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:

PERSONAL SKILLS AND PROFESSIONAL EXPERIENCE:

• Bachelor’s Degree in Life Sciences field and a minimum of 7 years relevant experience required.
• Experience in global clinical operations methods and processes in industry setting is required.
• 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.
• CRA experience is preferred.
• Experience in oncology is preferred.
• Familiarity with a Japan-based organization is beneficial.

COMPETENCIES / SOFT SKILL:

• Strong interpersonal skills and ability to effectively work cross-functionally and with others.
• Strong leadership, project management, risk/issue management.
• Ability to work independently as well as within a team.
• Ability to travel up to 10% globally.

ROLES AND RESPONSIBILITIES:

• Lead the core and extended cross-function study team to deliver on study milestones, time, quality and budget.
• Contribute to and interface with different levels of study governance, as required.
• 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.
• Reinforce CRO/Vendor accountability for trial execution and quality data delivery, fostering a culture of empowerment and accountability for internal issue resolution.
• 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.
• Define trial scope of work and lead CRO/vendor selection; lead trial feasibility; and contribute towards clinical database development.
• 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.
• 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).