20 beste Stellen als program in basel, bs – aktuell auf Personalsuche

Senior Director, Medicine Development Leader
Sobi —Basel, BS
- 100%
- Homeoffice
- Englisch
- Führungserfahrung
- Kommunikationsfähigkeit
Direkt bewerben
4 Std.
Account Manager - Switzerland
Agilent Technologies Schweiz AG —Basel, BS
- 100%
- Homeoffice
- Management-Erfahrung
- Doktorat
- Vertrieb
- Homeoffice-Möglichkeit
4 Std.
HSE Manager BSF Site Development 100% - Sisslerfeld(a)
Bachem Holding AG —Stein AG, AG
- 100%
- Homeoffice
- Management-Erfahrung
- Englisch
- Projektmanagement
- Pensionskasse
Chief Medical Officer
Swiss Biotech Association —Reinach, BL
- Doktorat
- Englisch
- Kommunikationsfähigkeit
Principal Real World Data Scientist
Roche —Basel, BS
- 100%
- Doktorat
- Datenanalyse
- Analysefähigkeit
Senior Enterprise Architect
Adobe —Basel, BS
- 100%
- Englisch
- Führungserfahrung
6 Tage
Senior Business Development Leader
TSP (A Syneos Health Company) —Basel, BS
- 100%
- Master
- Analysefähigkeit
- Bachelor
IT Security & Compliance Head (CHI) (m/w/d)
Lonza —Basel, BS
- 100%
- Informatik
- Englisch
- Master
Automationsingenieur - Betriebsengineering (w/m/d)
Glatt Gruppe —Pratteln, BL
- 100%
- AutoCAD
- Englisch
5 Tage
Research fellows hosted at the Centre for Pathogen Bioinformatics
SIB Swiss Institute of Bioinformatics —Basel, BS
- Doktorat
- Master
Mechanical Design Engineer Pressure Equipment
Sulzer —Allschwil, BL
- 100%
- Englisch
- Microsoft Office
- Kommunikationsfähigkeit
Executive Director, Regulatory Strategy
Neurocrine Bioscience —Allschwil, BL
- 100%
- Management-Erfahrung
- Doktorat
- Master
People Operations Lead (m/f/d)
Swiss IT Security Group AG —Basel, BS
- Englisch
- Verträge
- Kommunikationsfähigkeit
- Empfehlungsprogramm
Global Scientific Lead - Clinical Outcome Assessment (COA) Strategy Consulting - Multiple locations - Hybrid/Home-based
IQVIA —Basel, BS
- 100%
- Management-Erfahrung
- Doktorat
- Schreibfähigkeiten
Senior Process Automation Engineer (DSP) (a), 100%
Bachem Holding AG —Stein AG, AG
- 100%
- Englisch
- Forschungserfahrung
- SPS-Steuerung
11 Tage
Technology Manager - Industrial Networks & IIoT (m/f/d)
Endress+Hauser Digital Solutions Switzerland —Reinach, BL
- 100%
- Management-Erfahrung
- Englisch
- Kommunikationsfähigkeit
Doctoral Position in European Global Studies / Global History (60%)
Universität Basel —Basel, BS
- Teilzeit
- Doktorat
- Englisch
- Master
Senior Building Automation Engineer (SME BMS) - Large CAPEX Pharma Project (a), 100%
Bachem Holding AG —Stein AG, AG
- 100%
- Englisch
- Forschungserfahrung
- SPS-Steuerung
11 Tage
Senior Statistical Methodology Data Scientist
Roche —Basel, BS
- 100%
- Doktorat
- Mentoring
6 Tage
Technical Solutions & Innovation Lead (m/f/d)
Viatris —Allschwil, BL
- 100%
- Homeoffice
- Englisch
- AWS
- Analysefähigkeit

Ich möchte aktuelle Job-E-Mails für Stellen als program 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

program jobs near basel, bs

Jobs als Account Manager in Basel, BS

Jobs als It Manager in Zürich, Zh

Jobs als It Head in Wabern, Be

Jobs als Junior It in Bern, Be

Jobs als Junior It Security in Zürich, Zh

Jobs als Senior Compliance Officer in Zürich, Zh

Jobs als Senior Digital Marketing Manager in Zürich, Zh

Jobs als Cloud Architect in Zug, Zg

Jobs als Senior Enterprise Architect in Zürich, Zh

Jobs als Physician Assistant in Sion, Vs

Jobs als Physician Assistant in Dübendorf, Zh

Jobs als Coo, Chief Of Staff in Zürich, Zh

Jobs als Director Of Strategy in Genève, Ge

Jobs als Innovation Strategy in Zürich, Zh

Jobs als Head Of Project Management in Zürich, Zh

Jobs als Director Of Strategy in Basel, Bs

Jobs als Strategy Internship in Zürich, Zh

Jobs als Compliance Officer in Baar, Zg

Jobs als Directeur Commercial, Cco, Ceo, Chief Commercial Officer, Sales Director in Genève, Ge

Jobs als Compliance Officer in Zürich, Zh

Senior Director, Medicine Development Leader

Sobi -
Basel, BS

Direkt bewerben

Details zur Stelle

100% | Pensum: 90-100%
vor 4 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, bs

Senior Director, Medicine Development Leader

Account Manager - Switzerland

HSE Manager BSF Site Development 100% - Sisslerfeld(a)

Chief Medical Officer

Principal Real World Data Scientist

Senior Enterprise Architect

Senior Business Development Leader

IT Security & Compliance Head (CHI) (m/w/d)

Automationsingenieur - Betriebsengineering (w/m/d)

Research fellows hosted at the Centre for Pathogen Bioinformatics

Mechanical Design Engineer Pressure Equipment

Executive Director, Regulatory Strategy

People Operations Lead (m/f/d)

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

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

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

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

Senior Building Automation Engineer (SME BMS) - Large CAPEX Pharma Project (a), 100%

Senior Statistical Methodology Data Scientist

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

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

Related Searches

Weitere Job-Standorte erkunden

Tools für Jobsuchende

Arbeitgebertools

Durchsuchen

Bleiben Sie in Kontakt