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
23 Std.
Capgemini ERD - Life Science Client Partner
Capgemini —Basel, BS
- Management-Erfahrung
- Englisch
- Master
- Empfehlungsprogramm
Director, Clinical Development
Neurocrine Bioscience —Allschwil, BL
- 100%
- Doktorat
- Master
- Führungserfahrung
Director, Business Intelligence
BeiGene —Basel, BS
- CHF 186’600 - CHF 233’200 pro Jahr
- 100%
- Management-Erfahrung
- Master
- Projektmanagement
Postdoctoral Researcher (80-100% FTE) in Exercise and Environmental Physiology
Universität Basel —Basel, BS
- Doktorat
- Datenanalyse
- Englisch
- Weiterbildungen
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Chief Medical Officer
Swiss Biotech Association —Reinach, BL
- Doktorat
- Englisch
- Kommunikationsfähigkeit
Automationsingenieur - Betriebsengineering (w/m/d)
Glatt Gruppe —Pratteln, BL
- 100%
- AutoCAD
- Englisch
6 Tage
Doctoral Position at the Center for Cognitive and Decision Sciences
Universität Basel —Basel, BS
- 100%
- Doktorat
- Datenanalyse
- Englisch
Global Ecosystem Insights Beyond TA Insights Product Enablement Leader
Roche —Basel, BS
- 100%
- Forschungserfahrung
- Analysefähigkeit
- Bachelor
13 Tage
Associate Director/Director Study Lead
Ridgeline Discovery —Basel, BS
- 100%
- Homeoffice
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
Direkt bewerben
Technical Development Leader (TDL) Large Molecules
Roche —Basel, BS
- 100%
- Doktorat
- Master
- Bachelor
Director, Toxicology
Swiss Biotech Association —Basel, BS
- Doktorat
- Forschungserfahrung
- Master
6 Tage
Technology Manager - Industrial Networks & IIoT (m/f/d)
Endress+Hauser Digital Solutions Switzerland —Reinach, BL
- 100%
- Management-Erfahrung
- Englisch
- Kommunikationsfähigkeit
Principal Real World Data Scientist
Roche —Basel, BS
- 100%
- Doktorat
- Datenanalyse
- Analysefähigkeit
Global Manufacturing Excellence - Syngenta Production System Manager
Syngenta Crop Protection —Muttenz, BL
- 100%
- Management-Erfahrung
- Englisch
- Master
- Pensionskasse
Direkt bewerben
Associate / Global Medical Science Leader
Roche —Basel, BS
- 100%
- Doktorat
Senior Process Automation Engineer (DSP) (a), 100%
Bachem Holding AG —Stein AG, AG
- 100%
- Englisch
- Forschungserfahrung
- SPS-Steuerung
12 Tage
Senior Business Development Leader
TSP (A Syneos Health Company) —Basel, BS
- 100%
- Master
- Analysefähigkeit
- Bachelor
Technical Project Manager (m/f/d)
Syngenta Crop Protection —Muttenz, BL
- 100%
- Doktorat
- Wartung
- Englisch
- Pensionskasse
Direkt bewerben
Global Scientific Lead - Clinical Outcome Assessment (COA) Strategy Consulting - Multiple locations - Hybrid/Home-based
IQVIA —Basel, BS
- 100%
- Management-Erfahrung
- Doktorat
- Schreibfähigkeiten

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Senior Director, Medicine Development Leader

Sobi -
Basel, BS

Direkt bewerben

Details zur Stelle

100% | Pensum: 90-100%
vor 23 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

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

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