Neurocrine Biosciences
Executive Director/Senior Director, Medical Director MD - Immune or Neuro Immune
Neurocrine Biosciences, San Diego, California, United States, 92189
Who We Are:
At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering for people with great needs.
What We Do:
Neurocrine Biosciences is a leading
neuroscience-focused,
biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine, and neuropsychiatric disorders. Our portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, congenital adrenal hyperplasia, endometriosis* and uterine fibroids*, along with a pipeline of compounds in clinical development. For three decades, we've applied our neuroscience expertise to treat complex conditions, relentlessly pursuing medicines to ease the burden of debilitating diseases because you deserve brave science. For more information, visit neurocrine.com and follow us on LinkedIn, X, and Facebook. ( *in collaboration with AbbVie ) About the Role: This role is for a medical expert responsible for developing clinical research strategies and independently directing Phase 1-3 clinical studies in immune-driven and/or neuro immune-driven diseases. The role involves working with cross-functional teams (clinical project managers, pharmacology, biometrics, regulatory, drug safety) to create and execute development plans that will lead to product approvals. Experience with biomolecules, such as therapeutic antibodies, is required. The role includes providing expert medical advice to navigate complex drug development and working closely with Research and Preclinical Development to develop biomarkers for early clinical evaluation. Your Contributions (include, but are not limited to): Develop clinical development strategies and design studies for assigned programs, including protocol writing, data system design, data interpretation, and report preparation. Engage with external experts as needed. Represent Medical/Clinical on the Program Team as the Therapeutic Medical Lead, providing medical input to development plans and supporting clinical activities. Provide medical leadership to drive the execution of development plans. Develop and implement study protocols with multidisciplinary teams. Assist in selecting and communicating with clinical investigators, acting as Sponsor medical monitor. Conduct medical assessments of adverse events and evaluate safety during trials. Oversee clinical trial programs in accordance with SOPs, GCP, and regulations. Identify resource needs, lead budget and personnel planning, and contribute to team recruitment and training. Analyze and present clinical study results to internal and external audiences. Collaborate with Medical Affairs and external experts to secure new partnerships and present findings. Interface with Research, Product Development, and Business Development to evaluate new opportunities and develop strategies. Perform other duties as assigned. Requirements: MD/DO with 6+ years of clinical practice and Medical Affairs or related experience. Preferred: Clinical practice in Psychiatry, Neurology, or Movement Disorders. Recognized thought leader with expertise in immune-driven diseases. Deep expertise in functional area theories and techniques. Creative problem-solving skills in complex or novel situations. Ability to influence industry and internal issues impacting Neurocrine. Strong mentoring and leadership skills. Ability to translate strategy into tactical plans and achieve outcomes. Flexible, self-motivated, and capable of managing large workloads. Excellent interpersonal, collaborative, oral, and written communication skills. Proven project management success. Proficiency in software tools and filing systems. Deep knowledge of drug development, regulatory issues, and clinical research processes. Experience working with regulatory agencies on filings like INDs and NDAs. Strong knowledge of GCP, regulatory procedures, translational medicine, and biomarker evaluation. Ability to operate effectively in a matrix environment and manage external partnerships. Experience in program strategy, launch, and project management within Clinical Development. #LI-KM1 Neurocrine Biosciences is an
EEO/Disability/Vets
employer. We are committed to a workplace of belonging, respect, and empowerment, and encourage candidates to apply regardless of experience gaps. The annual base salary range is $314,000 - $454,600, with potential bonuses, equity incentives, and comprehensive benefits including retirement plans, paid leave, and health coverage.
#J-18808-Ljbffr
neuroscience-focused,
biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine, and neuropsychiatric disorders. Our portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, congenital adrenal hyperplasia, endometriosis* and uterine fibroids*, along with a pipeline of compounds in clinical development. For three decades, we've applied our neuroscience expertise to treat complex conditions, relentlessly pursuing medicines to ease the burden of debilitating diseases because you deserve brave science. For more information, visit neurocrine.com and follow us on LinkedIn, X, and Facebook. ( *in collaboration with AbbVie ) About the Role: This role is for a medical expert responsible for developing clinical research strategies and independently directing Phase 1-3 clinical studies in immune-driven and/or neuro immune-driven diseases. The role involves working with cross-functional teams (clinical project managers, pharmacology, biometrics, regulatory, drug safety) to create and execute development plans that will lead to product approvals. Experience with biomolecules, such as therapeutic antibodies, is required. The role includes providing expert medical advice to navigate complex drug development and working closely with Research and Preclinical Development to develop biomarkers for early clinical evaluation. Your Contributions (include, but are not limited to): Develop clinical development strategies and design studies for assigned programs, including protocol writing, data system design, data interpretation, and report preparation. Engage with external experts as needed. Represent Medical/Clinical on the Program Team as the Therapeutic Medical Lead, providing medical input to development plans and supporting clinical activities. Provide medical leadership to drive the execution of development plans. Develop and implement study protocols with multidisciplinary teams. Assist in selecting and communicating with clinical investigators, acting as Sponsor medical monitor. Conduct medical assessments of adverse events and evaluate safety during trials. Oversee clinical trial programs in accordance with SOPs, GCP, and regulations. Identify resource needs, lead budget and personnel planning, and contribute to team recruitment and training. Analyze and present clinical study results to internal and external audiences. Collaborate with Medical Affairs and external experts to secure new partnerships and present findings. Interface with Research, Product Development, and Business Development to evaluate new opportunities and develop strategies. Perform other duties as assigned. Requirements: MD/DO with 6+ years of clinical practice and Medical Affairs or related experience. Preferred: Clinical practice in Psychiatry, Neurology, or Movement Disorders. Recognized thought leader with expertise in immune-driven diseases. Deep expertise in functional area theories and techniques. Creative problem-solving skills in complex or novel situations. Ability to influence industry and internal issues impacting Neurocrine. Strong mentoring and leadership skills. Ability to translate strategy into tactical plans and achieve outcomes. Flexible, self-motivated, and capable of managing large workloads. Excellent interpersonal, collaborative, oral, and written communication skills. Proven project management success. Proficiency in software tools and filing systems. Deep knowledge of drug development, regulatory issues, and clinical research processes. Experience working with regulatory agencies on filings like INDs and NDAs. Strong knowledge of GCP, regulatory procedures, translational medicine, and biomarker evaluation. Ability to operate effectively in a matrix environment and manage external partnerships. Experience in program strategy, launch, and project management within Clinical Development. #LI-KM1 Neurocrine Biosciences is an
EEO/Disability/Vets
employer. We are committed to a workplace of belonging, respect, and empowerment, and encourage candidates to apply regardless of experience gaps. The annual base salary range is $314,000 - $454,600, with potential bonuses, equity incentives, and comprehensive benefits including retirement plans, paid leave, and health coverage.
#J-18808-Ljbffr