Are you interested in a highly visible leadership role, supporting delivery of our innovative portfolio of biopharmaceutical assets? This opportunity will allow you to influence the development strategy, lead delivery of the CMC, clinical supply and regulatory targets, and lead the high performing matrix team; thereby shaping the medicine and supporting our ambitions for patient treatments.
If so, this Senior Director, Medicine Process Delivery Leader, Large Molecules role is an exciting move to explore.This role is a Senior Director position.The role:
This is a key leadership position in GSK, leading across R&D and Pharma Supply Chain, defining and delivering the global CMC development and industrialisation strategy and plan for a new medicine. The successful candidate will join the Medicine & Process Delivery team, taking on a significant asset in our biopharmaceutical pipeline. Key responsibilities :Leads CMC development and industrialisation of a medicine:
Leads the CMC matrix team:
- Leads the definition and implementation of the global CMC development and industrialisation strategy and plan for a medicine, aligning with the global medicine development strategy and plan, the needs of the patient, the commercial intent for the medicine, the overall business context and the regulatory, compliance and manufacturing network requirements
- Provides options for CMC delivery to align with the project objectives, with recommendations based on sound judgement on both short- and long-term implications (risks, costs, resources and time) for the global lifecycle of the medicine
- Anticipates, and appropriately plans for, future CMC requirements and risks to enable the full global clinical and commercial lifecycle of the medicine
Voice of CMC for the project:
- Leads the cross-functional multi-disciplinary CMC matrix team (~10 core team members from R&D and Pharma Supply Chain encompassing technical, quality, regulatory, supply chain and manufacturing; ~50 extended team members) to develop and execute the CMC project plans to accomplish the project aligned objectives to time, budget and resource forecasts
- Owns the performance of the CMC matrix team: partners with line managers to appropriately resource the project with the right expertise, and to develop and support the core and extended team members to drive performance and deliver the project
- Scope of activities covered by CMC matrix team:
- Development of the physical product, process, device and analytical methods
- Establishment of the clinical and commercial supply chains, manufacturing processes and control strategies
- Supply of clinical and initial commercial material
- Clinical and commercial pack and label
- Transfer of the process and methods from R&D to first commercial manufacture/testing site
- Definition and delivery of the CMC regulatory strategy, submissions and responses to regulatory questions
- Launch readiness
Skills and competencies
- Provides the voice of the physical product and supply chain to influence the medicine development and commercialisation strategies and plans, ensuring appropriately gated commitment to, and investment in, CMC activities
- Provides the voice of the project to the CMC matrix team to align the CMC plans with the project intent and corporate goals, and to the CMC and commercial manufacturing functional lines to ensure they have the capability and capacity to deliver
- Aligns senior leaders across R&D and PSC (via governance bodies) on the strategic CMC objectives, plans and risk mitigation activities for the project and the investments and resources required to deliver these
- Integrates across R&D and PSC to deliver the project via the CMC Matrix Team and close communication with senior stakeholders
- Provides CMC input to due diligence reviews of new asset business development proposals, positioning the CMC opportunities and risks in the context of the proposed medicine and business strategy
This role requires the knowledge, gravitas, courage and credibility to lead a high performing multi-disciplinary matrix team of CMC and supply chain experts to develop and deliver the manufacturing process, supply chain, physical medicinal product and regulatory submissions to enable clinical trials, regulatory approval and a secure commercial supply of a medicine.An exceptional matrix leader
A highly credible CMC or supply chain expert
- Sets direction, empowers others to take ownership of their activities, monitors progress, knows when and how to intervene to avoid or manage risks and issues, helps remove barriers, holds team members accountable for their delivery and performance on behalf of the team and the enterprise
- A curious scientific intellect, a critical thinker with sound judgement
- Strong decision-making skills
- An agile and willing learner
- Creative problem solver: able to analyse and interpret complex situations to provide appropriate innovative solutions and clear strategic direction to others
- An active and empathetic listener who is aware of own limitations in knowledge, expertise or experience
- Able to influence at all levels in the business and across multiple disciplines
- Masterful manager of conflict
- Collaborative, cooperative, inclusive and transparent, builds and cultivates high performing teams and partnerships
- Excellent communicator both verbal and written
- Strong technical knowledge of process, product and analytical development or
- Strong CMC regulatory or compliance knowledge or
- Strong knowledge of commercial supply chain implementation
- Awareness of compliance and regulatory requirements for clinical and commercial manufacturing
- Advanced knowledge of the drug development process
- Awareness of CMC as part of the whole, with a broad knowledge of the E2E non-clinical, clinical, regulatory and commercial aspects of developing a medicine
- Analyses, interprets and critically evaluates data and information to determine and justify decisions or recommendations
- Connected to the broader business with a wide internal and external network
- Able to balance scientific, technical and manufacturing risks against the overall business impact
- Understands the business financial context within which decisions are made
Why you? Basic qualifications
- Significant experience working in a CMC and supply chain organisation (e.g. process, product or analytical development, manufacturing, supply chain, quality, CMC regulatory)
- Recognised internally, and preferably externally, as a thought leader or subject matter expert in a relevant CMC discipline
- Experience in CMC medicine development, particularly late stage and preferably through to successful product approval and launch
- Successful developer of people as a mentor, coach, matrix and line leader
- Successfully led large, complex, cross-functional teams, with high level of accountability, preferably in an international context and preferably with external partners
- Significant experience working directly with senior executives
- Bachelor of Science with director level CMC experience in the development and manufacture of relevant pharmaceuticals
- Experience of the relevant CMC and supply chain aspects of developing, manufacturing and industrializing biopharmaceuticals along with of the pharmaceutical industry, relevant regulations and requirements
- Experience creating and defending CMC development strategy, plan and data package for an asset
- Project leadership experience, specifically leadership of multi-disciplinary teams and preferably in a relevant pharmaceutical product development environment with global teams
- Experience in a senior director role with both internal and external groups
- PhD/EngD with extensive CMC experience in the development or manufacture of relevant pharmaceuticals
- Learning agility and desire to learn new things outside of one's comfort zone; willingness to take on diverse and agnostic assignments in product development
At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader inConsumer Health, strengthening our leadership, and transforming our commercial execution. Now, we're making the biggestchanges we've made to our business in over 20 years.We're on track to separate and create two new companies in 2022:
New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and geneticsscience; and a new world-leading consumer healthcare company of loved and trusted brands.
With new ambition comes new purpose. For New GSK, this is to unite science, talent and technology to get ahead of diseasetogether - all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; andas a new GSK where outstanding people thrive.
Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culturethat isambitious for patients
- so we deliver what matters better and faster;accountable for impact
- with clear ownership ofgoals and support to succeed; andwhere we do the right thing
. So, if you're ready to improve the lives of billions, join us at thisexciting moment in our journey. Join our challenge to get Ahead Together.
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