- Collaborate with Contract Research Organization (CROs) and identify, champion, and implement key improvements in the outsourced operating model for optimization, performance, and site engagement.
- Strategize local needs and help build resource needs to support the clinical trial delivery strategy in an effective, efficient, and compliant manner.
- Responsible for maintaining high level of visibility of operational topics among leadership and stakeholders.
- Lead and inform the direction & strategy for a potential insourced clinical trial model for the Europe region in alignment with global strategy.
- Accountable to lead, manage and drive operational excellence in Europe. This will be accomplished through CRO delivery and considerations of future internalization of GCO's operating model where appropriate.
- Responsible for operational deliverables in Europe in accordance with time, cost, and quality commitments. Partner with internal GCO functions (e.g Clinical Trial Business Operations Performance and Delivery, and Alliance Strategic Vendor Oversight (SVO)) to monitor Europe's performance as planned, including mitigation strategies.
- Function as a key point of escalation for issues and problem resolution impacting new and ongoing studies to ensure business critical milestones are achieved for Europe.
- In accordance with the global strategy and pace, support the creation and direct on a European regional strategy including resource requirements and capabilities needed.
- Build strong relationships with Daichi Sankyo Europe (DSE) Country Managers, Medical Directors and Regulatory, Clinical Development, Clinical Sciences, Regulatory, Biostats, Data Management, and other key stakeholder peer functions to ensure strong collaboration and early operational input into study design and trial delivery planning and execution. He/she will leverage this information to help guide in operational direction of disease area expertise and country specific expertise specific to European GCO needs.
- Feasibility: Understands and highlights country specific strength and opportunities in priority Therapeutic Areas while collaborating with the GCO Feasibility team in the creation of the strategy for selection of countries/sites. Ensures timely inclusion of robust regional/country-level insights and feasibility outcomes into the operational plans to enable effective and efficient delivery to plan.
- In partnership with the global study team, maintains European risks, proactively communicates progress, issues or changes that may impact timelines and costs. Identifies trends & patterns across study and program level and supports mitigation and prevention of European specific systemic issues and risks.
- Support the global team with EU Clinical Trials Regulations (CTR) and In Vitro Diagnostic Medical Device Regulation (IVDR) operational input.
- Accountable for the study level quality, and compliance with GCP, local laws and regulations and guide the team with local HA inspection readiness.
- Line management of regional team in line with business needs. This may include but not limited to GCO roles in the following areas - study management, site engagement, and/or other local staff working from the European region.
- Bachelor's degree required. Advanced degree preferred. Bachelor of Science/Masters of Science in related discipline, or equivalent work experience.
- 15+ years industry or related experience. Extensive early/late-stage drug development oncology experience ideally including time in role such as a Local or Global Project Leader.
- Knowledge and experience of drug development in European region.
- Proven line and performance management experience. Functional management experience, managing resourcing and budget planning and oversight.
- Demonstrated ability to set and manage priorities, resources, performance targets and project initiatives in a global environment.
- Proven organization design and change management experience.
- Excellent written and verbal communication skills.
- Proven ability to develop successful collaborations with internal and external partners.
-
Director HR Operations Europe
vor 1 Woche
AltoPartners Deutschland, Jack Russell Consulting GmbH Munich, DeutschlandOur client is a global specialist strategy consulting firm. The company has an extensive international reach with offices across Europe, the U.S., Australia, Latin America, and Southeast Asia, with successful projects completed across the globe in more than 100 countries. · Aufga ...
-
Legal Operation Senior Lawyer Central Europe
vor 4 Tagen
Plastic Omnium Munich, Deutschland**Date**:Apr 19, 2023 · **Location**: Munich, DE · **Company**:Plastic Omnium · Hungry for challenges? Join a group with innovation at its heart and contribute to the automotive revolution · With 30,000 team members located in 25 countries and with a 2021 revenue of €8 billion, P ...
-
Carrier Ismaning, Deutschland**Country**: · Germany · **Location**: · Carrier Klimatechnik GmbH, Gutenbergstraße 1, 85737 Ismaning, Germany · **HVAC Europe Business Field Operations Specialist** · The major tasks, duties, and responsibilities of the role includes: · - Develop and implement policies for maxim ...
-
Daiichi Sankyo Europe GmbH Munich, DeutschlandWith over 120 years of experience and more than 17,000 employees in over 20 countries, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world. In Europe, we focus on two areas: The goal of our ...
-
Bristol Myers Squibb Munich, Deutschland GanztagsWorking with Us · Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production li ...
-
Bristol Myers Squibb Munich, Deutschland Paid WorkWorking with Us · Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production lin ...
-
Sachbearbeiter Auftragsabwicklung
vor 1 Woche
Moxa Munich, Deutschland**Description** · Moxa ist ein führender Anbieter von industriellen Netzwerk-, Computer · - und Automatisierungslösungen für das industrielle Internet der Dinge. Mit 30 Jahren Branchenerfahrung hat Moxa weltweit mehr als 30 Millionen Geräte angeschlossen und verfügt über ein Vert ...
-
HR Director
vor 1 Woche
Morgan Philips Executive Search Munich, DeutschlandHR Director DACH/Europe (m/w/d) · Für unseren Kunden, ein europäisches Pharmaunternehmen, suchen wir einen dynamischen und erfahrenen HR Director DACH/Europe in München. Das Unternehmen agiert global und engagiert sich für die Verbreitung von Therapien für seltene Krankheiten und ...
-
Head of Operations
vor 5 Tagen
happybrush GmbH Munich, Deutschland**Lust auf eine neue Herausforderung?**: · Du bist begeistert von der Arbeit in einem schnell wachsenden, dynamischen und jungen Unternehmen? Du brennst für effiziente Prozesse, Operations und Customer Care und hast Lust, gemeinsam mit deinem Team maßgeblich zum Unternehmenswachs ...
-
Sales & Operations Specialist (M/w/d)
vor 1 Woche
happybrush GmbH Munich, Deutschland**Lust auf eine neue Herausforderung?**: · Du begeisterst dich für die Bereiche Vertrieb und Operations und konntest bereits Berufserfahrung im Vertriebsinnendienst und der Betreuung von B2B Kunden sammeln? Du übernimmst gern selbst Verantwortung und es macht dir Spaß, die Schnit ...
-
Sachbearbeitung Vertriebsinnendienst
vor 6 Tagen
happybrush GmbH Munich, Deutschland**Lust auf eine neue Herausforderung?**: · Du begeisterst dich für die Bereiche Vertrieb und Operations und konntest bereits Berufserfahrung im Vertriebsinnendienst und der Betreuung von B2B Kunden sammeln? Du übernimmst gern selbst Verantwortung und es macht dir Spaß, die Schnit ...
-
Sachbearbeitung Vertriebsinnendienst
vor 1 Woche
happybrush GmbH Munich, Deutschland**LUST AUF EINE NEUE HERAUSFORDERUNG?**: · Du begeisterst dich für die Bereiche Vertrieb und Operations und konntest bereits Berufserfahrung im Vertriebsinnendienst und der Betreuung von B2B Kunden sammeln? Du übernimmst gern selbst Verantwortung und es macht dir Spaß, die Schnit ...
-
ICTS Deutschland GmbH Munich, Deutschland**Über uns**: · Die ICTS Deutschland GmbH wurde 1988 gegründet, hat ihren Hauptsitz in Frankfurt am Main in unmittelbarer Nähe zum Flughafen und agiert vorrangig in den Bereichen Luftsicherheit und dem Objekt · - und Werkschutz. Unsere Kunden sind unter anderem öffentliche Behörd ...
-
Financial Controller Europe
vor 1 Woche
Emmes Munich, DeutschlandOverview: · **Financial Controller Europe** · **Germany - Munich - Hybrid** · The Emmes Company, LLC ("Emmes") is a global, full-service Clinical Research Organization dedicated to excellence in supporting the advancement of public health and biopharmaceutical innovation. We beli ...
-
Senior Underwriter Cyber
vor 1 Woche
QBE Munich, DeutschlandPrimary Details · Time Type: Full time · Worker Type: Employee · Für die QBE Europe SA/NV - Direktion für Deutschland - suchen wir zum nächstmöglichen Zeitpunkt für den Standort München, Düsseldorf oder Hamburg einen · Senior Underwriter Cyber (m/w/d) · Der QBE-Geschäftsbereich E ...
-
Aftersales Parts Operations Specialist
vor 2 Tagen
SAIC Motor Deutschland GmbH Munich, Deutschland**Ihre Aufgaben**: · - Entwicklung und Aufrechterhaltung optimaler Lagerbestände, um Kundenanforderungen zu erfüllen und Lagerkosten zu minimieren. · - Implementierung von Maßnahmen zur Bestandskontrolle, um Stockouts und Überbestände zu verhindern. · - Abstimmung mit Lieferanten ...
-
People Director Europe
vor 1 Woche
Hiscox Munich, Deutschlandjob description: · **People Director - Europe** · **Reporting to**:European CEO & Chief People Director · **Location**: Munich, Paris or Lisbon · **Other requirements**: Extensive travel throughout the region (France, Germany, Portugal, Ireland, Netherlands, Belgium, Spain, Luxem ...
-
Aftersales Networks Onboarding Specialist
vor 2 Tagen
SAIC Motor Deutschland GmbH Munich, Deutschland**Your mission**: · - Führung durch den Onboarding-Prozess und Gewährleistung einer reibungslosen Integration in unsere Plattform. · - Verwaltung von Datenbanken und Systemen, um genaue und aktuelle Informationen über Partnerunternehmen zu gewährleisten. · - Identifizierung von V ...
-
Entrepreneur in Residence
vor 1 Woche
BEAT81 Munich, Deutschland**YOUR RESPONSIBILITIES** · - Work closely with the Founding Team · - Project management in the fields of strategy, finance and operations · - Support daily operations · - High focus on launching new markets and improving our expansion and operations playbooks · - Support hiring ...
-
City Lead
vor 1 Woche
BEAT81 Munich, Deutschland**About BEAT81***: · BEAT81 is a fitness technology startup revolutionizing the way people get fit. By merging the very best of HIIT group training, heart rate technology and expert coaching we are empowering people around Europe, and soon the world, to Sweat Smarter Together · * ...
Senior Director, Global Clinical Operations Europe - Munich, Deutschland - Daiichi Sankyo Europe
Beschreibung
Passion for Innovation. Compassion for Patients.
With over 120 years of experience and more than 17,000 employees in over 20 countries, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world. In Europe, we focus on two areas: The goal of our Specialty Business is to protect people from cardiovascular disease, the leading cause of death in Europe, and help patients who suffer from it to enjoy every precious moment of life. In Oncology, we strive to become a global pharma innovator with competitive advantage, creating novel therapies for people with cancer. Our European headquarters are in Munich, Germany, and we have affiliates in 13 European countries and Canada.
For our European organization with it's headquarters in Munich, Germany we are seeking highly qualified candidates to fill the following position:
Senior Director, Global Clinical Operations (GCO), Europe (m/f/x)
The Position:
The Senior Director, Global Clinical Operations (GCO) Europe, is accountable for providing leadership and operational expertise into execution of Resarch & Development (R&D) studies conducted in Europe. The role will be part of the Global Clinical Operations (GCO) group in R&D. This position is expected to:
Scope of this role includes the geographical region of Europe, inclusive of European Union (EU0 countries and other European countries (e.g. UK, Switzerland, Turkey, Norway). Scope may include other geographical neighboring countries to Europe depending on business needs.
This position could preferably be filled either in Daiichi Sankyo Europe's headquarters in Munich, Germany, or in France. Applications from other countries in Europe with a Daiichi Sankyo presence are welcome, please check our website to see the Daiichi Sankyo office locations.
Roles & Responsibilities:
Education & Professional Experience:
Why work with us?
Working at Daiichi Sankyo is more than just a job – it is your chance to make a difference and change patients' lives for the better. We can only achieve this ambitious goal together. That is why we foster a culture of mutual respect and continuous learning, with a strong commitment to inclusion and diversity. Here, you will have the opportunity to grow, think boldly, and contribute your ideas. If you have a proactive mindset and passion for addressing the needs of patients, we eagerly await your application.
