Executive Medical Director, Clinical Development, Advanced Pipeline Unit - Waltham
2 weeks ago
Lead clinical development strategy from drug or program accountability including clinical components of Target Medicine Profile TMP leadership of clinical matrix team CMT.
Ensure cohesive comprehensive clinical development plans CDPs product/s indication/s provide strategic oversight management of trials Identify highlight transformational opportunities projects offer highly significant benefit patients Contribute develop Integrated Evidence Strategy IES oversee CDP component trials Drive delivery timelines complex assets decision points risk/cost analyses Go/No Go criteria PTRS evaluations study/project assess implement mitigation strategies Foster collaboration Commercial Regulatory Operations Affairs Statistics teams Act point contact senior management matrix stakeholders including regulators payors CROs consultants investigators Lead discussions teams global regulatory interactions Draft briefing documents presentations responses regulatory questions Manage technical leadership development staff direct line mentoring coaching organisation Drive strategic business organisational initiatives digital tools promote innovative methodologies processes encourage others think differently adopt new ways working Stay abreast advancements therapeutic area research trial methodologies competitive environment regulatory space maintain GSK competitive edge Basic qualifications Medical degree specialty training board qualification registration Experience global pharmaceutical/biotechnology industry Interstitial Lung Diseases IPF PPF autoimmune associated ILDs including connective tissue disease Associated ILD CTID experience late-stage Lung Disease drug ID Phase 2 Phase 3 trial design initiation execution closure Leading NDA BLA MAA submissions managing global trials experience line-management overseeing medical directors scientists leading matrix within setting Preferred qualifications Pulmonary Medicine Critical Care thorough understanding respiratory diseases underlying biology potential targets robust knowledge ICH GCP guidelines reimbursement data requirements solid understanding needs priorities regulators payers prescribers relevant market track record building maintaining strong relationships internal external stakeholders demonstrated problem-solving skills innovative thinking anticipate challenges developing approaches effectively communicating uncertainty stakeholders guiding through unclear circumstances enterprise mindset identifying synergy across organization ability use strategic thinking analyse interpret critically evaluate complex data information navigate ambiguity anticipating issues proactively addressing Valid Job:1}
Job description
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