Senior Director, CMC Project Leadership

Site Name: USA - Pennsylvania - Upper Providence, UK - Hertfordshire - Stevenage, UK - Hertfordshire - Ware

Posted Date: Mar

Senior Director, CMC Project Leadership

Are you interested in a highly visible, global role which allows you to use your leadership skills and partner with senior leaders while supporting the delivery of our innovative portfolio of assets? If so, the Senior Director, CMC Project Leadership is an exciting move to explore.

The role:

The Senior Director, CMC Project Leadership will lead the development, industrialisation and lifecycle delivery of all CMC aspects of a key small molecule physical medicine in the GSK portfolio. The successful candidate would lead from Commit to Phase 2 (C2P2), through the development of the Phase 3 (P3) and commercial process, the file, review and launch and the completion of the major clinical & CMC/ Supply Chain lifecycle work.

Key Responsibilities:

• Accountable for the seamless transition and knowledge transfer from the pre-C2P2 period and early CMC Leader, through to P2 and P3/commercial process development. The role holder will engage with early Medicine Development CMC Leader and team 6 to 12mths prior to C2P2 to prepare plans, resources (external and internal spends budgets for the C2P2 recommendations (noting that the timing may be earlier than C2P2 for complex, accelerated medicines)
• Partners to define the medicine development strategy and the medicine commercial vision through the Medicine Development Leader (MDL) as a member of the cross functional Medicine Development Team (MDT). Defines the drug substance (DS), drug product (DP) device, analytical, manufacturing, supply chain (SC), quality, and CMC regulatory approaches through the CMC/SC matrix team to meet the target product profile. Generates options and recommendations for Ph2 and Ph3 development & supply and global regulatory filings that balance time, costs, resources, and risk. Ensures requirements are captured in the medicine CMC/SC master strategy & plan and secure timely decisions on these through governance.
• Delivers the strategy & plan through the CMC/SC matrix team to the agreed timings, resources, and risk mitigation strategies. Manages integration, alignment and performance proactively, anticipating and addressing issues and risks, and securing Specialist Sign Off (SSO) and Subject Matter Expert (SME) inputs, as necessary throughout product development. Delivers through partnerships with internal and external development and manufacturing organisations and with development partners where required
• The role holder continually monitors for scope changes or impactful breaches in terms of the agreed timing, costs, resources and/or risks (and in relation to the agreed lifecycle project strategy), and engages with senior leaders and/or governance (CMC board, DRB and/or PIB), as necessary, to resolve these proactively
• During P3, generate options and recommendations for Product Performance Qualification (PPQ), PAI readiness, global commercial file and launch that balance time, resources (EPE & IPE), and risk. Ensure these are captured in the CMC strategy & plan. Additionally work with the Medicine Supply Chain Lead in commercial supply to develop agreements for the transfer of Accountability (ToA). Secure timely decisions on milestone progression through governance (CMC board, DRB & PIB)
• During P3 and prior to file/launch, identify post-launch medicine development and commercial needs through the MDL/MDT and the MSCL and the MCL/MCT. Define the full CMC and regulatory approaches for lifecycle plans. Generate options and recommendations that balance time, costs, resources and risk. Ensure plans are captured in the CMC master strategy.
• Provide the voice of the physical product to the MDL/MDT & Development, and through the MSCL to the MCL/MCT & Commercial, and the corresponding voice of the project to the CMC/SC matrix team, the CMC modalities & GSC
• After completing the transfer of accountability (ToA) contract commitments, seamlessly transfer knowledge and plans to the Medicine Supply Chain Leader (MSCL), and then, as applicable, lead any follow-on development activities, including support for specific marketing files, further P3 trials and specific development targets (e.g., paediatric sub-projects), and represent these to the ongoing MDL/MDT and in support of the MSCL and Medicine Commercial Leader / Team (MCL/MCT)
• May additionally: line manage MDI Directors; lead collaboration interfaces; lead CMC/SC due diligence reviews; and/or lead systems and process updates

The role will be required to own the CMC Accountability framework for their assigned asset(s), through which performance against portfolio objectives will be measured and monitored across CMC business functions that support CMC Project Leadership. The individual will need to be able to create and maintain performance dashboards targeting senior governance boards through line management in order to drive performance. This requires a knowledge of CMC and experience in working across senior stakeholders (Director through VP level).

The role will also lead strategic change program - for example the evolution of the CMC operating model - by working with VP/SVP across R&D and Global Supply Chain level to get direction and translate that direction into strategy/action. The role will own the CMC-wide portfolio control tower, requiring the creation of innovative visual solutions with Tech partners.

Why you?

Basic qualifications:

• BsC Life sciences, (bio)chemical engineering, pharmaceutical sciences or relevant area
• Significant experience of leading the development and commercialisation of pharmaceuticals, CMC & Supply Chain from phase 2 onwards through P3, file, launch and early lifecycle
• Breadth and depth of experience of P2, P3 & lifecycle CMC and supply chain aspects of the development, manufacture, commercial filing, review and approval and clinical and commercial supply of small molecule medicines and the associated regulatory & quality standards; this should include device development & marketing requirements, US, EU, China & Japan development, marketing & launch requirements, lifecycle CMC/SC changes & commercial compliance & quality standard.
• Experience at the director or preferably senior director level developing and implementing business/project strategies and delivering continuous improvement programs
• Experience of developing, presenting, and defending P2, P3 & lifecycle CMC/SC strategies, plans and resources to governance
• Experience working with, and influencing, very senior leaders internally and externally through decision making, changes, issues, and risk management: this should include US, EU, Japan & China health authorities and in both the marketing review and pre-approval inspection settings
• Leadership of international, multi-disciplinary P2, P3 & lifecycle CMC/SC teams; this should include external collaborators and CDMOs
• Experience developing people as a mentor, coach, teacher and either a matrix and/or line leader

Preferred qualifications:

• PhD/EngD with extensive CMC experience in the development or manufacture of relevant pharmaceutical manufacturing processes
• Demonstrated learning agility in the data / digital space, with ability to visualize complex data for effective business discussions
• Demonstrated effectiveness in communication and teamwork across complex matrices

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