Neurocrine Biosciences
Associate Clinical Trials Director
US CA San Diego · Director
Sponsorship not specified$174k-$237kDetected 15 days ago
GCPProject ManagementVendor ManagementClinical TrialsFDA RegulatoryLeadershipCommunicationCollaborationProblem SolvingMentoringPublic SpeakingOrganizational SkillsGxP
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odds of building a lasting career here
61Sponsors, lottery-bound
Cap-exempt (no lottery)0
Sponsors this role90
Entry-level history0
PERM / green-card track0
Lottery odds (Level IV)94
Fits your clock70
Sponsors, but it's cap-subject — you still face the weighted lottery (~61% per draw at Level IV). Good if you win; have a cap-exempt backup on your list.
Lottery odds assume a STEM candidate.
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About the role
- Provides leadership to the Clinical Operations study team (Clinical Trial Managers, Specialists, Clinical Trial Associates, and other subordinate employees)
- Ensures program activities are conducted in compliance with FDA regulations, EU Directive and ICH guidelines, and are in adherence with corporate and departmental Standard Operating Procedures (SOPs) and Good Clinical Practice (GCP)
- In collaboration with the Outsourcing function, works with the Clinical Trial Manager or Sr.
Responsibilities
- Contribute to the design and implementation of clinical strategies for area of responsibility and participate in formulating strategic plans and objectives for broader organization using internal and external resources
- In collaboration with the Outsourcing function, works with the Clinical Trial Manager or Sr. Clinical Trial Manager to manage vendor scopes individual study budgets, and change orders
- Supports the creation and establishment of critical metrics to benchmark activities needed to develop and revise performance and reach and maintain the highest possible standards of excellence
- Manages inter-department relationships (e.g., Regulatory, QA, DM, Stats, etc) to ensure adequate support for clinical programs as well as provide input into cross-functional meetings and documentation
- Support the recruitment, training, management, and career development of subordinates within the clinical operations group
- The Associate Director will also support the career development of multiple direct reports within the clinical operations group. _
Requirements
- BS/BA degree AND 12+ years of clinical trial management experience, including CRO/vendor management (domestic and international), monitoring of budget scope, clinical site monitoring or related experience required.
- Master's AND 10+ years of similar experience noted above
- Demonstrates broad expertise or unique knowledge
- Considered an expert within the company and may have external presence in area of expertise
- Applies in-depth expertise in discipline and broad knowledge of other closely related areas to improve efficiency of team
- Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency
- Detailed knowledge of clinical drug development process including working knowledge of ICH, GCPs, FDA regulations and EU directive
- Expertise directing global studies, particularly in endocrine related indications and/or rare diseases
Compensation
- The annual base salary we reasonably expect to pay is $173,600.00-$237,000.00.
Company info
- Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in Prader-Willi syndrome, 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 more than 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, Facebook and YouTube. ( *in collaboration with AbbVie )
- About the Role:
- Responsible for the overall management of the Clinical Operations team and may contribute to the development of strategic plans and objectives of the Clinical Operations team by executing Neurocrine's clinical studies (all phases). Ensures clinical study activities are conducted in compliance with FDA regulations, European Union (EU) Directive, International Conference of Harmonization (ICH) guidelines, and are in adherence with corporate and departmental Standard Operations Procedures (SOPs) and Good Clinical Practice (GCP). 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 Associate Director will also support the career development of multiple direct reports within the clinical operations group. _
- Your Contributions (include, but are not limited to):
- Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs.
- We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders.
- The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in Prader-Willi syndrome, 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 more than 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, Facebook and YouTube. ( *in collaboration with AbbVie )
- Biosciences is a leading biopharmaceutical company with a simple purpose:
- to relieve suffering for people with great needs.
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