Director, Early Development CMC Leader

GSK

2d•€88,500 - €195,000•Hybrid

About The Position

You will lead the early CMC research and development of clinical products from lead candidate optimization stage (Commit to Lead Optimisation, C2LO) through Phase 2 development, ahead of the start of the Phase 3/commercial process development. This is a matrix leadership role and you will work across multidisciplinary teams and with external partners to define development strategies, drive technical delivery and ensure regulatory readiness. The role holder will engage with the Research/ Discovery project leadership at or before C2LO milestone providing strategic CMC input and guidance, and lead CMC activities of an asset through candidate selection, Phase 1 process development, and preclinical and Phase 1 supply, before transitioning asset accountability to the late-stage CMC leader in support of Phase 3 delivery. The timing of this transition will depend on therapeutic area, modality, complexity and acceleration as needed by the business.

Requirements

Advanced degree (PhD or equivalent) in chemistry, pharmaceutical sciences, chemical engineering or a related scientific field, or equivalent experience.
At least 7 years’ experience in CMC/pharmaceutical development of small molecules, biologics or advanced modalities, spanning drug substance, drug product, analytical, manufacturing and/or supply chain activities.
Experienced in leading and direct management of CMC development work, preferably through leading cross-functional, matrix-based teams in a pharmaceutical, biotech or vaccines R&D environment.
Strong knowledge of the preclinical and Phase 1 (ex-CMC/SC) roadmap, including working knowledge of the subsequent Phase 2 and Phase 3 roadmaps.
Practical experience with tech transfer, process scale up and external manufacturing.
Experienced in authoring or contributing to CMC sections of regulatory submissions and good understanding of FDA/health agency regulations.
Excellent verbal and written communication skills, with a demonstrated ability to influence senior levels across the business and disciplines.
Strong problem-solving and decision-making skills, with the ability to analyze and interpret complex situations and provide clear direction.

Nice To Haves

CMC development experience across multiple modalities (small molecules, biologics, advanced modalities).
Knowledge of preclinical and Phase 1 acceleration strategies and tactics, including awareness of the downstream impact of Phase 1 decisions on Phase 2 and Phase 3 development.
Knowledge of clinical manufacturing, including end-to-end supply chain design, sourcing, impact assessment and implementation, and industry-standard clinical management cycles.
Demonstrated matrix leadership experience coordinating cross-functional teams, establishing priorities, managing risks, and delivering project objectives
Familiarity with digital tools for project planning, data management or analytics that support CMC decision-making.
Demonstrated ability to communicate complex technical and strategic information effectively to senior stakeholders and cross-functional teams.

Responsibilities

Lead the CMC strategy development and execution from early development through Phase 2 and into late-phase planning.
Seamlessly transition project from medicine design / early discovery into Phase 1 development and manufacture, taking matrix leadership accountability to establish the CMC matrix team during candidate lead optimization.
As core member of the Early Development team (EDT) and in partnership with Early Development Lead (EDL) define the early medicine development strategy and the early medicine commercial vision.
As leader of the CMC matrix team (including DS, DP, analytical, manufacturing, supply chain, quality and CMC regulatory), define the integrated CMC development strategy and generate fit-for-phase development plans, risk mitigations, and technical options that balance time, cost and regulatory expectations. This includes developing and implementing acceleration and fast to decision strategies, integration into the overall project strategy and plan, and securing timely decisions through relevant governance channels (technical & investment boards).
Deliver the CMC plan & commitments through the CMC matrix team, continually monitor scope changes or threshold breaches in terms of the agreed timing, costs, resources and/or risks, and engage with senior leaders and/or governance, as necessary, to resolve these proactively.
Manage CMC matrix team performance proactively, anticipating and addressing issues and risks, and securing Specialist Sign Off (SSO), Subject Matter Expert (SME) inputs and CMC cross functional reviews, as necessary.
Provide the voice of the physical product (both strategic and technical) to the EDL/EDT & Research organizations (including Research Units, ViiV & Global Health) and the corresponding voice of the project and its strategy to the CMC matrix team and CMC technical lines.
Prepare and provide technical input for regulatory filings and health agency consultations.
Seamlessly transition the project from early to mid/late-stage development and to the late-stage CMC leader including providing strategic input into Phase 3/commercial process development and supply chain design.
May lead collaboration interfaces & governance, CMC/SC due diligence reviews, and/or provide systems and process updates.
May join the Research/Discovery leadership teams and contribute to portfolio strategy.
Actively support people development through mentoring and coaching of functional project leads and other key talent.