Job Description

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, External CMC In-License and M&A 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 for in-licensing, codevelopment/co-commercialization, Mergers & Acquisitions (M&A) and divestments.

Key Responsibilities include:

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 development and continuous improvement of the overall due diligence workflow and post-deal implementation steps of the CMC aspects to enable integration of the project into the GSK portfolio.

Single point accountability for post-deal activities including knowledge transfer from the CMC Diligence Team to the CMC Project Matrix team, collaboration with IT (Tech), Alliance Management and Risk Management & Compliance to documents/knowledge are transferred into the GSK ecosystem.

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.

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.

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.

Fosters a team culture of ownership and accountability.

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 experience which includes pre-clinical drug development or biopharmaceutical manufacturing in a technical role.

Must have previous experience working on due diligence activities and in a business alliance environment.

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.

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.

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.

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 successfully navigating these strategies with 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.