Jobs at Neurocrine Biosciences

Leads clinical supply chain packaging, labeling, distribution, forecasting, budgeting, vendor management, and GMP outsourcing for international clinical programs involving large- and small-molecule assets. Oversees packaging strategies, documentation, distribution plans, regulatory compliance, process improvement, and cross-functional collaboration. Manages staff, develops policies and procedures, supports clinical trial material planning, and ensures delivery against portfolio timelines, quality standards, and costs.

Provides quality assurance support for GMP manufacturing, including reviewing CMO quality records, product disposition, deviation investigations, change controls, new product introductions, supplier audits, and inspection readiness. The role interfaces with internal and external stakeholders, supports compliance with FDA, EU, and ICH requirements, and promotes continuous improvement across Quality functions.

Leads regulatory CMC strategy and execution for pharmaceutical development and commercial programs. Prepares and supports IND, CTA, MAA, NDA, and BLA submissions; develops CMC regulatory plans; advises cross-functional teams; reviews regulatory documents; and leads interactions and negotiations with global regulatory agencies, including the FDA. The role also supports contract manufacturers and partners, ensures compliance with FDA and cGMP requirements, and provides project leadership, mentoring, and regulatory expertise.

Develop and apply hybrid LC-MS/MS and LC-HRMS methods for quantifying peptides and proteins in biological matrices. Support preclinical PK/TK bioanalysis, immunoaffinity workflows, protein digestion, intact protein analysis, peptide mapping, and biotransformation assessment of ADCs and protein conjugates. Analyze and document results, communicate findings, and improve bioanalytical methods.

Leads analytical development and characterization for peptides, antibodies, and bioconjugates across drug substance and drug product development. Develops, validates, qualifies, and transfers analytical methods; conducts laboratory studies; supports CMC, formulation, process development, manufacturing, regulatory activities, and external partners. Interprets complex analytical data, ensures cGMP compliance, contributes to regulatory strategies, and communicates scientific findings across cross-functional teams.

Responsible for promoting and growing Neurocrine pharmaceutical products within a designated territory. Builds relationships with healthcare providers, clinical staff, payers, pharmacies, advocacy groups, and other stakeholders. Executes territory sales strategies, educates customers, manages promotional resources, identifies market opportunities, and collaborates with cross-functional teams. The role requires ethical compliance, account management, strong sales performance, frequent territory driving, and expertise in specialty pharmaceutical, psychiatry, neurology, or related markets.

Leads commercial data management for Neurocrine’s endocrinology franchise, including VYKAT XR and CRENESSITY. Responsibilities include data strategy, governance, vendor and contract management, data quality monitoring, issue resolution, impact assessments, reporting controls, process documentation, and cross-functional project leadership. The role partners with Commercial Analytics and Operations to ensure reliable, scalable, compliant data supporting pharmaceutical commercial insights and business processes.

Leads analytical development for biologics from preclinical through commercial stages. Develops, validates, qualifies, and transfers analytical methods for drug substances, products, impurities, potency, characterization, stability, and CQAs. Directs internal and external laboratory work, supports CMC strategies and regulatory filings, ensures cGMP compliance, and represents analytical development on cross-functional teams. Provides technical leadership, contributes to departmental strategy, supports team development, and manages analytical deliverables across projects.

Provides senior scientific and technical leadership for pharmaceutical drug product development from discovery through commercialization. Leads formulation and manufacturing process development, scale-up, validation, technology transfer, CMC strategy, regulatory submissions, and continuous improvement. Oversees CRO, CMO, and CDMO partnerships, manufacturing campaigns, technical issue resolution, and cross-functional collaboration. Mentors scientists and manages multiple high-priority programs while ensuring cGMP compliance, product quality, regulatory readiness, and commercial manufacturability.

Performs recurring quality checks on commercial life sciences datasets, investigates anomalies, validates data ingestion and integrations in Databricks, maintains data dictionaries and lineage documentation, and collaborates with stakeholders and vendors to resolve issues. Supports governance standards, ad hoc analysis, reporting, training, automation, and continuous improvement of commercial data quality processes using SQL and data observability tools.

Promotes Neurocrine pharmaceutical products within an assigned territory, develops relationships with healthcare providers and other stakeholders, and drives product adoption and sales growth. The role executes territory strategies, educates customers, manages promotional resources, collaborates with cross-functional teams, and maintains compliance with FDA and industry standards. Frequent field travel and account management across psychiatric, neurological, pharmacy, payer, and care facility settings are required.

Lead and perform clinical data management for studies and programs, including eCRF design, edit checks, UAT, QC of external data transfers, discrepancy review, database lock activities, vendor oversight, CDISC/SDTM collaboration, coding with MedDRA/WHO Drug, SOP development, training, and support for regulatory submissions.

Promotes and grows Neurocrine pharmaceutical products within an assigned territory. Builds relationships with healthcare providers, clinical staff, payers, pharmacies, advocacy groups, and other stakeholders. Executes territory sales strategies, provides product education, manages promotional resources, identifies market opportunities, collaborates cross-functionally, and maintains compliance with FDA and industry standards. The role requires frequent territory driving and occasional evening or weekend events.

Supports full-cycle Accounts Payable operations, including high-volume invoice processing, wire, check, and ACH payments, supplier statement reconciliation, AP aging resolution, vendor setup verification, invoice authorization follow-up, and monthly reporting. Assists employees and suppliers with AP inquiries, researches year-end 1099s, supports audits, and meets month-end deadlines while completing multiple time-sensitive accounting tasks.

Executes omnichannel marketing campaigns across paid media, web, email, and marketing automation for healthcare professional and consumer audiences. Manages campaign implementation, testing, data centralization, performance monitoring, optimization, and content and UX execution. Partners with brand marketing, analytics, marketing operations, IT, and agencies to coordinate timelines, ensure compliant execution, and use insights to improve customer engagement and campaign outcomes.

Lead statistical programming efforts, mentor a team, manage vendor selection, ensure compliance with industry standards, and oversee project resources.

Coordinates and prepares regulatory submissions, including clinical trial applications, IND materials, annual reports, safety reports, renewals, and registrations. Reviews regulatory documents, performs quality checks, maintains compliance databases and tracking systems, coordinates revisions, and manages submission timelines. Supports investigator packages and drug shipments, interprets FDA and ICH requirements, ensures submission accuracy and completeness, and serves as a Regulatory Strategy contact for internal programs.

Leads program management for multiple preclinical drug development programs from early research through Development Candidate selection, IND/CTA readiness, and First-in-Human activities. Coordinates Toxicology, DMPK/ADME, bioanalytical, clinical pharmacology, and pharmacometrics teams; manages integrated plans, milestones, risks, dependencies, budgets, resources, governance, regulatory readiness, portfolio reporting, and continuous-improvement initiatives.

Serves as legal and compliance advisor to pharmaceutical commercial franchise teams. Advises on healthcare professional and organization interactions, speaker programs, sponsorships, sales and marketing, market access, medical affairs, and patient advocacy. Assesses risks, conducts monitoring, supports remediation, tracks regulatory developments, and contributes to compliance policies, training, governance, and continuous improvement.

Leads clinical pharmacology strategy and activities across clinical development programs, including PK/PD analysis, exposure-response modeling, dose selection, study design, regulatory documentation, and cross-functional scientific communication. Oversees CROs and vendors, ensures compliance with regulatory guidance, resolves complex issues, and mentors junior scientists. Applies modeling and simulation to support development and regulatory decisions, with potential supervisory responsibilities.