Are you energized by a highly-visible senior CMC leadership role that will allow you to drive and shape scientific innovation across an early phase portfolio? If so, Director, Early Phase CMC Medicine Research Leader may be an exciting opportunity to explore.
The purpose of this role is to ensure the successful CMC delivery of the early phase portfolio (large and small molecule) through influencing the medicine development strategy; leading delivery of the CMC, supply chain and regulatory targets; leading the high performing matrix team; and shaping the medicine and patient experience. Key Responsibilities:
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following.
Skills and competencies
- Leads the definition and implementation of the early CMC development strategy and 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 early development of the medicine.
- Leads the cross-functional multi-disciplinary CMC matrix team 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.
- Provides the voice of the physical product and supply chain to influence the early medicine development strategies and plans.
- Provides the voice of the project to the CMC matrix team to align the CMC plans with the project intent, and to the CMC functional lines to ensure they have the capability and capacity to deliver.
This role requires the knowledge, courage and credibility to lead a high performing multi-disciplinary matrix team of CMC experts to develop and deliver the manufacturing process, supply chain, physical medicinal product and regulatory submissions to enable early clinical trials.
- An exceptional matrix leader who 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.
- Creative problem solver: able to analyse and interpret complex situations to provide appropriate innovative solutions and clear strategic direction to others.
Why you? Basic Qualifications:
- A highly credible CMC expert: strong technical knowledge of process, product and analytical development with a broad knowledge of the end to end non-clinical, clinical, regulatory aspects of developing a medicine.
We are looking for professionals with these required skills to achieve our goals:
- Bachelor's of Science in Pharmacy, Biology, Chemistry, Engineering, or related CMC orientated field
- 8 yeras' experience in the pharmaceutical industry
- Experience in a technical CMC function
- Project leadership experience within a CMC function in a global matrixed environment
- Experience working in a CMC environment in Early Development
If you have the following characteristics, it would be a plus:
Why GSK? Why GSK? Uniting science, talent, and technology to get ahead of disease together
- Masters, PhD or MBA degree preferred with extensive CMC experience in the development or manufacture of relevant pharmaceuticals
- Learning agility and desire to learn; willingness to take on diverse and challenging assignments in product development
- Experience with relevant CMC and supply chain aspects of developing and manufacturing pharmaceuticals along with a thorough working knowledge of the pharmaceutical industry, relevant regulations and requirements
- People and / or Project Leadership of large, complex, multi-disciplinary teams with high level of accountability, and preferably in a relevant pharmaceutical development environment with global teams
- Experience creating and defending CMC development strategy, plan and data package for an asset in early development
- Experience leading, developing, coaching and mentoring CMC functional leaders
- Demonstrated ability to develop effective business strategies to address medium to long term problems
- Effective communication and influence skills with senior stakeholders and governance bodies
- Experience working with multiple stakeholders at different organizational levels with both internal and external groups
At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Healthcare, strengthening our leadership, and transforming our commercial execution. Now, we're making the most significant changes 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 genetics science; 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 disease together - all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as 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 culture that isambitious for patients
- so we deliver what matters better and faster;accountable for impact
- with clear ownership of goals and support to succeed; and where we do the right thing
. So, if you're ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together.
GSKBiopharm_development *This is a job description to aide in the job posting, but does not include all job evaluation details.
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