Neurocrine Bioscience
Director, Clinical Operations - Vendor Management
Neurocrine Bioscience, San Diego, California, United States, 92189
Overview
Who We Are: Neurocrine Biosciences is a company focused on neuroscience with a strong, inclusive culture dedicated to relieving suffering for people with great needs. What We Do: Neurocrine Biosciences is a leading neuroscience-focused biopharmaceutical company dedicated to discovering and developing treatments for patients with under-addressed neurological, neuroendocrine, and neuropsychiatric disorders. The portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis, and uterine fibroids, with a robust pipeline in mid- to late-phase development. More information is available at neurocrine.com, and follow us on LinkedIn, X, and Facebook. (*in collaboration with AbbVie) About the Role
Responsible for developing strategic plans, objectives and overall management for the Clinical Operations team executing Neurocrine's clinical studies (all phases). Ensure clinical study activities are conducted in compliance with FDA regulations, EU Directive, ICH guidelines, and adhere to corporate and departmental Standard Operating Procedures. A key focus will be on the oversight of CROs, external vendors and internal stakeholders to ensure studies are conducted according to timelines, budgets, and resources to achieve program objectives and corporate goals. The Director will also manage career development of multiple direct reports within the clinical operations group. Your Contributions (include, but are not limited to):
Design and implement clinical strategies using internal and external resources Provide leadership to the Clinical Operations study team (Associate Directors, Clinical Trial Managers, Specialists, Clinical Trial Associates, and other subordinate employees) Lead the tactical implementation and execution of the clinical development process (all phases) primarily for selected programs Ensure these activities are conducted in compliance with FDA regulations, EU Directive and ICH guidelines, and adhere to corporate and departmental SOPs Establish and manage overall clinical program budgets as well as individual study budgets Develop and maintain clinical trial timelines to achieve corporate goals Create and establish critical metrics to benchmark activities to develop and revise performance to reach and maintain highest possible standards of excellence Identify and introduce process improvements within the clinical organization Manage relationships and expectations with CROs and other clinical contract service providers. Act as point of contact with external bodies Manage inter-department relationships (Regulatory, QA, etc) to ensure adequate support for clinical programs as well as provide input into cross-functional meetings and documentation Interface with Medical Directors by providing operational input to clinical protocols, clinical development plans and clinical study reports Recruit, train, and manage career development of multiple direct reports within the clinical operations group Manage operational activities of clinical programs with corporate partners Perform additional tasks and duties as assigned Requirements
BS/BA degree in scientific or related field AND 12+ years of extensive experience with traditional progression in clinical research in pharmaceutical/biotech industry, or CRO or relevant experience required. Experience in clinical drug development process including working knowledge of ICH, GCPs, FDA regulations and EU directive also required. Prior experience directing global studies, particularly in endocrine related indications and/or rare diseases. Master's degree in scientific or related field or MBA AND 10+ years of similar experience shown above. Extensive previous managerial experiences also required Recognized as an internal thought leader with extensive technical and business expertise within a strategic organization Applies in-depth knowledge of own function, business / commercial / scientific expertise to solve critical issues successfully and innovatively Evaluates key business / scientific challenges and completes complex, ambiguous initiatives having cross-functional impact Ability to work independently and cooperate and collaborate with a wide variety of individuals, groups, and teams Ability to effectively operate in a multi-level matrix environment. Strong organizational, interpersonal and leadership skills Strong internal/external negotiation / influencing skills Detailed knowledge of clinical drug development process including working knowledge of ICH, GCPs, FDA regulations and EU directive Ability to effectively manage, mentor and train personnel and ability to motivate and influence personnel to achieve goals Expertise directing global studies, particularly in endocrine related indications and/or rare diseases Strategic vendor management skills, particularly CROs or similar complexity Neurocrine Biosciences is an EEO/Disability/Vets employer. We are committed to building a workplace of belonging, respect, and empowerment, 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. The annual base salary we reasonably expect to pay is $185,400.00-$268,400.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 35% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.
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Who We Are: Neurocrine Biosciences is a company focused on neuroscience with a strong, inclusive culture dedicated to relieving suffering for people with great needs. What We Do: Neurocrine Biosciences is a leading neuroscience-focused biopharmaceutical company dedicated to discovering and developing treatments for patients with under-addressed neurological, neuroendocrine, and neuropsychiatric disorders. The portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis, and uterine fibroids, with a robust pipeline in mid- to late-phase development. More information is available at neurocrine.com, and follow us on LinkedIn, X, and Facebook. (*in collaboration with AbbVie) About the Role
Responsible for developing strategic plans, objectives and overall management for the Clinical Operations team executing Neurocrine's clinical studies (all phases). Ensure clinical study activities are conducted in compliance with FDA regulations, EU Directive, ICH guidelines, and adhere to corporate and departmental Standard Operating Procedures. A key focus will be on the oversight of CROs, external vendors and internal stakeholders to ensure studies are conducted according to timelines, budgets, and resources to achieve program objectives and corporate goals. The Director will also manage career development of multiple direct reports within the clinical operations group. Your Contributions (include, but are not limited to):
Design and implement clinical strategies using internal and external resources Provide leadership to the Clinical Operations study team (Associate Directors, Clinical Trial Managers, Specialists, Clinical Trial Associates, and other subordinate employees) Lead the tactical implementation and execution of the clinical development process (all phases) primarily for selected programs Ensure these activities are conducted in compliance with FDA regulations, EU Directive and ICH guidelines, and adhere to corporate and departmental SOPs Establish and manage overall clinical program budgets as well as individual study budgets Develop and maintain clinical trial timelines to achieve corporate goals Create and establish critical metrics to benchmark activities to develop and revise performance to reach and maintain highest possible standards of excellence Identify and introduce process improvements within the clinical organization Manage relationships and expectations with CROs and other clinical contract service providers. Act as point of contact with external bodies Manage inter-department relationships (Regulatory, QA, etc) to ensure adequate support for clinical programs as well as provide input into cross-functional meetings and documentation Interface with Medical Directors by providing operational input to clinical protocols, clinical development plans and clinical study reports Recruit, train, and manage career development of multiple direct reports within the clinical operations group Manage operational activities of clinical programs with corporate partners Perform additional tasks and duties as assigned Requirements
BS/BA degree in scientific or related field AND 12+ years of extensive experience with traditional progression in clinical research in pharmaceutical/biotech industry, or CRO or relevant experience required. Experience in clinical drug development process including working knowledge of ICH, GCPs, FDA regulations and EU directive also required. Prior experience directing global studies, particularly in endocrine related indications and/or rare diseases. Master's degree in scientific or related field or MBA AND 10+ years of similar experience shown above. Extensive previous managerial experiences also required Recognized as an internal thought leader with extensive technical and business expertise within a strategic organization Applies in-depth knowledge of own function, business / commercial / scientific expertise to solve critical issues successfully and innovatively Evaluates key business / scientific challenges and completes complex, ambiguous initiatives having cross-functional impact Ability to work independently and cooperate and collaborate with a wide variety of individuals, groups, and teams Ability to effectively operate in a multi-level matrix environment. Strong organizational, interpersonal and leadership skills Strong internal/external negotiation / influencing skills Detailed knowledge of clinical drug development process including working knowledge of ICH, GCPs, FDA regulations and EU directive Ability to effectively manage, mentor and train personnel and ability to motivate and influence personnel to achieve goals Expertise directing global studies, particularly in endocrine related indications and/or rare diseases Strategic vendor management skills, particularly CROs or similar complexity Neurocrine Biosciences is an EEO/Disability/Vets employer. We are committed to building a workplace of belonging, respect, and empowerment, 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. The annual base salary we reasonably expect to pay is $185,400.00-$268,400.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 35% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.
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