Paul McManus

Global Clinical Supply Chain Leader | VP/Director-Ready | End-to-End Strategy · Risk Mitigation · Sustainable Trials | 25+ Years in Pharma & Biotech

Berlin, Berlin, Germany

About

I build clinical supply chains that don’t just work — they scale, adapt, and hold up under pressure. With 25+ years leading global clinical and commercial supply operations, I’ve spent my career turning complex, high-stakes trial logistics into reliable, efficient systems. Currently serving as Global Clinical Study Supply Head at Opella, I own end-to-end clinical supply strategy across a dynamic and evolving portfolio — ensuring continuity, efficiency, and alignment with the business’s shifting priorities. What I bring to organisations at the next level: 🔹 Strategic supply architecture — I’ve built global logistics and shipping functions from the ground up, establishing the policies, structures, and operating models that underpin supply reliability at scale. 🔹 Risk intelligence — I’m known for identifying supply risks early and executing corrective and mitigation strategies before they become disruptions. Supply continuity isn’t luck; it’s a discipline. 🔹 Forecasting & demand planning — I translate complex clinical trial designs — adaptive, rare disease, oncology, multi-regional — into rigorous demand forecasts and executable supply plans. 🔹 Cross-functional leadership — I’ve led large, complex projects spanning clinical operations, regulatory, manufacturing, and commercial teams, aligning stakeholders on logistics strategy from concept to operational reality. 🔹 Sustainability in clinical trials — I’m actively engaged in measuring and reducing the carbon footprint of clinical supply chains. This is an emerging imperative for the industry, and one I’m committed to advancing for the long term. I thrive in environments where supply chain isn’t just a support function — it’s a strategic enabler. If you’re building or scaling a clinical supply capability in pharma, biotech, or a CRO, I’d welcome a conversation. 📩 Open to VP and Director-level opportunities in Clinical Supply Chain | Global | Pharma · Biotech · CRO

Experience

  • Global Clinical Study Supply Head at Opella
    Apr 2025 - Present · 1 yr 3 mos

    - Lead the global end-to-end clinical supplies strategy, spanning demand planning, sourcing, packaging/labeling, distribution, and returns/reconciliation across Opella’s development portfolio. - Own functional strategy and operating model design to ensure an efficient, reliable, and scalable Clinical Supply organization aligned to evolving business priorities. - Partner with study teams to define and execute study-level supply strategies from start-up through close-out, ensuring on-time, right-first-time delivery and risk-mitigated continuity of supply. - Drive compliance with GCP, cGMP, and applicable global regulatory requirements; embed quality-by-design and robust documentation practices. - Collaborate cross-functionally with Clinical Operations, Medical, Regulatory Affairs, Pharmacovigilance, Clinical Supplies Quality, Clinical Quality, and CHC Development & Scientific Innovation to enable seamless study execution. - Champion continuous improvement and innovation in forecasting, IRT integration, vendor performance, and KPIs to optimize cost, cycle time, and patient availability.

  • Clinical Study Supply Head for Consumer Healthcare at Sanofi
    Feb 2023 - Apr 2025 · 2 yrs 3 mos

  • Affimed (Full-time · 3 yrs 6 mos)
    • Head of Drug Supply
      Feb 2022 - Jan 2023 · 1 yr

      - Directed the end-to-end clinical supply strategy to ensure uninterrupted patient supply while optimizing cost, cycle time, and waste reduction. - Built and led a high-performing clinical supply team; guided project and logistics functions with deep clinical logistics expertise to align internal and external partners and keep programs on schedule and budget. - Implemented robust demand/supply forecasting, inventory controls, and scenario planning; introduced a supply-optimization partner and processes delivering >20% savings. - Established SOPs and governance; strengthened compliance with ICH GCP, GLP, and GMP through quality-by-design and disciplined documentation. - Drove systems and operational enhancements to increase delivery efficiency and lower cost per shipment; instituted KPIs and vendor performance management to sustain improvements. - Analyzed demand vs. usage vs. supply to identify structural inefficiencies and executed corrective actions for durable cost avoidance and waste elimination.

    • Manager, Drug Supply
      Aug 2019 - Feb 2022 · 2 yrs 7 mos

      - Managed end-to-end clinical supply operations from raw materials through packaged, QP-released investigational product, ensuring schedule, quality, and budget adherence. - Built and executed S&OP processes integrating demand forecasts, manufacturing lead times, and study timelines to align supply with evolving clinical needs. - Optimized logistics and inventory through scenario planning, just-in-time labeling, and IRT coordination; improved on-time, in-full performance across studies. - Led vendor selection and management for manufacturing, packaging, distribution, forecasting, co-meds, and supply-optimization services; strengthened performance through clear KPIs and governance. - Drove SOP development and process improvements, delivering measurable savings in time, materials, and cost while enhancing compliance with ICH GCP, GLP, and GMP. - Partnered closely with CMC, Clinical Operations, Medical, and Quality to de-risk timelines, maintain audit-ready documentation, and support inspection readiness.

  • Parexel (Berlin Area, Germany)
    • Associate Supply & Logistics Director
      Dec 2017 - Jul 2019 · 1 yr 8 mos

      - Strengthened clinical trial supply and logistics programs through global leadership, disciplined execution, and clear governance. - Applied scenario-based forecasting to align directly with client demand, reducing waste and improving supply efficiency. - Met pharmaceutical and biotech requirements while enhancing business sustainability through fit-for-purpose management strategies. - Leveraged deep clinical and laboratory logistics expertise to lead CTS&L teams and streamline operations. - Defined and delivered tailored solutions that improved operational performance and reliability. - Built enduring client trust by providing accurate, study-long forecasting and transparent communication. - Grew accounts by managing scope changes and introducing value-added services that improved supply strategy and program financials.

    • Associate Portfolio Director / Portfolio Operations Leader (CTSL & IRT/RTSM)
      Oct 2012 - Nov 2017 · 5 yrs 2 mos

      - Owned end-to-end portfolio profitability and delivery excellence for CTS&L and PI (RTSM), meeting all sales targets and maintaining accurate pipeline reporting. - Built senior executive relationships across pharma and biotech, expanding the market for clinical logistics services and elevating the portfolio’s strategic position. - Grew regional revenue for supply-related services by 10–25% through rigorous needs analysis, tailored solutions, and value articulation. - Reactivated a lapsed client, generating more than $3M in new revenue and opening additional workstreams. - Drove client retention and satisfaction by leading a high-performing, award-winning project portfolio with consistent, high-quality outcomes. - Mentored clinical logistics leaders to create synergies, standardize best practices, and secure repeat business. - Managed proactive account plans for 10 global and emerging biopharma clients, improving financial performance, scope control, and forecast accuracy.

    • Senior Clinical Logistics Leader | Clinical Logistics Manager/Leader
      Jan 2010 - Sep 2012 · 2 yrs 9 mos

      - Promoted based on strong delivery across multiple pharma and biotech programs. - Led end-to-end project and program execution, owning timelines, quality, and profitability. - Met logistics expectations for four major pharmaceutical sponsors; reported directly to the team lead. - Streamlined operations by delegating effectively to project support staff and standardizing workflows. - Built program- and study-level synergies by leveraging sponsor-specific knowledge and prior lessons learned. - Mentored clinical logistics leaders to resolve global challenges, drive consistency, and secure repeat business. - Strengthened client trust through accurate, transparent forecasting and reliable supply planning throughout the study lifecycle.

  • Distribution Project Manager at Fisher Clinical Services
    Feb 2006 - Jan 2010 · 4 yrs

    - Delivered high-quality project management and clinical logistics services, consistently meeting the expectations of major pharmaceutical and biotechnology sponsors. - Managed a portfolio of 15 accounts and projects; led up to 55 distribution studies end to end. - Oversaw controlled drug (fentanyl & opiates) processes from a project management perspective, ensuring rigorous compliance and documentation. - Collaborated effectively with QPs, MHRA, FDA, clients, and U.S.-based colleagues to align on regulatory and operational requirements. - Built durable client trust through accurate, transparent forecasting and dependable supply planning throughout the study lifecycle.