Associate Director / Director Clinical Pharmacology

Das ist der Job

With our head office in Stockholm, Sweden, Sobi also has premises in Basel, Switzerland.

Darum lohnt es sich

ppSobi is an international biopharmaceutical company, dedicated to providing access to innovative treatments that transform life for people with rare diseases in the areas of haematology, immunology and specialty care.

The selected candidate will be responsible for the clinical pharmacology strategies and activities within projects including Pharmacokinetic (PK), PK/Pharmacodynamic (PD) analysis, and Modelling and Simulation (MS) to support Clinical and Core Asset Teams for products under development or geographic expansion of established products. /p h3Key Responsibilities /h3 ul liOverall accountability for quantitative clinical pharmacology strategies and activities in appointed clinical projects with focus on late-stage development including filing and life-cycle management. /li liDefine appropriate strategies for clinical pharmacology/translational medicine, clinical PK, PK/PD, exposure-response, and MS in clinical development plans that enable clinical development and regulatory decisions. /li liProvide matrix leadership to collaborate, align and influence across the cross-functional teams to identify and mitigate key project challenges related to the clinical pharmacology discipline. /li liProvide expert knowledge on clinical pharmacology and communicate clinical pharmacology aspects internally and during health authority interactions. /li liOversee that Model Based Drug Development (MBDD) is applied in clinical programs when clinically relevant. /li liEnsure that translational aspects are considered and that pre-clinical and clinical PK/PD information are optimally used and integrated into development plans. /li liContribute and decide on the biomarker strategy in clinical programs. /li liContribute to the clinical development plan. /li liResponsible for clinical pharmacology sections in regulatory documents and at interactions with regulatory authorities. /li liRepresent clinical pharmacology on project Core Teams. /li liContribute to clinical pharmacology evaluations at in-licensing and due-diligence activities. /li /ul h3Qualifications /h3 ul liPh.D. in relevant scientific area and 8 years of experience in clinical pharmacology (preferably in the pharmaceutical industry) or a minimum of Master’s degree in relevant scientific area with 10 years of experience in clinical pharmacology (preferably in the pharmaceutical industry). /li liSolid understanding of the drug-development process and challenges specific to clinical pharmacology. /li liExperience with clinical protocol design, in particular clinical pharmacology studies. /li liExperience in regulatory submissions and health authority interactions including preparation of relevant documents with regards to clinical pharmacology aspects. /li /ul h3Skills And Competences /h3 ul liProfound knowledge in PK and PD concepts and their integration into decision making processes of drug development. /li liStrong knowledge of state-of-the-art PK and PK/PD modelling and simulation techniques. /li liHands- on experience with PK/PD analysis and modeling software, i.e.

Phoenix or equivalent. /li liExperience with biologics and small molecules.Strong knowledge of regulatory requirements regarding clinical pharmacology. /li liExcellent communication and presentation skills. /li liFluency in written and spoken English. /li liEnergetic, driven and able to take initiative with a "can-do attitude". /li liResults and delivery focused as well as a structured way of working. /li liGood problem-solving ability and analytical mindset. /li liOpen, flexible, interested in colleagues' perspectives, team player. /li liStrong sense of personal accountability, working independently, as well as a strong ability to work in teams. /li /ul pAll your information will be kept confidential according to EEO guidelines. /p /p #J-18808-Ljbffr You can find more information about Sobi at /p h3Job Description /h3 pSobi is currently seeking an Associate Director/Director Clinical Pharmacology to join our Preclinical Development and Translational Medicine (PDTM) Department in Basel.