction-associated steatohepatitis and chronic kidney disease, and rare diseases.

Our proprietary GalXC™ and GalXC-Plus™ siRNA technologies have the potential to selectively target and modulate proteins that cause or contribute to the disease and thereby address conditions that are difficult or impossible to treat with other modalities.

The team is located in Lexington in close proximity to our Discovery and Development teams to facilitate collaboration and knowledge transfer throughout the lifecycle of a project.

About the Position

As Nonclinical Project Director you will be heading nonclinical project teams, and you will be an integrated member of the overall global project teams in research and development.

You will be coordinating complex cross-disciplinary nonclinical deliverables, such as toxicology, safety pharmacology, bioanalysis and DMPK, on research and development projects.

You will ensure a good collaborative environment internally in your teams as well as with other stakeholders inside and outside Novo Nordisk, and you will ensure follow-up on activities and support smooth milestone passages for your projects.

We are looking for an individual that can challenge status quo and has proven ability to optimize and design nonclinical development programs to support our growing siRNA project portfolio.

Relationships

Reports to Head of Global Discovery and Development Sciences Boston. Relationships include working in a multi-functional department with various nonclinical disciplines, including other Nonclinical Project Directors, interaction with external research collaborators (mainly industry-based), and frequent interaction with Project Vice Presidents and other colleagues across global R&D.

The Nonclinical Project Director will lead nonclinical project teams.

Essential Functions

• 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

Physical Requirements

0-10% overnight travel required.

Qualifications

• 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

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.