Sr. Principal Scientist, Toxicology 5/5/2020
San Diego, CA
JOB DESCRIPTIONAPPLY WHO WE ARE:
At Neurocrine Biosciences, we pride ourselves on having a strong, distinctive 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 patient suffering and enhance lives.
WHAT WE DO:
Neurocrine Biosciences (Nasdaq: NBIX) is a neuroscience-focused, biopharmaceutical company with more than 25 years of experience discovering and developing life-changing treatments for people with serious, challenging and under-addressed neurological, endocrine and psychiatric disorders. Headquartered in San Diego, Neurocrine Biosciences specializes in targeting and interrupting disease-causing mechanisms involving the interconnected pathways of the nervous and endocrine systems.
The company s diverse portfolio includes two FDA-approved treatments INGREZZA (valbenazine) for tardive dyskinesia and ORILISSA (elagolix) for endometriosis*, as well as clinical development programs in multiple therapeutic areas, including Parkinson s disease, chorea in Huntington disease, congenital adrenal hyperplasia, uterine fibroids* and polycystic ovary syndrome.* As part of a strategic collaboration with Voyager Therapeutics, Neurocrine Biosciences is also focused on the development of investigational gene therapy programs for the treatment of severe neurological diseases, including Parkinson s disease and Friedreich s ataxia. (*in collaboration with AbbVie)
ABOUT THE ROLE:
Among other responsibilities, the The Sr. Principal Scientist, Toxicology manages assigned Toxicology/Safety Pharmacology projects, oversees studies from planning through to final reporting, and provides strategic and operations direction ensuring all studies are conducted in line with appropriate guidelines and regulatory testing standards and individual program objectives. In addition, the Sr. Principal Scientist makes significant contributions to the scientific strategies for overall programs and/or department, represents Toxicology on Development teams and regularly interfaces with colleagues to ensure timely and accurate dissemination of Toxicology/Safety pharmacology findings and recommendations.
YOUR CONTRIBUTIONS (INCLUDE, BUT ARE NOT LIMITED TO):
* Contributes to the scientific strategies and leads the execution in order to develop and implement plans for preclinical testing of new and current drug candidates.
* Identify, evaluate, select and manages Toxicology and Safety Pharmacology CROs, act as technical expert and ensure CROs have sufficient capabilities, resoursces to executes against contractual obligations.
* Oversees and leads protocol preparation for assigned Toxicology and Safety Pharmacology studies. Manages the conduct and reporting of individual studies, including study placement, contract development/budgeting, coordination of pre-study activities, and approving study protocols and reports.
* Performs thorough analyses/interpretations of Toxicology/Safety Pharmacology data and one of the key opinion leader(s) making a go/no-go decision.
* Recommends process optimizations and SOP changes as needed to guide the Toxicology and Safety Pharmacology programs.
* Proactively researches and stays current with regulatory guidance, keeps key stakeholders aware of potential changes.
* Works collaboratively with other scientists, technicians and colleagues as part of multidisciplinary project teams.
* Assists in the preparation of documents and annual investigational new drug and new drug application reports.
* Authors and/or reviews Toxicology and Safety Pharmacology sections of all regulatory documents, including IND, CTA, IB, annual report, and NDA/MAA submissions.
* Performs quality control checks on non-clinical pharmacology and toxicology documents for regulatory submission
* May provide support to build and maintain technical databases, archives and department procedures manuals.
* Leads and mentors lower level scientists and/or team members
* May lead the development of intellectual property
* Performs other duties as assigned.
* BS/BA in Toxicology, Pharmacology, Biology or related discipline required and 15+ years of CRO and/or pharmaceutical industry experience, including Safety Pharmacology. Experience in with oversight of small molecule Toxicology/Safety Pharmacology programs. Technical leadership experience in managing preclinical Contract Research Organizations. Extensive experience with preparation of INDs, CTDs, NDAs, and MAAs, OR
* MS/MA in Toxicology or related discipline and 13+ years ofsimilar experience noted above, OR
* PhD in Toxicology or related discipline and 7+ years of similar experience noted above.
* DABT certification is desirable.
* Recognized expertise in Safety Pharmacology, Toxicology, Pathology or other other related specialization
* Demonstrated oversight of small molecule or gene therapy Toxicology/Safety Pharmacology programs
* Extensive and current knowledge of ICH and FDA guidance
* Technical leadership experience in managing preclinical Contract Research Organizations
* Extensive experience with preparation of INDs, CTAs, NDAs, and MAAs
* Proactive, innovative, with exceptional problem-solving skills
* Experience working in a cross functional team and matrix environment Applies understanding of the team's place in the larger organization, and discusses changes, progress, and issues as they relate to other areas
* Maintains substantial knowledge of principles and theories and acts as a technical lead on various projects
* May utilize working knowledge of other related disciplines to provide solutions to a wide range of difficult problems
* Ability to work as part of and lead multiple teams
* Good leadership, mentoring skills and abilities typically leads lower levels and/or indirect teams.
* Excellent communications, problem-solving, analytical thinking skills.
* Sees 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, strong project leadership skills.
* Ability to influence all levels of the organization and external resources.
Neurocrine Biosciences is an EEO/AA/Disability/Vets employer.