Scott Duncan

I deliver strategic program management consulting for virtual and mid-size pharma-biotech companies, leading cross-functional initiatives across Clinical Development, Regulatory Affairs, CMC, and Commercial functions. I optimize portfolio management and resource allocation while developing integrated R&D and regulatory strategies that streamline operations, ensure compliance, and align technical execution with critical business milestones.

My days are spent orchestrating what I like to think of as a complex symphony, making sure our late-stage CMC strategy doesn't just look good on paper but works in the real world, while serving as a translator between brilliant scientists, sharp business minds, and meticulous regulatory experts, while partnering with Product Development Team (PDT) members to build integrated asset plans and regulatory strategies, ensuring alignment with key milestones and timelines. + Became a tech evangelist in our traditionally old-school industry. I implemented AI-driven workflow tools that give us a vision into potential bottlenecks and compliance issues, turning risk management into an art form through proactive scenario planning and executive dashboards that tell a clear story. + Mastered the art of cross-functional communication and decision-making. Whether I'm drafting RFPs, leading quality audits, or presenting strategic updates to executives making million-dollar decisions, I've become equally comfortable diving deep into technical details and facilitating high-level strategic alignment. + Revolutionized our approach to contract manufacturing oversight. Instead of just hoping everything goes smoothly, I built robust systems for CDMO due diligence, vendor selection, and drug substance manufacturing that catch potential issues before they become program-killing problems, ensuring scalable supply chains for global clinical trials. + Became the go-to person for late-stage CMC strategy and execution. I'm the one ensuring our TB drug development programs stay aligned with regulatory timelines and business goals, turning "what if we could..." dreams from R&D into "here's exactly how we'll do it" execution plans through integrated cross-functional strategies.

Senior Director of CMC (Aug 2021 – Nov 2022) As a program management leader specializing in regulatory affairs and CMC development, I translate complex clinical programs from conception through approval, ensuring every regulatory filing tells a compelling story that health authorities can confidently support. My integrated approach to program management has consistently delivered results across multiple therapeutic areas, where I've learned that success is about building bridges between cross-functional teams. + Regulatory Excellence: Authored nearly a dozen critical regulatory submissions (INDs & IMPDs) across 18 months, presenting strategic program plans to senior leadership that significantly reduced regulatory risks and enhanced approval timelines across multiple health authorities. + Financial & Operational Leadership: Successfully managed $10M+ annual budgets while leading cross-functional teams through Finance, HR, and operational partnerships, establishing transparent communication protocols that consistently delivered programs on time and within scope. + Global Regulatory Expertise: Led authorship of DS, DP, and analytical sections for eCTD filings to FDA and international health authorities (EMA, MoH, BfArM, ANSM, AEMPS), facilitating seamless agency interactions across multiple regions and enhancing regulatory compliance standards. Roivant Discovery (fka Silicon Therapeutics) Aug 2020 – Aug 2021 + Program Leadership & Resource Management: Directed cross-functional teams including internal chemists, project managers, legal, and accounting alongside external consultants and vendors for Hemavant and STING CMC programs. + Drug Discovery Innovation: Led chemistry teams in designing and synthesizing novel non-covalent KRAS bifunctional degraders (PROTACs), optimizing key scaffolds with enhanced ADME properties, and successfully advancing the program toward IND candidate selection through strategic compound evaluation and testing protocols.

As a cross-functional program leader, I orchestrate clinical-stage development programs where precise coordination of vendors, regulatory timelines, and operational strategies determines whether breakthrough treatments reach patients who need them most. Throughout my career, I've discovered that success lies in building resilient systems that anticipate challenges and deliver results, guiding me through complex regulatory landscapes and high-stakes investor presentations while keeping patient impact at the center of every strategic decision. + Operational Excellence: Successfully managed cross-functional execution for 3 clinical-stage development programs, coordinating 24+ vendors to achieve 100% on-time delivery of clinical trial materials within budget, ensuring uninterrupted patient enrollment and regulatory milestone achievement. + Strategic Leadership & Stakeholder Management: Partnered with senior leadership on operational strategy and budget oversight while presenting program status and strategic recommendations to both internal executives and external investors during critical due diligence processes. + Regulatory & Planning Expertise: Authored comprehensive regulatory documentation (IND, NDA, IMPD) and developed integrated development plans alongside Product Development Team Leaders, maintaining robust risk registers and timelines that consistently delivered program objectives.

My role at Stealth BioTherapeutics has been a masterclass in wearing multiple hats while never losing sight of the goal of transforming innovative peptide-based therapies from laboratory concepts into life-changing treatments for patients. As lead researcher, CMC subject matter expert, and project manager, I've guided our clinical and pre-clinical candidates through every stage of development—from initial synthetic chemistry and process optimization to commercial manufacturing compliance. Working under aggressive timelines across pre-IND through Phase IV programs, I've learned that success in pharmaceutical development requires not just scientific expertise, but the ability to seamlessly integrate discovery, manufacturing, regulatory strategy, and vendor partnerships into a cohesive pathway that consistently delivers results. + Discovery & Process Innovation: Led discovery efforts producing 75+ SAR compounds while developing and optimizing multiple manufacturing processes for peptide-based clinical candidates under aggressive timelines, achieving near-100% delivery success across non-clinical and clinical studies. + Strategic Manufacturing & CRO Partnerships: Successfully transferred and optimized manufacturing processes in collaboration with US and international CROs, consistently delivering high-quality API on time to support critical program milestones and regulatory submissions. + Integrated Vendor & Regulatory Management: Managed $1-2M annual vendor budgets while serving as CMC lead author for SOPs, analytical methods, and regulatory documentation, ensuring compliance and performance standards that supported successful progression from pre-IND through commercial programs.

As lead researcher, CMC subject matter expert, and project manager across four major clinical programs, I've orchestrated the complex journey of API supply management, where every decision impacts not just regulatory timelines but ultimately patient access to critical medications. Managing over $10M in annual outsourcing budgets, I've learned that success in pharmaceutical development requires equal parts scientific rigor, strategic partnership management, and unwavering commitment to quality, especially when working on treatments for mental health disorders and addiction recovery, where patient need is most urgent. + Commercial Process Leadership: Led critical process parameter studies and validation oversight for Aripiprazole Lauroxil (Aristada®), scaling from 20kg for Phase III trials to 120kg for commercial launch, while serving as lead author for the complete 3.2.S regulatory module that enabled successful market approval. + Innovative Therapeutic Development: Developed comprehensive manufacturing processes for a non-addictive opiate antagonist targeting refractory depression, designing and leading teams to establish Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs) for commercial-scale production. + Strategic Program & Budget Management: Served as CMC subject matter expert across four major clinical programs with >$10M annual outsourcing budget responsibility, ensuring seamless API supply chain management and regulatory compliance from early development through commercial manufacturing.

CAMBRIDGE MAJOR LABORATORIES, Milwaukee, WI Jul 2008 - Dec 2009 Senior Project Manager • Coordinated all aspects of project communication between clients and CML, serving as the project manager for over 30 projects and clients annually, enhancing portfolio management. • Provided scientific oversight and coordinated daily activities of over a dozen Ph.D., Masters, Bachelors, and kilo lab and production staff, achieving a >95% success rate in meeting client requirements on time, within budget, and quality specifications. • Resolved synthetic, manufacturing, resource, and communication challenges related to route design, process optimization, and safety concerns, significantly increasing customer retention over two years. SAFC PHARMA – TETRIONICS, Madison, WI Nov 2002 - Jun 2008 Senior Scientist and Chemistry Team Leader • Managed all aspects of API projects, supervising junior staff and maintaining effective communication, achieving a high success rate in delivering materials on time, within budget, and quality targets. • Initiated and implemented infrastructure for the site process safety program, leading a harmonization team to establish corporate guidelines, increasing compliance with state and federal guidelines. • Established design of experiments, automating parallel reaction screening and quantitative thermal hazard assessment, increasing site revenue.

Thesis Title " The Total Synthesis of Epi-C16, Epi-C18-Cytochalasin D" Advisor: Professor Edwin Vedejs.

Organic Chemistry