Senior Nonclinical PM Lead – Small Molecules

Novo Nordisk; Måløv; Vor Ort; DKK 847.000 - 1.245.000; Vollzeit

Zusammenfassung

Novo Nordisk in Måløv seeks an Associate Director, Nonclinical Project Management for small-molecule programmes from lead candidate selection through clinical development and regulatory submission.

You will lead cross-functional teams, coordinate toxicology, safety pharmacology, drug metabolism and pharmacokinetics, and establish integrated project plans with timelines, budgets and deliverables to drive milestones.

Qualifikationen

• Academic degree in veterinary medicine, pharmacology, toxicology, pharmaceutical sciences or another life-science discipline.
• Several years of experience in pharmaceutical or biotechnology drug development, including small-molecule development.
• At least three years of nonclinical project management or cross-functional development experience.
• Strong understanding of nonclinical small-molecule development, including DMPK, safety pharmacology and toxicology.
• In-depth knowledge of nonclinical regulatory guidance and expectations.
• Strong planning, prioritisation, risk-management and stakeholder-management skills with excellent English communication.

Aufgaben

• Lead nonclinical project management for a portfolio of small-molecule projects from lead selection through clinical development and market.
• Coordinate work across toxicology, safety pharmacology, drug metabolism and pharmacokinetics, bioanalysis and related development disciplines.
• Establish and maintain integrated project plans covering timelines, budgets, risks, dependencies, resources, and key deliverables.
• Bring teams together to identify and resolve issues, maintain momentum, and prepare projects for important development milestones.
• Drive the preparation of high-quality nonclinical data packages and documentation for regulatory submissions.
• Plan and facilitate nonclinical design reviews and the first Safety Committee Meeting before first human dose trial, supporting regulatory interactions.

Kenntnisse

Nonclinical PM

Leadership

English comms

Regulatory know-how

Risk management

Ausbildung

Life-science degree

PhD preferred

Jobbeschreibung

Novo Nordisk in Måløv seeks an Associate Director, Nonclinical Project Management for small-molecule programmes from lead candidate selection through clinical development and regulatory submission.

You will lead cross-functional teams, coordinate toxicology, safety pharmacology, drug metabolism and pharmacokinetics, and establish integrated project plans with timelines, budgets and deliverables to drive milestones.