Pioneering Medicines: Director, Analytical 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.  

About Flagship Pioneering: 

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, Analytical Development. This role will lead the design, development, and implementation of analytical strategies to support the advancement of Pioneering Medicines’ portfolio from discovery through IND and into clinical development. The role requires deep expertise in biologics and small molecule analytical development and, ideally, exposure to other modalities such as peptides, and nucleic acids. This leader will ensure analytical methods are robust, phase-appropriate, and compliant with global regulatory expectations, while enabling innovation and scalability across the pipeline.

Key Responsibilities:

1. Leadership and Strategy:
• Lead the analytical development team, fostering a culture of innovation and scientific excellence.
• Define and drive the analytical development strategy across modalities to enable pipeline progression.
• Partner cross-functionally with drug substance, process development, quality, regulatory, and program leadership teams to align on priorities and execute the deliverables.
2. Analytical Development:
• Oversee development, qualification, and validation of analytical methods for characterization, release, and stability testing.
• Guide implementation of advanced technologies (e.g., mass spectrometry, chromatographic techniques, bioassays) to ensure deep product understanding.
• Establish phase-appropriate control strategies to support IND submissions and clinical manufacturing.
3. Project Management:
• Provide technical leadership for analytical deliverables across multiple programs and modalities.
• Manage timelines, resources, and budgets to ensure on-time delivery of analytical packages for IND and beyond.
• Oversee interactions with external CDMOs/CROs to ensure analytical work is executed to standards.
4. Regulatory and Compliance:
• Ensure analytical activities comply with ICH, FDA, EMA, and other global regulatory standards.
• Lead preparation and review of CMC analytical sections for IND, IMPD, and BLA/MAA submissions.
• Support regulatory agency meetings, providing clear scientific and technical rationale for analytical strategies.
5. Innovation and Continuous Improvement:
• Drive adoption of novel analytical platforms and digital tools to increase efficiency, sensitivity, and throughput.
• Implement continuous improvement initiatives for method lifecycle management.
6. Team Development:
• Build, mentor, and lead a high-performing team of scientists with expertise across multiple modalities.
• Foster a culture of collaboration, accountability, and scientific excellence.

Qualifications:

• Ph.D. or master’s degree in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or a related field.
• 10+ years of experience in analytical development within the biopharmaceutical industry
• Strong expertise in biologics (proteins, antibodies, mAbs, complex modalities) and small molecules. Experience with other modalities including peptides, nucleic acids is desirable.
• Proven track record of delivering IND-enabling analytical packages and regulatory submissions
• Excellent knowledge of global regulatory requirements for analytical methods and CMC submissions.
• Demonstrated success in leading teams and managing external partners.
• Excellent leadership, communication, and interpersonal skills.
• Ability to work effectively in a fast-paced, dynamic environment.

About Flagship Pioneering:

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.  

The salary range for this role is $179,000 - $236,500. Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Pioneering Medicines currently offers healthcare coverage, annual incentive program, retirement benefits and a broad range of other benefits. Compensation and benefits information is based on Pioneering Medicines’s good faith estimate as of the date of publication and may be modified in the future.