Director, Safety and Mechanistic Pharmacology
3 weeks ago
To help deliver our growing portfolio, we are currently seeking an experienced Safety Pharmacologist to join the Safety & Mechanistic Pharmacology team at AstraZeneca as a Director, Safety and Mechanistic Pharmacology.
The Regulatory Toxicology and Safety Pharmacology team sits within CPSS and plays a central role in progressing a rich and diverse pipeline comprising many different modalities across all of our therapeutic areas. We work collaboratively to deliver safety science from early discovery through clinical development, with emphasis on the science and studies required to enable the clinical development of new medicines. Clinical Pharmacology & Safety Sciences (CPSS) is a multi-faceted department which underpins AstraZeneca’s Biopharmaceutical and Oncology Portfolio from target selection through to Life-cycle management.
What you will do:
In this role you will apply your extensive drug discovery expertise to support the progression of a progression of a broad portfolio of drug projects. You’ll be responsible for authoring Safety Pharmacology sections of submission documents, engaging with and responding to Health Authority questions and contributing to the labelling of new products. Earlier in the drug discovery pipeline, you will be designing and interpreting safety pharmacology studies enabling first time in human submissions as well as investigative work at all stages. This will involve close collaboration with a wide range of experts in a highly matrixed environment across the development chain, for multiple project safety teams in parallel. You’ll be working with many different modalities beyond classical biopharmaceuticals, so you’ll need to be creative and work in areas where there are no pre-defined solutions, utilising the best capabilities within and outside AstraZeneca.
In this role you will use your extensive drug discovery expertise to set the overall Safety Pharmacology strategy for the Cardiovascular, Renal and Metabolic (CVRM) portfolio, and applying this to enable the progression of a broad range of drug projects. To achieve this you’ll work closely with multiple project safety teams, collaborating with a wide range of experts in a highly matrixed environment across the development chain. You’ll be responsible for designing and interpreting safety pharmacology studies enabling first time in human submissions as well as investigative work at all stages. You’ll be working with many different modalities beyond classical biopharmaceuticals, so you’ll need to be creative and work in areas where there are no pre-defined solutions, utilising the best capabilities within and outside AstraZeneca.
Design and interpret fit for purpose safety pharmacology packages and guide projects with tangible, quantitative risk assessments that underpin science-driven decisions. Develop patient-centric safety pharmacology risk assessment strategies applicable to novel therapeutic modalities, where conventional approaches may not be appropriate or possible. Author non-clinical safety pharmacology sections of regulatory submission documents and engage with regulatory authorities to secure approval of IMPD/IND and MAA/NDA submissions. Extend the Safety Pharmacology beyond the boundaries defined by ICH S7A and S7B and shape the discipline externally with publications, collaborations and involvement in consortia.Essential in the role:
Extensive experience in pharmaceutical development, with a PhD (or equivalent experience) in pharmacology, toxicology, pathology or a related Natural Science field. Experience of Safety Pharmacology in drug discovery and development, with exposure to non-clinical safety assessment in a project setting. Experience with nonclinical regulatory submissions and health authority interactions Demonstrable expertise in the design and interpretation of in vitro and in vivo studies, translating scientific findings into applicable information in a drug development environment. Familiarity with pharmacokinetic-pharmacodynamic and systems pharmacology approaches. Validated ability to run a large portfolio of projects including prioritize activities in a matrix environment. Understanding of the external factors that shape the scientific and regulatory landscapes relevant to Safety Pharmacology. Proven strong scientific track record and problem-solving capabilities.
We also believe that the successful candidate should have high ability to communicate and present your work in a natural and clear way and enjoy working across multi-disciplinary teams with efficiency.
Desirable in the role:
In depth knowledge of cardiac function, ECG and imaging modalities. Diplomat of Safety Pharmacology, DABT or ERT accreditation.Date Posted
23-Apr-2024Closing Date
30-May-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.-
Director Pathologist CVRM Pathology
3 weeks ago
Gothenburg, Sweden AstraZeneca Full timeAstraZeneca is looking for a dynamic and experienced Medical/Veterinary Pathologist to support our work in the Cardiovascular, Renal and Metabolism (CVRM) disease area. This role is broad in scope and offers significant potential for professional development – and you will be placed either in Gothenburg, Sweden or Gaithersburg, US . CVRM Pathology...
-
Gothenburg, Sweden AstraZeneca Full timeAssociate Director Integrated Bioanalysis – Proteomics specialist (level E) Bold Disruptors. Push the boundaries of science. Fearlessly break new ground. Are you ready to work at the cutting-edge, where scientific innovations and an entrepreneurial spirit are the norm? We’re looking for dynamic thought leaders with curious minds, who are comfortable...
-
Reproductive Toxicologist
3 weeks ago
Gothenburg, Sweden AstraZeneca Full timeReproductive Toxicologist – Clinical Pharmacology and Safety Sciences Are you passionate about working for a global health care company who truly puts patients first, and would like to apply your toxicology expertise in a company that is accelerating innovative science and turns ideas into life changing medicines? AstraZeneca discovers and develops...
-
Director - Pathology
3 days ago
Gothenburg, Västra Götaland, Sweden Proclinical Full timeDirector Pathology | Permanent | Pharmaceutical Industry | Sweden or USProclinical are seeking a dynamic and experienced Medical/Veterinary Pathologist with expertise in toxicologic or disease area pathology to join our cardiovascular and metabolic team.Responsibilities:- Provide expert anatomic pathology support to multiple drug projects across all...
-
Director - Pathology
3 days ago
Gothenburg, Sweden Proclinical Full timeDirector Pathology | Permanent | Pharmaceutical Industry | Sweden or USProclinical are seeking a dynamic and experienced Medical/Veterinary Pathologist with expertise in toxicologic or disease area pathology to join our cardiovascular and metabolic team.Responsibilities:- Provide expert anatomic pathology support to multiple drug projects across all...
-
Digital portfolio sales director
3 weeks ago
Gothenburg, Västra Götaland, Sweden Boeing Full timeQualifications: Our Digital Aviation Services Europe Sales team are based in Crawley, Gothenburg and Frankfurt, and are responsible for planning, developing and managing sales campaigns across the region. We are seeking experienced Sales Directors to join our successful and supportive team in Gothenburg, Sweden to drive sales within our Digital Portfolio. As...
-
Digital Portfolio Sales Director
4 weeks ago
Gothenburg, Sweden Boeing Full timeDescription Qualifications: Our Digital Aviation Services Europe Sales team are based in Crawley, Gothenburg and Frankfurt, and are responsible for planning, developing and managing sales campaigns across the region. We are seeking experienced Sales Directors to join our successful and supportive team in Gothenburg, Sweden to drive sales within our...
-
Senior Scientist
4 weeks ago
Gothenburg, Sweden AstraZeneca Full timeWe are looking for a Senior Scientist to join the Bioscience team within Research and Early Development, Respiratory & Immunology (R&I) in Gothenburg, Sweden. This is a great opportunity to be part of a highly dynamic team that works closely with other departments, focusing on Translational Science, Bioscience In vitro, Cell Therapy, and Drug...
-
Gothenburg, Sweden Chalmers tekniska högskola Full timeThis project is interfaces between industry, Swedish safety authorities, and the university. It exemplifies how atomistic 1st principles studies contribute complementary insight to field studies and experiments characterized by for example atom probe tomography or microscopy. It will give you unique insight into the nuclear energy sector. You will find a...
-
Senior Medical Director
4 weeks ago
Gothenburg, Sweden AstraZeneca Full timeLocation US: Boston or Gaithersburg, MD Spain: Barcelona Sweden: Gothenburg Are you an experienced drug developer with expertise in immunology, rheumatology or inflammatory bowel disease? Would you like to be a part of a talented and high performing team of clinical research professionals, clinical scientists and physicians who are translating...
-
Head of Scaffolding Industry, Nordics
1 week ago
Gothenburg, Sweden AT-PAC Full timeJob DescriptionSupports the creation and execution of the industrial scaffolding strategy for the countries including Sweden, Norway, Denmark and Finland.The individual will be P&L responsible for the region, ensuring detailed Sales pipeline and material planning whilst operating within the financial parameters set forth.Develops the branch network strategy...
-
Head of Scaffolding Industry, Nordics
2 weeks ago
Gothenburg, Sweden Doka Full timeJob Description Supports the creation and execution of the industrial scaffolding strategy for the countries including Sweden, Norway, Denmark and Finland. The individual will be P&L responsible for the region, ensuring detailed Sales pipeline and material planning whilst operating within the financial parameters set forth. Develops the branch...
-
Gothenburg, Sweden Boeing Full timeDescription Qualifications: Boeing Digital Aviation Solutions, is one of the largest software development businesses in Gothenburg. We develop and implement innovative resource management and optimization solutions for the world’s leading airlines. We are dedicated to continuous improvement, delivering more value to our clients, and exploring...
-
Product and Service Program Manager
3 weeks ago
Gothenburg, Sweden Boeing Full timeDescription Qualifications: Boeing Digital Aviation Solutions (DAS) is seeking a Product & Services Program Manager in Gothenburg, Sweden . DAS offers more than 80 digital solutions that save customers time, money, and resources in every phase of flight. These software and data analytics powered solutions help customers navigate and operate more...
