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Associate Director Medical Affairs and Clinical

West Chester, PA

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TheBiosurgery platform in The Ethicon Franchise, a member of Johnson &nJohnson's Family of Companies, is recruiting for an Associate Director,nMedical Affairs & Clinical located in Somerville, NJ, WestnChester, PA, Warsaw, IN, Cincinnati, OH, or Raynham, MA. From creatingnthe first sutures, to revolutionizing surgery with minimally invasivenprocedures, Ethicon has made significant contributions to surgery for more thann60 years. Our continuing dedication to Shape the Future of Surgery is built onnour commitment to help address the worldu2019s most pressing health care issues,nand improve and save more lives. Through Ethiconu2019s surgical technologies andnsolutions including sutures, staplers, energy devices, trocars and hemostatsnand our commitment to treating serious medical conditions like obesity andncancer worldwide, we deliver innovation to make a life-changing impact. Thriving on andiverse company culture, celebrating the uniqueness of our employees andncommitted to inclusion. Proud to be an equal opportunity employer. Operatingnon behalf of the Ethicon MCP platform, this individual will provide scientificnand technical information to NeuWave Medicalu2019s key customers. They willninitiate and maintain relationships to increase awareness of company's productsnby designing, developing and delivering effective presentations and byncoordinating symposia and continuing education seminars. Additionally, theynwill lead a team of clinical research professionals to support the developmentnof evidence generation / dissemination strategies (EGS/EDS) for multiple and /nor complex projects for the NeuWave platform. OVERALL RESPONSIBILITIES: Responsiblenfor Medical Affairs and Clinical R&D activities for multiple and / orncomplex projects, including:Worksnindependently with key thought leaders and academic institution to advocate thenresponsible use of innovative therapies. DiscussesnInvestigator initiated study concepts with clinicians. Buildsnand maintains supportive relationships with key opinion leaders on clinicalnapplication of company's products. Plansnand organizes continuing educational workshops, seminars, programs and advisorynboards (clinical discussion & debating forums) for physicians, pharmacistsnand scientists.Evaluatesnanalysis of clinical studies to ensure information integrity of the company'snproducts. Issues analysis report for management use. Leadsnkey product presentations to demonstrate the benefits to thought leaders,nmedical groups, government agencies and health systems. Supportnclinical scientific discussions with regulatory agencies / notified bodies tondrive support of the clinical and regulatory strategy, including proposednclinical investigations; review process of clinical evidence generated fornmarketing authorization, line extensions, etc., including during sponsornregulatory inspections; Leadnteam of clinical research professionals to develop and deliver appropriatenGlobal EGS / EDS to support New Product Development and Life-Cycle Managementn(NPD & LCM) within the assigned platforms, with collaborative relationshipsnwith all relevant CR&D partners and cross-functional partners (e.g. GlobalnStrategic Marketing, Medical Affairs, Regulatory Affairs, HEMA, R&D, etc.),nensuring cross- functional alignment;Responsiblenfor delivery of assigned clinical programs, through effective partnership withnthe Clinical Operations and BSDM teams, to enable optimized engagement leadingnto delivery of clinical project commitments (delivery on time, within budgetnand in compliance with regulations and SOP); Ensureninput and strong alignment from key regional MD CR&D leads and othernstrategically important countries/regions in the development of the EGS / EDS;Supportnthe design of appropriate clinical trials to meet the NPD / LCM needs; Leadnteams to ensure appropriate interpretation and dissemination of all evidencengenerated, based on EDS, including CSRs, abstracts, manuscripts, etc.Responsiblenfor teamu2019s interface and collaboration with key opinion leaders, investigators,nIRBu2019s/ECu2019s, Regulatory Agencies, societies, associations, etc.Fosternstrong relationships with external stakeholders to shape and influence relevantnpolicies, etc.Partnernwith internal stakeholders to ensure accurate dissemination of clinicalndata/evidence in value briefs and technical summaries for market access andnreimbursement. Functional and Technical Competencies: Expertise in clinical research science and processes along with anbroad and extensive understanding of product development processes, teamndynamics, related healthcare market environment, clinical trends, and globalnclinical trial regulations;Demonstrated ability to build collaborative relationships with keyninternal and external partners and stakeholders;Ability to lead a team of clinical scientists to provide strategicnand scientific clinical research input across NPD and LCM projects;Proven track record in delivering clinical programs withinnclinical / surgical research setting, on time, within budget and in compliancento SOPs and regulations;Comprehensive understanding of clinical trial regulations acrossnmultiple regions; Ability to lead teams to deliver critical milestones;Ability to collaborate across different functional areas withinnCR&D to ensure alignment with governance processes (assigning roles andnresponsibilities, setting priorities, managing deliverables, etc). and to meetnbusiness objectives;Leadership requirement u2013 ability to influence, shape and leadnwithout direct reporting authority;Change agent in team progression; Experience in effective management of project budget processes;Through transparent leadership, be a key leader in developing anhigh-performing team with a global culture; Leadership Competencies: Strongnleadership required in alignment with J&J Leadership Imperatives: Connect,nShape, Lead, Deliver as noted below. Connect - foster strategic partnerships with key internal &nexternal stakeholders to ensure development and timely delivery of innovativenEGS / EDSShape u2013 build strong relationships with external stakeholders tonshape and influence relevant policiesLead u2013 develop talent to provide strategic and scientific clinicalnresearch capability, including responsibility for professional development ofndirect reportsDeliver u2013 ensure clinical programs are delivered on time, withinnbudget and in compliance to regulations and SOPsKnow and follow all laws and policies that apply to one's job, andnmaintain the highest levels of professionalism, ethics and compliance at allntimes.Diligently participate in our compliance program-relatednactivities as denoted by your supervisor or our Chief Compliance Officer.Performs other related duties as required. QualificationsA minimum of a Bacheloru2019s degree in Biological Science or anrelated discipline is required. An advanced degree (Masters or PhD) isnpreferred.A minimum of 8 years of related experience within ClinicalnResearch or Medical Affairs function is requiredExperience working in Oncology Therapeutic Area is required At least 2 years of people management-related experience isnpreferred for this role.A minimum of 2 yearsu2019 experience interacting with customers in anmedical or clinical atmosphere is required Experience managing Investigator Initiated Studies is required This position will be located in located in Somerville, NJ, WestnChester, PA, Warsaw, IN, Cincinnati, OH, or Raynham, MA, and may require up to 50%ntravel (domestic and international)

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