Neurocrine Biosciences Job Trends

The Executive Director, Health Economics and Outcomes Research (HEOR), successfully plans, manages and leads completion of product/disease specific projects to determine and express the health care value of Neurocrine marketed products or assets in various stages of development. Works closely with the U.S. Product Development Teams, Commercial Teams, Government Affairs Teams, Key Stakeholders within the Medical Affairs team and Departments dedicated to Managed Care and Patient Advocacy to develop and communicate data that allow, patients, clinicians and payers to make informed health care decisions regarding Neurocrine products. _ Your Contributions (include, but are not limited to) Oversight of broader HEOR...

Manages the day to day Chemistry, Manufacturing and Controls (CMC) regulatory activities for one or more development and/or marketed projects and through this is responsible for achieving results that impact the success of the department and company. _ Your Contributions (include, but are not limited to) Manages several projects simultaneously with an emphasis on CMC while adapting to changing project priorities Maintains all CMC aspects of US regulatory filings and clinical trial applications outside the US, ensuring that they remain compliant with all applicable regulations and relevant guidelines (domestic and international) Assists and provides guidance to other departments and submission...

The Regional Patient Access Manager (RPAM) is responsible for three (3) main functions 1) to provide field access support services and education to Healthcare Professionals (HCPs), helping to maximize patient access to Company products and accelerate time to treatment. 2) communicating with all Specialty Pharmacies (SPs), Closed Door Pharmacies (CDPs) – including Genoa, and Patient-Physician Services (HUB partner) in support of Neurocrine Biosciences marketed products in the U.S. 3) building and upholding the integrity of Neurocrine Biosciences pharmacy distribution network by conducting all vetting activities within an assigned geography, including communication of approval, and denial or any subsequent removal from...

Develop, design and execute formulation and process related studies to support development projects from Phase I through commercial. Manage, with an enabled formulation slant, full product development programs from excipient compatibility through process validation, including formulation screening and prototyping, scale-up and optimization, packaging, packaging and stability testing of drug products. Establish CMO relationships to support clinical programs. Oversee process development and successful technical transfer for Neurocrine drug products to CDMOs. Represent CMC within project teams to deliver high-quality, phase-appropriate drug products that address molecule- and therapeutic indication-specific challenges of solubility, permeability, and target product profile. Key areas of focus include...

Addresses a broad array of legal matters to support the Company’s commercial business. Works closely with members of the Commercial Legal Team to support internal business clients to address legal issues across several disciplines. Reviews promotional materials, ensures compliance with laws and regulations, advises clients, and offers all necessary legal support to the business. Drafts and negotiates life sciences arrangements and contracts. _ Your Contributions (include, but are not limited to) Works at the direction of senior attorneys and provides clear and business-savvy legal advice and risk guidance to commercial business partners and key stakeholders focused on the following Commercial...

An Analytical Scientist is responsible for performing analytical development based on new and existing methodologies for small molecule pharmaceuticals. Responsible for performing analytical laboratory activities to support manufacturing of drug products intended for use in clinical studies (all phases). Develops, establishes, and validates testing methodology used to control final drug products. Establishes, validates, and documents new or existing compound specific methods. Conducts testing of analytical samples for the laboratory area, the separation and characterization of drug candidates, develops assays in support of new formulations, and other analytical methods of development. Conducts work in the spirit of cGMP, with a focus...

As a Sr. Leader, serves as the lead for Nonclinical Safety (anatomic and clinical pathology & toxicology) of multiple drug candidates of NBI's pipeline. Act as the Principal Investigator for pathology components of non-GLP and GLP-compliant studies to ensure high-quality toxicology and pathology assessments. Provide comprehensive support for nonclinical studies, including primary histopathology and pathology peer reviews, interpretation of all nonclinical study data/findings, and guiding study designs, execution, and reporting to support regulatory submissions (IND, CTA, NDA, briefing books, Investigator Brochures, etc.). Represents Preclinical development on discovery and development teams and regularly interfaces with internal and external colleagues to ensure...

Responsible for providing QA support for CGMP drug substance and/or drug product manufacturing. Responsibilities include, with general supervision, reviewing batch documentation, supporting quality events (e.g., deviations, investigations, change management) and interacting with cross functional team members and external manufacturing representatives to ensure product is made in compliance with FDA and EU regulations and other appropriate local regulations and guidance. May participate in conducting internal and/or external audits to ensure compliance with company policies and procedures and applicable guidance and regulations. _ Your Contributions (include, but are not limited to) Review quality records related to the manufacturing of drug substances and/or...

Develops and executes instrumental methods of analysis for development compounds, drug substances, raw materials, intermediates, drug product, and packaging materials to develop assays based on new and existing methodologies. Responsible for coordinating and supporting day-to-day operations in an Analytical Development (AD) GMP lab. This role will focus mainly on GMP laboratory workflows. The person will also schedule all analytical instruments calibrations, maintenance and qualification activities. This role will ensure full compliance with GMP regulation and support continuous improvement of lab processes and equipment readiness. _ Your Contributions (include, but are not limited to) Develops and executes instrumental methods (e.g. HPLC,...

Provides expertise in employee relations, workforce planning, performance management, compensation, employee retention, coaching/development, conflict management and ad hoc projects as necessary. Assumes a variety of roles and responsibilities to help achieve Human Resource (HR) and business objectives. Plays a strategic role within an assigned sub-set of the business to deliver effective HR solutions to changing business objectives. Collaborates with other HR-Center of Excellence teams that increase employee engagement, achieve company goals and drive the company’s diversity initiatives. Counsels employees through complicated work-related problems acts as a credible activist for the organization’s values passion, integrity, collaboration, tenacity, and innovation. _ Your...

Prepares and reviews clinical/regulatory documents to support all phases of drug development by leading the writing activities of a multi-disciplinary team to develop documents that are concise, high quality, and comply with internal and external standards. Medical Writing activities include leading the authoring process, identifying and managing contractors, planning New Drug Applications (NDAs) and global Marketing Authorization Applications (MAAs), and building the submission writing team with in-house and contract resources. _ Your Contributions (include, but are not limited to) Leads the authoring process for all clinical/regulatory documents (eg, clinical study protocols, clinical study reports, investigator brochures, briefing documents, M2 Clinical...

Provides strategic direction and oversight of all HCP marketing strategies and initiatives for the assigned brand and identifies new opportunities. Member of Extended Branded promotion Leadership Team. Leads strategic planning for all branded promotion marketing initiatives and collaborates across multiple functional areas to ensure alignment on branded promotion objectives. Accountable for the development, management, and execution of assigned branded promotion initiatives. Drives collaboration and coordination with Legal and Compliance with respect to the management of risk involved with branded promotion initiatives. Leads collaboration across key stakeholder groups including Field Medical, Field Medical Marketing, Marketing Operations, Field Operations, Field Sales, Sales...

Serves as the overall statistical lead on one or more clinical programs and will provide statistical input in design, analysis, and reporting of clinical studies to expedite conduct and evaluation of clinical trials and basic research. Leads statistical analysis and develops tracking systems to determine the efficiency of clinical trials. Interacts with clinical investigators to determine protocol design. Evaluates databases and statistical analysis programs and interacts with computer groups to determine hardware/software compatibility. _ Your Contributions (include, but are not limited to) Provides statistical leadership and strategic input to the Dev Core Team in all areas of drug development and...

Supports market research and competitive intelligence activities under direct supervision. Assists in gathering and organizing market research data, including helping to compile healthcare provider insights and prescription trends. Helps maintain competitive intelligence information and supports the development of market landscapes through assigned tasks. Contributes to the team's efforts in understanding market opportunities and competitive dynamics for Neurocrine's pipeline programs. _ Your Contributions (include, but are not limited to) Market Research Assists in gathering and organizing primary and secondary market research data under supervision, including helping to compile healthcare provider feedback and basic prescription data Supports the team by maintaining organized...

Responsible for leading the execution, communication, and administration of all company health and wellbeing programs, including retirement. Manage vendor relationships, compliance requirements, and annual budget administration. Act as a collaborative partner across teams, including HR, Legal, Accounting, and Senior Leadership. May occasionally support absence management. _ Your Contributions Responsible for the planning, analysis, obtaining leadership/organizational buy-in, development and implementation for all benefits offerings through collaboration with the HR team and the appropriate Senior Leadership to align with the organization's strategic goals Analyzes benefits policies and practices. Negotiates coverage, services and costs with carriers and brokers. Ensures that programs are...

This position will serve as the SME for separation method development and analytical development lead for multiple projects, with a focus on antibodies and bio-conjugates. Guide analytical activities related to drug substance and drug product development from preclinical through commercial phase. Develop, establish, and validate/qualify separation methods used to control in process intermediates, drug substance, and drug products. Contribute to the development and implementation of control strategies. Responsible for keeping work in compliance with cGMP, safety, and regulatory requirements. Participates in analysis and evaluation of material and products at all stages of development process. Monitors and evaluates completion of tasks...

Lead global regulatory strategy and execution for our innovative biologics/combination product portfolio. As Sr. Director of Regulatory Strategy, you will shape and drive regulatory pathways from preclinical through commercialization and lifecycle management. This key leadership role combines strategic oversight of registration requirements, regulatory submissions, and health authority interactions across markets. The ideal candidate brings deep expertise in global biologics regulations, with demonstrated success in navigating complex regulatory landscapes for combination products. Join our dynamic team to advance breakthrough therapies while ensuring regulatory excellence and compliance across all stages of drug development. The ideal candidate will live in the San Diego...

Support pharmacovigilance (PV) Operations activities including vendor oversight, case processing and submission. Develops and implements PV guidelines and ensures the uniform and timely processing of adverse event for NBI compounds in clinical development and post-approval. Ensures compliance with standard operating procedures and global regulations. The Sr. Specialist, Safety will work independently, with limited supervision. _ Your Contributions (include, but are not limited to) Provide oversight of outsourced safety-related functions Coordinates and performs adverse event data entry, coding and assessment of adverse events, case review, follow-up, tracking of reports, and regulatory reporting activities to comply with protocol and regulatory specific requirements...

Support one or more product development teams to drive team performance and communication. Ensure that cross-functional teams are aligned on goals and timelines and work with them to deliver milestones on or ahead of schedule. Escalate issues that require management review as well as highlight team successes to the wider organization. Assist in the creation and execution of product development plans while adhering to budget, scope and schedule requirements. Help ensure consistent practices throughout all phases of the project life cycle. Create high quality, integrated cross-functional plans for development programs. Apply best practices in the development, initiation, planning, execution, control...