Medical Director, Neurology

OverviewNeurocrine Biosciences is a neuroscience-focused biopharmaceutical company dedicated to relieving suffering for people with great needs.
Our culture emphasizes inclusion, purpose, and brave science.
For more information, visit neurocrine.com and follow the company on LinkedIn, X, and Facebook.
(In collaboration with AbbVie for certain programs.)About the RoleResponsible for the development of clinical research strategies and independent direction of Phase 1-3 clinical studies while working with cross-functional project teams (clinical project managers, preclinical/clinical pharmacology, biometrics, regulatory, drug safety).
May collaborate with Research and Preclinical Development to develop biomarkers for early clinical development.
Oversees medical aspects of Drug Safety activities in conjunction with the Drug Safety Director and partners with Business Development in assessing external innovation.Your Contributions (include, but are not limited to):Develops and implements study protocols in conjunction with a multidisciplinary Development TeamAssist in the identification and selection of clinical investigators for trials and maintain professional Sponsor medical monitor/representative relationshipsConduct medical assessment and disposition of adverse events with the Drug Safety physician; evaluate safety of clinical compounds before and during studiesOversee the clinical trials program with Clinical Operations in accordance with NBI SOPs, Good Clinical Practice, and applicable regulationsAnalyze, interpret, and present results of clinical studies to internal and external audiences as directed by Sr.
ManagementIdentify resource requirements, assist in budget planning and personnel forecasting for clinical research programsAssist in recruitment, training, and development of clinical teamsIdentify and select clinical consultantsProvide or assist in scientific writing and review of clinical study reports and regulatory documentsProvide periodic status updates and communicate with Senior Management TeamLead the development of clinical biomarker strategies for early clinical developmentWork with Medical Affairs and external opinion leaders to secure new collaborators and present trial resultsInterface with Research, Product Development, and Business Development to assess new product opportunities and develop clinical research strategy and product development plansOther duties as assignedRequirements:MD or DO with accredited residency training and board certification in a relevant clinical specialty for the therapeutic area; 2+ years of experience in clinical research and development (Phase 1-4) in pharma/biotech or clinical research/academic settingKnowledge of Good Clinical Practice and regulatory procedures relevant to investigational drug developmentStrong knowledge in translational medicine, biomarker evaluation, clinical study execution, regulatory documents, study design, biostatistics, data analysis, report writing, and data presentationAbility to operate effectively in a multi-level matrix environment and interact with physicians, scientists, monitors, regulatory, commercial, and consultant personnelDemonstrated success managing interactions with external CROs and consultants, especially in a small groupProven track record across all phases of drug development and in clinical trial designRecognized as an internal thought leader with extensive technical and business expertiseStrong problem-solving and innovative capabilities within a strategic organizationEvaluates key business and scientific challenges and leads cross-functional initiativesStrong interpersonal, organizational, and leadership skillsAbility to work independently and prioritize multiple tasks to meet timelines and budget targets#LI-KM1Neurocrine Biosciences is an EEO/Disability/Vets employer.
We are committed to belonging, respect, and empowerment, and we encourage you to apply even if your experience or qualifications don't line up exactly with what is outlined in the job description.The annual base salary we reasonably expect to pay is $246,500.00-$356,950.00.
Individual pay decisions depend on location, role complexity, duties, and relevant experience.
The position offers an annual bonus target of 35% of base salary and eligibility for our equity-based long-term incentive program.
Benefits include a retirement plan with company match, paid vacation, holidays, personal days, caregiver/parental and medical leave, and health benefits (medical, prescription, dental, vision) per plan terms.
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