Director, Early Medicine Development CMC Leader (Large Molecule)

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 Medicine Development CMC Leader (Large Molecule) may be an exciting opportunity to explore.

The Role

The purpose of this role is to ensure the successful CMC delivery of the large molecule early phase portfolio 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

Leads CMC development of medicines and CMC matrix teams:

• 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.

Voice of CMC for 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.

• Aligns senior leaders across R&D (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.

• 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.

Skills and Competencies

This role requires 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:

• 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.

• Strong decision-making and influencing 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

• Excellent communicator both verbal and written

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, and regulatory aspects of developing a medicine.

• Analyses, interprets, and critically evaluates data and information to determine and justify decisions or recommendations

We are looking for professionals with these required skills to achieve our goals:

• Bachelor of Science in Pharmacy, Biology, Chemistry, Engineering, or related CMC orientated field

• 10+ years of experience in biopharm CMC development, manufacture, supply and regulations

• 2+ years of line and/or matrix leadership experience of multi-disciplinary global teams

• Experience in the pharmaceutical industry with specific experience in a technical CMC function

• 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

• Project leadership experience

If you have the following characteristics, it would be a plus:

• Masters, PhD or MBA degree preferred with extensive CMC experience in the development or manufacture of relevant pharmaceuticals

• Experience in the development or manufacture of antibody drug conjugates (ADCs)

• Learning agility and desire to learn; willingness to take on diverse and challenging assignments in product development

• Experience in 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

• Leadership experience with a high level of accountability, and preferably in a relevant pharmaceutical development environment with global teams

• Demonstrated ability to develop effective business strategies to address medium to long-term problems

• Project leadership experience, specifically leadership of large, complex, multi-disciplinary teams

• 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

#LI-GSK

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is 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. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

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.

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