Takeda Pharmaceuticals
GMS Business Development, Licensing, and Divestitures/CMB Lead
Takeda Pharmaceuticals, Lexington, Massachusetts, United States, 02421
Job Title
Help drive Takeda's long-term growth and continuous portfolio/network rationalization for Global Manufacturing and Supply (GMS). As part of CMC team conduct due diligence for inbound opportunities in support of Global Business Development efforts. Overall accountability to lead and manage seasoned, cross-functional teams to support outbound assets, align across GMS functions and Global Business Development, and develop sound, business-based recommendations for senior leadership. Inbound licensing/partnering opportunities and asset acquisitions: Leverage hands-on and leadership experience in process development as well as cross-functional product development throughout the product lifecycle to lead GMS due diligence efforts to identify risks or showstoppers, verify alignment with Takeda's technology, network, business, and regulatory strategies, assess capabilities fit, ensure timeline vs. deal value alignment, verify process, analytical, formulation-development, stability data, manufacturing capacity, capabilities and supply meet the needs of the proposed program strategy and, confirm overall alignment of deal model assumptions with GMS: e.g. projected COGS, network/tax assumptions, supply related investments, expenses, etc. Engage with potential partners, licensees or sellers as needed to ensure comprehensive due diligence and shared understanding of deal or partnership parameters. Support overall planning for inbound assets internally and externally through seamless transition to Takeda's Global Program Team, who carry the programs forward, and the establishment of post-deal structures with partner. Monitor deal prospecting activities, help route to appropriate GMS functions, engage at relevant times to allow robust due diligence, while avoiding the inefficiencies of too early engagement. Outbound portfolio and physical asset divestitures: Bring past commercial, supply chain, external supply experience to lead GMS and cross-functional resources to clarify assumptions (sales order to cash flows, SKU lists, entanglements, standard costs, compliance status, inventory levels, financials, etc.), help find solutions to close gaps, support vendor due diligence, external due diligence, as well as help develop and propose deal structures that support Takeda's long-term business and supply continuity. Prepare and execute aggressive, achievable separation plans jointly aligned with the Buyer(s) that minimize cut-over periods and rapidly transition to the proposed post-Close future-state of outbound assets. All such plans must be developed in conformance with local anti-trust regulations. Ensure long-term benefit for Takeda by negotiating key contracts or GMS-relevant contract terms that balance overall deal benefit with acceptable levels of risk and profitability across Takeda's supply chain and manufacturing network. General: Responsible to prepare for, or directly engage with, Takeda executive leadership, including pre-governance socialization of proposed deals emphasizing risk/benefit trade-offs, deviations from originally envisioned deal structure, risk mitigation proposals with resource and budget needs, negotiation guardrails, etc. Help drive continuous improvement of Takeda GMS's inbound and outbound processes by partnering within GMS BD, Divestments, & CMB as well as throughout GMS and Global Business Development to streamline processes and governance, develop best practices, improve communication, and mature training supporting Takeda's M&A and Divestitures activities. As GMS small molecule expert on GMS Business Development & Licensing team, provide mentoring and guidance to staff less familiar with small molecules to grow organizational knowledge and ensure solutions on transactions that align with the unique needs of small molecule pharmaceutical products. Accountabilities: Clear, timely, and relevant deal communication to GMS senior leadership in context of overall GMS business priorities, prior assumptions, and broader deal status. Includes GMS reporting and decision-making support. Lead cross-functional Takeda GMS teams supporting inbound and outbound business development activities. Lead, develop, and summarize deal-related assessments: e.g. due diligence, COGS, business projections, manufacturing, testing, and business network impact, etc. Go-to lead, or mentor, for small molecule assets. Support Partner/Seller/Buyer engagements, clarification of assumptions, due diligence, site visits, planning, problem solving, establishment of post-deal structures, and alignment. Partner with Global and Functional Business Development teams to advance projects through each stage of deal development including non-binding and binding offers, term sheets, deal agreement negotiations, as well as execution and close. Operate effectively across all Takeda regions and time zones; travel may be required. Deliver deals under aggressive timelines, finding solutions where needed to achieve Takeda goals. Support Takeda outbound contract manufacturing business relationships Efficient GMS reporting and decision making. Deploy internal and external resources as required to achieve project needs. Be a role model for Takeda-ism, the Leadership Behaviors and the 4 commitments (Patient-Trust-Reputation-Business) in all activities. Education, Experience, Knowledge, and Skills: 15+ years of pharma/biotech industry CMC experience, including at least 5 years' experience leading cross-functional operations (GMS) teams and supporting cross-functional product development. Experience with multiple modalities (large molecule, small molecule, ADC, cell therapy, etc.) a plus; small molecule experience is a must. Masters, or Ph.D. (preferred) in chemistry, pharmaceutics, or biochemistry or relevant engineering discipline. Demonstrated CMC/Operations experience from early development through commercial. Background in process development and product development. Past partnership or external business role experience is required. Past experience with M&A, in-licensing and divestitures at a large, multinational pharmaceutical /biotech is highly preferred. Demonstrated executive presence and demonstrated business acumen in stakeholder management critical. Strong cross-functional leadership and project management skills of multi-disciplinary, multicultural teams that contain internal employees and external contractors. Extensive contract negotiation skills: clinical and commercial MSAs, transitional agreements, technology and partnership agreements. Demonstrated experience leading negotiations from both the supply-side and client-side is a plus. A strong legal and cGMP compliance mindset is a must. Strong, persuasive written and oral communication skills. Embraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organization. Technical/Functional Expertise: Inbound BD (M&A and partnerships) experience is preferred. Broad experience across all development stages from pre-clinical to commercial is necessary, across a variety of modalities (small molecules, biologics, plasma, gene- and cell therapy, etc.) experience a plus; small molecule experience is a must. Process development experience with prior roles as a technical expert in one or more of the following areas: drug substance, drug product, analytical, device Robust understanding of pharmaceutical drug development life-cycle demonstrated through prior roles actively supporting product development, preferably in one or more of the following therapeutic areas (Gastroenterology ("GI"), Inflammation, Rare Diseases, Oncology, Neuroscience) Ability to manage deal financial elements to support business cases and pressure-test deal models is critical: e.g. COGS, P&L, capital projects, etc. Deep expertise leading contract negotiations, balancing contractual risks, and proposing negotiated solutions to business disagreements is fundamental to the role. The incumbent must have strong project management skills, including timeline development and optimization, effective management of core and sub-team as well as individual R&Rs, the ability to successfully deploy contractor resources, and have a clear understanding of how to effectively navigate Takeda governance structures. Leadership: Motivating teams to deliver success under ambiguous conditions with hard to resolve problems is required. Credibility and respect must be inspired while shielding team members from distracting uncertainties. Cross-functional relationships must be built and maintained at all levels. Demonstrated ability to act as Takeda's representative in critical negotiations, ongoing CMB relationships, as well as for nascent partnerships and potential sellers of inbound assets. Decision-making and Autonomy: The incumbent must be self-driven and successfully motivate team members to achieve complex, challenging deliverables without management supervision. Understanding what decisions can be taken at each level of team, governance, and line management structure is critical to success
Help drive Takeda's long-term growth and continuous portfolio/network rationalization for Global Manufacturing and Supply (GMS). As part of CMC team conduct due diligence for inbound opportunities in support of Global Business Development efforts. Overall accountability to lead and manage seasoned, cross-functional teams to support outbound assets, align across GMS functions and Global Business Development, and develop sound, business-based recommendations for senior leadership. Inbound licensing/partnering opportunities and asset acquisitions: Leverage hands-on and leadership experience in process development as well as cross-functional product development throughout the product lifecycle to lead GMS due diligence efforts to identify risks or showstoppers, verify alignment with Takeda's technology, network, business, and regulatory strategies, assess capabilities fit, ensure timeline vs. deal value alignment, verify process, analytical, formulation-development, stability data, manufacturing capacity, capabilities and supply meet the needs of the proposed program strategy and, confirm overall alignment of deal model assumptions with GMS: e.g. projected COGS, network/tax assumptions, supply related investments, expenses, etc. Engage with potential partners, licensees or sellers as needed to ensure comprehensive due diligence and shared understanding of deal or partnership parameters. Support overall planning for inbound assets internally and externally through seamless transition to Takeda's Global Program Team, who carry the programs forward, and the establishment of post-deal structures with partner. Monitor deal prospecting activities, help route to appropriate GMS functions, engage at relevant times to allow robust due diligence, while avoiding the inefficiencies of too early engagement. Outbound portfolio and physical asset divestitures: Bring past commercial, supply chain, external supply experience to lead GMS and cross-functional resources to clarify assumptions (sales order to cash flows, SKU lists, entanglements, standard costs, compliance status, inventory levels, financials, etc.), help find solutions to close gaps, support vendor due diligence, external due diligence, as well as help develop and propose deal structures that support Takeda's long-term business and supply continuity. Prepare and execute aggressive, achievable separation plans jointly aligned with the Buyer(s) that minimize cut-over periods and rapidly transition to the proposed post-Close future-state of outbound assets. All such plans must be developed in conformance with local anti-trust regulations. Ensure long-term benefit for Takeda by negotiating key contracts or GMS-relevant contract terms that balance overall deal benefit with acceptable levels of risk and profitability across Takeda's supply chain and manufacturing network. General: Responsible to prepare for, or directly engage with, Takeda executive leadership, including pre-governance socialization of proposed deals emphasizing risk/benefit trade-offs, deviations from originally envisioned deal structure, risk mitigation proposals with resource and budget needs, negotiation guardrails, etc. Help drive continuous improvement of Takeda GMS's inbound and outbound processes by partnering within GMS BD, Divestments, & CMB as well as throughout GMS and Global Business Development to streamline processes and governance, develop best practices, improve communication, and mature training supporting Takeda's M&A and Divestitures activities. As GMS small molecule expert on GMS Business Development & Licensing team, provide mentoring and guidance to staff less familiar with small molecules to grow organizational knowledge and ensure solutions on transactions that align with the unique needs of small molecule pharmaceutical products. Accountabilities: Clear, timely, and relevant deal communication to GMS senior leadership in context of overall GMS business priorities, prior assumptions, and broader deal status. Includes GMS reporting and decision-making support. Lead cross-functional Takeda GMS teams supporting inbound and outbound business development activities. Lead, develop, and summarize deal-related assessments: e.g. due diligence, COGS, business projections, manufacturing, testing, and business network impact, etc. Go-to lead, or mentor, for small molecule assets. Support Partner/Seller/Buyer engagements, clarification of assumptions, due diligence, site visits, planning, problem solving, establishment of post-deal structures, and alignment. Partner with Global and Functional Business Development teams to advance projects through each stage of deal development including non-binding and binding offers, term sheets, deal agreement negotiations, as well as execution and close. Operate effectively across all Takeda regions and time zones; travel may be required. Deliver deals under aggressive timelines, finding solutions where needed to achieve Takeda goals. Support Takeda outbound contract manufacturing business relationships Efficient GMS reporting and decision making. Deploy internal and external resources as required to achieve project needs. Be a role model for Takeda-ism, the Leadership Behaviors and the 4 commitments (Patient-Trust-Reputation-Business) in all activities. Education, Experience, Knowledge, and Skills: 15+ years of pharma/biotech industry CMC experience, including at least 5 years' experience leading cross-functional operations (GMS) teams and supporting cross-functional product development. Experience with multiple modalities (large molecule, small molecule, ADC, cell therapy, etc.) a plus; small molecule experience is a must. Masters, or Ph.D. (preferred) in chemistry, pharmaceutics, or biochemistry or relevant engineering discipline. Demonstrated CMC/Operations experience from early development through commercial. Background in process development and product development. Past partnership or external business role experience is required. Past experience with M&A, in-licensing and divestitures at a large, multinational pharmaceutical /biotech is highly preferred. Demonstrated executive presence and demonstrated business acumen in stakeholder management critical. Strong cross-functional leadership and project management skills of multi-disciplinary, multicultural teams that contain internal employees and external contractors. Extensive contract negotiation skills: clinical and commercial MSAs, transitional agreements, technology and partnership agreements. Demonstrated experience leading negotiations from both the supply-side and client-side is a plus. A strong legal and cGMP compliance mindset is a must. Strong, persuasive written and oral communication skills. Embraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organization. Technical/Functional Expertise: Inbound BD (M&A and partnerships) experience is preferred. Broad experience across all development stages from pre-clinical to commercial is necessary, across a variety of modalities (small molecules, biologics, plasma, gene- and cell therapy, etc.) experience a plus; small molecule experience is a must. Process development experience with prior roles as a technical expert in one or more of the following areas: drug substance, drug product, analytical, device Robust understanding of pharmaceutical drug development life-cycle demonstrated through prior roles actively supporting product development, preferably in one or more of the following therapeutic areas (Gastroenterology ("GI"), Inflammation, Rare Diseases, Oncology, Neuroscience) Ability to manage deal financial elements to support business cases and pressure-test deal models is critical: e.g. COGS, P&L, capital projects, etc. Deep expertise leading contract negotiations, balancing contractual risks, and proposing negotiated solutions to business disagreements is fundamental to the role. The incumbent must have strong project management skills, including timeline development and optimization, effective management of core and sub-team as well as individual R&Rs, the ability to successfully deploy contractor resources, and have a clear understanding of how to effectively navigate Takeda governance structures. Leadership: Motivating teams to deliver success under ambiguous conditions with hard to resolve problems is required. Credibility and respect must be inspired while shielding team members from distracting uncertainties. Cross-functional relationships must be built and maintained at all levels. Demonstrated ability to act as Takeda's representative in critical negotiations, ongoing CMB relationships, as well as for nascent partnerships and potential sellers of inbound assets. Decision-making and Autonomy: The incumbent must be self-driven and successfully motivate team members to achieve complex, challenging deliverables without management supervision. Understanding what decisions can be taken at each level of team, governance, and line management structure is critical to success