Job description
TITLE:
Toxicologist
Title: Toxicologist
Reports To: Head of Technology
Location: Slough or Hull, UK (preferred); Richmond, VA or Fort Collins, CO (optional) or hybrid remote work
Indivior is a global specialty pharmaceutical company with a 20-year legacy of leadership in patient advocacy, health policy and evidence-based best practice models that have revolutionized modern addiction treatment. The name is the blend of the words individual and endeavour, and the tagline “Focus on you” makes the company’s commitment clear. It represents and empathizes with the often-difficult journey each individual patient takes to overcome the challenges of addiction – a chronic relapsing disease.
Indivior is dedicated to transforming addiction from a global human crisis to a recognized and treated chronic disease. The Indivior logo radiates its patient-focused, holistic focus on expanding access to quality treatment for addiction worldwide. The company has a strong pipeline of products and candidates designed to both expand on its heritage in global opioid use disorder treatment and address other substance use disorders as well as mental health co-morbidities such as schizophrenia.
POSITION SUMMARY: Contributing to the business objectives of Indivior by supporting safety assessments of small molecules and biologics; providing safety findings in investigational new drug (IND), new drug application (NDA) or Marketing Authorisation Application (MAA) programs; and defending pre-clinical sections of these submissions with regulatory authorities.
ESSENTIAL FUNCTIONS:
The responsibilities of this job include, but are not limited to, the following:
- Designing, and monitoring contracted in vitro or in vivo pharmacokinetic and toxicity animal studies to meet specific project team goals and regulatory requirements for IND and NDA or MAA submissions,
- Overseeing all aspects of the conduct of pre-clinical studies, including protocol development, GLP and SOP compliance, interpretation of results, and issuance of the final report,
- Working as part of an interdepartmental and multidisciplinary team in acquisition and evaluation of study materials, coordination of all study activities, and interpretation and reporting of pre-clinical studies results,
- Represent toxicology function on Medicine Development Teams
- Preparing of IND/NDA or MAA pre-clinical parts of submissions to the FDA, EMA, MHRA and rest of world,
- Interacting/defending pre-clinical sections of regulatory submissions with regulatory authorities,
- Preparing nonclinical section of annual investigational new drug and new drug application reports,
- Building and maintaining technical databases, archives and department procedures manuals,
- Selecting and collaborating with external preclinical vendors, consultants, and partners,
- Tracking and anticipating industry trends and maintaining cutting edge understanding of best pre-clinical practices,
- Participating in the development of best practices across the organization.
MINIMUM QUALIFICATIONS:
Education:
Ph.D. in a relevant field of study (e.g., toxicology, pharmacology) with experience in animal research. Optional Board Certification in toxicology (DABT) plus or minus DVM degree.
Field of Study: Toxicology, pharmacology, or veterinary medicine
Experience
- 5+ years’ experience in animal research and/or
- Pharmaceutical industry (including contract research organization) work experience,
- Excellent interpersonal and communication skills,
- Demonstrated experience in technical writing,
- Ability to support projects and the work of interdisciplinary team members.
License/Certifications: Optional Board Certification in toxicology (DABT) plus or minus DVM degree
Travel: Study site monitoring and meeting with regulatory authorities as needed, professional conferences.
COMPETENCIES/CONDUCT:
In addition to the minimum qualifications, the employee will demonstrate:
Capable of building strong working relationships to deliver outstanding results
Ability to transform solid thinking into action (a thinker and an achiever).
PREFERRED QUALIFICATIONS:
5+ years of animal research experience OR pharmaceutical industry (including contract research organization) work experience preferred
BENEFITS:
- Indivior is committed to providing a culture driven by guiding principles and top-tier benefits that match the importance of the work we do. The Indivior experience includes:
- 25 days holiday plus public holidays
- Flexible working; core hours are 10am-3pm, and we offer upto 2 days working from home/ week for office based roles, as well as a flexible Friday programme, subject to completion of contractual hours.
- Paid Volunteer Time Off
- 10% company pension
- EAP service including Legal, Health and Wellbeing support
- Optional Health Insurance with BUPA
- Company Death in Service and Payment Protection Insurance
- Access to platform for discounts on such as gym membership, shopping, holidays
- Our Guiding Principles, Core Values and Vision provide a culture that unites and guides our employees.
GUIDING PRINCIPLES:
Indivior’s guiding principles are the foundation for each employee’s success and growth. Each employee is expected to demonstrate understanding and adherence to our guiding principles in their everyday performance.
The duties and responsibilities identified in this position description are considered essential but are not limited to only those outlined. The employee may perform other functions that may be assigned. Management retains the discretion to add or change the duties of this position at any time.
EQUAL EMPLOYMENT OPPORTUNITY
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