Application Guide

How to Apply for Head of Clinical Development

at Flagship Pioneering

🏢 About Flagship Pioneering

Flagship Pioneering is a unique venture creation firm that conceives, creates, resources, and grows first-in-category bioplatform companies. Unlike traditional biotech companies, Flagship operates through its Pioneering Medicines division to rapidly advance multiple therapeutic programs simultaneously, offering the opportunity to work across diverse platforms rather than a single pipeline. This role offers exposure to Flagship's ecosystem of over 40 portfolio companies and their pioneering approach to solving major health challenges.

About This Role

As Head of Clinical Development, you'll lead clinical strategy and execution for Flagship's Pioneering Medicines portfolio, overseeing multiple clinical programs simultaneously across different therapeutic areas. This role is impactful because you'll be shaping the clinical development of potentially groundbreaking therapies from Flagship's unique bioplatform companies, with direct influence on regulatory strategy and patient safety across a diverse portfolio rather than a single product.

💡 A Day in the Life

A typical day involves reviewing clinical data across multiple immunology programs, leading cross-functional meetings with different portfolio company teams, developing regulatory strategies for upcoming submissions, and overseeing clinical operations across various studies. You might spend the morning analyzing Phase 1 data from one Flagship company's program, then pivot to preparing for an FDA meeting on another company's immunology asset, while also mentoring junior clinical staff on portfolio management approaches.

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🎯 Who Flagship Pioneering Is Looking For

  • An M.D. or Ph.D. with 8+ years specifically in small molecule drug development within biopharma, not just general pharmaceutical experience
  • Deep therapeutic expertise in immunology/inflammation with demonstrated success in clinical development programs in this area
  • Proven experience as a functional leader in early clinical development or clinical pharmacology who has successfully built or scaled clinical operations teams
  • Experience with regulatory submissions and agency interactions for small molecule therapies, particularly in immunology indications

📝 Tips for Applying to Flagship Pioneering

1

Highlight specific small molecule development experience in immunology/inflammation - quantify your impact (e.g., 'led Phase 2 trial for small molecule IL-17 inhibitor resulting in...')

2

Demonstrate understanding of Flagship's unique model by referencing specific portfolio companies or platforms (like Laronde, Generate Biomedicines, or Tessera Therapeutics) in your application

3

Emphasize experience with multiple concurrent clinical programs, as this role oversees portfolio development rather than single-product focus

4

Showcase regulatory interaction experience with specific examples of FDA/EMA submissions for immunology small molecules

5

Include examples of building or scaling clinical operations functions, particularly in a multi-program environment

✉️ What to Emphasize in Your Cover Letter

["Your specific experience with small molecule development in immunology/inflammation and how it applies to Flagship's portfolio", 'Examples of successful regulatory submissions and agency interactions for immunology therapies', 'Experience leading multiple clinical programs simultaneously and building/scaling clinical operations teams', "Understanding of Flagship's unique venture creation model and how you would contribute to their Pioneering Medicines approach"]

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🔍 Research Before Applying

To stand out, make sure you've researched:

  • → Flagship's Pioneering Medicines division and their portfolio approach to drug development
  • → Specific Flagship portfolio companies working in immunology/inflammation (like Generate Biomedicines, Laronde, or others)
  • → Flagship's unique bioplatform model versus traditional biotech development approaches
  • → Recent regulatory developments in immunology small molecule therapies that might impact Flagship's programs

💬 Prepare for These Interview Topics

Based on this role, you may be asked about:

1 How would you approach clinical strategy for multiple immunology programs across different Flagship portfolio companies simultaneously?
2 Describe your most challenging regulatory interaction for a small molecule immunology therapy and how you resolved it
3 How have you built or scaled clinical operations functions in previous roles, particularly in multi-program environments?
4 What experience do you have with translational medicine approaches in immunology drug development?
5 How would you ensure patient safety and data integrity across diverse clinical programs with different mechanisms of action?
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⚠️ Common Mistakes to Avoid

  • Focusing only on large molecule/biologic experience without emphasizing small molecule development expertise
  • Presenting as a single-product specialist rather than someone who can manage portfolio-level clinical development
  • Failing to demonstrate specific immunology/inflammation therapeutic area expertise in clinical development context

📅 Application Timeline

This position is open until filled. However, we recommend applying as soon as possible as roles at mission-driven organizations tend to fill quickly.

Typical hiring timeline:

1

Application Review

1-2 weeks

2

Initial Screening

Phone call or written assessment

3

Interviews

1-2 rounds, usually virtual

✓

Offer

Congratulations!

Ready to Apply?

Good luck with your application to Flagship Pioneering!

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