Summary You will be collaborating cross-functionally to drive program success and regulatory alignment, in a dynamic environment with bold corporate objectives. This is a critical role within our PharmTox team, requiring a strong scientific background and excellent communication skills to collaborate across various capabilities.
Role Responsibilities
Provide expert scientific advice on risk assessment of potential impurities of products
Be the single point of contact for impurity and E&L risk assessments in drug substances and drug products across the portfolio
Be a single point of contact and support EHS by managing toxicological risk assessments linked to safety datasheets
Outsource, guide and approve toxicological evaluations of E&L profiles associated with container closure systems, devices, and manufacturing components
Oversee the appropriate application of risk assessment methodologies (e.g., PDE, TTC, OEL) in accordance with ICH and EMA/FDA guidelines
Together with our expert partners, interpret in silico (Q)SAR analyses and, where appropriate, propose and evaluate in vitro/in vivo studies
Collaborate with cross-functional teams to elaborate compliant and scientifically sound control strategies
Develop best practices, identify resources, gaps and opportunities for improvement. Ensure that risk assessments remain contemporaneous of industry trends and regulatory requirements
Support Regulatory processes for mature product (geographic expansions and license maintenance)
Be the main partner for colleagues in the regulatory groups and support with expert advice on toxicology aspects of assigned projects
Responsible for non-clinical aspects of periodic safety reporting of assigned projects
Together with expert partners and CMC, support biological safety risk assessments of medical devices
Lead network of external partners, together with Global Sourcing, maintain and expand productive relationships
Desired Skills And Experience
Ph.D degree or equivalent by experience
Degree in toxicology or equivalent, professional board certification preferred
At least 5 years of industry experience in a relevant position
Board certification (ERT, DABT) is a plus
Effective in organizing self and others, highly structured
Strong literature mining and excellent authoring skills of technical and regulatory documents
Clear communication, can influence stakeholders effectively, both internally and externally, with outstanding presentation, written and verbal communication skills
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Role Responsibilities
Provide expert scientific advice on risk assessment of potential impurities of products
Be the single point of contact for impurity and E&L risk assessments in drug substances and drug products across the portfolio
Be a single point of contact and support EHS by managing toxicological risk assessments linked to safety datasheets
Outsource, guide and approve toxicological evaluations of E&L profiles associated with container closure systems, devices, and manufacturing components
Oversee the appropriate application of risk assessment methodologies (e.g., PDE, TTC, OEL) in accordance with ICH and EMA/FDA guidelines
Together with our expert partners, interpret in silico (Q)SAR analyses and, where appropriate, propose and evaluate in vitro/in vivo studies
Collaborate with cross-functional teams to elaborate compliant and scientifically sound control strategies
Develop best practices, identify resources, gaps and opportunities for improvement. Ensure that risk assessments remain contemporaneous of industry trends and regulatory requirements
Support Regulatory processes for mature product (geographic expansions and license maintenance)
Be the main partner for colleagues in the regulatory groups and support with expert advice on toxicology aspects of assigned projects
Responsible for non-clinical aspects of periodic safety reporting of assigned projects
Together with expert partners and CMC, support biological safety risk assessments of medical devices
Lead network of external partners, together with Global Sourcing, maintain and expand productive relationships
Desired Skills And Experience
Ph.D degree or equivalent by experience
Degree in toxicology or equivalent, professional board certification preferred
At least 5 years of industry experience in a relevant position
Board certification (ERT, DABT) is a plus
Effective in organizing self and others, highly structured
Strong literature mining and excellent authoring skills of technical and regulatory documents
Clear communication, can influence stakeholders effectively, both internally and externally, with outstanding presentation, written and verbal communication skills
#J-18808-Ljbffr
Toxicologist Late Stage Asset Lead - Switzerland Arbeitgeber: Planet Pharma
Unser Unternehmen bietet eine inspirierende Arbeitsumgebung in München, wo Innovation und Zusammenarbeit im Mittelpunkt stehen. Als Therapeutic Area Medical Lead im Bereich Onkologie haben Sie die Möglichkeit, an der Spitze bahnbrechender Krebstherapien zu arbeiten und Ihre Karriere durch kontinuierliche Weiterbildung und Entwicklung voranzutreiben. Wir fördern eine offene Unternehmenskultur, die Vielfalt schätzt und Ihnen die Freiheit gibt, Ihre Ideen einzubringen und einen echten Unterschied im Leben von Patienten zu machen.
