Johnson & Johnson Innovative Medicine
Director, Study Responsible Physician, Clinical Development, Neuroscience
Johnson & Johnson Innovative Medicine, Spring House, Pennsylvania, United States, 19477
Director, Study Responsible Physician, Clinical Development, Neuroscience
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Our Neuroscience team tackles the world’s toughest brain health challenges including Alzheimer’s disease, Parkinson’s disease, myasthenia gravis, major depressive disorder, bipolar disorder, and schizophrenia. This patient-focused team helps address some of the most complex diseases of our time. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. The Study Responsible Physician (SRP) is responsible for design and execution of Ph3 studies in neurologic disorders. The SRP is a critical member of a cross-functional clinical team led by a Clinical Lead, and provides active medical and scientific contribution to the team. The SRP provides input and helps with the clinical development plan, the development of the clinical trial protocol, clinical trial materials including protocol training, content of clinical study reports and relevant documents for regulatory filings. The SRP provides critical oversight of the medical safety of patients in the clinical trial through frequent and detailed medical data reviews, adverse event and medical history codings, review and coding of protocol deviations, and frequent site interactions to ensure protocol compliance, data quality, and patient safety. Essential Functions: Responsible for medical monitoring/reporting and company safety officer activities Works on clinical development plans, trial protocols and takes ownership of clinical study reports Evaluates adverse events (pre- and post-marketing) for relationship to treatment Assists Regulatory Affairs in determining requirements for any corrective actions or health authority reporting related to study conduct or outcome May act as a medical contact at the company for health authorities concerning clinical/medical issues Interprets, reports, and prepares oral and written results of product research, in concert with senior clinical personnel, in preparation for health authority submissions Close interactions with Project Clinical Scientists and Physicians across programs Qualifications: MD (or equivalent) is required. Board Certification (or equivalent) in Neurology with experience in interpreting neurophysiologic studies (electromyography- EMG, nerve conduction studies - NCS, repetitive nerve studies - RNS) is strongly preferred. Strong experience in neurodegenerative disorders may be considered in place of experience in neurophysiology. Two or more years' experience in Pharma (clinical development, medical affairs or pharmacovigilance) is required. Experience with neurology trials in industry setting is preferred. Additional Requirements: Exceptional interpersonal and communication skills, with the ability to build strong relationships and influence without reporting authority. Excellent problem-solving and conflict resolution skills, with the ability to navigate complex and challenging situations. Proven experience and expertise in leading and managing in a matrix organizational structure. Exceptional problem-solving skills with the capacity to anticipate risks, to develop creative solutions and to meet objectives. Demonstrated ability to develop deep insights (e.g., big picture thinking) based on data analysis and interpretation. Results oriented, able to think creatively, critically, and proactively, to drive innovative solutions. Exceptional analytical and critical thinking skills, with the ability to translate complex data (financial/operational) into actionable insights for strategic decision making. Exceptional communication and presentation skills, with the ability to clearly articulate complex ideas to cross functional teams and stakeholders The anticipated base pay range for this position is: $193,000 - $334,650 Johnson & Johnson is an equal employment opportunity company, and we are committed to providing equal employment opportunities to all applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or any other characteristic protected by law.
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At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Our Neuroscience team tackles the world’s toughest brain health challenges including Alzheimer’s disease, Parkinson’s disease, myasthenia gravis, major depressive disorder, bipolar disorder, and schizophrenia. This patient-focused team helps address some of the most complex diseases of our time. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. The Study Responsible Physician (SRP) is responsible for design and execution of Ph3 studies in neurologic disorders. The SRP is a critical member of a cross-functional clinical team led by a Clinical Lead, and provides active medical and scientific contribution to the team. The SRP provides input and helps with the clinical development plan, the development of the clinical trial protocol, clinical trial materials including protocol training, content of clinical study reports and relevant documents for regulatory filings. The SRP provides critical oversight of the medical safety of patients in the clinical trial through frequent and detailed medical data reviews, adverse event and medical history codings, review and coding of protocol deviations, and frequent site interactions to ensure protocol compliance, data quality, and patient safety. Essential Functions: Responsible for medical monitoring/reporting and company safety officer activities Works on clinical development plans, trial protocols and takes ownership of clinical study reports Evaluates adverse events (pre- and post-marketing) for relationship to treatment Assists Regulatory Affairs in determining requirements for any corrective actions or health authority reporting related to study conduct or outcome May act as a medical contact at the company for health authorities concerning clinical/medical issues Interprets, reports, and prepares oral and written results of product research, in concert with senior clinical personnel, in preparation for health authority submissions Close interactions with Project Clinical Scientists and Physicians across programs Qualifications: MD (or equivalent) is required. Board Certification (or equivalent) in Neurology with experience in interpreting neurophysiologic studies (electromyography- EMG, nerve conduction studies - NCS, repetitive nerve studies - RNS) is strongly preferred. Strong experience in neurodegenerative disorders may be considered in place of experience in neurophysiology. Two or more years' experience in Pharma (clinical development, medical affairs or pharmacovigilance) is required. Experience with neurology trials in industry setting is preferred. Additional Requirements: Exceptional interpersonal and communication skills, with the ability to build strong relationships and influence without reporting authority. Excellent problem-solving and conflict resolution skills, with the ability to navigate complex and challenging situations. Proven experience and expertise in leading and managing in a matrix organizational structure. Exceptional problem-solving skills with the capacity to anticipate risks, to develop creative solutions and to meet objectives. Demonstrated ability to develop deep insights (e.g., big picture thinking) based on data analysis and interpretation. Results oriented, able to think creatively, critically, and proactively, to drive innovative solutions. Exceptional analytical and critical thinking skills, with the ability to translate complex data (financial/operational) into actionable insights for strategic decision making. Exceptional communication and presentation skills, with the ability to clearly articulate complex ideas to cross functional teams and stakeholders The anticipated base pay range for this position is: $193,000 - $334,650 Johnson & Johnson is an equal employment opportunity company, and we are committed to providing equal employment opportunities to all applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or any other characteristic protected by law.
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