Pioneering Medicines : Senior Director, Regulatory Affairs

Senior Director, Regulatory Affairs

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.

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 :

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.

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.

Recruitment & Staffing Agencies : Flagship Pioneering and its affiliated Flagship Lab companies (collectively, "FSP") do not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to FSP or its employees is strictly prohibited unless contacted directly by Flagship Pioneering's internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of FSP, and FSP will not owe any referral or other fees with respect thereto.