Pioneering Medicines: Senior Director, Regulatory Affairs

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 programs transitioning to the clinic and in 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 drug modalities and have led regulatory filings for IND and/or CTA opening studies. Experience with end of phase meetings and successful NDAs or BLAs is a plus. They must possess a strong background in regulatory science, regulatory intelligence, have demonstrated leadership skills, an entrepreneurial spirit, and a compulsion to be challenged every day.  

 

Key Responsibilities:  

• Work with the SVP of Project Leadership and Development, the Development Project Lead/Clinical Lead and other company leaders, as well as program and clinical trial teams, to develop and implement regulatory strategy, development plans and associated activities across our innovative pipeline.  

• Represent regulatory affairs on Program teams and Clinical Trial teams - owning regulatory timelines and process, and the application of appropriate regulations and guidance. 

• Plan and execute successful engagements, including pre-IND/CTA and other scientific advice meetings, with regulatory agencies and serve as the primary contact for PM with the FDA and other regulators.  

• Provide regulatory guidance to project teams from product concept stage through human proof of concept trials, including strategic considerations, building timelines, regulatory submissions, and risk assessments and mitigations.  

• Own the development of asset-specific Regulatory Development Plans, author and manage creation of IND/CTA & Briefing Books, drive pre-IND meetings and other Health Authority-facing interactions related to specific clinical trials. 

• Develop and maintain current regulatory intelligence knowledge, including evolving policies and emerging guidance, and disseminate to project teams and PM management.  

• Drive the development of regulatory policies, processes, and SOPs for PM and help establish a compliance-focused culture.