Pioneering Medicines : Director, Drug Substance Development

Director, Drug Substance Development

What if... We could harness the power of Flagship's scientific platforms and create novel treatment options that benefit more patients, sooner?

Pioneering Medicines, an initiative of Flagship Pioneering, is building a world-class biopharmaceutical R&D capability focused on conceiving and developing life-changing treatments for patients by harnessing the power of Flagship's scientific platforms and applying those innovative approaches to serious diseases with unmet medical need. Unique to Pioneering Medicines' approach is the opportunity to combine platforms to create truly novel and potentially transformative treatments.

Flagship Pioneering conceives, creates, resources, and develops first-in-category life science platform companies to transform human health and sustainability. Since its founding in 2000, the firm has originated and fostered the development of more than 100 scientific ventures, resulting in over $34 billion in aggregate value, 500+ issued patents, and more than 50 clinical trials for novel therapeutic agents.

Position Overview

We are seeking a highly experienced and visionary Director of Drug Substance Development to lead and expand our development capabilities across biologics and other modalities, including small molecules, peptides, and nucleic acids. The successful candidate will drive technical strategy, oversee process development activities, and ensure regulatory compliance while fostering innovation and high-performance team culture. This role is critical to advancing our pipeline from early research through IND and beyond.

Key Responsibilities

Leadership and Strategy :

• Define the strategy and lead the drug substance development team, fostering a culture of innovation and scientific excellence.
• Provide subject matter expertise in biologics process development, with strong cross-modality awareness.
• Collaborate with cross-functional teams, including Research, Development, Quality to align R&D activities. Represent the function in governance meetings and strategic collaborations.

Process Development :

Project Management :

Regulatory and Compliance :

Innovation and Continuous Improvement :

Team Development :

Qualifications

Preferred Qualifications

Flagship Pioneering and our ecosystem companies are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.