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Stevenage

    Associate Director Development Management - Stevenage, Hertfordshire, United Kingdom - GSK

    GSK background
    Description

    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.

    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.

    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.

    subject matter experts necessary to visit, monitor and assess the work proposed or produced such as MDS technical leads, Regulatory, Quality, EHS; Build effective with high priority external partners doing pharmaceutical development and clinical manufacturing at both executive and operational levels.

    Ensure appropriate monitoring of safety, quality, technical capabilities, and performance at high priority external partners in pharmaceutical development and clinical supply; 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.

    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.

    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.

    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 of non-regulated, GLP and GMP processes necessary to develop a medicine ready for commercial release and supply to the clinic.

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

    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).

    If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at US Toll Free) or outside US).
    GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles.

    This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

    GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site.

    All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK.

    The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK.

    In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK.

    GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

    Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment.

    This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements.

    For more information, please visit GSK's Transparency Reporting For the Record site.
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