Neurocrine Biosciences
Sr. Medical Director, MD (Neuropsychiatry)
Neurocrine Biosciences, San Diego, California, United States, 92154
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, but few options.
Are you ready to apply Make sure you understand all the responsibilities and tasks associated with this role before proceeding. What We Do:
Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs, but few options. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine, and neuropsychiatric disorders. The company’s diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington’s disease, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X (Formerly Twitter) and Facebook. (*in collaboration with AbbVie) About the Role: Medical expert responsible for the development of clinical research strategies and independent direction of Phase 1-3 clinical studies in the Neuropsychiatry therapeutic area while working with cross-functional project teams (clinical project managers, preclinical/clinical pharmacology, biometrics, regulatory, drug safety) in the creation and execution of clinical development plans and in the development of strategies that will ultimately lead to approvals of Neurocrine's products. Provide expert medical advice to advance the development portfolio and help the company navigate the complex drug development landscape. Works closely with Research and Preclinical Development to develop biomarkers necessary for the most effective evaluation of novel molecules in early clinical development. Your Contributions (include, but are not limited to):
For assigned programs, develops clinical development strategies and is accountable for the study design of clinical trials in Development, leading on the preparation of clinical study synopses and being a major contributor to the writing of protocols/major amendments, the design of data collection systems, interpretation of clinical data, and the preparation of final clinical study reports. Engages with external experts and organizations as needed to achieve these aims.
Represents Medical/Clinical on the cross-functional Program Team as the Program/Therapeutic Medical Lead. Accountable and responsible for the medical input to integrated development plans prepared by the Program Team and the clinical development plans that underpin them. Collaborate cross-functionally to support medical activities for clinical studies.
Provides medical leadership to the Program Team. Accountable and responsible for driving the execution of the clinical development plan.
Develops and implements study protocols in conjunction with a multidisciplinary Development Team.
Assists in the identification and selection of clinical investigators for clinical trials and maintains appropriate communication and professional relationships as Sponsor medical monitor/representative.
Conducts medical assessment and disposition of adverse events (in conjunction with Drug Safety physician) and evaluates safety of clinical compounds prior to and during ongoing clinical studies.
Oversees the clinical trials program in conjunction with Clinical Operations in accordance with NBI SOPs, Good Clinical Practice, and applicable regulations.
Identifies resource requirements, leads budget planning and personnel forecasting for clinical research programs; key contributor in the recruitment, training and development of the clinical teams, as well as identifies and selects clinical consultants as needed.
Leads the analysis, interpretation, and presentation of results of assigned clinical studies to internal and external audiences.
Works with Medical Affairs and external opinion leaders to secure new collaborators and present trial results.
Interfaces with Research, Product Development and Business Development to assess new product opportunities, develop clinical research strategy and product development plans.
Other duties as assigned.
Requirements:
MD or DO (or equivalent) degree in relevant clinical specialty for the therapeutic area required and 4+ years clinical experience with broad bio/pharmaceutical/CRO industry experience in drug development.
Accredited residency training and board certification preferred.
Recognized Internal thought leader and deep expertise in a discipline.
Requires broad, deep and comprehensive expertise in leading-edge theories and techniques for functional area.
Applies ingenuity and creativity to problem analysis and resolution in complicated and/or novel situations.
Influences internal/external business and/or industry issues that have an impact on Neurocrine.
Strong mentoring skills and leadership abilities to supervise lower levels and/or lead indirect teams.
Proven ability to translate strategy into tactical plans and drive outcomes.
Must be flexible, adaptable, self-motivated, able to prioritize, and able to manage/progress a large volume of work with minimal supervision.
Strong interpersonal skills and outstanding collaborative skills; proven track record and success in building relationships and having scientific discourse with medical and scientific experts.
Outstanding oral and written communication skills, with close attention to detail; ability to translate complex scientific concepts into simple language tailored for different audiences.
Demonstrated success with project management.
Proficiency with word processing, spreadsheet, database, and presentation software and with filing (archiving) systems.
Deep knowledge and understanding of the drug development process including technical, business, and regulatory issues.
Proven track record working with regulatory agencies and providing clinical leadership for the filing of INDs, NDAs, or other similar government filings.
Strong knowledge of Good Clinical Practice, regulatory procedures relevant to 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 scientific presentation of data.
Able to effectively operate in a multi-level matrix corporate environment, requiring interaction with, and/or direction of clinical research project teams, including physicians, scientists, monitors, administrative, regulatory, commercial, and consultant personnel.
Demonstrated success managing interactions with external CROs, consultants and other contract organizations, especially from the context of a small group.
Has successfully driven program strategy, launch and project management within Clinical Development.
Previous experience with developing and implementing policies and processes.
#LI-SW1 Neurocrine Biosciences is an EEO/AA/Disability/Vets employer. We are committed to building a diverse, equitable, and inclusive workplace, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don’t line up to exactly what we have outlined in the job description.
#J-18808-Ljbffr
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, but few options.
Are you ready to apply Make sure you understand all the responsibilities and tasks associated with this role before proceeding. What We Do:
Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs, but few options. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine, and neuropsychiatric disorders. The company’s diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington’s disease, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X (Formerly Twitter) and Facebook. (*in collaboration with AbbVie) About the Role: Medical expert responsible for the development of clinical research strategies and independent direction of Phase 1-3 clinical studies in the Neuropsychiatry therapeutic area while working with cross-functional project teams (clinical project managers, preclinical/clinical pharmacology, biometrics, regulatory, drug safety) in the creation and execution of clinical development plans and in the development of strategies that will ultimately lead to approvals of Neurocrine's products. Provide expert medical advice to advance the development portfolio and help the company navigate the complex drug development landscape. Works closely with Research and Preclinical Development to develop biomarkers necessary for the most effective evaluation of novel molecules in early clinical development. Your Contributions (include, but are not limited to):
For assigned programs, develops clinical development strategies and is accountable for the study design of clinical trials in Development, leading on the preparation of clinical study synopses and being a major contributor to the writing of protocols/major amendments, the design of data collection systems, interpretation of clinical data, and the preparation of final clinical study reports. Engages with external experts and organizations as needed to achieve these aims.
Represents Medical/Clinical on the cross-functional Program Team as the Program/Therapeutic Medical Lead. Accountable and responsible for the medical input to integrated development plans prepared by the Program Team and the clinical development plans that underpin them. Collaborate cross-functionally to support medical activities for clinical studies.
Provides medical leadership to the Program Team. Accountable and responsible for driving the execution of the clinical development plan.
Develops and implements study protocols in conjunction with a multidisciplinary Development Team.
Assists in the identification and selection of clinical investigators for clinical trials and maintains appropriate communication and professional relationships as Sponsor medical monitor/representative.
Conducts medical assessment and disposition of adverse events (in conjunction with Drug Safety physician) and evaluates safety of clinical compounds prior to and during ongoing clinical studies.
Oversees the clinical trials program in conjunction with Clinical Operations in accordance with NBI SOPs, Good Clinical Practice, and applicable regulations.
Identifies resource requirements, leads budget planning and personnel forecasting for clinical research programs; key contributor in the recruitment, training and development of the clinical teams, as well as identifies and selects clinical consultants as needed.
Leads the analysis, interpretation, and presentation of results of assigned clinical studies to internal and external audiences.
Works with Medical Affairs and external opinion leaders to secure new collaborators and present trial results.
Interfaces with Research, Product Development and Business Development to assess new product opportunities, develop clinical research strategy and product development plans.
Other duties as assigned.
Requirements:
MD or DO (or equivalent) degree in relevant clinical specialty for the therapeutic area required and 4+ years clinical experience with broad bio/pharmaceutical/CRO industry experience in drug development.
Accredited residency training and board certification preferred.
Recognized Internal thought leader and deep expertise in a discipline.
Requires broad, deep and comprehensive expertise in leading-edge theories and techniques for functional area.
Applies ingenuity and creativity to problem analysis and resolution in complicated and/or novel situations.
Influences internal/external business and/or industry issues that have an impact on Neurocrine.
Strong mentoring skills and leadership abilities to supervise lower levels and/or lead indirect teams.
Proven ability to translate strategy into tactical plans and drive outcomes.
Must be flexible, adaptable, self-motivated, able to prioritize, and able to manage/progress a large volume of work with minimal supervision.
Strong interpersonal skills and outstanding collaborative skills; proven track record and success in building relationships and having scientific discourse with medical and scientific experts.
Outstanding oral and written communication skills, with close attention to detail; ability to translate complex scientific concepts into simple language tailored for different audiences.
Demonstrated success with project management.
Proficiency with word processing, spreadsheet, database, and presentation software and with filing (archiving) systems.
Deep knowledge and understanding of the drug development process including technical, business, and regulatory issues.
Proven track record working with regulatory agencies and providing clinical leadership for the filing of INDs, NDAs, or other similar government filings.
Strong knowledge of Good Clinical Practice, regulatory procedures relevant to 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 scientific presentation of data.
Able to effectively operate in a multi-level matrix corporate environment, requiring interaction with, and/or direction of clinical research project teams, including physicians, scientists, monitors, administrative, regulatory, commercial, and consultant personnel.
Demonstrated success managing interactions with external CROs, consultants and other contract organizations, especially from the context of a small group.
Has successfully driven program strategy, launch and project management within Clinical Development.
Previous experience with developing and implementing policies and processes.
#LI-SW1 Neurocrine Biosciences is an EEO/AA/Disability/Vets employer. We are committed to building a diverse, equitable, and inclusive workplace, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don’t line up to exactly what we have outlined in the job description.
#J-18808-Ljbffr