Senior Clinical Scientist - Clinical Pharmacology
BioInvent International AB / Biomedicinjobb / Lund
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to join BioInvent's clinical development team
At BioInvent, we are world experts on antibodies and cancer biology, and we strive for developing first or best-in-class immuno-modulatory antibodies to treat cancer; new drugs that have the potential to transform cancer treatment and the quality of life of cancer patients. At BioInvent we carry out all aspects of drug development, including preclinical research, manufacturing and clinical development.
Together we are creating an exciting future for patients, for our company employees and for our investors. We welcome you to be part of it - as a Senior Clinical Scientist.
Key Responsibilities
As a Senior Clinical Scientist, you will be part of our engaging clinical development team. You will support the development of critical and essential documents such as clinical study protocols, investigator's brochure, briefing packages, lab manuals, preclinical/clinical PK reports, and clinical study reports. You will be a point of contact for regulatory, PK/ADA, and other internal and external contributors. You will support regulatory submissions (e.g. INDs, CTAs) to European, US and other regulatory agencies. You will interact with pharmacodynamic (PD) scientists to support the development of BioInvent's clinical drug candidates, as well as biomarker development. You will conduct literature reviews and prepare summaries to support clinical development decisions, and you will support the development of product concepts, target product profiles (TPPs), and clinical development plans for BioInvent's drug candidates.
Requirements
MD or PhD degree or equivalent.
You have experience as a Clinical Scientist, and preferably experience of phase I/II studies in oncology and/or hematology. Knowledge about ICH-GCP and other relevant regulations to conduct clinical trials is essential.
5+ years of clinical research experience, in particular in clinical pharmacology. You are familiar with ICH-GCP regulatory guidance documents.
Good working understanding of pharmacokinetic questions, and a good familiarity of bioanalytical methods.
Experience working in a matrix environment and interacting with a variety of experts (e.g. CRO's, vendors, consultants, clinical investigators, biostatisticians, clinical pharmacologists).
Advanced understanding and learning appetite of clinical practice in oncology and how clinical practice is evolving with the introduction of new therapies, in particular immunotherapy.
Proficiency in PK/PD and PBPK software, such as Phoenix Win-nonlin and PK-sim is a plus.
Skills and Capabilities
We are looking for a driven, structured, autonomous, self-motivated individual, who easily collaborates and communicates with others both orally and in writing. You have excellent business judgment, problem solving skills and you enjoy creating and participating in an efficient working environment. You have superior communication skills in cross-cultural environments, and you are proficient in written and spoken English. You are enthusiastic and enjoy creating results and achieving goals both individually and together with your teams.
The position is based in Lund, but there is flexibility with respect to presence in the office.
Application
If you match this profile and you are looking to contribute to the development of transformational cancer treatments, you are welcome to apply for the position.
Please send your application (CV and personal letter) through our website
https://careers.bioinvent.com/Selection is on-going and interviews will be held continuously which means the positions can be filled before deadline. Please make sure to send in your application as soon as possible, at the latest 2021-03-19
BioInvent has a collective agreement and contact persons for the Unions are:
Fredrik Wiberg, Akademikerföreningen and Jenny Nilsson, Unionenklubben
Publiceringsdatum2021-01-28Så ansöker duSista dag att ansöka är 2021-03-19
Klicka på denna länk för att göra din ansökanAdressBioinvent International AB
SÖLVEGATAN 41
22370 LUND
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Bioinvent International AB (org.nr 556537-7263)
Sölvegatan 41 (
visa karta)
223 70 LUND
Arbetsplats BioInvent International AB
Jobbnummer 5547222
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