From Neurocrine's posting. “We” and “our” refer to the employer.
Who We Are:
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):
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
Provides leadership to the Clinical Operations study team (Clinical Trial Managers, Specialists, Clinical Trial Associates, and other subordinate employees)
Supports the tactical implementation and execution of the clinical development process (all phases) primarily for selected programs
Accountable for smaller subfunctions
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. Clinical Trial Manager to manage vendor scopes individual study budgets, and change orders
Maintains clinical trial timelines to achieve corporate goals
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
Identifies and introduces process improvements within the clinical organization
In collaboration with Outsourcing, manages relationships and expectations with CROs, external vendors, and other clinical contract service providers. Act as point of contact with external bodies
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
Interfaces with Clinical Development by providing operational input to clinical protocols, clinical development plans, and clinical study reports
Support the recruitment, training, management, and career development of subordinates within the clinical operations group
Manages operational activities of clinical programs with corporate partners
Performs additional tasks and duties as assigned
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. OR
Master’s AND 10+ years of similar experience noted above
Anticipates business and industry issues; recommends relevant process / technical / service improvements
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 work as part of and lead multiple teams
Good leadership, mentoring skills and abilities typically leads lower levels and/or indirect teams
Proven ability to work through others to deliver results to the appropriate quality and timeline metrics, monitoring/managing performance and providing feedback; experience productively partnering cross functionally and with customers to advance work effectively and efficiently
Proven ability at analyzing data and information to derive conclusions and drive sound decision making
Works to improve tools and processes within functional area
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
Must posses strong presentation and communication skills for internal and external presentations
Strong computer skills, organizational skills, interpersonal and team participation skills are essential
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.
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The annual base salary we reasonably expect to pay is $173,600.00-$237,000.00. 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 30% 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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