Sr. Clinical Transparency Manager

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.

Neurocrine Biosciencesis a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. 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, classic congenital adrenal hyperplasia, 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, visitneurocrine.com, and follow the company onLinkedIn,XandFacebook. (*in collaboration with AbbVie)

About the Role:

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As the Senior Clinical Transparency Manager, you will play a pivotal role in ensuring the integrity and transparency of Neurocrine's clinical trial activities. Your key contributions will include, but are not limited to:

• Independently oversee and execute clinical trial registry posting activities to ensure compliance with regulatory requirements

• Skillfully redacting confidential and personally protected information from clinical and non-clinical documents

• Craft clear and concise plain language summaries for protocol synopses and trial results to enhance understanding and transparency

• Conduct thorough quality checks on documents and content to maintain high standards of accuracy and compliance

• Effectively manage timelines and communication with internal teams and stakeholders to uphold legal and regulatory obligations

• Vigilantly track the status of all active clinical trials and upholding reporting on disclosure activities and compliance

• Support administrative functions related to maintaining US and international clinical trial registry and results database websites

• Serve as Neurocrine's primary point of contact for global registries and inquiries, ensuring seamless communication and compliance

• Proactively stay informed on evolving global transparency requirements and advising teams on compliance needs in various countries

• Collaborate with cross-functional groups to operationalize data collection processes for transparency deliverables

• Steer the management of the Data Sharing Policy in partnership with key stakeholders

• Ensure the accuracy and compliance of Neurocrine's website information to meet regulatory, legal, and publication requirements

• Oversee vendors engaged in transparency and disclosure activities to ensure alignment with Neurocrine's standards

• Provide comprehensive training to staff and teams on transparency requirements and practices

• Manage data sharing requests from internal and external stakeholders effectively and transparently

• Lead the development and upkeep of essential documents such as SOPs, Data Sharing Policy, and Process Manuals to support transparency initiatives

• Undertake any other duties as assigned, contributing to the overall success of Neurocrine's clinical transparency goals

Your expertise and dedication in these areas will be instrumental in upholding Neurocrine's commitment to transparency, compliance, and ethical clinical practices.

• BS/BA degree and 8+ years of clinical research/drug development experience in biotech or the pharmaceutical environment. Direct experience with transparency and disclosure in the biopharmaceutical industry OR

• Master's degree and 6+ years of similar experience as noted above

• Recommends relevant process / technical / service improvements

• Demonstrates expertise or unique knowledge in the area of transparency and disclosure

• 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 independently, in teams, and as the project lead

• Good leadership skills and enjoys working successfully with a variety of personalities

• Excellent computer skills

• Excellent communications, problem-solving, analytical thinking skills

• Sees broader picture and longer-term impact on division/company

• Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency

• Excellent project management, strong project leadership skills

• Demonstrated ability to present to groups informing and training on transparency topics

• Ability to setup data sharing capability with external researchers

• Assess capabilities of contracting resources and experience managing vendor staff

• Demonstrated knowledge of drug development or clinical science

• Experience training teams and staff on the topic of transparency and data disclosure

• Ability to take published data and discern how it could affect future transparency requirements

• Extensive knowledge of global transparency and data disclosure regulations

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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.

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