Senior Director, Clinical Leader Neuropsychiatry at Johnson & Johnson

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at Job Function: Discovery & Pre-Clinical/Clinical DevelopmentJob Sub Function: Clinical Development & Research MDJob Category:People LeaderAll Job Posting Locations:Allschwil Switzerland Beerse Antwerp Belgium Cambridge Massachusetts United States of America San Diego California United States of America Titusville New Jersey United States of AmericaJob Description:At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at SUMMARY:The Senior Director Clinical Leader (CL) is responsible for development and execution of medical and scientific strategies for late phase compounds (Ph2b/3) and operational implementation delivered through the effective leadership of a cross-functional Clinical Team (CT). The CL leads the team to develop products in a timely and cost-effective manner and is responsible for the clinical development plans (including life-cycle management geographic expansion and post-marketing commitments) protocol development quality execution of clinical studies preparation and ownership of clinical study reports and for the preparation and approval of essential documents for global regulatory filings. The CL will manage direct reports who are project physicians. Team leadership via matrix interactions also includes individuals from project management TA strategy global regulatory affairs finance legal quality assurance quality monitoring & compliance clinical supplies unit data management medical writing biostatistics global medical safety pharmacogenomics early clinical development clinical pharmacology data science digital health global clinical operations health economics epidemiology global medical affairs and other scientific and business related disciplines. The CL is also expected to assist in the leadership of the evaluation of scientific opportunities in the therapeutic area.ESSENTIAL FUNCTIONS:Responsible for the development and execution of the clinical development plan and has ownership for the design of clinical trials and for the content of clinical study reportsLeads Cross-functional Clinical Team; supervises develops and recruits junior medical staffMolecule responsible physician; Responsible for the oversite of medical monitoring/reporting and safety activities; Evaluates adverse events (pre and post-marketing) for relationship to treatment.Responsible for overseeing content for the Independent Data Monitoring Committee (IDMC) and adjudication meetings as neededInterprets reports and prepares results of product research in preparation for global health authority submissions and external communicationResponsible for assessment of medical publications emerging from the Team and its affiliatesAssists Regulatory Affairs in the development of drug/device regulatory strategiesand determining requirements for any corrective actions or health authority reportingActs as medical contact at company for global health authorities concerning clinical/medical issuesMay act as company spokesperson regarding publication of clinical research findings and presentations to relevant global health authorities and advisory committeesHelps explore and evaluate new product ideas to assist in identifying new marketing opportunitiesSupports general Clinical/Medical Affairs activities involving product evaluation labeling and surveillanceSupports early clinical development involving product potential and development for registrationManages the budget for all project related clinical activitiesEducation and Experience: MD (or equivalent) in relevant area with appropriate post-doctoral training and certificationA minimum of 5 years clinical research or pharmaceutical industry experience is required inclusive of a minimum of 3 years of Phase II/III development experience within industry.An MD (or international equivalent) is required.Board Certification or Eligibility in Psychiatry or neurology preferred.A minimum of 3 years of highly successful managerial/supervisory or related experienceA minimum of 5 years clinical research or pharmaceutical industry experience is required inclusive of a minimum of 3 years of Phase II/III development experience within industry.Expertise in clinical drug development including demonstrated ability to develop clinical development plans meeting the highest standards is required.Global registration experience strongly preferred as is experience working or interacting with Health Authorities.Experience working in a Matrix environment is required. Ability to interface effectively with clinical operations medical affairs and marketing is essential.Required Technical Knowledge and Skills:Fluent in written and spoken EnglishWorking knowledge of the use of Microsoft suite of software products including Excel and WordExperience and knowledge of Good Clinical Practices and regulatory requirements for the conduct of clinical trials and for the appropriate contributions to regulatory filingsRequired Skills: Preferred Skills:Required Experience:Exec Key Skills CSS,Cloud Computing,Health Education,Actuary,Building Electrician Employment Type : Full-Time Experience: years Vacancy: 1