Neurocrine Biosciences

Lead global regulatory strategy and submissions for drug development projects, ensure compliance with regulatory authorities, provide leadership to regulatory teams, and advise senior management on regulatory matters. | 15+ years pharmaceutical regulatory experience with demonstrated success in regulatory submissions and health authority interactions, extensive managerial experience, and a relevant life sciences degree. | Sr. Director, Regulatory Strategy remote type Hybrid locations US CA San Diego time type Full time Responsible for management and leadership of regulatory activities for assigned commercial and/or development products within our VMAT Franchise. Accountable for ensuring alignment and compliance with local and regional registration requirements as well as with company policies. Oversees the development and implementation of global regulatory strategies, ensures timely preparation, review and submission of documents to regulatory authorities, collaborates with development partners, and drives compliance with applicable regulatory requirements. Provides leadership and direction to program teams on the regulatory requirements, processes, and logistics to conduct global drug development activities for compounds from the preclinical stage through the initial marketing application, and lifecycle management. This role requires experience with post market/post approval and/or oversite on lifecycle management. Previous experience as a people leader is ideal. _ Your Contributions (include, but are not limited to): Responsible for the regulatory leadership of one or more development projects, including responsibility for global regulatory strategy, IND/CTA/NDA/MAA submission preparation, application maintenance and update activities, interaction with and preparation for key milestone meetings with regulatory agencies Authoring and oversight of various submission documents, meeting requests, briefing documents; coordination and preparation of teams for health authority meetings Oversees the development and implementation of regulatory strategies to ensure the earliest possible marketing approvals by global regulatory authorities Accountable for the strategic oversight on global regulatory requirements to management and project teams on all regulatory issues for the strategic development, planning, compilation and submission of IND/CTA and NDA/MAA, ensuring effective integration of global regulatory understanding and responsibilities in developing strategy and development of regulatory submission documents For commercial products, provides regulatory guidance on all aspects of lifecycle management including strategic label development, safety label changes and regulatory management of the product Serve as the primary designated program regulatory health authority contact and/or oversees designated health authority contacts. Represents Neurocrine by facilitating interactions with regulatory agencies during all stages of development, registration and commercialization Lead the global regulatory subteam for assigned projects and oversee development of dossier filing plan and associated regulatory activity timelines Responsible for critical review of all documentation supporting regulatory applications; effectively ensure compliance with internal data standards and regulatory authority submission requirements Counsels and advises senior management on status of regulatory strategies and tactics, procedures and practices Addresses complex issues, providing advanced regulatory solutions and guidance to cross-functional teams Actively partner with key stakeholder groups to define science-based regulatory decision making Acts as strategic regulatory liaison with partner companies Conducts due diligence activities as a regulatory expert for assigned projects Leads continuous improvement efforts on existing department processes and strategies, providing recommendations in area of expertise Other duties as assigned Requirements: BS/BA degree in life sciences or related field and 15+ years of experience in Pharmaceutical industry, including drug development experience with demonstrated success in regulatory authority submission strategy, execution and health authority interaction. Prior US marketing application filing experience preferred; Ex-US experience strongly preferred. Experience in writing and leading regulatory documents (e.g., meeting requests/briefing book activities) OR Master's degree in life sciences or related field and 13+ years of related experience OR PhD in life sciences or related field and 10+ years of related experience Extensive previous managerial experiences also required The annual base salary we reasonably expect to pay is $229,000.00-$331,650.00. 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 35% 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.

Manage patient access support, build relationships with pharmacies and HCPs, provide education on payer coverage and patient assistance programs, and maintain pharmacy distribution network integrity. | 6+ years pharma/biotech commercial experience with specialty pharmacy/market access, strong understanding of payer processes, excellent communication and project management skills, and ability to travel up to 60%. | Who We Are 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. What We Do Neurocrine Biosciences is 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, visit neurocrine.com, and follow the company on LinkedIn, X and Facebook. (*in collaboration with AbbVie) About The Role The Regional Patient Access Manager (RPAM) is responsible for three (3) main functions: • 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. • 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. • 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 the network. Provide support & education to all HCP entities on coverage issues for on-label prescriptions for Company products already in process; access support services, processes and forms; education on payer specific coverage issues and Company patient financial support programs. Subject matter expert on regional and national payer coverage policies & processes. Work cross-functionally and collaboratively with field sales, network pharmacies, market access, commercial analytics and operations. Work closely with Payer Marketing, creating material useful in building customers’ awareness of critical coverage requirements. In addition, the RPAM will be a key operational professional ensuring the distribution network is operating at the highest levels of effectiveness by utilizing end-user feedback. The RPAM will continuously monitor processes, propose new strategies related to workflow and share best practices with trade leadership on specialty distribution efficiency. _ Your Contributions (include, But Are Not Limited To) • Builds and sustains relationships with pharmacies, physicians and their office staff and other HCPs to help resolve coverage problems for written prescriptions already in process • Works cross-functionally with field sales leadership, specifically Regional Sales Managers (RSM), Account Specialists, national account directors (NAD), network pharmacies, and home office colleagues within market access and other related functional departments, such as commercial analytics and operations, to support patient access with specific payers • Provides training and education to HCPs on payor specific coverage policies and documentation requirements, appeals processes for specific payers and patient financial assistance support programs, including Company copay assistance program and patient assistance program for relevant audiences, including internal and external customers • Introduces technology options (e.g-CoverMyMeds) for electronic Patient Access (PA) submission, explains payer criteria, forms, processes, PA, Letter of Medical Necessity, appeals, step edits, formulary exception requests and provides support for other related coverage issues and documentation requirements. Problem solves and conducts case resolution • Communicates effectively and compliantly with field sales, corporate office employees, HCPs, network pharmacies and HUB employees to help identify and resolve coverage and patient access issues • Identifies and communicates payer issues with National Account Directors (NAD) team • Interfaces with local closed-door pharmacies and LTC pharmacies providing support services and education • Communicates regularly to management the opportunities and challenges related to patient access issues • Presents insight into payer coverage policies and processes at internal business reviews and national/regional sales meetings • Conducts Patient Access workshops during POA meetings and assists with new hire training, as needed • Works to ensure a diverse and inclusive environment free from all forms of discrimination and harassment • Builds and upholds the company's pharmacy distribution network through the vetting process, maintaining its integrity and monitoring pharmacies to ensure their effective and efficient operations • Other duties as assigned Requirements • BS/BA degree in related field and 6+ years of pharma/biotech commercial experience, with 2+ years of experience with specialty pharmacy/market access. Specialty product experience, with CNS preferred. Previous experience in other functions in pharma/biotech desired OR • Master’s degree or MBA preferred and 4+ years of related experience OR • PharmD or PhD and 2+ years of related experience OR • Strong understanding of specialty pharmacies, managed care, pharmacy benefit managers and government payers and their impact on product access • Excellent working knowledge of patient support programs, including reimbursement support, financial assistance adherence programs, etc. • Strong understanding of prescription adjudication process • Ability to communicate payer coverage criteria and prior authorization processes • Previous experience in other functions in pharma/biotech desired; i.e- sales, management, marketing, managed markets etc. • Possesses good understanding of current issues within the marketplace, pharmaceutical industry, and national health care system • Ability to travel overnight up to 60% (travel consists of working with field sales, attending business meeting, industry meetings, and working with key customers) • These roles will be geographically dispersed across the US • Has knowledge of best practices in the functional discipline and familiarity with the broader underlying concepts of related business disciplines • Works to improve tools and processes within functional area • Developing reputation inside the company as it relates to area of expertise • Ability to work as part of and lead multiple teams • Exhibits leadership skill and ability, typically leads lower levels and/or indirect teams • Excellent computer skills • Excellent communications, problem-solving, analytical thinking skills • Sees broader picture, impact on multiple departments/divisions • Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency • Excellent project management skills and ability to work in a cross functional environment and handle multiple tasks • Excellent interpersonal skills and cross functional team success 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. _ The annual base salary we reasonably expect to pay is $142,600.00-$206,400.00. 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.

Manage and grow Neurocrine products in a geographic territory by building relationships with healthcare providers and executing sales strategies. | Requires BS/BA with 4+ years in specialty pharmaceutical or neurology sales, strong sales performance, knowledge of healthcare regulations, and ability to work in a fast-paced, ethical environment. | Who We Are 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. What We Do Neurocrine Biosciences is 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, visit neurocrine.com, and follow the company on LinkedIn, X and Facebook. (*in collaboration with AbbVie) About The Role Responsible for a specific geographic territory and the successful promotion and growth of Neurocrine products. Manages and develops long-term relationships with physicians and other customers for targeted accounts in their assigned territory and represent Neurocrine brand(s) and their approved indications. This role also plays an important part in educating external customers such as physicians, nurses, medical assistants, case managers, etc. and helping them learn about the benefits of our product(s). _ Your Contributions (include, But Are Not Limited To) • Creates product acceptance and manages sales and product growth through education opportunities in targeted accounts • Effectively executes sales force strategies and marketing plans to meet or exceed sales objectives through face-to-face and/or virtual communications via in-office visits, in-service presentations and speaker programs • Creates and implements successful strategies to further penetrate and segment the psychiatric and movement disorder marketplace, consisting, where applicable, of Psychiatrists, Neurologists, Community Mental Health Clinics (CMHC) and Long Term Care (LTC) • Effectively uses promotional resources and budget • Establishes and maintains excellent communication and sound working relationships with co-workers and cross-functional partners, including managed care, Medical Science Liaisons, and medical communications • Demonstrates honesty and integrity while modeling behaviors consistent with company standards, values and corporate compliance policies • Identifies territory-specific opportunities and barriers to ensure product and company success • Develops local Opinion Leader relationships to achieve aligned objectives • Performs all responsibilities following the highest ethical standards, including FDA guidelines and best practices for the pharmaceutical/biotech industry • Effectively utilizes account selling strategies to achieve goals through building relationships with and meeting the needs of all members of the patients' care team (Pharm D, MD/NP/PA, LPN/RN) • Manages relationships with important customers, including key opinion leaders, local professional groups and advocacy groups, long-term care facilities, local and regional payers, and pharmacies • Other duties as assigned Requirements • BS/BA degree in science or related field and 4+ years of commercial pharma/biotech or related experience, including 3+ years of specialty pharmaceutical or LTC, Psychology, or Neurology sales experience is highly desired. Close-door or specialty pharmacy distribution experience is strongly preferred. Psychiatry, neurology or antipsychotic experience strongly preferred. Experience with business systems, salesforce automation platforms, and other business intelligence tools (e.g., Salesforce.com, Oracle database, SAP, Business Objects, COGNOS, QlikView, Veeva, etc.) OR • Master's degree in science or related field and 2+ years of similar experience noted above • Must have a strong sales and account management disposition, solid business acumen and excellent verbal and written communication skills • Proven sales performance as evidenced by % to quota, ranking reports, and recognition awards in specialty pharmaceutical or biotech markets • Proven track record of meeting or exceeding sales objectives and goals • Proven successful launch experience in highly complex and competitive environments • Strong understanding of healthcare regulatory and enforcement environments • Entrepreneurial attitude and/or experience in a start-up environment • Working knowledge of business systems, salesforce automation platforms, and other business intelligence tools (e.g., Salesforce.com, Oracle database, SAP, Business Objects, COGNOS, QlikView, Veeva, etc.) • Results-oriented sales professional who: • Thrives in an environment driven by ownership and accountability with high ethical standards • Seeks to understand and successfully navigate complex and challenging accounts in highly varied sites of care • Understands how to support and provide pull-through with customers through diverse specialty fulfillment and payer requirements • Challenges the status quo with intellectual curiosity and entrepreneurial spirit • Derives great job satisfaction through purposeful and passionate work • Should reside within the geographic area of the assigned territory • This position requires frequent driving, therefore a valid driver's license, clean driving record, and ability to operate a motor vehicle are required as part of the job responsibilities • Has knowledge of best practices in the functional discipline and familiarity with the broader underlying concepts of related business disciplines • Works to improve tools and processes within functional area • Developing reputation inside the company as it relates to area of expertise • Ability to work as part of and lead multiple teams • Exhibits leadership skill and ability, typically leads lower levels and/or indirect teams • Strong computer skills • Excellent communications, problem-solving, analytical thinking skills • Sees broader picture, impact on multiple departments/divisions • Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency • Excellent project management skills • Ability to thrive in a collaborative culture that is performance based, fast-paced and results oriented • Demonstrated ability to work cross-functionally • High ethical standards 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. _ The annual base salary we reasonably expect to pay is $120,600.00-$174,700.00. 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 incentive compensation plan with a target of $44,000.00 annually 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.