Neurocrine Biosciences
Executive Director, Toxicology
Neurocrine Biosciences, San Diego, CA, United States
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, but few options.
What We Do:
Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs, but few options. 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, 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 (Formerly Twitter) and Facebook. (*in collaboration with AbbVie)
About the Role:
Oversees and directs the activities of the Toxicology group. Provides strategic and operational direction ensuring that toxicology studies are conducted in line with the appropriate guidelines and regulatory test standards (FDA, WHO, GLP, and ISO). Oversees and evaluates protocol preparation for toxicology studies. Ensures that all safety testing plans, registration activities, government submissions, and design control activities are addressed in accordance with Research and Development requirements. Responsible for in-life resource planning, maintaining current testing procedures, program development, performance monitoring, budget planning and resource management.
Your Contributions (include, but are not limited to):
#LI-DM1
Neurocrine Biosciences is an EEO/AA/Disability/Vets employer.
We are committed to building a diverse, equitable, and inclusive workplace, 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 $253,400.00-$366,875.00. 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.
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, but few options.
What We Do:
Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs, but few options. 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, 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 (Formerly Twitter) and Facebook. (*in collaboration with AbbVie)
About the Role:
Oversees and directs the activities of the Toxicology group. Provides strategic and operational direction ensuring that toxicology studies are conducted in line with the appropriate guidelines and regulatory test standards (FDA, WHO, GLP, and ISO). Oversees and evaluates protocol preparation for toxicology studies. Ensures that all safety testing plans, registration activities, government submissions, and design control activities are addressed in accordance with Research and Development requirements. Responsible for in-life resource planning, maintaining current testing procedures, program development, performance monitoring, budget planning and resource management.
Your Contributions (include, but are not limited to):
- Provides leadership, mentorship, and oversight to the Toxicology function in their conduct of all nonclinical safety assessments for Neurocrine's discovery and development compounds
- Drives the strategic vision and direction of the Toxicology function at Neurocrine to enable development of world-class capabilities in support of numerous small molecule and biologic modalities
- Works in collaboration with other Research and Development Team members and with Neurocrine leadership to ensure safety pharmacology and toxicology support is provided to ensure provision of requisite data in a timely manner to meet development goals.
- Critically evaluate toxicology results and provides timely strategic advice to project teams and senior management on the potential impact of toxicology results on Program and Clinical/Regulatory strategy
- Oversee and provide direction in the preparation of Safety Pharmacology and Toxicology sections of regulatory documents (IND, CTA, NDA, briefing books, Investigator Brochures, etc.)
- Represent Preclinical Development on discovery and development-stage program teams
- Develops critical insights from data summaries and shapes presentations of results to peers, colleagues and Neurocrine Management.
- Oversees the adherence to all SOPs for Toxicology.
- Proactively research and stay current on all applicable regulatory guidances
- Other duties as assigned
- PhD in Toxicology, Pathology or closely related discipline and 12+ years of pharmaceutical/biotech experience, including managing clinical Contract Research Organizations. Experience in toxicologic pathology is beneficial OR
- D.V.M and 8+ years of similar experience noted above
- Extensive previous leadership experiences also required
- Acts as a "trusted advisor" across the company and may be recognized as an external expert
- Provides strategy, vision and direction regarding issues that may have company-wide impact
- Requires in-depth knowledge of the functional area, business strategies, and the company's goals
- Possesses industry-leading knowledge of Toxicology assessment of small molecules and biologics
- Must be self-motivated, detail-oriented, decisive
- Ability to quickly learn and think independently
- Excellent interpersonal & communication skills with the ability to interact professionally and effectively with peers, management, and leadership both within and outside the Company
- Excellent managerial skills and experience fostering career development of direct and indirect reports
- Demonstrated ability to influence and lead others
- Extensive knowledge of toxicologic pathology is beneficial
- Extensive knowledge of managing clinical Contract Research Organizations (CRO's)
- Demonstrated involvement in the of preparation of INDs, CTAs, NDAs, and MAAs
- Maintains broad knowledge of scientific principles and theories and possesses intellectual mastery of multiple scientific areas
#LI-DM1
Neurocrine Biosciences is an EEO/AA/Disability/Vets employer.
We are committed to building a diverse, equitable, and inclusive workplace, 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 $253,400.00-$366,875.00. 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.