Associate Director / Director Clinical Pharmacology

Position

Vollzeit

Festanstellung

Director

Wissenschaft & Forschung

Konditionen

Basel, BS, Switzerland

Endet in 30 Tagen

Anforderungen

8+ J. Erfahrung

Doktortitel

EU/EFTA-Bewilligung

Sprachen

Englisch C2

Beschreibung

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.

Aufgaben

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 strategy in clinical programs.
Contribute to the clinical development plan.
Responsible for clinical pharmacology sections in regulatory documents and at interactions with regulatory authorities.
Represent clinical pharmacology on project Core Teams.
Contribute to clinical pharmacology evaluations at in-licensing and due-diligence activities.

Anforderungen

Ph.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).
Solid understanding of the drug-development process and challenges specific to clinical pharmacology.
Experience with clinical protocol design, in particular clinical pharmacology studies.
Experience in regulatory submissions and health authority interactions including preparation of relevant documents with regards to clinical pharmacology aspects.

Technologien

Phoenix or equivalent

Vorteile

All your information will be kept confidential according to EEO guidelines.

Unternehmen

sobi

Biopharmaceuticals

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.