Neurocrine Biosciences
Sr. Medical Director, MD- (Neuropsychiatry)
Neurocrine Biosciences, Prairie Home, Missouri, United States
Overview
Neurocrine Biosciences is a leading neuroscience-focused biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We pursue medicines to ease the burden of debilitating diseases and disorders by applying neuroscience insights to patient care. For more information, visit neurocrine.com and follow the company on LinkedIn, X, and Facebook. This role is a Medical expert responsible for the development of clinical research strategies and independent direction of Phase 1-3 clinical studies in the Neuropsychiatry therapeutic area, working with cross-functional project teams to create and execute clinical development plans that support product approvals. The role collaborates with Research and Preclinical Development to develop biomarkers for early clinical development.
Your Contributions
For assigned programs, develop clinical development strategies and lead study design of clinical trials in Development, prepare clinical study synopses, contribute to writing protocols/major amendments, design data collection systems, interpret clinical data, and prepare final clinical study reports. Engage external experts and organizations as needed. Represent Medical/Clinical on the cross-functional Program Team as the Program/Therapeutic Medical Lead. Provide medical input to integrated development plans and clinical development plans; collaborate cross-functionally to support medical activities for clinical studies. Provide medical leadership to the Program Team and drive the execution of the clinical development plan. Develop and implement study protocols in conjunction with a multidisciplinary Development Team. Assist in the identification and selection of clinical investigators for trials and maintain communication and professional relationships as Sponsor medical monitor/representative. Conduct medical assessment and disposition of adverse events (in conjunction with Drug Safety) and evaluate the safety of clinical compounds during ongoing studies. Oversee the clinical trials program in conjunction with Clinical Operations in compliance with NBI SOPs, Good Clinical Practice, and applicable regulations. Identify resource requirements, lead budget planning and personnel forecasting for clinical research programs; contribute to recruitment, training, and development of clinical teams and identify clinical consultants as needed. Lead analysis, interpretation, and presentation of results of assigned clinical studies to internal and external audiences. Collaborate with Medical Affairs and external opinion leaders to secure new collaborators and present trial results. Interface with Research, Product Development, and Business Development to assess new product opportunities and develop clinical research strategy and product development plans. Other duties as assigned. Requirements
MD or DO (or equivalent) degree in a relevant clinical specialty for the therapeutic area; 4+ years of clinical experience with broad bio/pharmaceutical/CRO industry experience in drug development. Accredited residency training and board certification preferred. Recognized internal thought leader with deep expertise in a discipline. Broad, deep, and comprehensive expertise in leading-edge theories and techniques for the functional area. Ability to apply ingenuity to problem analysis and resolution in complicated or novel situations. Influences internal/external business and/or industry issues impacting Neurocrine. Strong mentoring and leadership abilities; supervises lower levels and/or leads indirect teams. Proven ability to translate strategy into tactical plans and drive outcomes. Flexible, adaptable, self-motivated, able to prioritize and manage a large volume of work with minimal supervision. Strong interpersonal and collaborative skills; track record of building relationships with medical and scientific experts. Excellent oral and written communication skills with attention to detail; ability to translate complex scientific concepts for different audiences. Demonstrated success with project management. Proficiency with word processing, spreadsheet, database, and presentation software and with filing/archiving systems. Deep knowledge of the drug development process including technical, business, and regulatory issues. Proven track record working with regulatory agencies and providing clinical leadership for filing INDs, NDAs, or other government filings. Strong knowledge of Good Clinical Practice and regulatory procedures for investigational drug development. Strong knowledge in translational medicine and biomarker evaluation, clinical study execution, regulatory requirements and documents, study design, biostatistics, data analysis, report writing, and data presentation. Ability to operate effectively in a multi-level matrix environment, interacting with and directing clinical research project teams including physicians, scientists, monitors, regulatory, and consultants. Demonstrated success managing interactions with external CROs, consultants, and other contract organizations, especially for small groups. Experience driving program strategy, launch, and project management within Clinical Development. Experience developing and implementing policies and processes. #LI-SW1 Neurocrine Biosciences is an EEO/Disability/Vets employer and is committed to building a workplace of belonging, respect, and empowerment. We encourage you to apply even if your experience or qualifications don’t line up exactly with the job description. The annual base salary range is $290,300.00-$420,250.00, with bonuses and equity-based incentives. Benefits include retirement savings with company match, paid vacation/holiday/personal days, caregiver/parental and medical leave, and comprehensive health benefits.
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Neurocrine Biosciences is a leading neuroscience-focused biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We pursue medicines to ease the burden of debilitating diseases and disorders by applying neuroscience insights to patient care. For more information, visit neurocrine.com and follow the company on LinkedIn, X, and Facebook. This role is a Medical expert responsible for the development of clinical research strategies and independent direction of Phase 1-3 clinical studies in the Neuropsychiatry therapeutic area, working with cross-functional project teams to create and execute clinical development plans that support product approvals. The role collaborates with Research and Preclinical Development to develop biomarkers for early clinical development.
Your Contributions
For assigned programs, develop clinical development strategies and lead study design of clinical trials in Development, prepare clinical study synopses, contribute to writing protocols/major amendments, design data collection systems, interpret clinical data, and prepare final clinical study reports. Engage external experts and organizations as needed. Represent Medical/Clinical on the cross-functional Program Team as the Program/Therapeutic Medical Lead. Provide medical input to integrated development plans and clinical development plans; collaborate cross-functionally to support medical activities for clinical studies. Provide medical leadership to the Program Team and drive the execution of the clinical development plan. Develop and implement study protocols in conjunction with a multidisciplinary Development Team. Assist in the identification and selection of clinical investigators for trials and maintain communication and professional relationships as Sponsor medical monitor/representative. Conduct medical assessment and disposition of adverse events (in conjunction with Drug Safety) and evaluate the safety of clinical compounds during ongoing studies. Oversee the clinical trials program in conjunction with Clinical Operations in compliance with NBI SOPs, Good Clinical Practice, and applicable regulations. Identify resource requirements, lead budget planning and personnel forecasting for clinical research programs; contribute to recruitment, training, and development of clinical teams and identify clinical consultants as needed. Lead analysis, interpretation, and presentation of results of assigned clinical studies to internal and external audiences. Collaborate with Medical Affairs and external opinion leaders to secure new collaborators and present trial results. Interface with Research, Product Development, and Business Development to assess new product opportunities and develop clinical research strategy and product development plans. Other duties as assigned. Requirements
MD or DO (or equivalent) degree in a relevant clinical specialty for the therapeutic area; 4+ years of clinical experience with broad bio/pharmaceutical/CRO industry experience in drug development. Accredited residency training and board certification preferred. Recognized internal thought leader with deep expertise in a discipline. Broad, deep, and comprehensive expertise in leading-edge theories and techniques for the functional area. Ability to apply ingenuity to problem analysis and resolution in complicated or novel situations. Influences internal/external business and/or industry issues impacting Neurocrine. Strong mentoring and leadership abilities; supervises lower levels and/or leads indirect teams. Proven ability to translate strategy into tactical plans and drive outcomes. Flexible, adaptable, self-motivated, able to prioritize and manage a large volume of work with minimal supervision. Strong interpersonal and collaborative skills; track record of building relationships with medical and scientific experts. Excellent oral and written communication skills with attention to detail; ability to translate complex scientific concepts for different audiences. Demonstrated success with project management. Proficiency with word processing, spreadsheet, database, and presentation software and with filing/archiving systems. Deep knowledge of the drug development process including technical, business, and regulatory issues. Proven track record working with regulatory agencies and providing clinical leadership for filing INDs, NDAs, or other government filings. Strong knowledge of Good Clinical Practice and regulatory procedures for investigational drug development. Strong knowledge in translational medicine and biomarker evaluation, clinical study execution, regulatory requirements and documents, study design, biostatistics, data analysis, report writing, and data presentation. Ability to operate effectively in a multi-level matrix environment, interacting with and directing clinical research project teams including physicians, scientists, monitors, regulatory, and consultants. Demonstrated success managing interactions with external CROs, consultants, and other contract organizations, especially for small groups. Experience driving program strategy, launch, and project management within Clinical Development. Experience developing and implementing policies and processes. #LI-SW1 Neurocrine Biosciences is an EEO/Disability/Vets employer and is committed to building a workplace of belonging, respect, and empowerment. We encourage you to apply even if your experience or qualifications don’t line up exactly with the job description. The annual base salary range is $290,300.00-$420,250.00, with bonuses and equity-based incentives. Benefits include retirement savings with company match, paid vacation/holiday/personal days, caregiver/parental and medical leave, and comprehensive health benefits.
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