
phenox · Remote
DEINE AUFGABEN * Leitung des gesamten Managements klinischer Studien für Medizinprodukte der Klasse III – von der Machbarkeitsbewertung bis zum Studienabsc...
Studienabschluss
Anforderungen durchgeführt werden
(CRAs) und weiteren relevanten Stakeholdern
einschließlich Definition des Leistungsumfangs, Leistungsüberwachung sowie Sicherstellung von Meilensteinen und Ergebnissen
Meilensteine
Bedarf
im Studienteam
Vorlagen, Tools und Formularen
Best Practices im klinischen Bereich
Managern und Teammitgliedern
von Vorteil
prägen
hybrid oder remote möglich
DIE ROLLE Als Senior Clinical Project Manager steuern Sie klinische Studien mit Fokus auf wissenschaftliche Integrität, methodische Präzision und effiziente Umsetzung. Sie koordinieren interdisziplinäre Teams, erkennen Risiken und betreuen Studien valide, reproduzierbar und regulatorisch belastbar. DIE MISSION Wissenschaftliche Qualität, regulatorische Konformität und operative Effizienz durch präzise Planung, vorausschauendes Risikomanagement und die enge Zusammenarbeit mit interdisziplinären Teams sicherzustellen. DIE AUFGABEN * Projektmanagement von komplexen internationalen klinischen Studien der Phasen II-IV (Planung, Durchführung und Überwachung aller operativen Prozesse) * Zielorientierte und gleichzeitig partnerschaftliche Führung des eigenen Projektteams * Mentoring von Teammitgliedern mit weniger Projektmanagement-Erfahrung und gezielte Weitergabe von Wissen und Erfahrung * Mitwirkung an abteilungsübergreifenden Themen in der Zusammenarbeit mit anderen Fachabteilungen zur ständigen Verbesserung der Prozesse und Schnittstellen * Selbstständige Koordination und Sicherstellung der Einhaltung des Budgetrahmens, der Timelines, des Scope of Work von Beginn an bis zum Studienende. Auswahl und Zahlungsabwicklung benötigter Vendoren * Leitung zielgerichteter interner und externer Meetings * Berichterstattung intern und extern (Steering Committee, Sponsor o.ä.) * Bearbeitung sämtlicher behördlicher Anfragen * Weiterentwicklung firmeninterner SOPs WAS WIR ERWARTEN * Abgeschlossenes naturwissenschaftliches oder medizinisches Hochschulstudium * Mehrjährige relevante Erfahrung im Projektmanagement internationaler klinischer Studien (vorzugsweise in der Onkologie). Erfahrung mit ATMP – oder MPG - Studien ist von Vorteil. * Erfahrung in der Zusammenarbeit mit internationalen externen Partnern, Sponsoren und Dienstleistern * Regulatorische Kenntnisse, ICH-GCP- und AMG-Kenntnisse sowie Umgang mit entsprechenden Qualitätsstandards * Verhandlungssicheres Englisch in Wort und Schrift * Selbstständige und strukturierte Arbeitsweise, Problemlösungs- und Entscheidungsfindungsfähigkeiten * Führungsstärke und Durchsetzungsvermögen sowie Verhandlungsgeschick * Ausgeprägte Fähigkeit, Beziehungen und Netzwerke aufzubauen * Stressresistenz und Kommunikationsstärke, um auch Hochphasen eines Projektes souverän und sicher zu gestalten WARUM GBG? * Beteiligung an spannenden, klinischen Studien und translationalen Forschungsprojekten mit internationaler Aufmerksamkeit * Ein internationales Arbeitsumfeld mit regelmäßigem Austausch mit anderen, international aktiven Studiengruppen und Sponsoren * Einblick in aktuelle Forschungsschwerpunkte in der Brustkrebsforschung durch aktive Teilnahme an Subboard-Meetings sowie Scientific Meetings * Work-Life-Balance: Vertrauensarbeitszeit, Flexible Arbeitszeiten, Möglichkeit für mobiles Arbeiten * Zahlreiche Angebote für Weiterentwicklung: interne und externe Fortbildungen * Sonderleistungen (z.B. JobRad, Parkplatz, Zuschuss zum „Deutschland-Ticket“) Haben wir Ihr Interesse geweckt? Wir bieten Ihnen einen Arbeitsplatz in einem dynamischen Unternehmen mit kurzen Entscheidungswegen in einem motivierten Team. Innovations- und Einsatzbereitschaft zeichnet unsere Zusammenarbeit aus. Bitte senden Sie Ihre aussagekräftige Bewerbung mit Motivationsschreiben, Lebenslauf, Angabe Ihrer Einkommensvorstellung und dem nächstmöglichen Eintrittstermin auf unserer Karriereseite
Company Overview Mindpeak is a Hamburg-based scale-up at the forefront of AI-driven cancer diagnostics. Our software helps pathologists analyze medical images more efficiently and accurately - already clinically deployed in more than 25 countries. Our vision is to enable personalized and effective treatment for every cancer patient - to truly improve medical care and patient outcomes around the world. Position Summary Role: Senior Medical Project Manager We are looking for a Senior Medical Project Manager who acts as the execution engine for Mindpeak’s clinical and pharmaceutical partnerships. In this role, you bridge the gap between complex biological science and high-speed software delivery. You will take full end-to-end ownership of our most important projects, ensuring they move from kickoff to completion through rigorous planning and superior stakeholder management. Your mission is to ensure that complex project requirements turn into reliable, scalable execution. You are not just a coordinator; you are an operational architect. You build the backbone of our partnership delivery by introducing standardized workflows that make scaling predictable. You don't just follow a process—you improve it. When things go wrong, you don't offer excuses; you find creative solutions to keep the customer happy and the project on track. You’ll work on: * Driving High-Stakes Projects: Leading pharma partnerships with zero "hand-holding" and full accountability for results. * Scaling Operations: Reducing onboarding times and automating repetitive tasks to move from 25 labs in 2026 to 100+ in 2027. * Bridging Science & Tech: Translating clinical requirements and pathology results into technical requirements for our engineering teams. * Maintaining Excellence: Ensuring high-quality delivery while navigating the high-pressure environment of a fast-growing AI startup. What You’ll Do: Project Governance & Execution * Lead the end-to-end delivery of high-priority pharmaceutical and clinical projects. * Identify "red flags" (data bottlenecks, regulatory hurdles) weeks in advance and implement mitigation plans. * Balance partner "feature creep" with internal resources, ensuring commitments are met without compromising quality. Stakeholder Architecture * Act as a trusted, "high-presentability" advisor to our Pharma partners. * Navigate difficult conversations regarding delays or technical limitations while maintaining excellent long-term relationships. * Keep the customer happy through proactive communication and solution-oriented management. Process Engineering & Scalability * Identify inefficiencies in internal workflows and implement standardized documentation to reduce manual overhead. * Aim for radical efficiency: reduce onboarding time for new partners to less than one hour. * Connect scientific needs to the product roadmap to ensure long-term business value. Scientific & Analytical Leadership * Interpret IHC/pathology results and translate them for the engineering team. * Apply the "80/20 rule": know when a project requires 100% scientific depth and when pragmatic speed is needed to hit a commercial deadline. Candidate Profile * Science-Tech Hybrid: Master’s degree in Biology, Molecular Biology, Biomedical Sciences, or a related field, combined with a "software-native" mindset. * Proven PM Toolkit: 5+ years of professional experience in project management, ideally in Biotech, Pharma, or MedTech. * Execution Drive: You take full responsibility for outcomes. No excuses—you find a way to get it done. * Operational Mindset: A natural discomfort with "messy" folders or manual tasks; you have a drive to automate and standardize. * Communication: C1/C2 English level; confident in negotiating with and presenting to high-level external stakeholders. * Pragmatic Thinker: You stay calm under pressure and handle shifting priorities with ease. * Nice-to-Have: A PhD in Pathology/Histology, basic Python skills, or a background in top-tier management consulting. * Based in Hamburg with regular on-site presence. What Mindpeak Offers * The opportunity to build AI systems that power both clinical cancer diagnostics and data-driven drug development. * An open, creative work environment with flat hierarchies and quick decision-making. * Be part of an excellent leadership team that invests in continuous development. * A centrally located Hamburg office with a beautiful view over the harbor. Application Details Please apply via our website including documents like CV, university certificates, transcripts, references, salary expectations, and earliest start date. Contact: jobs@mindpeak.ai or reach out to Christine Stamer at christine.stamer@mindpeak.ai Website: mindpeak.ai Note: Direct applicants only; agencies are not considered.
Lead change that lasts At Mölnlycke, we believe that real impact starts with people. People who are bold enough to challenge the status quo. People who care deeply for their work, their colleagues, and the world around them. People who know exactly why they do what they do. As a global medical solutions company, we design and deliver innovative products and services across wound care, operating room solutions, gloves, and antiseptics. Our mission is to advance performance in healthcare by supporting professionals, improving outcomes, and making a difference where it matters most. Mölnlycke is now looking for a Senior Global Project Manager to join our newly established Wound Care PMO. Why This Role Matters This isn't just an opportunity to lead strategic projects—it's an opportunity to help build the future of project management at Mölnlycke. As part of our newly established Global PMO, you will play a pivotal role in shaping how we execute strategy across the organization. We are transforming from a landscape where project management has often been performed as a side responsibility into a professional, value-driven project organization that enables stronger execution, greater business impact, and consistent delivery excellence. This role is a true lighthouse position within the PMO. We're looking for an experienced project leader who can set the benchmark for project excellence, bring fresh external perspectives, and help establish the standards, behaviours, and ways of working that will define our PMO for years to come. Here's how you'll make an impact in this role: Lead complex, cross-functional global projects and programs that are critical to Mölnlycke's strategic priorities. Drive initiatives across new product development, innovation, business transformation, and M&A integration. Translate strategy into executable plans and deliver measurable business value. Build alignment across global stakeholders including R&D, Marketing, Supply Chain, Regulatory, Commercial and Operations teams. Apply Agile, Waterfall, or Hybrid delivery approaches depending on business needs and project context. Drive governance, decision-making, risk management, and benefit realization throughout the project lifecycle. Help shape and mature the newly established Global PMO, contributing to standards, methodologies, governance, and capability development. Act as a role model and trusted advisor, demonstrating what great project leadership looks like across the organization. Support knowledge sharing, mentoring, and the professionalization of project management practices at Mölnlycke. What you'll get Be part of a culture built on trust, care, and shared ownership Your growth and development You'll gain experience that matters, in a company that's clear on its mission and bold in its ambitions. Flexibility, wellbeing and benefits that reflect our commitment to you Permanent position. Hybrid working approach aligned with company policy (minimum 3 days/week onsite) Competitive compensation package including bonus scheme. Generous vacation and benefits package. Wellbeing initiatives supporting physical, mental, and emotional health. A purpose-driven culture where your work contributes to better healthcare outcomes worldwide. What you bring Extensive experience as a professional Project Manager or Program Manager leading complex, cross-functional initiatives. Experience navigating ambiguity, organizational change, and evolving business environments. Outstanding stakeholder management skills and the ability to influence without formal authority. Excellent communication skills and the confidence to engage with senior leaders and executive stakeholders. Strong business and commercial acumen, with the ability to connect projects to value creation and strategic outcomes. Strong expertise across project delivery methodologies, including Agile, Waterfall, Stage-Gate, and Hybrid approaches. A proven track record of delivering projects in regulated environments. Knowledge and experience of working in SAFe or other agile at scale settings Bachelor's or Master's degree in Engineering, Life Sciences, Business, or a related field. Nice-to-haves Experience helping build, transform, or mature a PMO function. Experience with M&A integration projects. Exposure to value-stream organizations. PMP, PRINCE2, or similar project management certification. RTE, LPM or similar certifications Experience within Medical Devices, Pharma, Automotive, or other highly regulated industries. Experience delivering projects involving hardware or combined hardware/software products. Beyond experience and qualifications, we're looking for someone with natural leadership presence, curiosity, resilience, and a strong drive to create positive change. Someone who combines urgency with empathy, builds trust through influence, and is energized by helping shape both a team and a function during an exciting period of growth and transformation. Our approach to Diversity & Inclusion We're building a workplace where everyone feels seen, heard, and valued. We believe that a diverse mix of people from different cultures, ages, geographies, and genders makes us stronger. It brings fresh perspectives, drives better decisions, and helps us deliver solutions that reflect the world we serve. Inclusion isn't just a value—it's how we work, grow, and lead together. Please submit your application by August 16. About Mölnlycke Mölnlycke is a world-leading medical products and solutions company that equips healthcare professionals to achieve the best patient, clinical and economic outcomes. Our business is organised in the four business areas Wound Care, Operating Room Solutions, Gloves and Antiseptics, where customer centricity, sustainability and digitalisation are at the heart of everything we do. Mölnlycke employs around 8,700 people. The company headquarters are in Gothenburg, Sweden and we operate in more than 100 countries worldwide. Mölnlycke is a founding partner of GoCo Health Innovation City, a world-class innovation cluster for health. Since 2007, the company has been part of Investor AB, an engaged owner of high-quality, global companies which was founded by the Wallenberg family in 1916. For more information, please visit www.molnlycke.com and www.molnlycke.com/careers.