With over 120 years of experience and approximately 19,000 employees in more than 30 countries/regions, 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 are driving innovation in solid tumours and blood cancers, founded on breakthrough science from our own labs in Japan. We aspire to create better tomorrows for people living with cancer and their loved ones.
Our European headquarters are in Munich, Germany, and we have affiliates in 15 European countries and Canada.
We are seeking highly qualified candidates to fill the position of:
Study Delivery Lead (SDL), Global Clinical Operations Europe (m/f/x)
This role could be filled in the following European countries: UK, Germany, France, Spain, Switzerland or Italy; on site, hybrid or according to local remote regulations. We are looking for multiple candidates to establish a strong Clinical Operations presence in our European R&D organization.
The position:
The Study Delivery Lead (SDL) leads the cross functional core and extended clinical study team in end-to end delivery of the clinical trial with consistency, quality, within budget and per planned timelines. The SDL has the accountability for 1 or several complex studies in various settings including Phase I-III, within a delivery model comprising of outsourced studies or outsourced studies with elements of insourcing. This includes global operational execution and delivery of clinical studies across multiple geographic regions, in adherence to Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Health Authority regulations, International Conference on Harmonization (ICH) guidelines and local regulations, as required.
The SDL is accountable for study level operational planning and execution (from planning, start-up, conduct, reporting and close out) including timeline and budget development and management. The SDL collaborates with core and extended teams to ensure effective oversight of CROs and third-party vendors, achieving study milestones and deliverables according to agreed quality standards and timelines, and ensuring data quality is suitable for regulatory submission. The SDL also partners with cross-functional stakeholders to monitor and drive progress and regularly interacts with internal and external stakeholders to discuss project status, address issues, and resolve inquiries. Additionally, the SDL serves as a mentor to junior colleagues on clinical trial execution.
The SDL fosters an environment where the core study team maximizes their expertise and contribution to trial delivery, including but not limited to issue resolution, risk mitigation and escalation to Global Project Team (GPT), and other governance bodies as needed.
For this role, strong written and verbal communication skills in English, operational leadership, decision-making, strategic thinking, conflict resolution, clinical project management experience, and attention to detail are required. Outside interfaces may include other Daiichi-Sankyo business groups and subsidiaries in the US and abroad, governmental, academic, community, and industry organizations.
The SDL is the reference and role model within the study delivery lead team that drives the culture for a healthy team. The role is primarily responsible for Operational Study Strategy and Study Execution while exhibiting leadership qualities.
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