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Neurocrine Biosciences

Executive/Senior Medical Director - Immune or Neuro Immune

Neurocrine Biosciences, San Diego, California, United States, 92189

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Who We Are: At Neurocrine Biosciences, we pride ourselves on fostering a robust, inclusive, and positive culture rooted in our shared purpose and values. We are deeply passionate about our people, just as much as we are about our mission - to relieve suffering for individuals with pressing needs. What We Do: Neurocrine Biosciences is a frontrunner in the biopharmaceutical sector, focusing on neuroscience, with a clear purpose: to alleviate suffering for those in need. We are enthusiastic about discovering and developing transformative treatments for patients facing under-addressed neurological, neuroendocrine, and neuropsychiatric disorders. Our portfolio features FDA-approved treatments for conditions such as tardive dyskinesia, chorea associated with Huntington's disease, congenital adrenal hyperplasia, endometriosis, and uterine fibroids, alongside a promising pipeline of clinical compounds. For over three decades, we have harnessed our neuroscience expertise to tackle complex health challenges, relentlessly pursuing innovative therapies to ease the burdens of debilitating diseases. For more information about our work, visit neurocrine.com or find us on LinkedIn, X, and Facebook. About the Role: This position is for a medical expert responsible for shaping clinical research strategies and overseeing Phase 1-3 clinical studies in immune-driven and/or neuro immune-driven diseases. You will collaborate with cross-functional teams, including clinical project managers, pharmacology, biometrics, regulatory, and drug safety, to devise and implement development plans aimed at obtaining product approvals. A strong background with biomolecules, specifically therapeutic antibodies, is essential. This role also requires providing expert medical insight to navigate intricate drug development processes and fostering collaborations with Research and Preclinical Development to identify biomarkers for early clinical evaluation. Your Contributions (include, but are not limited to): Craft and execute clinical development strategies and design studies for assigned programs, featuring protocol writing, data system design, data interpretation, and report preparation. Serve as the Therapeutic Medical Lead on the Program Team, offering medical input for development plans and supporting clinical initiatives. Provide leadership in medical matters to propel the execution of development plans. Collaborate with multidisciplinary teams to establish and implement study protocols. Assist in identifying and engaging clinical investigators, acting as the Sponsor medical monitor. Conduct assessments of adverse events and evaluate safety throughout trials. Supervise clinical trial programs in full compliance 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 outcomes to both internal and external stakeholders. Work with Medical Affairs and external experts to create new partnerships and share findings. Engage with Research, Product Development, and Business Development to assess new opportunities and formulate strategies. Perform additional duties as assigned. Requirements: MD/DO with 6+ years in clinical practice and experience in Medical Affairs or a related field. Preferred: Clinical background in Psychiatry, Neurology, or Movement Disorders. A recognized thought leader with specialization in immune-driven diseases. Extensive knowledge of theories and techniques in the functional area. Creative problem-solving abilities in complex or novel situations. Capability to influence both industry and internal challenges affecting Neurocrine. Strong mentoring and leadership qualities. Adept at translating strategy into actionable plans and achieving results. Self-motivated, adaptable, and capable of managing substantial workloads. Exceptional interpersonal, collaborative, oral, and written communication skills. Proven success in project management. Proficient in relevant software tools and filing systems. Thorough understanding of drug development, regulatory considerations, and clinical research protocols. Experience collaborating with regulatory agencies on INDs and NDAs. In-depth knowledge of GCP, regulatory processes, translational medicine, and biomarker assessment. Ability to navigate effectively within a matrix environment and manage external collaborations. Background in program strategy, launch, and project management within Clinical Development. Neurocrine Biosciences is an EEO/Disability/Vets employer. We are committed to fostering a workplace of belonging, respect, and empowerment, encouraging 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.