Senior Director, Early Phase CMC Medicine Research Leader

Job description

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: This role will provide you with the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: 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. Why You? 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. 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: If you have the following characteristics, it would be a plus 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. #GSK-LI Skills Communication, Cross-Functional Leadership, Drug Development, Project Development, Project Implementations, Project Leadership, Scientific Research • 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. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave. If salary ranges are not displayed in the job posting for a specific country, the relevant compensation will be discussed during the recruitment process. 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 positive