Senior Director, CDMO Strategic Sourcing
Otsuka Pharmaceutical Co., Princeton, NJ, United States
Position Summary:
The Senior Director, CDMO Strategic Sourcing, GEM serves Otsuka’s global pharmaceutical business units by developing and executing Contract Development and Manufacturing Organizations (CDMOs) sourcing strategies to support drug development and commercial manufacturing. This leader will lead cross-functional sourcing initiatives and ensure the company's external manufacturing network is cost-effective, reliable, and aligned with quality and regulatory requirements. They will partner within the Global External Manufacturing (GEM) team to co-lead the process for the selection of CDMOs. The Senior Director will also serve as the lead for contract negotiations for all global CDMOs in partnership with the business units.
The Senior Director role is responsible for setting the vision, strategic direction, expectations, contractual governance, annual and long-term objectives for CDMO sourcing. Additionally, the Senior Director of CDMO Strategic Sourcing, GEM partners with global affiliates and key stakeholders (e.g., business leaders) to execute global sourcing strategy, with the remit to achieve ongoing year over year improvements & reduce Otsuka’s cost of doing business while maintaining/improving quality and adherence to regulatory guidelines
Key Responsibilities : Strategic Oversight: o Responsible for leading the CDMO pillar within the R&D Technical Operations team, including one direct report o Develop and execute sourcing strategies for CDMO services across drug substance, drug product, and analytical services. o Develop operating metrics and reports that provide Otsuka Senior Leadership with visibility into portfolio performance. o Partner with senior leadership in key manufacturing functions (Manufacturing, Supply Chain, CMC, GPQ), and Shared Services (Finance, Legal, and Procurement) to develop outsourcing models that support key business objectives. o Focus on challenging the status quo to establish new ways of working faster and smarter, while delivering higher quality, increasing value and minimizing risk, especially regarding early phase clinical manufacturing and speed to clinic.
Vendor Selection & Management Process: o Lead the RFI/RFP process, vendor evaluation, bid analysis and contract negotiations for clinical, and commercial stage CDMOs. o Lead contract negotiations, including pricing, service levels, and intellectual property terms o Collaborate with GPPS/GEM function to ensure there is alignment on contractual governance, annual and long-term objectives for the CDMO o Develop and execute against a best-in-class contracting strategy that ensures industry competitive commercial contracts & rates with preferred vendor contracts
Contracting & Budgeting: o Oversee development and negotiation of Master Services Agreements (MSAs), Statements of Work (SOWs), and Change Orders (COs). o Collaborate on budgeting, forecasting, and cost-reduction initiatives related to outsourced manufacturing.
Compliance & Risk Management: o Ensure outsourcing activities comply with GMP, ICH guidelines, company SOPs, and all applicable regulations. o Identify outsourcing risks and develop mitigation strategies. o Ensure compliance with corporate procurement policies and applicable regulatory standards. o Lead or support supply risk assessments and business continuity planning for critical outsourced activities.
Leadership: o Ensure operating model is appropriately structured to support business demand, including oversight of resource allocation and team performance o Leads, teaches, coaches and directs Category/Sourcing professionals throughout the sourcing processes as well as key processes/skills (i.e., spend management analysis, stakeholder management, collaboration, process improvement, etc.). o Support the roll out of key end to end enablement tools/systems, processes, and templates that will improve the buying channel experience. o Responsible for the delivery of operations and general portfolio execution Monitor market trends, emerging suppliers, and innovations in outsourcing models.
Qualifications and Preferred Experience : • Bachelor’s degree in Science, Engineering, Business, or related field (MBA or advanced degree a plus). • 12-15+ years of experience in strategic sourcing or external manufacturing, preferably in pharmaceuticals or biotech. International experience essential. • Proven ability to work with international colleagues. • Deep knowledge of CDMO landscape and manufacturing processes (e.g., small molecule, biologics, sterile fill-finish, etc.). • Thorough knowledge of GMPs (CFR title 21, parts 210-211 and Part 600), GCPs (current Good Clinical Practices) along with EU, MHRA and other global health authority regulations. • Strong negotiation, contract management, and supplier relationship management skills. • Ability to influence and collaborate with cross-functional stakeholders in a matrixed organization. • Excellent analytical, communication, and project management skills.
The Senior Director role is responsible for setting the vision, strategic direction, expectations, contractual governance, annual and long-term objectives for CDMO sourcing. Additionally, the Senior Director of CDMO Strategic Sourcing, GEM partners with global affiliates and key stakeholders (e.g., business leaders) to execute global sourcing strategy, with the remit to achieve ongoing year over year improvements & reduce Otsuka’s cost of doing business while maintaining/improving quality and adherence to regulatory guidelines
Key Responsibilities : Strategic Oversight: o Responsible for leading the CDMO pillar within the R&D Technical Operations team, including one direct report o Develop and execute sourcing strategies for CDMO services across drug substance, drug product, and analytical services. o Develop operating metrics and reports that provide Otsuka Senior Leadership with visibility into portfolio performance. o Partner with senior leadership in key manufacturing functions (Manufacturing, Supply Chain, CMC, GPQ), and Shared Services (Finance, Legal, and Procurement) to develop outsourcing models that support key business objectives. o Focus on challenging the status quo to establish new ways of working faster and smarter, while delivering higher quality, increasing value and minimizing risk, especially regarding early phase clinical manufacturing and speed to clinic.
Vendor Selection & Management Process: o Lead the RFI/RFP process, vendor evaluation, bid analysis and contract negotiations for clinical, and commercial stage CDMOs. o Lead contract negotiations, including pricing, service levels, and intellectual property terms o Collaborate with GPPS/GEM function to ensure there is alignment on contractual governance, annual and long-term objectives for the CDMO o Develop and execute against a best-in-class contracting strategy that ensures industry competitive commercial contracts & rates with preferred vendor contracts
Contracting & Budgeting: o Oversee development and negotiation of Master Services Agreements (MSAs), Statements of Work (SOWs), and Change Orders (COs). o Collaborate on budgeting, forecasting, and cost-reduction initiatives related to outsourced manufacturing.
Compliance & Risk Management: o Ensure outsourcing activities comply with GMP, ICH guidelines, company SOPs, and all applicable regulations. o Identify outsourcing risks and develop mitigation strategies. o Ensure compliance with corporate procurement policies and applicable regulatory standards. o Lead or support supply risk assessments and business continuity planning for critical outsourced activities.
Leadership: o Ensure operating model is appropriately structured to support business demand, including oversight of resource allocation and team performance o Leads, teaches, coaches and directs Category/Sourcing professionals throughout the sourcing processes as well as key processes/skills (i.e., spend management analysis, stakeholder management, collaboration, process improvement, etc.). o Support the roll out of key end to end enablement tools/systems, processes, and templates that will improve the buying channel experience. o Responsible for the delivery of operations and general portfolio execution Monitor market trends, emerging suppliers, and innovations in outsourcing models.
Qualifications and Preferred Experience : • Bachelor’s degree in Science, Engineering, Business, or related field (MBA or advanced degree a plus). • 12-15+ years of experience in strategic sourcing or external manufacturing, preferably in pharmaceuticals or biotech. International experience essential. • Proven ability to work with international colleagues. • Deep knowledge of CDMO landscape and manufacturing processes (e.g., small molecule, biologics, sterile fill-finish, etc.). • Thorough knowledge of GMPs (CFR title 21, parts 210-211 and Part 600), GCPs (current Good Clinical Practices) along with EU, MHRA and other global health authority regulations. • Strong negotiation, contract management, and supplier relationship management skills. • Ability to influence and collaborate with cross-functional stakeholders in a matrixed organization. • Excellent analytical, communication, and project management skills.