Associate Director – Drug Substance Project Lead

About the role

Novartis is seeking an experienced Associate Director to lead drug substance development programs for innovative biologic medicines. Based in Mengeš, Slovenia, the role combines strategic oversight with hands‑on operational leadership, guiding projects from early research through commercial launch.

Key responsibilities

• Lead drug substance development across all phases, defining integrated strategies and ensuring milestone delivery.
• Serve as the central integration point for Drug Substance Development, Analytical Development, Drug Product Development, Regulatory Affairs, Quality, Clinical Supply and external partners.
• Influence cross‑functional teams without direct authority, building credibility and aligning stakeholders to shared goals.
• Present strategy, progress and recommendations to governance bodies and senior leadership.
• Drive scientific and technical excellence, promote continuous improvement and data‑driven decision making.
• Translate strategy into actionable plans, remove barriers and hold teams accountable.
• Coach and mentor junior leaders, fostering an inclusive, psychologically safe environment.

Required profile

• PhD in a life‑science discipline or equivalent with at least 8 years of biologics development experience.
• Minimum 5 years of proven leadership managing cross‑functional teams and complex projects.
• Excellent scientific and technical writing, communication and presentation skills.
• Fluency in English; additional languages are a plus.

Required skills

• Biologics development (mAbs, cell therapy or similar platforms).
• Regulatory affairs experience, including IND/BLA submission processes.
• Project management of complex drug substance programs.
• Scientific writing and data‑driven decision making.

What we offer

• Opportunity to lead high‑impact programs that affect millions of patients.
• Collaboration with world‑class scientific experts across a global organization.
• Leadership role with strategic responsibility and career growth potential.