Sobi
Biotech
AssociateDirector/DirectorClinicalPharmacology
Neural analysis suggests this role is
optimal for director candidates.
“Associate Director / Director Clinical Pharmacology at Sobi. Skills: Clinical pharmacology, Drug development, Regulatory affairs. Accountability for quantitative clinical pharmacology strategies. Define strategies for clinical pharmacology”
Industry & Context.
Problem-solving ability; Analytical mindset
What They're Looking For.
Must Have
Ph.D. in relevant scientific area, 8 years of experience in clinical pharmacology, Master´s degree in relevant scientific area, 10 years of experience in clinical pharmacology, Solid understanding of drug-development process, Experience with clinical protocol design, Experience in regulatory submissions, Experience with health authority interactions
Nice to Have
Experience in pharmaceutical industry
What You'll Do.
Accountability for quantitative clinical pharmacology strategies
Define strategies for clinical pharmacology
Provide leadership to collaborate
Align and influence cross-functional teams
Mitigate project challenges
Provide expert knowledge on clinical pharmacology
Communicate clinical pharmacology aspects
Oversee Model Based Drug Development application
Ensure translational aspects are considered
Integrate pre-clinical and clinical PK/PD information
Contribute to biomarker strategy
Contribute to clinical development plan
Responsible for clinical pharmacology sections
Represent clinical pharmacology on project Core Teams
Contribute to clinical pharmacology evaluations
How You'll Work.
Team & Collaboration
Cross-functional teams; Clinical and Core Asset Teams; Project Core Teams
Communication Scope
Presentation skills; Health authority interactions
Full Job Description
Sobi 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. With our head office in Stockholm, Sweden, Sobi also has premises in Basel, Switzerland. You can find more information about Sobi at [www.sobi.com](http://www.sobi.com). Sobi is currently seeking an Associate Director/Director Clinical Pharmacology to join our Preclinical Development and Translational Medicine (PDTM) Department in Basel. 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 (M&S) to support Clinical and Core Asset Teams for products under development or geographic expansion of established products. Key Responsibilities * Overall accountability for quantitative clinical pharmacology strategies and activities in appointed clinical projects with focus on late-stage development including filing and life-cycle management. * Define appropriate strategies for clinical pharmacology/translational medicine, clinical PK, PK/PD, exposure-response, and M&S in clinical development plans that enable clinical development and regulatory decisions. * Provide 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. * Provide expert knowledge on clinical pharmacology and communicate clinical pharmacology aspects internally and during health authority interactions. * Oversee that Model Based Drug Development (MBDD) is applied in clinical programs when clinically relevant. * Ensure that translational aspects are considered and that pre-clinical and clinical PK/PD information are optimally used and integrated into development plans. * Contribute and decide on the biomarker strateg
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