20 beste Stellen als program in basel bl – aktuell auf Personalsuche

Senior Director, Medicine Development Leader
Sobi —Basel, BS
- 100%
- Homeoffice
- Englisch
- Führungserfahrung
- Kommunikationsfähigkeit
Direkt bewerben
8 Std.
Internship - Business Systems Support - 6 months
Jet Aviation —Basel, BS
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
Quantum Startup Founders (Venture Building with QAI Ventures)
QAI Ventures AG —Arlesheim, BL
- Teilzeit
- Hybrides Arbeiten
- Doktorat
Direkt bewerben
Global Manufacturing Excellence - Syngenta Production System Manager
Syngenta Crop Protection —Muttenz, BL
- 100%
- Management-Erfahrung
- Englisch
- Master
- Pensionskasse
Direkt bewerben
Project- and Qualification-Engineer (m/w/d)
Glatt Gruppe —Pratteln, BL
- 100%
- Englisch
- Master
- Bachelor
Blue Yonder WMS Specialist (m/w/d)
Kuehne+Nagel —Möhlin, AG
- Englisch
- SQL
- Erfahrung in der IT
13 Tage
Doctoral Position in European Global Studies / Global History (60%)
Universität Basel —Basel, BS
- Teilzeit
- Doktorat
- Englisch
- Master
Technology & Patent Manager - Industrial Networks & IIoT (m/f/d)
Endress+Hauser Digital Solutions Switzerland —Reinach, BL
- 100%
- Management-Erfahrung
- Wartung
- Englisch
Global Scientific Lead - Clinical Outcome Assessment (COA) Strategy Consulting - Multiple locations - Hybrid/Home-based
IQVIA —Basel, BS
- 100%
- Management-Erfahrung
- Doktorat
- Schreibfähigkeiten
Senior Statistical Methodology Data Scientist
Roche —Basel, BS
- 100%
- Doktorat
- Mentoring
7 Tage
Technical Solutions & Innovation Lead (m/f/d)
Viatris —Allschwil, BL
- 100%
- Homeoffice
- Englisch
- AWS
- Analysefähigkeit
SAP Solution Architect (a) 80% -100%
Bachem Holding AG —Bubendorf, BL
- Homeoffice
- Englisch
- Forschungserfahrung
- Master
- Pensionskasse
Senior Clinical Pharmacologist
Idorsia Pharmaceuticals Ltd. —Allschwil, BL
- 100%
- Doktorat
- Master
2 Tage
Postdoctoral Fellow - Neuroscience/Neurobiology (100%)
Universität Basel —Basel, BS
- 100%
- Doktorat
- Analysefähigkeit
- Kommunikationsfähigkeit
Director, Global Regulatory Affairs
Mirum Pharmaceuticals —Basel, BS
- Management-Erfahrung
- Bachelor
- Mentoring
13 Tage
Mgr, EH&S Gnrlist
Carrier —Pratteln, BL
- 100%
- Management-Erfahrung
- Englisch
- Erfahrung im Bauwesen
- Aufstiegsmöglichkeiten
Lead Kernel Engineer/Architect
EPAM Systems, Inc. —Basel, BS
- C++
- Bachelor
- Ohne Hochschulabschluss
- Eltern-/Erziehungsurlaub
- Pensionskasse
MES System Engineer (a), 80 - 100%
Bachem Holding AG —Stein AG, AG
- Bereitschaftsdienst
- Homeoffice
- Englisch
- Forschungserfahrung
- Master
- Pensionskasse
1 Tag
Group Lead Device Process Engineering - Global MSAT
Roche —Basel, BS
- 100%
- Doktorat
- Master
- Montage
Avionics Engineer (H/F)
Hubworkair —Basel, BS
- Wartung
- Englisch
- Microsoft Office

Ich möchte aktuelle Job-E-Mails für Stellen als program in basel bl 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

program jobs near basel bl

Jobs als Enterprise Architect in Bubendorf, BL

Jobs als Group Leader in Basel, BS

Jobs als Key Account Manager in Zürich, Zh

Jobs als Customer Success Manager in Zürich, Zh

Jobs als Project Manager in Zug, Zg

Jobs als Machine Learning Engineer in Lausanne, Vd

Jobs als Pre Sales Engineer in Zürich, Zh

Jobs als Security Engineer in Kanton Bern

Jobs als Security Architect in Zürich, Zh

Jobs als Team Lead Customer Service in Zürich, Zh

Jobs als Physician Assistant in Sion, Vs

Jobs als Physician Assistant in Dübendorf, Zh

Jobs als Architect Salary in Zürich, Zh

Jobs als Enterprise Architect in Zug, Zg

Jobs als It Architect in Zug, Zg

Jobs als Software Architect in Bern, Be

Jobs als Enterprise Architect in Altstetten, Zh

Jobs als Enterprise Architect in Genève, Ge

Jobs als It Architect in Zürich, Zh

Jobs als System Engineer in Grenchen, So

Senior Director, Medicine Development Leader

Sobi -
Basel, BS

Direkt bewerben

Details zur Stelle

100% | Pensum: 90-100%
vor 8 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

program Jobs in basel bl

Senior Director, Medicine Development Leader

Internship - Business Systems Support - 6 months

Quantum Startup Founders (Venture Building with QAI Ventures)

Global Manufacturing Excellence - Syngenta Production System Manager

Project- and Qualification-Engineer (m/w/d)

Blue Yonder WMS Specialist (m/w/d)

Doctoral Position in European Global Studies / Global History (60%)

Technology & Patent Manager - Industrial Networks & IIoT (m/f/d)

Global Scientific Lead - Clinical Outcome Assessment (COA) Strategy Consulting - Multiple locations - Hybrid/Home-based

Senior Statistical Methodology Data Scientist

Technical Solutions & Innovation Lead (m/f/d)

SAP Solution Architect (a) 80% -100%

Senior Clinical Pharmacologist

Postdoctoral Fellow - Neuroscience/Neurobiology (100%)

Director, Global Regulatory Affairs

Mgr, EH&S Gnrlist

Lead Kernel Engineer/Architect

MES System Engineer (a), 80 - 100%

Group Lead Device Process Engineering - Global MSAT

Avionics Engineer (H/F)

Ich möchte aktuelle Job-E-Mails für Stellen als program in basel bl erhalten

Related Searches

Weitere Job-Standorte erkunden

Tools für Jobsuchende

Arbeitgebertools

Durchsuchen

Bleiben Sie in Kontakt