Senior Director, Early Phase CMC Medicine Research Leader

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   a n 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   G enAI   to   optimize   and   expedite   the delivery of CMC for GSKs   early-stage   pipeline .
• Appoi ntment 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 s eamless transition   of p rojects 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?

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.

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

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.