Study Associate Director, Monitor for Nonclinical Toxicology Studies

Found in: beBee S DK - 1 month ago

Valby, Denmark Genmab AS Full time

The Role & Department

The Nonclinical Safety & Toxicology Team are looking for an experienced toxicologist for a newly created position as sponsor monitor for nonclinical safety studies with Genmab’s pharmaceutical drug candidates outsourced to our CRO laboratory partners.

The Nonclinical Safety Team at Genmab is responsible for the nonclinical safety evaluation of our innovative therapeutic antibodies. At the intersection of pharmacology, immunology, toxicology, medical and regulatory sciences, and with a strong dedication to laboratory animal welfare, Nonclinical Safety & Toxicology supports the safety of patients in clinical trials with our new drug candidates or being treated with our marketed medicines.In this position you will work in close collaboration with the project toxicologists and the CRO study coordinator in our department, as well as with scientists in bioanalysis, pharmacokinetics, pharmacology, translational research, pathology, CMC, QA and other departments, to set up and oversee regulatory nonclinical safety studies performed at CROs in Europe. You will support the project toxicologists with the regulatory nonclinical safety evaluation of Genmab’s antibody-based drug candidates prior to the clinical trials.

Responsibilities include

Work in close collaboration with the Genmab NonClinical Safety Lead/project toxicologist, other scientists, QA, and the CRO Study Director to generate GLP and non-GLP Study Plans for in vivo and in vitro nonclinical safety studies, to support FiH and later stage clinical trials and marketing of Genmab’s pharmaceutical drug candidates

Ensure that the study designs and setup are scientifically rigorous, and in accordance with applicable regulatory and quality guidelines (ICH, regional, national, Good Laboratory Practice, and Genmab standards)

Ensure implementation of applicable legal and company animal welfare requirements

Coordinate safe and timely delivery/shipment of test articles/study samples with appropriate safety and quality documentation between Genmab and CRO partners

During the conduct of the studies at CROs, be the primary Genmab sponsor contact for the CRO Study Directors

Coordinate collaboration between the Study Director and Genmab-based Principal Investigators (bioanalysis, pharmacokinetics, etc.)

Conduct on-site sponsor monitor visits at the CROs during in-life phases of study conduct

On an ongoing basis monitor and evaluate observations and data from ongoing studies and communicate essential information to the project toxicologist and project team

On behalf of Genmab, facilitate and conduct Genmab scientific review of principal investigator and study reports before finalization

Requirements

You have a BS or MS degree in biological sciences (toxicology, pharmacology, veterinary, pathology, human biology, immunology or similar)

You have practical experience with the scientific and regulatory development process for new pharmaceutical drug candidates, in particular with nonclinical development of biopharmaceuticals

You have at least 5-10 years experience as a study monitor and/or study director conducting non-GLP and GLP toxicology studies, e.g. as Study Director at a CRO or in a pharma company

You are familiar with the regulatory, legal and ethical issues relating to the use of laboratory animals

You can analyze and present the results from complex, large datasets from toxicology studies

Travelling regularly between EU and UK for site visits of ongoing studies

You have excellent English written and spoken communication skills,  

You are highly proficient with the organizational tools and skills needed to lead complex projects

You are able to work with an international and diverse team to accomplish organizational goals

This role is based in Copenhagen, Denmark and reports to the Senior Director, Non-Clinical Safety & Toxicology.

About You

You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatmentYou bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solvingYou are a generous collaborator who can work in teams with diverse backgroundsYou are determined to do and be your best and take pride in enabling the best work of others on the teamYou are not afraid to grapple with the unknown and be innovativeYou have experience working in a fast-growing, dynamic company (or a strong desire to)You work hard and are not afraid to have a little fun while you do so

Locations

Genmab leverages the effectiveness of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are designed as open, community-based spaces that work to connect employees while being immersed in our state-of-the-art laboratories. Whether you’re in one of our collaboratively designed office spaces or working remotely, we thrive on connecting with each other to innovate.

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