Senior Research Scientist - Huningue, France - Elanco

Elanco

Entreprise vérifiée

Huningue, France

il y a 2 semaines

Posté par:

Sophie Dupont

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Description

Education :

EQUIVALENTEXPERIENCE

As a leading global animal health company, Elanco delivers innovative products and services to improve the health of pets and farm animals around the world because we believe making animals' lives better, makes life better. Since 1954, we have provided solutions that support veterinarians, farmers and pet owners to advance our vision of Food and Companionship Enriching Life.

Elanco's promise to employees:
Together, we foster an inclusive culture where everyone can make a difference, encouraging ownership, growth and well-being.

We are seeking an experienced non-clinical toxicology / safety scientist to join the Global Non-Clinical Development team in Global Clinical Development.

This position will be responsible for, or will assist with, human (user & consumer) safety and target animal safety program strategy and execution for all phases of global veterinary pharmaceutical drug/product and feed additive research and development and will provide support for marketed products.

Your tasks

Independent and selfresponsible design, organize, monitor, report, and resolve issues for outsourced in vitro and in vivo safety/toxicology studies utilizing external CROs and/or consultants, as applicable. Toxicology and related invitro and invivo studies include most typical rodent and nonrodent species. Target animal safety may include companion animals (dogs & cats) and food production animals (cattle, pigs, chickens, sheep, goats, fish).
Perform literature searches and author expert reports, position papers, safety and risk assessments or other strategic scientific / technical / medical assessments to address safety issues for veterinary drugs (small molecules and biologics), feed additives, E&L, excipients, impurities, or other chemicals.
Providing internal expert advice (expert statements, healthbased exposure limits e.g. PDE and OEL, target and product safety assessments, etc.)
Interact with regulatory agencies to address safety concerns with products in development or marketed products, including preparation/submission of documents and formal presentations.
Prepare human and target animal safety sections of product registration dossiers and product labels for submission to European, US and international regulatory agencies.
Closely collaborate with Human Food Safety, ADME&PK and Environmental Safety colleagues to accomplish multidisciplinary nonclinical objectives for projects and products.
Proactively collaborate within global and crossfunctional project teams (e.g., clinical, pharmaceutical development, regulatory affairs, quality, manufacturing, etc.) within a matrix organization.
Maintain technical and professional expertise by staying up to date with developments in the field and sharing that information within the company as appropriate.

Your profile

University degree, DVM and/or PhD (preferred) in toxicology or other relevant biomedical science discipline (e.g., veterinary medicine, biology, chemistry) with at least five (5) years of experience in nonclinical safety or equivalent combination of education, training, and relevant experience or master's degree with at least seven (7) years of experience.
Board certification as toxicologist (ERT, DABT or equivalent), preferred.
A working understanding of European and international veterinary drug/product development and various agribusiness practices affecting companion and production animals, including aquaculture.
Excellent understanding of nonclinical veterinary drug development process (from safety target assessment, early in silico predictions, target, user and consumer safety assessment and further life cycle management).
Sound expertise in the development of large molecules, biologics, vaccines, and antibodies.
Proficiency at placing, designing, monitoring, and reporting in vivo studies (e.g., toxicology, safety) at CROs.
Experience using in vitro and in vivo data and published data/literature to support drug and/or product development, registration and/or defense.
Proven experience and knowledge in pharmaceutical drug development and with global regulatory submissions for companion and food animal drugs.
Experience successfully authoring risk assessments / expert reports / scientific position papers for a nonexpert audience.
Working knowledge of the Good Laboratory Practice (GLP) regulations.

Additional Skills

Strong verbal and written communication skills are crucial for success in this position.
Excellent language skills in English.
You are a teamplayer with excellent interpersonal skills and experience collaborating in a diverse global crossfunctional team environment.
Ability to work independently and selfmanage assigned workload including diverse deliverables and timelines with competing priorities.

Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientatio