Study Delivery Lead (SDL), Global Clinical Operations Europe (m/f/x)

Daiichi Sankyo; München; Vor Ort; EUR 60.000 - 100.000; Vollzeit

Zusammenfassung

An established industry player is seeking a Study Delivery Lead to drive the end-to-end delivery of clinical trials in a dynamic and collaborative environment. This role offers the opportunity to lead cross-functional teams, ensuring high-quality execution of complex studies while adhering to regulatory standards. The ideal candidate will possess strong leadership and project management skills, with a passion for innovation in clinical research. Join a company that values inclusion, diversity, and continuous learning, and make a meaningful impact on patients' lives through your work.

Qualifikationen

• 7+ years of relevant experience in global clinical operations required.
• Experience in clinical project management and oncology preferred.

Aufgaben

• Lead cross-functional teams to deliver clinical study milestones and quality.
• Monitor trial performance and ensure compliance with GCP and SOPs.

Kenntnisse

Operational Leadership

Clinical Project Management

Communication Skills

Strategic Thinking

Conflict Resolution

Attention to Detail

Ausbildung

Bachelor's Degree in Life Sciences

Jobbeschreibung

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Study Delivery Lead (SDL), Global Clinical Operations Europe (m/f/x)

Date: 24 Apr 2025

Passion for Innovation. Compassion for Patients.

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 one 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.

Roles and responsibilities:

1. Lead the core and extended cross-function study team to deliver on study milestones, time, quality and budget.
2. Contribute to and interface with different levels of study governance, as required.
3. Lead escalation and resolution of issues with CRO/vendors/site/country performance including serious quality incidents and GCP breaches. Triage, resolve or escalate study issues/risk mitigations according to governance and oversight protocols. The SDL is accountable for appropriate functional escalation of risks and issues.
4. Reinforce CRO/Vendor accountability for trial execution and quality data delivery, fostering a culture of empowerment and accountability for internal issue resolution.
5. Provide operational input and review of study/asset related documents such as protocols, amendments, ICF, IB, DSUR, IND, and CSR. Oversee and ensure adherence to clinical study plans and documents, including trial feasibility, recruitment, risk management, monitoring, database lock, and study close-down.
6. Define trial scope of work and lead CRO/vendor selection; lead trial feasibility; and contribute towards clinical database development.
7. Monitor clinical trial performance and quality metrics, regularly share updates with study and global project teams, and ensure necessary actions are taken at the study team, CRO and vendor levels. Escalate issues and risks to project team level and relevant governance bodies.
8. Support inspection readiness and quality initiatives pertaining to assigned study(ies) and serve as primary SME engaged in dialogue with inspector(s) to address study inquiries throughout course of HA inspection. Ensure trial master file is complete and accurate for assigned study(ies).

Personal skills and professional experience:

1. Bachelor's Degree in Life Sciences field and a minimum of 7 years relevant experience required.
2. Experience in global clinical operations methods and processes in industry setting is required.
3. Experience considered relevant includes clinical or basic research in a pharmaceutical company, a medical device/Diagnostic company, Academic Research Organization (ARO), hospital/medical setting or Contract Research Organization (CRO). Clinical Project Management experience required.
4. CRA experience is preferred.
5. Experience in oncology is preferred.
6. Familiarity with a Japan-based organization is beneficial.
7. Strong interpersonal skills and ability to effectively work cross-functionally and with others.
8. Strong leadership, project management, risk/issue management.
9. Ability to work independently as well as within a team.
10. Ability to travel up to 10% globally.

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.