Job Description

Careers That Change Lives An exciting opportunity to be an integral part of growth for the clinical research and medical science team across SEA Primary Responsibilities This role will manage a team of high performing clinical professionals and provide leadership for the Development and execution clinical/medical projects in the region for either a specific therapeutic area or across several therapeutic areas. People Management Leads and manages a team of individual clinical professionals and related staffs in his/her region. Manages cross functional clinical study teams in accordance with the tasks linked to Clinical Research Manager and Study Manager roles. Manages and coaches Clinical professionals and staff, including hiring, objective setting and appraisals mainly focusing on aligning projects (objectives, strategy, scope and schedule) according to and to meet business plans. Clinical and Medical Affairs Represents Medtronic as \'the Clinical face\' within the country / geography and acts at the same time as the \'voice\' of the local customers and authorities towards relevant stakeholders at Medtronic. Develop clinical project/study and documents in collaboration with relevant stakeholders within Medtronic and oversee the execution in region. Ensures appropriate resources and priorities are maintained for the projects assigned to the geography/country. Has the ability to manage clinical research projects over all of the Medtronic therapies cross BU. For global studies: Take up the role of local Clinical study Manager and Clinical Research Manager as assigned. Authors/co-authors (or supports physician authorship) results of studies in the medical literature and/or presents at scientific meetings. Assures successful & timely execution of assigned clinical and medical affairs programs consistent with clinical plans and applicable regulations and policies interfacing with representatives from key functional groups within Medtronic Provides input to the local clinical strategy and ensures full alignment with the global clinical strategy Identifies potential local clinical studies in line with local and Operating Unit (OU) strategy. Develops and manages the study- and cost centre budgets. Provide Clinical inputs and support to clinical studies Advises local marketing organization on outcome of publications and advises on a communication strategy Provides expert review of marketing/sales presentations, scientific communications, and publications Drive clinical evidence dissemination to internal and external stakeholders If needed, provides inputs to supporting tenders External Relations Builds and maintains a strong network with key-opinion leaders and relevant external stakeholders specific to the country/geography. Ensures intake for investigator-initiated research ideas and ensure appropriate follow-up within the organization through the relevant policy and SOP. Be the first point of contact for Local customers, authorities and KOLs about local Clinical Affairs Lead Health Care Professional (HCP) education and engagement plans Builds the right level of knowledge in reimbursement, health management in the country/region to address those with relevant clinical solutions. Quality, Regulatory and Therapy Expertise Assures that clinical studies meet highest scientific, statistical, quality and ethical standards. Has working knowledge of SEA regional Medical Device regulations, clarifies the interpretation with Regulatory Affairs Department and other regulatory bodies in countries when necessary. Maintains a high level of professional scientific, technical and clinical expertise through familiarity with relevant literature, by attending scientific meetings and appropriate trainings, and by interacting with various inside/outside experts or departments/institutes. Must Have Bachelors Degree required. Master\'s Degree in relevant Science or biomedical field preferred. (Medicine, Biomedical Engineering, Medical Physics, Medical Biology, Health Sciences, etc.) MBBS/MD Preferred Your Profile More than 8 years\' experience directly leading clinical research/Medical affairs or similar experience in a medical/scientific area 3 years or more experience managing people, budgets and clinical studies Demonstrable experience in setting clinical/medical strategy and KOL engagement plans

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