Senior Director, Early Phase CMC Medicine Research Leader

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 Position Summary As the Senior Director, Early Phase CMC Medicine Research Leader you will ensure the successful CMC delivery of GSK's early phase portfolio (Rx and Vx) through the coaching, training, mentoring and recruiting of CMC project matrix leaders who lead programs in support of Early Development Leaders (EDLs) across the GSK, ViiV and partnered portfolios. You will lead the early CMC research and development of clinical products from Commit to Lead Optimization (C2LO) through Commit to Phase 3 (C2P3), ahead of the start of development of the Phase 3/commercial process. This is a matrix leadership role, engaging with Research/Discovery project leadership at or before the C2LO milestone to provide strategic CMC input and guidance, and leading CMC activities of an asset through candidate selection, Phase 1 process development, and pre‑clinical and Phase 1 supply, before transitioning accountability to the Development & Industrialization organization in support of Phase 3 delivery. Responsibilities Develop and maintain an industry leading CMC project leadership capability in the early phase through the recruitment, retention and development of CMC matrix leaders. Design and implement next generation ways of working using design by intent, phase appropriate practices and GenAI to optimize and expedite the delivery of CMC for GSKs early‑stage pipeline. Appointment of CMC leaders to individual projects, in consultation with EDLs and CMC functions, and take accountability for assessing and escalating early phase portfolio CMC risks. Ensure appropriate CMC input into early phase business development opportunities, including appointment of diligence leads and approval of CMC diligence sections and risk assessments. Ensure CMC line functions have advanced awareness of early phase portfolio demands, putting plans in place that enable aligned and seamless delivery across functions. Serve as the CMC accountable person with early phase stakeholders on CMC‑impacting objectives, such as acceleration, attrition‑reduction strategies, and upper‑quartile performance. Serve as the single point accountable person for all CMC and supply chain aspects during the development of a medicine, from Lead Optimization up to handover to the CMC Development and Industrialization Leader. Deliver seamless transition of projects from medicine design/early discovery into Phase 1 development and manufacture, taking matrix leadership accountability to establish the CMC team during Lead Optimization. Define the integrated drug substance, drug product, analytical, manufacturing, supply chain, quality and CMC regulatory strategy through leadership of the CMC/Supply Chain matrix team, generating options and recommendations for Phase 1 development and supply that balance time, cost, resources and risk. Lead delivery of the CMC strategy and plan through the CMC/Supply Chain matrix team and the R&D and CDMO network, delivering to agreed timings, costs, resources and risk‑mitigation strategies. Take an active part in people's development through mentoring and coaching of Workstream leads and other key talents. Basic Qualifications Advanced degree (PhD or equivalent) in chemistry, pharmaceutical sciences, chemical engineering or a related scientific field, or equivalent experience. Significant experience (15 yrs minimum) in CMC/pharmaceutical development, spanning drug substance, drug product, analytical, manufacturing and supply chain activities in early phase development. Proven experience leading leaders and 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. Demonstrated matrix leadership skills: setting direction, empowering team members, holding team members to account, monitoring progress, and proactively managing issues and risks. 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 Knowledge of early phase regulatory filing strategies, requirements, and guidance relevant to major markets. 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. Experience across both pharmaceutical (Rx) and vaccines (Vx) portfolios. Experience with portfolio, product and project management standards and skills. Broad understanding of the wider enterprise, business and financial context, with the ability to balance scientific, technical, manufacturing, quality and CMC regulatory risk against overall business impact. Experience positioning options and recommendations for governance bodies to support decision‑making. A collaborative, cooperative, inclusive and transparent leadership style, with a track record of building and cultivating high‑performing partnerships. An agile and willing learner with an innovation and continuous improvement mindset, and a courageous mindset with a willingness to take smart risks. Ability to travel nationally and internationally. Required Skills Communication Cross‑Functional Leadership Drug Development Project Development Project Implementations Project Leadership Scientific Research Salary If you are based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA, the annual base salary for new hires in this position ranges $202,125 to $336,875. If you are based in another US location, the annual base salary range is $183,750 to $306,250. The US salary ranges take into account a number of factors including work location within the US market, the candidate’s skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Benefits Health care and other insurance benefits (for employee and family) Retirement benefits Paid holidays Vacation Paid caregiver/parental and medical leave Equal Opportunity Employer GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law. Company Culture We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are. Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us at View email address on click.appcast.io where you can also request a call. Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a Recruitment FAQ guide. Click the link where you will find answers to multiple questions we receive. We are a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. Find out more on our career site. #J-18808-Ljbffr GlaxoSmithKline