Role summary
the executive medical director will be primarily responsible for developing and executing the neurology strategy and driving clinical programs for neurodegenerative diseases.
this role includes leading development of clinical research strategies, development plans, and directing phase 1-4 studies within cross-functional teams.
it also covers medical oversight of clinical studies, input on study design, data collection and analysis, and collaboration with external partners and regulatory bodies.
responsibilities
drive strategic direction for neurology programs during development and oversee clinical phases, including design and implementation of clinical plans and communication of results
lead planning and execution of global clinical development projects in compliance with gxp and regulatory requirements
foster relationships with external scientific leaders and investigators
report to senior management on strategies, research plans, budgets, and data deliverables
oversee regulatory submission documents in collaboration with cross-functional teams
lead process improvement to develop and implement best practices for r&d
supervise monitoring procedures and data collection
monitor clinical trials through operational teams, qa systems, and cros
contribute to publication and presentation of data externally
identify factors that could impact neurocrine's strategies and propose innovative solutions
manage direct or indirect members of the clinical development organization in a matrix environment
other duties as assigned
qualifications
md or equivalent degree with accredited residency training and board certification in neurology; subspecialization (fellowship trained) preferred and 8+ years of experience in clinical drug development (phase 1-3) in a pharmaceutical/biotech company, including significant leadership experience
advanced degree (ms, phd) in a relevant scientific discipline preferred
demonstrated success in leading clinical programs in neurodegenerative diseases, with recent experience in alzheimer's disease and neurocognitive syndromes, parkinson's disease, and related disorders
experience in developing various treatment modalities (small molecules and biologic/genetic therapies) desired
extensive knowledge of clinical drug development, including development planning, regulatory requirements, study design, biostatistics, gcp, and oversight of internal and cro resources
ability to operate in a multi-level matrix environment with internal and external personnel
first-hand clinical and research expertise in neurology
proven ability to partner with stakeholders, collaborators, scientific organizations, and patient advocacy groups
broad and comprehensive expertise in leading-edge clinical drug development theories and techniques
ingenuity and creativity in problem analysis and resolution for novel situations
ability to influence internal/external business and industry issues impacting neurocrine
strong analytical and critical thinking skills to synthesize and communicate complex information
ability to set longer-term vision for the department
ability to meet multiple deadlines with high quality and efficiency
excellent project leadership, communication, and interpersonal skills
strong accountability and ability to collaborate and lead in a cross-functional team
education
md or equivalent degree with residency in neurology; board certification required; fellowship training preferred
advanced degree (ms, phd) in a relevant field preferred
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