Director, Early Development CMC Leader

Position Summary

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 1supply, 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.

Key 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.

Basic Qualifications

We are seeking professionals with the following required skills and qualifications to help us achieve our goals 

• 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. 

Preferred Qualifications: 

If you have the following characteristics, it would be a plus 

• 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. 

Work Location:

This role can be based at Upper Providence (USA), Ware (United Kingdom), Siena (Italy) or Rixensart/Wavre (BE) and offers a hybrid working model, combining on-site and remote work. Fully remote arrangements are not available.

Ready to take the next step?

If you are excited to lead CMC for impactful medicines and grow your career, please apply. Tell us how your experience will help get medicines to patients faster.

Business Introduction
At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together.
Find out more:
Our approach to R&D

Skills

Communication, Cross-Functional Leadership, Drug Development, Project Development, Project Implementations, Project Leadership, Scientific Research

 

 

Italian Salary Range / Fascia retributiva in Italia: EUR 88,500 to EUR 147,500Belgium Salary Range / Fourchette salariale – Belgique: EUR 117,000 to EUR 195,000The annual gross base salary range for new hires in this position is listed above for each applicable location. These ranges take into account a number of factors including the candidate’s skills, experience, education level and the market rate for the role. In addition, this position may offer an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. More detailed information on the total benefits package will be supplied during the recruitment process. This role is available for applicants from multiple locations, and therefore salary ranges for certain locations are also shown. Salary ranges for other locations are shown because some markets have pay transparency laws that require salary information on job postings, and those locations are potential job sites for this role. If salary ranges are not displayed in the job posting for a specific location or country, the relevant compensation will be discussed during the recruitment process. Please note salaries vary by country based on the candidate’s skills, experience, education level and the market rate for the role. Offers are typically made within the advertised range based on the candidate’s skills, experience and qualifications, with the upper end generally reserved for highly experienced candidates or other exceptional circumstances aligned with these criteria.

Please visit  GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

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