Experience in set-up and conduct of Phase II clinical trials including in depth knowledge of early phase study designs, protocol writing and clinical pharmacology. Additional experience in conduct of Phase I and Phase III trials would be an advantage.
The Study Physician ensures state-of-the-art medical oversight from the Trial Design Outline (TDO) kickoff through to the Clinical Trial Report (CTR) and serves as a core member of both the Trial Team and the Evidence Network Team.
Provide scientific, clinical, and operational advice to internal stakeholders developing proposals: this may include, but is not limited to, providing the strategy to protocol design/clinical development plan, mining data to address important clinical questions relevant to the study, reviewing the protocol for scientific/regulatory soundness and feasibility, identification of target site and principal investigator profiles, anticipated patient recruitment, standard of care and competitive landscape.
Provide scientific, clinical, and operational advice to internal stakeholders developing proposals: this may include, but is not limited to, providing the strategy to protocol design/clinical development plan, mining data to address important clinical questions relevant to the study, reviewing the protocol for scientific/regulatory soundness and feasibility, logistics challenges, identification of target site and principal investigator profiles, anticipated patient recruitment, standard of care and competitive landscape.
Responsible for the inclusion of Cardiovascular elements into proposals.Provide scientific, clinical, and operational advice to internal stakeholders developing proposals: this may include, but is not limited to, providing the strategy to protocol design/clinical development plan, mining data to address important clinical questions relevant to the study, reviewing the protocol for scientific/regulatory soundness and feasibility, identification of target site and principal investigator profiles, anticipated patient recruitment, standard of care and competitive landscape.Support preparation of customer and bid defense meetings, e.g. training and preparation of the assigned project team; provide specific content; ensure presentation focus and content effectively conveys Cardiovascular strategy.
This role requires a highly experienced biostatistician capable of working independently, representing the Biostatistics function within cross‑functional teams, and delivering high‑quality statistical input throughout study design, execution, and analysis. Key Responsibilities Statistical Leadership & Study Support Serve as the primary statistical lead and main point of contact on the Clinical Trial Team (CTT), representing Biostatistics with confidence and professionalism.Work independently to support clinical teams, providing proactive statistical guidance throughout the study lifecycle.Lead statistical strategy discussions, including endpoint definitions, analysis methods, risk mitigation, and regulatory expectations.
Key Responsibilities: Leadership: Serve as a biostatistical consultant for other members of the department and staff members from other Biostatistics departments within the company Represent sponsors at meetings with regulatory agencies or other regulatory meetings, may participate as a member of a Data and Safety Monitoring Committee Participate in independent research activities, teaching opportunities, presentations, and preparation of manuscripts for publication Participate as high level lead biostatistician on major projects, including developing/reviewing protocols, preparing analysis plans, and writing sections of joint clinical/statistical reports, integrated summaries and/or NDA sections Leading studies at an operational level Provide expert review and initiate methodology development work with regards to statistical standards and validation procedures Consult on operational/statistical/therapeutic area topics Knowledge Sharing: Maintain knowledge and awareness of developments in biostatistics and clinical trial methodology, and regulatory requirements that impact on analyses Performs as subject matter expert (SME) Risk Management: Identifies risks to project delivery and/or quality, leads in a way to minimize risks Anticipates risks to avert need for study level escalations, supports lead in implementing risk mitigation actions Lock and Unblinding Process: Leads the database lock and unblinding process for the statistical team Participate on the biostatistics randomization team (drafts randomization specifications and/or perform quality control (QC) review of randomization schedules) Statistical Expertise: Provide expert statistical input into review of statistical deliverables (i.e. statistical section of a protocol, statistical analysis plans, table shells, programming and table specifications, data review, tables, listings, figures, and statistical sections for complex and/or integrated reports) Provide expert input into data management deliverables (i.e. database design, CRF design, validation checks and critical data) Provide expert review of ADaM reviewers guide (ADRG) and metadata Perform senior biostatistical review (SBR) Produce or perform quality control review of sample size calculations for complex studies Requirements: Masters or PhD degree in Biostatistics or a related field with relevant experience within the life-science industry Expert in a broad range of complex statistical methods that apply to Phase 2-3 clinical trials Expert in strategically collaborating with clinical and drug development expertsExperience in serving as statistical lead for regulatory submissions, including preparation of submission datasets, eCTD support, meeting with regulatory teams, and responding to regulatory queries In-depth knowledge of applicable clinical research regulatory requirements, Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines Strong working knowledge of SAS or RExcellent knowledge of CDISC Data Standards Superb communication and collaboration skills Independent and pro-active problem solving skills IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries.
Clinical and market insight: Collect product performance and user feedback for R&D, MACA, and commercial teams to inform life cycle management, next-generation innovations, clinical study designs, and commercial strategies. Share insights, best practice, and data with national and regional MSL networks. Cross-functional collaboration and influence: Partner with internal cross-functional teams, including MACA, R&D, Regulatory, Marketing and national Market Access, to ensure integration of insights into our strategies.
In addition to the responsibilities listed above, the Therapeutic Strategy VP will be expected to: Lead and support clinical trial design and all associated aspects for various clients. Provide strategic and therapeutic area guidance for clinical development plans in compliance with applicable regulatory, medical, and ethics guidelines.
Develop and execute strategies to enhance advocacy and engagement among key eye-care providers, ensuring alignment with overall brand and commercial objectives Design and implement training approaches that enable local SSCs to identify, recruit, and cultivate strong relationships with KOLs within their regions Build and sustain robust relationships with the ophthalmic medical community- including academic institutions and specialized physicians-using a scientific, needs-based approach to deliver targeted solutions Conduct an annual needs assessment for KOL activities and create regional execution plans in collaboration with key internal stakeholders; provide leadership with ongoing progress updates on the impact of regional KOL initiatives Contribute to the development of advanced communication programs to ensure KOLs receive timely updates on company developments, products, and clinical data Oversee and maintain the regional KOL database to ensure accuracy, completeness, and effective engagement tracking through honoraria; annually update contracted HCP biographies and publications, ensuring all documentation remains current; deliver periodic utilization and budget reports to the Global KOL Director Act as the primary liaison with the legal department to develop and manage KOL contracts and service agreements in full compliance with regulatory requirements; coordinate and process all onboarding documentation Plan, coordinate, and execute approved regional advisory boards in support of KOL Management and the Chief Medical Officer Represent the company at regional medical congresses and scientific meetings, supporting KOL strategy execution and identifying emerging key influencers Serve as an internal expert on disease state and product knowledge, empowering internal and field teams to better understand clinical needs, strengthen KOL loyalty, and foster broader adoption within the ophthalmic community Collaborate closely with internal teams-including Marketing, R&D, and Professional Education—to address cross-functional KOL needs and ensure smooth coordination of activities Solid direct experience working with Key Opinion Leaders, ideally within the ophthalmology sector Exceptional communication and interpersonal skills, with the ability to build trust-based relationships across diverse stakeholder groups Full professional proficiency in English, both spoken and written Strong business acumen and a demonstrated ability to effectively manage timelines, processes, and procedural workflows Experience with product launches, advisory boards, and post-approval studies is highly advantageous Relevant academic background required (e.g., life sciences, healthcare, business, or a related field) A very renowned company Other Locations: Oberkochen/Jena/Berlin Ihr Kontakt Referenznummer 865508/1 Kontakt aufnehmen Telefon:+ 49 621 1788-4297 E-Mail: positionen@hays.de Anstellungsart Anstellung bei der Hays Professional Solutions GmbH
Skills and Abilities: Ability to identify additional service/system requirements or shortfalls and co-ordinate and/or design the delivery of innovative solutions to maximise service quality, efficiency and continuity. Ability to ensure professional and quality service standards are maintained and applied within own area of activity.
Du erarbeitest mit uns einen Entwicklungsplan und übernimmst dessen Management, um mit uns einen Innovationsvorsprung aufzubauen.Du baust mit uns ein Team aus talenterten Ingenieuren auf, die bei Design und Entwicklung der Elektroden und Chips unterstützen.Du unterstützt anschließend den weiteren Aufbau des Unternehmens: du etablierst und leistest Quality-, Regulatory- oder Clinical‑Trial‑Funktionen oder entwickelst Market‑Access‑ und Vertriebsstrukturen und sicherst die erfolgreiche Markteinführung unseres BCIs.Du koordinierst die Schnittstellen zu unseren Entwicklungspartnern und internen FUTRUE-Teams und steuerst Timeline und Budget der Entwicklung.
Du betreust unser Portfolio an Cannabis-Vollextrakten und begleitest aktiv die Markteinführung unseres neuen Fertigarzneimittels VER-01.Du konzeptionierst und pflegst Marketing‑ und Vertriebsunterlagen für Ärzte und Apotheker in enger Abstimmung mit QS, Außendienst und Grafik.Du planst, steuerst und realisierst unsere Messeauftritte – von Konzept und Layout über Standbaukoordination bis hin zu Budget‑ und Zeitplanung - gemeinsam mit Messebauern, Scientific Marketing und Grafik.Du entwickelst, betreust und optimierst das Schulungskonzept für den Außendienst (Präsenztrainings, eLearning) – inklusive Inhaltserstellung, Moderation und Erfolgskontrolle.Du betreust unsere eLearning-Plattform und verantwortest Kursmanagement, Contentpflege, Nutzerverwaltung, Reporting und die kontinuierliche Verbesserung der Lernpfade.Du entwickelst unsere Web- und Fachkreisseite laufend weiter und hältst diese aktuell.Du konzipierst unsere Fachpressekampagne, setzt PR‑Maßnahmen in Abstimmung mit Agenturen um und pflegst aktiv Pressekontakte.Du steuerst externe Dienstleister (PR‑ und Mediaagenturen, Messebauer, Druckereien) und übernimmst Briefings, Auswahl und Budgetkontrolle.Du arbeitest eng mit unseren Fachabteilungen im Bereich Quality Assurance, Operations/Supply Chain, Scientific Marketing, Clinical Trials, Grafik und Web Development zusammen.Du kannst ein erfolgreich abgeschlossenes (Fach-)Hochschulstudium, vorzugsweise im Bereich Marketing, BWL, Kommunikationswissenschaften, Naturwissenschaften oder Pharmazie, vorweisen.Du bringst mind. 2 Jahre Berufserfahrung im Produktmanagement mit — idealerweise im Healthcare/Pharma‑Umfeld.Du koordinierst cross-funktionale Teams sicher und verfügst über eine strukturierte und selbstständige Arbeitsweise: Stakeholder Management und Priorisierung sind für Dich Routine.Du verfügst über eine schnelle Auffassungsgabe und ein hohes Maß an Eigeninitiative.Du hast ein Gespür für Kreativität, Gestaltung / Design und Text und besitzt eine hohe Sprach- und Kommunikationskompetenz.Du bringst ein ausgeprägtes Business Mindset mit, hast Spaß an aktivem Austausch und kreativer Lösungsfindung über alle Unternehmensebenen hinweg und Lust, in einem dynamischen Umfeld viel zu bewegen und Großes zu schaffen.Du bringst verhandlungssichere Deutsch- und Englischkenntnisse (mind.
Vacancy open for Madrid or Berlin. Key Responsibilities • Design and implement ML models for automating and processing 3D data in orthodontic treatment. • Develop algorithms for teeth segmentation in 3D scans and imaging data. • Work on material reconstruction of teeth for realistic visualization and simulation. • Collaborate with domain experts (orthodontists, clinical specialists and biomechanical engineers) to refine requirements and validate solutions. • Optimize computational geometry workflows for efficiency and accuracy. • Integrate solutions into production-ready pipelines and software tools. • Stay updated with the latest research in ML, 3D graphics, and medical imaging.
Spannende Aufgaben warten auf Sie: Leitung anspruchsvoller Beratungsprojekte in o.g. Themenbereichen (z.B. Design von Vertriebsorganisationen, Optimierung von Kundensegmentierungen) für unsere Pharma-Kunden sowie Kunden aus angrenzenden Branchen (z.B.
Comfortable interpreting commercial / financial trends and results, with ability to guide teams to design and execute research and analysis and translate outputs into strategic implications for investorsWell-developed written and verbal communication skills including presentations, chairing meetings / Q&A sessions and report writingKnowledge of key issues and current developments in the biopharma / life sciences industryEvidence of career progression in consulting and/or transaction advisory roles In addition to the skills and experience above, a Manager should have: Bachelor’s degree or equivalent.
Principal Accountabilities: Collaboration in projects of the European Data Science & Advanced Analytics Team.Concept, design, development and execution of complex innovative AI/Machine Learning solutions as well as execution and implementation of concept studies using advanced statistical methods.Development of deep learning models for structured medical concept extraction from unstructured data.Productionalization of machine learning algorithms in Big Data platforms.Application of modern data mining and machine learning techniques in connection with Healthcare Big Data to identify complex relationships and link heterogeneous data sources.Advanced usage of Large Language Models for summarization, chatbot, entity extraction etc.Develop foundational Deep Learning Models for assets and patients.Builds and trains new production grade algorithms that can learn from complex, high dimensional data to uncover patterns from which machine learning models and applications can be developed.