Job Description

Principal Scientist / Sr. Principal Scientist, Toxicology

Join to apply for the Principal Scientist / Sr. Principal Scientist, Toxicology role at Neurocrine Biosciences.

About Neurocrine Biosciences

Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company dedicated to discovering and developing lifechanging treatments for patients with underaddressed neurological, neuroendocrine and neuropsychiatric disorders. We are passionate about our people and our purpose to relieve suffering for people with great needs.

Responsibilities

• Participate in formulating toxicology strategies and lead execution to develop and implement plans for nonclinical safety testing of new and current drug candidates.
• Design, evaluate and implement protocol preparation for assigned Toxicology and Safety Pharmacology studies; manage conduct and reporting of individual studies including study placement, contract development/budgeting and coordination of prestudy activities.
• Continuously perform extensive analyses/interpretations of Toxicology/Safety Pharmacology data, prepare clear technical reports and oral presentations, and serve as a key opinion leader making go/nogo decisions.
• Author and/or review Toxicology/Safety Pharmacology sections of all regulatory documents, including IND, CTA, IB, annual report and NDA (BLA)/MAA submissions.
• Own preparation of documents and annual investigational new drug and new drug application reports.
• Independently perform quality control checks on Toxicology/Safety Pharmacology documents for regulatory submission.
• Drive identification, evaluation, selection and management of Toxicology/Safety Pharmacology CROs, act as technical expert and ensure CROs have sufficient capabilities, resources to execute against contractual obligations.
• Proactively recommend and drive process optimizations and SOP changes as needed to guide the Toxicology/Safety Pharmacology programs.
• Proactively research and stay current with regulatory guidance, keeping key stakeholders aware of potential changes.
• Work collaboratively with other scientists, technicians and colleagues as part of multidisciplinary project teams.
• May provide support to build and maintain technical databases, archives and department procedures manuals.
• Direct and oversee junior level scientists and/or team members.
• Lead the development of intellectual property.

Qualifications

• BS/BA in Toxicology, Pharmacology, Biology or related discipline required and 15+ years of CRO and/or pharmaceutical industry experience.
• Experience in small molecules, peptides/peptide conjugates, and/or biologics including monoclonal and bispecific antibodies.
• Technical leadership experience in managing preclinical Contract Research Organizations.
• Experience with preparation of INDs, CTDs, NDAs, and MAAs.
• MS/MA in Toxicology, or related discipline and 13+ years of similar experience noted above OR PhD in Toxicology or related discipline and 7+ years of similar experience noted above.
• DABT certification desirable.
• Strong expertise in Safety Pharmacology, Toxicology, Pathology or other related specialization.
• Demonstrated oversight of small molecules, peptides/peptide conjugates, and/or biologics including monoclonal and bispecific antibodies Toxicology/Safety Pharmacology programs.
• Expert and current knowledge of ICH and FDA guidance.
• Experience with preparation of regulatory documents (IB, IND, CTA, NDA/BLA, MAA).
• Emerging as an internal thought leader with technical and/or business expertise.
• Excellent ability to communicate effectively both orally and in writing in an interdisciplinary environment.
• Proactive, innovative, with exceptional problemsolving, analytical thinking, and influencing skills.

Salary and Benefits

The annual base salary we reasonably expect to pay is $153,800.00$222,850.00. This position offers an annual bonus with a target of 30% of the earned base salary and eligibility to participate in our equitybased longterm incentive program. Benefits include a retirement savings plan with company match, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits covering medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.

EEO Statement

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 dont line up to exactly what we have outlined in the job description.

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