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Sr. Director, Early Phase Medicine Development CMC Leader

4 months ago

Durham, North Carolina, United States GlaxoSmithKline Full time
Site Name: USA - Pennsylvania - Upper Providence, UK - Hertfordshire - Stevenage, UK - Hertfordshire - Ware, USA - Massachusetts - Waltham, USA - North Carolina - Durham
Posted Date: May

Are you energized by a highly visible senior Chemistry, Manufacturing, and Controls (CMC) leadership role that will allow you to drive and shape scientific innovation across GSK's early phase pharmaceutical portfolio? If so, the Senior Director, Early Phase Medicine Development CMC 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 the coaching, training, mentoring and recruiting of CMC project matrix leaders who lead programs in support of Early Development Leaders (EDLs) for the Research and ViiV portfolio.

Key Responsibilities:

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following.
  • Develop a strong CMC project leadership capability in the early phase through the recruitment, retention, and development of CMC matrix leaders
  • Will also lead early phase projects through performing the role of a CMC matrix leader, accountable for delivery of the CMC strategy to time and budget and providing CMC development expertise to Discovery and Early Development teams
  • Design and implement processes for the structured peer-review of early phase project deliverables, aligned to the implementation of decision making and governance for CMC
  • Responsible for the appointment of leaders to individual projects, in consultation with Early Development Leaders and CMC line functions as necessary
  • Accountable for assessing and escalating early phase portfolio CMC risks to the VP Portfolio & Technology Delivery MDS, SVP of MDS, CMC line function leaders, and other Research Unit governance boards as required
  • Responsible for ensuring appropriate CMC input into early phase business development opportunities, which may include appointment of diligence lead, approval of CMC diligence sections and risks in reports
  • Responsible for ensuring CMC line functions have advance awareness of early phase portfolio demands and that plans are put in place that ensure aligned and seamless delivery across functions
  • Accountable for the successful transition of early phase programs to late phase CMC project leaders
  • Understand the CMC capability needs for the longer-term portfolio, and ensure these are communicated to CMC line heads so that long term business strategies can be developed
  • Serve as the CMC accountable person with early phase stakeholders on CMC-impacting objectives, e.g. acceleration, attrition reduction strategies, upper quartile performance


Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:
  • Bachelor's degree in a CMC-oriented scientific discipline (such as pharmacy, engineering, biology, analytical or synthetic chemistry)
  • 15+ years in CMC project delivery in a line or matrix leadership capacity
  • Experience in the pharmaceutical industry with specific experience in a technical CMC function and supply chain aspects of developing and manufacturing pharmaceuticals
  • Experience creating and defending CMC development strategy, plan and data package for an asset in early development
  • Second-line leader experience


Preferred Qualifications:

If you have the following characteristics, it would be a plus:
  • PhD preferred with extensive CMC experience in the development or manufacture of relevant pharmaceuticals
  • Thorough working knowledge of the pharmaceutical industry, relevant regulations and requirements
  • Project leadership experience, specifically leadership of large, complex, multi-disciplinary teams with 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
  • 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


Please visit GSK US Benefits Summary t o 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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