StellenbeschreibungppAt Johnson Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through 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 humanity.Learn more at jnj.com. /p pAs guided by Our Credo, Johnson Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson Johnson, we respect the diversity and dignity of our employees and recognize their merit. /p h3Job Function: /h3 pDiscovery Pre-Clinical/Clinical Development /p h3Job Sub Function: /h3 pClinical Development Research – MD /p h3Job Category: /h3 pPeople Leader /p h3All Job Posting Locations: /h3 pAllschwil, Basel-Country, Switzerland /p h3Job Description: /h3 pJohnson J (JJ) is seeking an bExecutive Director, Clinical Leader – Neuropsychiatry /b to be located in Allschwil, Switzerland. /p pOur expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. /p pOur Neuroscience team tackles the world’s toughest brain health challenges including multiple sclerosis, Alzheimer’s disease, Parkinson’s disease, myasthenia gravis, epilepsy, major depressive disorder, bipolar disorder, schizophrenia, and autism. This patient-focused team helps address some of the most complex diseases of our time. /p pJoin us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. /p pLearn more at /p pThe Executive 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. /p h3Essential Functions: /h3 ul lipResponsible 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 reports /p /li lipLeads Cross-functional Clinical Team; supervises, develops and recruits junior medical staff /p /li lipMolecule responsible physician; Responsible for the oversite of medical monitoring/reporting and safety activities; Evaluates adverse events (pre and post-marketing) for relationship to treatment. /p /li lipResponsible for overseeing content for the Independent Data Monitoring Committee (IDMC) and adjudication meetings as needed /p /li lipInterprets, reports and prepares results of product research in preparation for global health authority submissions and external communication /p /li lipResponsible for assessment of medical publications emerging from the Team and its affiliates /p /li lipAssists Regulatory Affairs in the development of drug/device regulatory strategiesand determining requirements for any corrective actions or health authority reporting /p /li lipActs as medical contact at company for global health authorities concerning clinical/medical issues /p /li lipMay act as company spokesperson regarding publication of clinical research findings and presentations to relevant global health authorities and advisory committees /p /li lipHelps explore and evaluate new product ideas to assist in identifying new marketing opportunities /p /li lipSupports general Clinical/Medical Affairs activities involving product evaluation, labeling and surveillance /p /li lipSupports early clinical development involving product potential and development for registration /p /li lipManages the budget for all project related clinical activities /p /li /ul h3Education and Experience: /h3 ul lipMD (or equivalent) in relevant area with appropriate post-doctoral training and certification /p /li lipA minimum of 7 years clinical research or pharmaceutical industry experience is required, inclusive of a minimum of 3 years of Phase II/III development experience within industry. /p /li lipBoard Certification or Eligibility in Psychiatry or neurology preferred. /p /li lipA minimum of 3 years of highly successful managerial/supervisory or related experience /p /li lipA minimum of 7 years clinical research or pharmaceutical industry experience is required, inclusive of a minimum of 3 years of Phase II/III development experience within industry. /p /li lipExpertise in clinical drug development including demonstrated ability to develop clinical development plans meeting the highest standards is required. /p /li lipGlobal registration experience strongly preferred, as is experience working or interacting with Health Authorities. /p /li lipExperience working in a Matrix environment is required. Ability to interface effectively with clinical operations, medical affairs and marketing is essential. /p /li /ul h3Required Technical Knowledge and Skills: /h3 ul lipFluent in written and spoken English /p /li lipWorking knowledge of the use of Microsoft suite of software products including Excel and Word /p /li lipExperience and knowledge of Good Clinical Practices and regulatory requirements for the conduct of clinical trials and for the appropriate contributions to regulatory filings /p /li /ul h3Required Skills: /h3 pClinical Research and Regulations, Clinical Trials, Collaboration, Corporate Governance, Data Management and Informatics, Developing Others, Drug Discovery Development, Global Market, Health Care Regulation, Inclusive Leadership, Industry Analysis, Innovation, Leadership, Market Research, Research Ethics, Scientific Evaluation, Scientific Research, Stakeholder Management, Strategic Change /p h3Preferred Skills: /h3 pClinical Research and Regulations, Clinical Trials, Collaboration, Corporate Governance, Data Management and Informatics, Developing Others, Drug Discovery Development, Global Market, Health Care Regulation, Inclusive Leadership, Industry Analysis, Innovation, Leadership, Market Research, Research Ethics, Scientific Evaluation, Scientific Research, Stakeholder Management, Strategic Change /p p#LI-Hybrid /p pPlease note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s): /p ul lipUnited States- Requisition Number: R- /p /li lipBelgium- Requisition Number: R- /p /li lipSwitzerland- Requisition Number: R- /p /li /ul pRemember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission. /p pJohnson Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. /p pJohnson Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please contact us via or contact AskGS to be directed to your accommodation resource. /p /p #J-18808-Ljbffr
