职位描述

职位描述： Education/Qualifications:•Life Sciences degree and higher qualificationExperience, Skills, Knowledge•Thorough understanding, knowledge and experience of drug development across the value chain, with particular focus on Phase I and Phase II studies•Thorough understanding and experience of the execution of large global clinical studies in a diverse range of patient populations•Good knowledge and experience of working with external specialist vendors•Demonstrated experience of global clinical program (ie a series of studies comprising a clinical development plan) implementation•Experience in the relevant DTA, including knowledge of external service providers and needs for drug development within the DTA•Demonstrated experience in managing external partners/vendors across clinical programs Significant line management experience, and proven ability to lead and manage a cross functional team•Strong analytical and strategic agility skills•Experience of working within a matrix team•Demonstrated experience in managing outsourced studies and programs•Flexibility to provide specialized operational support to a number of stakeholder groups, including TMLs, CP, BEML•Excellent planning and organizational skills•High level of initiative and ability to work independently•Exceptional leadership skills, including motivation and delegation•Highly effective team player and exceptional interpersonal skills (globally, internally and externally)•Demonstrated ability in external Partnership/ Relationship management•Good business awareness•Demonstrated pragmatism and willingness to drive and support change•Demonstrated ability to challenge established practices and concepts•Proven ability to support innovation even if taken outside of his/her comfort zone•Highly effective verbal and written communication skills in EnglishJob Scope / Summary:•Leadership role in pRED Operations, with strategic oversight and accountability for delivery of specific clinical development programs within pRED.•The CPL provides leadership to all operations functions assigned to the implementation of a pRED clinical project and represents Clinical Development functions as core member of the Disease Biology Project Team (DBPT) and the Clinical Team. The CPL is responsible and accountable for all operational activities within a project and ensures these activities are performed according to quality, schedule and cost standards set by a given Discovery and Translational Area (DTA), Roche SOPs and GCP. Through appropriate leadership, direction and operational expertise, the CPL contributes to the clinical development strategies of DBPT for specific projects in the DTA. The CPL acts as a key partner with internal stakeholders including Translational Medicine Leaders, Clinical Pharmacologists, Science & Methodology Experts, Biomarker Leaders, and Project Team Leaders to ensure the effective implementation of the early clinical development strategy through deployment of resources from the pRED Clinical Development Expert Resource Group. The CPL may also have responsibility as the Key Account Manager for specific external partners. CPLs report to the Senior CPL for the DTA.Job Primary Responsibilities and Accountabilities:•Providing strategic input to the development of an optimal Clinical Development Plan and providing constructive and challenging critique (risk management/business value assessment).•Accountable to the DBPTs for the operational implementation of DTA clinical development programs within agreed timelines, budget and Roche standards. These include trials from Entry Into Human through phase IIb dose ranging studies as well as clinical pharmacology and experimental medicine studies.•Interface with SCPL to ensure planning & decision-making on study placement is in line with pRED sourcing strategy.•Membership of Clinical Team & DBPT, providing operational input to the definition of project strategy and robust feasibility of execution.•Accountable to DBPT for timely and accurate forecasting and delivery of operations project resource and budget•Accountable to DBPT for planning, tracking and managing the operational budget, resources (allocation) and timelines for the project against the agreed goals of the team•Collaborating with the appropriate Functions in defining the resourcing and the outsourcing strategy for the early development programs.•Provide input to SCPL in case of project prioritization exercises within the DTA portfolio•May participate in Business Development/ in-licensing assessments.•May be required to assume leadership of project sub-teams e.g. Clinical Team•The CPL will ensure all programs under their remit are implemented according to ethical/regulatory/legal requirement.•For outsourced studies/programs under their remit, the CPL is accountable for the selection of the CRO.•The CPL will contribute to the functional excellence efforts and initiatives in pRED Operations and at pRED Development level as requested.These statements are not intended to be an exhaustive list of all responsibilities, duties, and skills required of people assigned to this job, but are instead intended to describe the general nature and level of the work. Different levels of responsibilities and accountabilities may be assigned to take account of the skills capabilities and experience of the individual. 职能类别： 生物工程/生物制药

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