2 beste Stellen als process analytical in basel, bs – aktuell auf Personalsuche

Associate Director / Director Clinical Pharmacology
Sobi —Basel, BS
- 100%
- Hybrides Arbeiten
- Doktorat
- Englisch
- Master
Direkt bewerben
5 Std.
Associate Director, Good Clinical Practice (GCP) Audit and Vendor Management
BeiGene —Basel, BS
- CHF 105’800 - CHF 186’100 pro Jahr
- 100%
- Homeoffice
- Microsoft Powerpoint
- Microsoft Excel
- Microsoft Outlook

More jobs to discover

Find similar jobs that you might be interested in.

Associate Director, Good Clinical Practice (GCP) Audit and Vendor Management
BeiGene —Basel, BS
Train internal teams on the use of Veeva Vault for vendor oversight and document management. Partner with Clinical Operations, Quality Assurance, Regulatory…
CHF 105’800 - CHF 186’100 pro Jahr

Ich möchte aktuelle Job-E-Mails für Stellen als process analytical in basel, bs erhalten

Wenn Sie sich bei Ihrem Konto anmelden, stimmen Sie den Nutzungsbedingungen, den Richtlinien zur Verwendung von Cookies sowie der Datenschutzerklärung von SimplyHired zu.

Weitere Job-Standorte erkunden

process analytical jobs near basel, bs

Jobs als Associate Director in Basel, BS

Jobs als Director Of Technology in Zürich, Zh

Jobs als Associate Director in Zürich, Zh

Jobs als Client Associate in Zürich, Zh

Jobs als Associate Director in Nyon, Vd

Jobs als Customer Success Manager in Luzern, Lu

Jobs als Klinik Manager in Kanton Bern

Jobs als Office Manager in Genf, Ge

Jobs als Vendor Manager in Zürich, Zh

Associate Director / Director Clinical Pharmacology

Sobi -
Basel, BS

Direkt bewerben

Details zur Stelle

100% | Pensum: 90-100%
vor 5 Stunden

Qualifikationen

Doktorat
Englisch
Klinische Erfahrung
Master
Analysefähigkeit
Kommunikationsfähigkeit

Vollständige Stellenbeschreibung

Company 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.

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.

Job Description

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 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.

Qualifications

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.

Skills and Competences

Profound knowledge in PK and PD concepts and their integration into decision making processes of drug development.
Strong knowledge of state-of-the-art PK and PK/PD modelling and simulation techniques.
Hands-on experience with PK/PD analysis and modeling software, i.e. Phoenix or equivalent.
Experience with biologics and small molecules.
Strong knowledge of regulatory requirements regarding clinical pharmacology.
Excellent communication and presentation skills
Fluency in written and spoken English.
Energetic, driven and able to take initiative with a “can-do attitude”.
Results and delivery focused as well as a structured way of working.
Good problem-solving ability and analytical mindset.
Open, flexible, interested in colleague´s perspectives, team player.
Strong sense of personal accountability, working independently, as well as a strong ability to work in teams.

Additional Information

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

Direkt bewerben

Erweiterte Suche

process analytical Jobs in basel, bs

Associate Director / Director Clinical Pharmacology

Associate Director, Good Clinical Practice (GCP) Audit and Vendor Management

More jobs to discover

Ich möchte aktuelle Job-E-Mails für Stellen als process analytical in basel, bs erhalten

Related Searches

Weitere Job-Standorte erkunden

Tools für Jobsuchende

Arbeitgebertools

Durchsuchen

Bleiben Sie in Kontakt