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Director, External CMC Diligence

Employer
GSK
Location
Collegeville, Pennsylvania; King of Prussia, Pennsylvania
Salary
Competitive
Closing date
Oct 14, 2022

View more

Discipline
Other, Other
Job Type
President/CEO/Director/VP
Organization Type
All Industry, Pharma
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Are you interested in a matrix leadership role with high visibility that supports building GSK's portfolio of innovative products through in-licensing, partnerships, acquisitions and divestments? This opportunity will allow you to operate in a fast paced environment where you can put your CMC development and manufacturing expertise to work in a high-performance cross-functional matrix team to conduct technical CMC-related due diligence for small molecules, large molecules and oligonucleotide assets.

If so, the Director, CMC Matrix Leader - small & large molecule Diligence is an exciting role for you to consider. The successful individual will join the Medicine Development & Supply (MDS) Scientific Licensing and External CMC Diligence team which has enterprise accountability for CMC input into all stages of the due diligence process including contracting.

Key Responsibilities:
  • For selected full-diligences, direct and lead the cross-functional CMC matrix team positioning the CMC opportunities and risks/mitigation plans across drug substance, drug product, analytical, stability and manufacturing, identify key showstoppers/deal-breakers, create options for development & supply chain strategy etc. in the context of the proposed medicine and business strategy. Works closely with the CMC diligence team to outline the budget required to support the proposed clinical development plan and commercial forecasts.
  • Direct and lead operational aspects for full-diligences to ensure a harmonized approach is being taken to meet the overall expectations of the diligence process. Works closely with the CMC diligence lead to drive completion of the diligence outputs (e.g. risk register, diligence report etc.) upon agreed timelines. Identifies opportunities across multiple diligences for continuous improvement of the diligence process.
  • Direct and lead the CMC input into early and late stage diligences. For this responsibility, the selected individual will work closely with Business Development when an early diligence is initiated and an early view of the CMC information is required.
  • This role requires negotiation, enrolling, aligning, facilitating risk management conversations etc. with the appropriate stakeholders to ensure that all the CMC-related aspects are appropriately captured in the contractual agreements as part of the overall diligence process
  • Upon deal closure, drives the integration, operationalization and knowledge transfer to ensure smooth transition and onboarding of the program into the GSK portfolio.
  • Fosters a team culture of ownership and accountability.

Skills & Competencies:
  • Experience in CMC medicine development, particularly late stage and preferably through to successful product approval and launch
  • Experience with contract development and a broader understanding of how to effectively include CMC terms into external contracts
  • Experience in partnering with business development in due diligence efforts
  • Ability to hold team members accountable for their delivery and performance on behalf of the team and the enterprise
  • Ability to work under pressure, meeting time sensitive deadlines, while maintaining a high level of confidentiality.
  • Clear presentation skills and ability to articulate technical/business drivers at all levels in the organization
  • Ability to influence at all levels in the business and across multiple disciplines
  • Collaborative, cooperative, inclusive and transparent, builds and cultivates high performing teams and partnerships
  • Ability 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:

We are looking for professionals with these required skills to achieve our goals:
  • BS/MS degree with minimum of 10+ years, or PhD with minimum of 8+ years of relevant industrial experience which includes pre-clinical drug development or biopharmaceutical manufacturing in a technical role
  • Minimum of 3 years of experience of leadership in a matrix environment as a CMC lead (e.g. drug substance lead, drug product lead or analytical lead) to create and defend CMC development strategy, plan and data package for a small molecule, large molecule or oligonucleotide product


Preferred Qualifications:

If you have the following characteristics, it would be a plus:
  • PhD degree in chemical/biochemical engineering, chemistry, biology, biochemistry, or related technical discipline, or BS/MS degree with MBA
  • Previous experience working on due diligence activities and in a business alliance environment.
  • Broad understanding and experience of business aspects of contracting (e.g. collaboration/partnership agreements, CDMO contracts etc.)
  • Demonstrated leadership skills in leading within a matrix environment, and the ability to work across various functional organizational interfaces.
  • Extensive experience with small and large molecule CMC development is strongly preferred
  • Experience creating integrated CMC development & supply chain strategy, plan and data package for drug substance or drug product and defending them in front of senior CMC stakeholders
  • Prior experience and understanding of contractual language with CDMOs or partner organizations
  • Working knowledge of early and late stage development activities associated with regulatory submissions (IND/IMPDs and NDA/BLA/MAA submissions) for both small and large molecules
  • Industry-tested problem solving and risk management skills.




    Why GSK?

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

    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.

    *LI-GSK

    GSKBiopharm_development

    *This is a job description to aide in the job posting, but does not include all job evaluation details.

    If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).

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