20 beste Stellen als project and qualification in basel, bs – aktuell auf Personalsuche

Senior Director, Medicine Development Leader
Sobi —Basel, BS
- 100%
- Homeoffice
- Englisch
- Führungserfahrung
- Kommunikationsfähigkeit
Direkt bewerben
7 Std.
Process Engineer (m/f/d)
Exyte GmbH —Basel, BS
- Englisch
- Master
- Bachelor
8 Tage
Verification & Validation Engineer
Sentec —Therwil, BL
- 100%
- Datenanalyse
- Englisch
- Master
Direkt bewerben
Senior Process Engineer
Jacobs —Basel, BS
- Englisch
2 Tage
Senior Group Director, Safety Development & Processes
Roche —Basel, BS
- 100%
- Master
- Betriebswirtschaftslehre
- Führungserfahrung
6 Tage
Technology Transfer Lead 80-100%
Lonza —Basel, BS
- Doktorat
- Englisch
- Master
Global Director Medical Affairs
Sobi —Basel, BS
- 100%
- Homeoffice
- Doktorat
- Englisch
- Kommunikationsfähigkeit
Direkt bewerben
Senior Banking Systems Integration Engineer
Bank J. Safra Sarasin AG —Basel, BS
- 100%
- Englisch
- Analysefähigkeit
1 Tag
D365 Finance & HR Consultant
Joyful Craftsmen AG —Basel, BS
- 100%
- Hybrides Arbeiten
- Microsoft Powerpoint
- Microsoft Excel
- Management-Erfahrung
Direkt bewerben
Senior Project Engineer
PM Group —Basel, BS
- Produktion
Senior Project and Business Development Manager for the chemical and pharmaceutical Industry - DE/EN-FR (M/F)
Artelia —Basel, BS
- 100%
- Microsoft Excel
- Englisch
- Projektmanagement
Direkt bewerben
Principal/Sr Principal, Global Advisory Services
IQVIA —Basel, BS
- 100%
- Master
- Bachelor
- Betriebswirtschaftslehre
13 Tage
Senior Business Development Leader
TSP (A Syneos Health Company) —Basel, BS
- 100%
- Master
- Analysefähigkeit
- Bachelor
Senior Process Automation Engineer (DSP) (a), 100%
Bachem Holding AG —Stein AG, AG
- 100%
- Englisch
- Forschungserfahrung
- SPS-Steuerung
11 Tage
Associate Director/Director Study Lead
Ridgeline Discovery —Basel, BS
- 100%
- Homeoffice
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
Direkt bewerben
Innovative Process Technician
Ecolab —Witterswil, SO
- 100%
- Englisch
- Bachelor
- Produktion
- Aufstiegsmöglichkeiten
Director, Business Intelligence
BeiGene —Basel, BS
- CHF 186’600 - CHF 233’200 pro Jahr
- 100%
- Management-Erfahrung
- Master
- Projektmanagement
Network & Security Engineer IT-OT
SKAN AG —Allschwil, BL
- Informatik
- Englisch
- Projektmanagement
IT Desktop Support Technician (m/w/d) - limited contract of 12 months
IMI plc —Füllinsdorf, BL
- 100%
- Homeoffice
- Software-Fehlerbehebung
- Englisch
- Windows
7 Tage
Electrical Project Engineer (m/w/d)
Syngenta Crop Protection —Muttenz, BL
- 100%
- Doktorat
- Wartung
- Englisch
- Pensionskasse
Direkt bewerben

Ich möchte aktuelle Job-E-Mails für Stellen als project and qualification 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

project and qualification jobs near basel, bs

Jobs als Medical Director in Basel, BS

Jobs als Associate Director in Basel, BS

Jobs als Process Engineer in Basel, BS

Jobs als Staff Software Engineer in Kanton Zürich

Jobs als Ai Software Engineer in Zurigo, Zh

Jobs als Technical Sales Engineer in Zürich, Zh

Jobs als Sap Cloud Integration in Zürich, Zh

Jobs als Systems Integration Engineer in Lausanne, Vd

Jobs als Technical Lead in Zürich, Zh

Jobs als Technology Lead in Kaiseraugst, Ag

Jobs als Lead Business Analyst in Zürich, Zh

Jobs als Senior Senior in Kanton Freiburg

Jobs als Consultant Transformation in Genf, Ge

Jobs als Hr Consultant in Zürich, Zh

Jobs als Hr Consultant in Canton De Genève

Jobs als Hr Consultant in Kanton Genf

Jobs als Hr in Dietikon, Zh

Jobs als Data Analyst in Geneva, Ge

Jobs als It Business Analyst in Genf, Ge

Jobs als Business Intelligence Analyst in Baden, Ag

Senior Director, Medicine Development Leader

Sobi -
Basel, BS

Direkt bewerben

Details zur Stelle

100% | Pensum: 90-100%
vor 7 Stunden

Qualifikationen

Englisch
Klinische Erfahrung
Führungserfahrung
Kommunikationsfähigkeit

Vollständige Stellenbeschreibung

Company Description

Sobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting the high medical needs of rare disease patients and providing treatment and services to them. Our employees come from a variety of backgrounds within research, healthcare, industry and the academic sphere.

Job Description

The Medicine Development Leader (MDL) has the overall accountability for developing, driving and representing the clinical development strategy for the nephrology program within the Core Asset Team (CAT), including benefit/risk evaluation, pharmacovigilance (PV) and safety. The MDL leads the Medicine Development Team (MDT) and assures, in close collaboration with the TA head, the appropriate communication flow between the CAT, the MDT and other associated teams (e.g. the Study Team).

Key Responsibilities

Drives the clinical development strategy for the assigned compound(s) across the medicine lifecycle, from proof of concept to successful global regulatory approval(s)/market access for multiple treatment indications.
Provides clinical and scientific expertise to set and execute the asset strategy and optimize project success.
Works with functional members, TA head and CAT Leaders to develop Integrated Project Plans (IPP) documents.
Identifies risks for the program with other functions and develops mitigation strategies to address them.
Presents the nephrology clinical program to internal (including the CEO and the Executive Committee of the Organisation) and external stakeholders (Health Authorities, Steering Committees, Independent Data Monitoring Committees, and Patient Organisations etc), engages when necessary with Key Opinion Leaders across geographies.
Is a core member of the benefit risk team (BRT), of regulatory submission teams and of the labeling working group.
Ensures endorsement of clinical development plans and study documents by Sobi governance bodies (e.g. Sobi Evidence Generation Board, Study Document Review Forum).
Leads in a matrix the clinical scientists and the Medicine Development Team (consists of representatives from Medical Affairs, Clinical Science, Regulatory, Safety/PV, non-clinical/PK, Biostatistics/Data management, Clinical Program Management, Heath Economics and Outcome Research, RWE, Program Management), providing strategic guidance and being the ultimate accountable for:

Clinical trial design (clinical study synopsis and protocol development), planning (e.g. sites and countries selection), execution (e.g.medical monitoring, resolution of safety issues; interpretation of statistical analyses) and internal and external communication of study results
Creation of clinical components of key documents (Clinical Development Plans, Clinical Study Protocols, Investigator’s Brochures, Clinical Study Reports, regulatory documents including maintenance of product licenses, Clinical Modules of registration dossiers, Briefing Books for interactions with Health Authorities) with high quality and consistency with the Integrated Project Plan and Target Product Profile.
Provision of required input on clinical efficacy, safety, dosing/administration, mechanism of action, etc for the Target Product Profile (TPP)
Support to registration and market access (Core Data Sheet, Development Safety Update Report, Periodic Safety Update Report, clinical benefit-risk assessment) o Collaboration with Regulatory team to determine international submission strategy

Qualifications

Medical degree with 10+ years of relevant clinical experience in academic and/or pharmaceutical Global Research & Development roles
Solid track record in drug development programmes, preferably within nephrology
Extensive knowledge of clinical trial methodology, global regulatory requirements, and experience in designing and executing clinical studies
Advanced knowledge of clinical trial operational aspects, including budget and timeline management
Demonstrated ability to build and execute strategic and tactical plans
Experience engaging with key internal and external stakeholders
Specialty in relevant therapeutic area with at least 5 years clinical experience treating patients and successful interactions with major Health Authorities leading to drug approvals
Strong leadership skills with demonstrated capability to lead cross-functional teams in a matrix environment
Ability to coach, mentor, and communicate effectively with all audiences internally and externally
Excellent organisational skills with self-motivated drive to implement best practices
Demonstrated ability to evaluate and analyse medical and scientific literature
Fluent written and verbal communication in English
Alignment with Sobi's core values: Care, Ambition, Urgency, Ownership, and Partnership

Additional Information

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

Direkt bewerben

Erweiterte Suche

project and qualification Jobs in basel, bs

Senior Director, Medicine Development Leader

Process Engineer (m/f/d)

Verification & Validation Engineer

Senior Process Engineer

Senior Group Director, Safety Development & Processes

Technology Transfer Lead 80-100%

Global Director Medical Affairs

Senior Banking Systems Integration Engineer

D365 Finance & HR Consultant

Senior Project Engineer

Senior Project and Business Development Manager for the chemical and pharmaceutical Industry - DE/EN-FR (M/F)

Principal/Sr Principal, Global Advisory Services

Senior Business Development Leader

Senior Process Automation Engineer (DSP) (a), 100%

Associate Director/Director Study Lead

Innovative Process Technician

Director, Business Intelligence

Network & Security Engineer IT-OT

IT Desktop Support Technician (m/w/d) - limited contract of 12 months

Electrical Project Engineer (m/w/d)

Ich möchte aktuelle Job-E-Mails für Stellen als project and qualification in basel, bs erhalten

Related Searches

Weitere Job-Standorte erkunden

Tools für Jobsuchende

Arbeitgebertools

Durchsuchen

Bleiben Sie in Kontakt