Director Regulatory Toxicology
Basel | Full-Time
Contract Type: Permanent
Closing date:
Reference: VN1277
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About the role:
As the Director Regulatory Toxicology, you and your team will work closely with the Scientific Innovation leadership and play a pivotal role in the development and success of our Innovation Centre in this dynamic and quickly evolving market.
This is a real opportunity to play a central role in ensuring the continuation and ongoing development of robust and accountable science behind our Health and Wellness portfolio.
The successful candidate will bring a strong understanding of drug development and the commercialization processes alongside a good knowledge of the regulatory environment and experience in overseeing or conducting pre-clinical studies. In addition a proven understanding of study design and methodology and the ability to balance safety and efficacy aspects will be required.
Working across a wide spectrum encompassing supplier evaluation and qualification, materials science and product development, this role is part of a global team but will be required to work autonomously, and drive the agenda locally in alignment with Vectura Fertin Pharma leaders, commercial and technical partner organizations and third partly supply chain partners. Experience being an active contributor to cross-functional teams and/or working in matrix organizations will be key to your success.
This role will be based at our state of the art research and development center located in Neuchâtel, Switzerland or could be based remotely (with regular travel to Neuchatel) for the right incumbent
Core responsibilities:
• Preparation of complex Toxicological (risk & hazard) assessments of innovative botanical drugs and consumer products (determination of ADE/PDE and/or safety risk assessment) in respect to various legislations, leveraging in vitro and in vivo data and in-silico SAR approaches.
• Interpretation of in-vitro and in-vivo preclinical studies to investigate the safety pharmacology, mutagenic/genotoxic and carcinogenic properties of oral and inhalable botanical products and their components
• Planning, organization, management and supervision of preclinical programs (including inhalation toxicity, PD/PK, genotoxicity, reproductive and embryotoxicity,) in accordance with internal and external resources, timelines, regulatory and professional standards.
• Proactive and ongoing functional area development / implementation of new methodologies and techniques.
• Active collaboration with cross-functional partners (Scientific Innovation Team , Product Development; Clinical Team, ) .Co-ordination and oversight on 3rd party service providers/CROs in preclinical toxicity and efficacy testing
Role Requirements:
Previous pharmaceutical or biopharmaceutical industry experience is of significant benefit.
Academic degree in life sciences (pharmacy, biochemistry, medicine, biology, veterinary), with preferably specialization in toxicology (Certified European Registered Toxicologist (ERT) or equivalent).
• Proven Industrial experience in toxicological (risk) assessments of natural products or biopharmaceuticals
Demonstrable experience in overseeing or conducting preclinical studies, including studies to investigate the pharmacodynamic, mutagenic/genotoxic and carcinogenic properties
• Understanding of drug development and commercialization processes; knowledge of the regulatory environment; experience in overseeing or conducting pre-clinical studies; understanding of study design and methodology and have an understanding of the need to balance safety and efficacy concerns.
• Experience in leading cross-functional teams and/or working in matrix organizations. Has strategic mind-set, with ability to see a broader picture; attention to detail; High quality, critical thinking, process and performance orientated; prioritizes activities and projects;
• Exercises good judgment on regulatory, legal, quality and technical related compliance issues;
• Positive and ‘can-do’ approach; biased towards finding solutions and win/wins; responsiveness and flexibility. High personal integrity; trustworthy; strong compliance and quality mind-set.
As the Director Regulatory Toxicology, you and your team will work closely with the Scientific Innovation leadership and play a pivotal role in the development and success of our Innovation Centre in this dynamic and quickly evolving market.
This is a real opportunity to play a central role in ensuring the continuation and ongoing development of robust and accountable science behind our Health and Wellness portfolio.
The successful candidate will bring a strong understanding of drug development and the commercialization processes alongside a good knowledge of the regulatory environment and experience in overseeing or conducting pre-clinical studies. In addition a proven understanding of study design and methodology and the ability to balance safety and efficacy aspects will be required.
Working across a wide spectrum encompassing supplier evaluation and qualification, materials science and product development, this role is part of a global team but will be required to work autonomously, and drive the agenda locally in alignment with Vectura Fertin Pharma leaders, commercial and technical partner organizations and third partly supply chain partners. Experience being an active contributor to cross-functional teams and/or working in matrix organizations will be key to your success.
This role will be based at our state of the art research and development center located in Neuchâtel, Switzerland or could be based remotely (with regular travel to Neuchatel) for the right incumbent
Core responsibilities:
• Preparation of complex Toxicological (risk & hazard) assessments of innovative botanical drugs and consumer products (determination of ADE/PDE and/or safety risk assessment) in respect to various legislations, leveraging in vitro and in vivo data and in-silico SAR approaches.
• Interpretation of in-vitro and in-vivo preclinical studies to investigate the safety pharmacology, mutagenic/genotoxic and carcinogenic properties of oral and inhalable botanical products and their components
• Planning, organization, management and supervision of preclinical programs (including inhalation toxicity, PD/PK, genotoxicity, reproductive and embryotoxicity,) in accordance with internal and external resources, timelines, regulatory and professional standards.
• Proactive and ongoing functional area development / implementation of new methodologies and techniques.
• Active collaboration with cross-functional partners (Scientific Innovation Team , Product Development; Clinical Team, ) .Co-ordination and oversight on 3rd party service providers/CROs in preclinical toxicity and efficacy testing
Role Requirements:
Previous pharmaceutical or biopharmaceutical industry experience is of significant benefit.
Academic degree in life sciences (pharmacy, biochemistry, medicine, biology, veterinary), with preferably specialization in toxicology (Certified European Registered Toxicologist (ERT) or equivalent).
• Proven Industrial experience in toxicological (risk) assessments of natural products or biopharmaceuticals
Demonstrable experience in overseeing or conducting preclinical studies, including studies to investigate the pharmacodynamic, mutagenic/genotoxic and carcinogenic properties
• Understanding of drug development and commercialization processes; knowledge of the regulatory environment; experience in overseeing or conducting pre-clinical studies; understanding of study design and methodology and have an understanding of the need to balance safety and efficacy concerns.
• Experience in leading cross-functional teams and/or working in matrix organizations. Has strategic mind-set, with ability to see a broader picture; attention to detail; High quality, critical thinking, process and performance orientated; prioritizes activities and projects;
• Exercises good judgment on regulatory, legal, quality and technical related compliance issues;
• Positive and ‘can-do’ approach; biased towards finding solutions and win/wins; responsiveness and flexibility. High personal integrity; trustworthy; strong compliance and quality mind-set.
About Vectura
We’re an international community of scientists, clinicians, engineers, regulatory specialists, quality managers and more. Working closely together in an open and inclusive way, we push ourselves and each other to develop innovative, world-leading drug delivery solutions that improve people’s lives.