Sr. Clinical Trials Manager

Neurocrine Biosciences is a leading biopharmaceutical company 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 of compounds in mid- to late-phase clinical development.

About the Role

Contribute to overall clinical trial strategy and manage the operational activities to support planning, initiation, conduct, and close-out phases of clinical studies. Lead and manage the end-to-end operational activities of assigned Clinical Studies (domestic and global). Oversee studies using multiple Contract Research Organizations (CROs) and manage internally run studies. Ensure the integrity of clinical trial data and completeness of Trial Master File (TMF) documentation.

Responsibilities

• Develop, lead, and manage NBI trials on an end-to-end basis and contribute to the overall trial study strategy and planning.
• Serve as the primary point of contact for clinical operations aspects of assigned clinical studies; may oversee other clinical trials assigned to lower-level team members.
• Participate in and may lead technical and study design discussions; provide expert-level counsel and input to clinical trial outlines, protocols, and clinical study reports.
• Manage multiple contract research organizations (CROs) and other contract service providers (CSPs) for assigned studies.
• Oversee study team meetings and manage study issues; develop and manage study timelines in accordance with corporate goals; identify barriers to enrollment and develop recruitment solutions.
• Manage internally run studies (without CROs), including the management of trial monitoring team(s); develop various study plans, on-site monitoring guidelines, forms, tools, and perform onsite monitoring and co-monitoring visits as necessary.
• Collaborate with the clinical operations department in developing, implementing, and enforcing NBI standard processes across all clinical programs.
• Manage Trial Master File (TMF) content, ensuring all study documents are appropriately filed and inspection-ready throughout the conduct of the study and at study completion.
• Ensure clinical studies are conducted in compliance with FDA regulations, EU Directive, International Conference on Harmonization (ICH) guidelines, and NBI Standard Operating Procedures (SOPs) and policies.
• Incorporate Risk-Based Monitoring with Clinical Quality Assurance counterparts to assure subject safety and data integrity across NBI Development Programs.
• Support the recruitment, training, management, and career development of subordinates within the clinical operations group.
• Other duties as assigned.

Requirements

• BS/BA degree AND 8+ 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 6+ years of similar experience.
• Expert knowledge of the clinical drug development process, including working knowledge of ICH, Good Clinical Practices (GCPs), FDA regulations, and EU Directive.
• Excellent knowledge of clinical operations, specifically conducting clinical studies from start-up through close-out, and understanding of clinical development efforts of trials.
• Strong understanding of trial development and extensive trial management protocol and process knowledge across all phases of clinical studies.
• In-depth understanding of the Clinical Research industry and the relevant environments in which it operates.
• Ability to identify and organize clinical resources needed to accomplish major projects, set overall trial(s) objectives, and provide clear direction to others.
• Expertise in planning activities in advance and taking account of possible changing circumstances; manages time effectively.
• Strong presentation and communication skills for internal and external presentations.
• Strong computer, organizational, interpersonal, and team participation skills.
• Ability to anticipate business and industry issues; recommend relevant process/technical/service improvements.
• Demonstrates broad expertise or unique knowledge; considered an expert within the company and may have an external presence in the area of expertise.
• Applies in-depth expertise in discipline and broad knowledge of other closely related areas to improve team efficiency.
• Ability to work as part of and lead multiple teams; good leadership and mentoring skills, typically leads lower levels and/or indirect teams.
• Excellent problem-solving, analytical thinking, and communication skills; sees the 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 and strong project leadership skills.
• Proven ability to work through others to deliver results to the appropriate quality and timeline metrics; experience productively partnering cross-functionally and with customers to advance work effectively and efficiently.
• Proven ability to analyze data and information to derive conclusions and drive sound decision-making.
• Works to improve tools and processes within the functional area.

Pay

The annual base salary we reasonably expect to pay is $156,900.00 - $214,000.00. 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

• Retirement savings plan (with company match).
• Paid vacation, holiday, and personal days.
• Paid caregiver/parental and medical leave.
• Health benefits to include medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans.