Pioneering Medicines: Executive Director, CMC

Flagship Pioneering, Inc.•Cambridge, MA

10h

About The Position

Pioneering Medicines (PM), 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. We are seeking an Executive Director, CMC (Chemistry, Manufacturing & Controls) with a proven track record of driving portfolio-level CMC strategy and execution across multiple emerging modality programs simultaneously. This is a senior leadership role operating at the intersection of science, strategy, and operations—requiring the ability to set direction across a complex multimodality pipeline, and build CMC function as a competitive advantage for Pioneering Medicines. This position reports to the SVP, CMC & Technical Operations. This role will serve as the strategic and operational owner of CMC across the full PM portfolio from research interface through early and late clinical development. This leader will be equally comfortable shaping long-range CMC strategy at the portfolio level and resolving complex technical challenges at the program level. They will define how PM approaches emerging modalities, build and leverage a best-in-class external Contract Development and Manufacturing Organizations (CDMO) network, combined with the strategic acumen to make portfolio-level resourcing decisions. They will be a thought leader in innovative approaches and champion adoption of AI-enabled CMC tools.

Requirements

PhD in a relevant scientific discipline with 15+ years of progressive CMC experience (MS with 18+ or BS with 20+ considered); Minimum 5 years in senior leadership with direct accountability for CMC strategy across multiple simultaneous programs
Deep hands-on expertise in small molecules and biologics. Expertise is preferred (but not required) in advanced modalities incl. nucleic acids, cell or gene therapies
Demonstrated track record of filing and defending regulatory dossiers (INDs, CTAs, BLAs/NDAs, or MAAs) across multiple programs and modalities; Current working knowledge of global regulatory expectations (FDA, EMA, PMDA) and direct experience in agency interactions on CMC topics.
Proven ability of owning CMC strategy and execution across a multi-program portfolio simultaneously, including developing and managing CMC budgets, risk management, and delivery against aggressive timelines
Extensive experience identifying, selecting, contracting, and managing CDMOs and CROs with specialized emerging modality capabilities, including leading technology transfer and resolving technical challenges at external sites
Thought leadership in innovation, including novel delivery, high-throughput process development, and platform-based approaches to elevate program / portfolio value
Strong understanding of AI/ML, digital process development tools, and data-driven manufacturing platforms to improve development speed and efficiency
Executive presence and demonstrated ability to influence and align cross-functional PM and platform company leaders; Strong communicator who can translate complex CMC strategy and risk for non-specialist audiences
Experience partnering with GxP Quality to establish quality systems appropriate for a development-stage organization, including SOPs, change control, and deviation management in a GxP environment
Entrepreneurial builder energized by creating structure in ambiguous, fast-moving environments; high accountability orientation with a bias for action and the ability to make sound decisions with incomplete information
Collaborative, low-ego leadership style with genuine investment in team development and cross-functional relationships

Nice To Haves

Expertise is preferred (but not required) in advanced modalities incl. nucleic acids, cell or gene therapies

Responsibilities

Serve as a key member of the Technical Operations leadership team. Lead CMC functions including Drug Substance Development, Drug Delivery / Pre-formulation, Analytical Development, Product Development and Regulatory CMC. Accountability for all aspects of CMC functional strategy and portfolio deliverables.
Responsible for building and scaling the CMC organization and defining its strategic direction. Recruit, develop, and retain a high-performing CMC team; invest in talent and cultivate a culture of excellence, accountability, and continuous improvement
Own and drive end-to-end CMC execution across an increasing portfolio of multimodality compounds, ensuring programs advance on time and on strategy; accountable for portfolio-level CMC risk identification, prioritization, and mitigation
Build and manage a high-performing external CDMO network in partnership with VP, CMC Operations. This includes selection, assessment and establishment of strategic relationships; Maintain a forward-looking view of the CDMO landscape to anticipate portfolio capacity and manufacturing needs
Oversee the identification, evaluation, and implementation of novel technologies and innovations to drive greater program / portfolio value. Leverage emerging AI-driven technical development, manufacturing and advanced analytics approaches to accelerate CMC timelines and improve efficiency across the portfolio
Engage and align key stakeholders across Technical Operations, Research, Translational Medicine, and Regulatory Affairs to establish CMC development paradigms, resolve cross-functional trade-offs, and ensure portfolio decisions reflect both scientific rigor and operational reality
Oversee CMC handoffs and establishing fit-for-purpose development and manufacturing pathways for novel modalities originating within the FSP ecosystem. Act as CMC strategic advisor, as needed
Serves as an ambassador of PM for external stakeholders and industry as a whole