At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.
Lead Toxicologist
Major Tasks:
• Provide critical review and toxicology risk assessment reports in support of assigned projects
• Participate in multi-functional New Product Development (NPD) teams as a Toxicology representative to guide safety strategy for supporting new products and technologies
• Contribute to the design and execution of preclinical toxicology studies to support clinical trials and product registration for BCH’s global market
• Produce documents for Health Authorities for non-clinical purposes, e.g. CTD nonclinical modules and justification documents, with minimal guidance and supervision
• Generate biocompatibility risk assessments for medical device products according to ISO (International Organization for Standardization) guidance
• Compile European Cosmetic Product Safety Reports (CPSR) following the appropriate regulation
• With guidance from PVRM management, conduct evaluation on safety, toxicology, pharmacology and pharmacokinetics on external licensing candidates and Rx-to-OTC switches
• Identify global product safety/regulatory trends, communicate their potential impact on New Product Development as well as BCH’s existing portfolio to leadership teams and develop/implement appropriate corporate responses as necessary.
This position must provide timely and accurate toxicology assessments with minimal supervision. Most issues that need to be assessed are not planned but arise from various sources ad hoc.
The Lead Toxicologist must be able to reprioritize work with the supervisor’s guidance quickly and address emerging needs in a highly expeditious manner, as essential decisions regarding potential safety impact are based on this assessment.
The Lead Toxicologist must therefore have a very strong technical background allowing for a quick, thorough review and assessment of data, and the ability to synthesize a cogent report with minimal supervision and guidance. In addition, the Lead Toxicologist must be able to effectively communicate technical information to a broad audience, including non-scientists.
Major Decisions: Indicate important decisions made by position; illustrate the type of situations where recommendations influence others.
• Assessments of safety of ingredients or products, influence product development decisions, and enables project teams to choose the most viable options
• Safety assessments for emerging technical issues are used to guide decision-making at high levels of management (eg, product recalls)
Who you are?
• Doctoral degree (eg, Ph.D.) in Toxicology, Pharmacology, or a closely related field, and solid relevant industry experience or overall equivalent experience profile
• In-depth knowledge of regulations and guidance’s administered by FDA, EMA, ISO, and European Commission on medicinal, medical device, and cosmetic products
• Expertise in toxicology and risk assessment
• Certified toxicologist (e.g. Diplomate of American Board of Toxicology) is preferred but not required
• Experience in the OTC drug industry, medical device, and/or cosmetic industry is preferred
• Ability to work under pressure in an environment of constantly changing priorities
• Ability to work well in a team environment but contribute
Be You at Bayer where you have the opportunity to be part of a culture influencing Health for all and Hunger for none.
To achieve our vision we see reward for all our employees as incredibly important and include the following list of benefits and working conditions:
competitive salary and performance bonus 28 days annual leave plus bank holidays Private Healthcare, generous pension scheme and Life Insurance Employee discount scheme State of the art offices International career possibilities Flexible and remote working Help with home office equipment
#LI-UK
#Hybrid
Bayer welcomes applications from all individuals, regardless of age, disability, gender identity/expression, family status, pregnancy and maternity, race, religion or belief, sex, and sexual orientation. We are committed to treating all applicants fairly and without discrimination. We continue to progressively embrace and adopt actions to advance our Diversity Equity & Inclusion (DE&I) commitments and aspirations, #ForBetter.
Bayer is committed to providing access and support for all individuals with disabilities and / or long term conditions - during the application process and beyond. Let us know if there is anything about the recruitment process that you would like to discuss, in particular if there are any changes or adjustments that would make it easier for you to apply please contact .
Location:
United Kingdom : Berkshire : Reading
Division:
Consumer Health
Reference Code:
818063
Job Segment:R&D, Medical Device, Physician, Product Development, Esthetician, Research, Healthcare, Hospitality
