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 Summary: 

Pioneering Medicines is seeking a curious, driven Senior Director, Regulatory Affairs with pharma/biotech experience to support Clinical Development for one or more early development programs. Experience in early phase clinical development is essential. This role is responsible for generating the regulatory strategy and approval for novel pharmaceuticals that are going into clinical trials.  This role will collaborate across groups within Pioneering Medicines and with Flagship and pharma partner companies and CROs. This leader will deliver regulatory strategies for a growing pipeline of diverse assets in the PM portfolio, with an emphasis on early development. This individual will also provide input into clinical development for early asset companies and explorations within the Pioneering Medicines’ portfolio and to companies across the Flagship Ecosystem, as needed. This individual would report to the SVP of Project Leadership and Development, Pioneering Medicines 

The preferred candidate will have expertise in multiple therapeutic areas, including metabolic diseases and obesity, and across drug modalities, and have led regulatory filings for IND and CTA opening studies. Experience with scientific advice meetings and successful NDAs or BLAs is a plus.  

Flagship is built on institutional, entrepreneurial innovation within a small, dynamic company environment. We seek individuals with an entrepreneurial mindset, strong communication skills, and the ability to thrive in a cross-functional team setting. 

Key Responsibilities:  

• Collaborate with the SVP of Project Leadership and Development, Clinical Leads, and other senior leaders to develop and implement comprehensive regulatory strategies for early-stage programs. 
• Serve as the primary regulatory representative on program and clinical trial teams, managing regulatory timelines and ensuring adherence to applicable regulations and guidance. 
• Provide strategic regulatory guidance from product concept through proof-of-concept trials, including risk assessments and mitigation strategies. 
• Lead the preparation and submission of regulatory documents, including INDs/CTAs and briefing packages, ensuring high-quality and timely submissions. 
• Plan and execute regulatory agency engagements, such as pre-IND/CTA and scientific advice meetings, serving as the primary contact with agencies like the FDA. 
• Develop asset-specific Regulatory Development Plans and drive health authority interactions related to clinical trials. 
• Monitor and interpret evolving regulatory policies and guidance, disseminating relevant information to project teams and senior management. 
• Develop and implement regulatory policies, processes, and standard operating procedures (SOPs) to foster a compliance-focused culture. 
• Participate in the evaluation of assets across the FSP landscape, assisting teams in presenting findings and recommendations to the Development Committee. 
• Leverage regulatory expertise to support nascent FSP platform companies in developing their asset portfolios. 
• Maintain and interact with a network of external partners, key opinion leaders, consultants, CROs, and strategic consulting organizations to advance programs. 
• Prepare and deliver presentations for both internal and external audiences, effectively communicating regulatory strategies and updates.  

Minimum Qualifications: 

• Advanced degree (Ph.D., PharmD, M.D., M.S., or equivalent) in a relevant scientific discipline such as pharmaceutical sciences, regulatory science, or life sciences. 
• Minimum of 12 years in the pharmaceutical or biotechnology industry, with at least 10 years in regulatory affairs roles. Demonstrated experience leading regulatory strategies and submissions across early-stage development programs. 
• Proven track record in preparing and managing regulatory submissions (e.g., INDs, CTAs) and direct interactions with regulatory authorities, including the FDA and EMA. Familiarity with regulatory requirements in Australia and New Zealand is a plus. 
• In-depth understanding of FDA, EMA, and ICH regulations and guidelines. Experience with various therapeutic modalities (e.g., small molecules, biologics, peptides, nucleic acids, or cell therapies).  
• Prior involvement in metabolic diseases, immunology, or rare disease drug development is highly desirable. 
• Demonstrated ability to lead within cross-functional teams and foster effective relationships with regulatory agencies. 
• Regulatory Affairs Certification (RAC) is preferred. 
• Comfortable working in a fast-paced biotech environment, managing multiple projects, and adapting to evolving regulatory landscapes. 
• Excellent written and verbal communication skills, with the ability to effectively present regulatory strategies and updates to internal and external stakeholders. 
• Willingness to travel domestically and internationally, as required. 

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.