Associate Director, External Partnerships, Biologics - Durham, United States - GlaxoSmithKline

Description

Site Name:
USA - Pennsylvania - Upper Providence, Durham Blackwell Street, UK - Hertfordshire - Stevenage, Waltham


Posted Date:
May 3 2024

The Strategic External Development (SED) team is an empowered, innovative, and agile CMC development organization within MDS that will unlock the potential to rapidly deliver an increased number of transformative medicines to patients through exceptional relationships with trusted global partners.

The primary purpose of this job is to manage oversight of and develop and maintain strong trusted relationships with high priority external partners for MDS, supporting product development and clinical supply of the pharmaceutical portfolio across different modalities and enable accelerated supply of medicines to patients with a focus on the biologics portfolio (eg. Monoclonal antibodies, antibody drug conjugates, sterile drug product presentations).

High priority external partners for MDS are third parties that are sole suppliers of a critical MDS business activity for delivery of pipeline, third parties delivering a fully externalised R&D asset of critical or high priority, or third parties that are critical to MDS business continuity.

The role is crucial to build relationships that ensure continuous improvement of how GSK and our partners work together and is essential for ensuring that the relationships are managed, and issues are appropriately escalated, across the governance framework including interactions with senior leaders of the suppliers to ensure the relationships deliver value to GSK long-term.

This position establishes and enforces necessary governance needed to minimize the risk across the portfolio of projects/activities executed at the high priority external partners for GSK.

Within each relationship both the appropriate quality, safety and technical (scientific and engineering) processes and systems must be in place to ensure delivery to GSK and external standards.

This position is also accountable for driving continuous improvement to ensure GSK is getting the most value from the spend with these suppliers.

Key Responsibilities:
Leading the interactions with key priority external partners

• Ensure relationships with high priority external partners are built and maintained. Act as the primary external interface with partners / suppliers who are delivering services globally and across pharmaceutical development and clinical supply, with a scope spanning non-regulated through to GxP services to support the R&D portfolio and ultimate commercialization of assets derived from internal GSK discovery pipeline or through business development deals.
• Lead the CMC matrix of individuals who interact with high priority external partners including MDS staff who are operationally contracting work; subject matter experts necessary to visit, monitor and assess the work proposed or produced such as MDS technical leads, Regulatory, Quality, EHS; Procurement to build incentivisation into contractual obligations and Third Party Resourcing to report into the framework.
• Build effective with high priority external partners doing pharmaceutical development and clinical manufacturing at both executive and operational levels. Influence such external leaders to develop capabilities that meet GSK's future needs as well as addressing current expectations.
• Ensure appropriate monitoring of safety, quality, technical capabilities, and performance at high priority external partners in pharmaceutical development and clinical supply; driving continuous process improvement between GSK and high priority external partners. Responsible for execution of the CMC strategy and keeping teams aligned for successful and timely delivery of agreed objectives.
• Lead the integration of 2nd party CMC supply chains for assets acquired through in-licensing or whole company acquisitions. The leadership of these activities will be end to end to ensure that all aspects of business as usual activities are covered including contracting, business oversight, data transfer, and any other operational requirements needed. Its not intended that this individual will perform all (or any) of these activities nor would they necessarily 'own' the supplier after integration, rather they would provide the leadership to ensure all related support functions complete their portions of the activity and a smooth transition into GSK's standard ways of working is achieved.

Shape supplier selection and performance assessment

• Build close collaboration with key internal partners including SED Program Delivery, MDS External Diligence and Scientific Licensing, CMC leads, MDS technical lines, Procurement, and Third Party Resourcing - with this role acting at a finer level of safety and quality and deeper technical knowledge - and with other GSK business units including EHS, Corporate Regulatory, GSC Technical, Supply and Quality functions to continually optimise how suppliers are managed.
• Make visible and influence strategically with a range of senior decision makers to ensure GSK makes the right choices on external suppliers and that the capabilities of high priority external partners are well understood. This includes liaising with senior project owners (e.g. CMC Leaders), portfolio owners, platform owners in MDS, and assurers (GSC, MSAT), as well as appropriate engagement at governance.
• Objectively assess the performance of high priority external partners and feed into wider frameworks for vendor selection, formal assessments of their capability, risk escalation and partnership governance.

Drive the strategic direction for managing high priority external partners of pharmaceutical development and clinical supply activities

• Develop and lead implementation of a pharmaceutical development and clinical supply relationship strategy with short, medium and long-term deliverables. Simplify the current interactions with external suppliers and coordinate interactions across multiple business units who need to interact with or assure the activities in the suppliers' facilities both before and during work.
• Continually survey the external landscape to strengthen knowledge of supplier capabilities and ability to meet GSK expectations. Map and benchmark current suppliers using a variety of lenses including book of business, strength of relationship, unique technical capabilities, technical strength, quality management system, safety record and capabilities versus GSK. Use this insight to influence supplier simplification and supplier selection.

Why you?


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

• 5+ years' experience with the Pharmaceutical Industry, ideally in drug development / CMC activities for biologics including, for example, monoclonal antibodies, antibody drug conjugates, and sterile drug product presentations.
• Experience working with third parties and developing effective relationships
• Experience of non-regulated, GLP and GMP processes necessary to develop a medicine ready for commercial release and supply to the clinic.

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

• Experience working closely with procurement functions.
• Ability to effectively communicate (written and verbal) and influence key stakeholders at all levels of the organization both internally and externally.
• Expansive and visionary thinker to drive strategic vision of the partnerships.
• Strong relationship builder with negotiation skills
• Ability to successfully manage a global matrix team.
• Ability to translate complex concepts into actionable and measurable tasks
• Thrives in a faced paced environment with potential for significant change

#LI-GSK

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

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

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We prevent and treat disease with vaccines, specialty and general medicines.

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