Associate Director, Monitor for Nonclinical Toxicology Studies

Found in: beBee jobs DK - 2 weeks ago

Valby, Copenhagen, 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 essentia l 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 soLocations 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.

  • Landscape Design Assistant

    Found in: beBee jobs DK - 2 weeks ago

    Valby, Copenhagen, Denmark BIG - Bjarke Ingels Group Full time

    Job Area:InternApplication Deadline:OngoingLocation:Sundkaj 1652150 NordhavnDenmarkCopenhagenJoin BIGBIG is a group of 700+ architects, engineers, urbanists, inventors, researchers and business minds from all over the world who are based in our Copenhagen, New York, London and Barcelona offices. Our built work ranges from the most diverse urban playground...

  • Design Assistant

    Found in: beBee jobs DK - 2 weeks ago

    Valby, Copenhagen, Denmark BIG - Bjarke Ingels Group Full time

    Job Area:InternApplication Deadline:OngoingLocation:Ronda de Sant Pere 56, Bajos08010 BarcelonaSpainBarcelonaJoin BIGBIG is a group of 700+ architects, engineers, urbanists, inventors, researchers and business minds from all over the world who are based in our Copenhagen, New York, London and Barcelona offices. Our built work ranges from the most diverse...

  • Industrial Design Assistant

    Found in: beBee jobs DK - 1 week ago

    Valby, Copenhagen, Denmark BIG - Bjarke Ingels Group Full time

    Application Deadline:UnsolicitedJoin BIGBIG is a group of 700+ architects, engineers, urbanists, inventors, researchers and business minds from all over the world who are based in our Copenhagen, New York, London and Barcelona offices. Our built work ranges from the most diverse urban playground and Michelin-star dining - to affordable housing and a school...

  • Structural Engineer Assistant

    Found in: beBee jobs DK - 2 weeks ago

    Valby, Copenhagen, Denmark BIG - Bjarke Ingels Group Full time

    Job Area:EngineeringApplication Deadline:OngoingLocation:Sundkaj 1652150 NordhavnDenmarkCopenhagenJoin BIGBIG is a group of 700+ architects, engineers, urbanists, inventors, researchers and business minds from all over the world who are based in our Copenhagen, New York, London and Barcelona offices. Our built work ranges from the most diverse urban...

  • Få et studiejob, hvor juraen er i fokus

    Found in: beBee jobs DK - 4 days ago

    Valby, Copenhagen, Denmark Styrelsen for International Rekruttering og Integration Full time

    Styrelsen for International Rekruttering og Integration (SIRI) søger lige nu flere nye studentermedhjælpere til kontorerne Studie, Landbrug og Fast Track og Erhverv. Hos os får du et studierelevant job, hvor du fra dag et bruger dine juridiske kompetencer i praksis og får et stærkt udgangspunkt for din fremtidige karriere. Hvad kan vi tilbyde dig? Som...

  • Architectural Technology Assistant

    Found in: beBee jobs DK - 2 weeks ago

    Valby, Copenhagen, Denmark BIG - Bjarke Ingels Group Full time

    Job Area:InternApplication Deadline:OngoingLocation:Sundkaj 1652150 NordhavnDenmarkCopenhagenJoin BIGBIG is a group of 700+ architects, engineers, urbanists, inventors, researchers and business minds from all over the world who are based in our Copenhagen, New York, London and Barcelona offices. Our built work ranges from the most diverse urban playground...

  • Manager Solution Architect

    Found in: beBee jobs DK - 2 weeks ago

    Valby, Copenhagen, Denmark DXC Technology Full time

    Job Description:The Manager Solution Architect's primary role is to design competitive, deliverable, and profitable solutions that enable DXCs' clients to meet their business objectives. This Role brings a combination of technical and digital subject matter expertise in the application services area, knowledge in at least one vertical industry segment, the...

  • Associate Director, Monitor for Nonclinical Toxicology Studies

    Found in: beBee S DK - 2 weeks ago

    Valby, Denmark Genmab AS Full time

    The Role & DepartmentThe 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...

  • Associate Director/Director, CMC Writing

    Found in: beBee S DK - 3 weeks ago

    Valby, Denmark Genmab AS Full time

    The Role Genmab is now searching for an Associate Director/Director, Team Lead CMC Writing, to join CMC Operations in Copenhagen.Genmab´s clinical pipeline is in an intensive growth period. While existing projects go from First-in-Human trials to Late-stage development, new projects continuously are added to broaden the Early-Stage development pipeline....

  • (Associate) Director, Global Regulatory Affairs Project Lead

    Found in: beBee S DK - 3 weeks ago

    Valby, Denmark Genmab AS Full time

    The Role & DepartmentAs an (Associate) Director, Global Regulatory Affairs Project Lead you will join our Global Regulatory Affairs organization. In this capacity, you will assume responsibility for the EU/ROW regulatory strategy, closely collaborating with the Global Regulatory Team on one or multiple compounds in early or late-stage development. The...

  • (Associate) Director, Global Regulatory Affairs Project Lead

    Found in: beBee S DK - 2 weeks ago

    Valby, Denmark Genmab AS Full time

    The Role & DepartmentAs an (Associate) Director, Global Regulatory Affairs Project Lead you will join our Global Regulatory Affairs organization. In this capacity, you will assume responsibility for the EU/ROW regulatory strategy, closely collaborating with the Global Regulatory Team on one or multiple compounds in early or late-stage development. The...

  • Associate Director/Senior Manager, Global Regulatory Affairs Project Lead

    Found in: beBee S DK - 3 weeks ago

    Valby, Denmark Genmab AS Full time

    The Role & DepartmentAs a Senior Manager/Associate Director, Global Regulatory Affairs Project Lead you will be a part of our Global Regulatory Affairs organization. In this role, you will represent RA in the Clinical Trial Teams and work closely with the CRO and internal stakeholders to ensure regulatory oversight and progress of the clinical trial...

  • Director, EU Compliance

    Found in: beBee S DK - 4 weeks ago

    Valby, Denmark Genmab AS Full time

    The Role & Department As an EU Compliance Director, you will be in the Global Compliance & Risk function and responsible for compliance advisory and program management in EU region. You will report to Global Compliance Program & EU Compliance Lead, Senior Director. The EU Compliance Director strategically partners with and advises the business, including...

  • Associate Director, Solutions Architecture

    Found in: beBee S DK - 4 weeks ago

    Valby, Denmark Genmab AS Full time

    The Role  At Genmab, AI and Digital Technologies are being developed, implemented, and utilized at a pace never seen before. Join Genmab as an Associate Director, Solution Architecture and Engineering, R&D Digital Products as part of our IT & Digital Team and become a key player in revolutionizing antibody-based medicines for cancer and serious diseases....

  • Landscape Design Assistant

    Found in: beBee S DK - 4 weeks ago

    Valby, Denmark BIG - Bjarke Ingels Group Full time

    Job Area:InternApplication Deadline:OngoingLocation:Sundkaj 1652150 NordhavnDenmarkCopenhagenJoin BIG!BIG is a group of 700+ architects, engineers, urbanists, inventors, researchers and business minds from all over the world who are based in our Copenhagen, New York, London and Barcelona offices. Our built work ranges from the most diverse urban playground...

  • Landscape Design Assistant

    Found in: beBee S DK - 2 weeks ago

    Valby, Denmark BIG - Bjarke Ingels Group Full time

    Job Area:InternApplication Deadline:OngoingLocation:Sundkaj 1652150 NordhavnDenmarkCopenhagenJoin BIG!BIG is a group of 700+ architects, engineers, urbanists, inventors, researchers and business minds from all over the world who are based in our Copenhagen, New York, London and Barcelona offices. Our built work ranges from the most diverse urban playground...

  • Student Assistant, Business Intelligence

    Found in: beBee S DK - 4 weeks ago

    Valby, Denmark Lundbeck Pharma AS Full time

    Business intelligence student assistant, Advanced Analytics and Process Optimization  Are you interesting in improving production and supply chain processes from data insights and business intelligence development, and would like to supplement your studies by working at Lundbeck? Then we have an exciting job ready for you as our new Business...

  • Architect/Designer

    Found in: beBee S DK - 4 weeks ago

    Valby, Denmark BIG - Bjarke Ingels Group Full time

    Job Area:ArchitectureApplication Deadline:As soon as possibleLocation:310 Wilshire Boulevard, 2nd floor90401 Santa Monica, CaliforniaUnited StatesLos AngelesJoin BIG!BIG is a group of 700+ architects, engineers, urbanists, inventors, researchers and business minds from all over the world who are based in our Copenhagen, New York, London and Barcelona...

  • Process Validation-Support of late-stage development and process validation, CMC Biologics.

    Found in: beBee S DK - 4 weeks ago

    Valby, Denmark Lundbeck Pharma AS Full time

    Process Validation Support of late-stage development and process validation, CMC Biologics.   As a Validation Responsible, you will serve as a subject matter expert (SME) and support the development and implementation of the validation strategy for biologics production including Upstream Cell Culture Production, Downstream Processing, or Drug Product...

  • Experienced Regulatory Science Lead in Regulatory Science

    Found in: beBee S DK - 4 weeks ago

    Valby, Denmark Lundbeck Pharma AS Full time

    Experienced Regulatory Science Lead in Regulatory Science & Policy In Lundbeck we proudly serve the purpose of restoring brain health, so every person can be their best. While we progress in the field of neuroscience to develop new medicines conquering brain diseases, we contribute to this important purpose in Regulatory Science & Policy by informing...

  • Senior Information Security

    Found in: beBee S DK - 2 weeks ago

    Valby, Denmark Csc Scandihealth AS Full time

    Job Description: Brief info about the company: DXC Technology is the world’s leading independent, end-to-end IT services company, helping clients harness the power of innovation to thrive on change. Created by the merger of CSC and the Enterprise Services business of Hewlett Packard Enterprise, DXC Technology serves nearly 6,000 private and public...

  • Landscape Architect

    Found in: beBee S DK - 4 weeks ago

    Valby, Denmark BIG - Bjarke Ingels Group Full time

    Job Area:LandscapeApplication Deadline:As soon as possibleLocation:1 Finsbury AvenueEC2M 2PF LondonUnited KingdomLondonJoin BIG!BIG is a group of 700+ architects, engineers, urbanists, inventors, researchers and business minds from all over the world who are based in our Copenhagen, New York, London and Barcelona offices. Our built work ranges from the most...

  • Design Assistant

    Found in: beBee S DK - 4 weeks ago

    Valby, Denmark BIG - Bjarke Ingels Group Full time

    Job Area:InternApplication Deadline:OngoingLocation:Ronda de Sant Pere 56, Bajos08010 BarcelonaSpainBarcelonaJoin BIG!BIG is a group of 700+ architects, engineers, urbanists, inventors, researchers and business minds from all over the world who are based in our Copenhagen, New York, London and Barcelona offices. Our built work ranges from the most diverse...

  • Design Assistant

    Found in: beBee S DK - 2 weeks ago

    Valby, Denmark BIG - Bjarke Ingels Group Full time

    Job Area:InternApplication Deadline:OngoingLocation:Ronda de Sant Pere 56, Bajos08010 BarcelonaSpainBarcelonaJoin BIG!BIG is a group of 700+ architects, engineers, urbanists, inventors, researchers and business minds from all over the world who are based in our Copenhagen, New York, London and Barcelona offices. Our built work ranges from the most diverse...

  • Architect/Designer with CA Experience

    Found in: beBee S DK - 4 weeks ago

    Valby, Denmark BIG - Bjarke Ingels Group Full time

    Job Area:ArchitectureApplication Deadline:As soon as possibleLocation:310 Wilshire Boulevard, 2nd floor90401 Santa Monica, CaliforniaUnited StatesLos AngelesJoin BIG!BIG is a group of 700+ architects, engineers, urbanists, inventors, researchers and business minds from all over the world who are based in our Copenhagen, New York, London and Barcelona...

  • Industrial Design Assistant

    Found in: beBee S DK - 1 week ago

    Valby, Denmark BIG - Bjarke Ingels Group Full time

    Application Deadline:UnsolicitedJoin BIG!BIG is a group of 700+ architects, engineers, urbanists, inventors, researchers and business minds from all over the world who are based in our Copenhagen, New York, London and Barcelona offices. Our built work ranges from the most diverse urban playground and Michelin-star dining - to affordable housing and a school...

  • Structural Engineer Assistant

    Found in: beBee S DK - 2 weeks ago

    Valby, Denmark BIG - Bjarke Ingels Group Full time

    Job Area:EngineeringApplication Deadline:OngoingLocation:Sundkaj 1652150 NordhavnDenmarkCopenhagenJoin BIG!BIG is a group of 700+ architects, engineers, urbanists, inventors, researchers and business minds from all over the world who are based in our Copenhagen, New York, London and Barcelona offices. Our built work ranges from the most diverse urban...