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:

QUALIFICATION, PERSONAL SKILLS AND PROFESSIONAL EXPERIENCE:

• A Master’s degree in the Life Sciences is required. PhD or PharmD is of advantage
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• 8 years strong GxP related, clinical operations experience in a pharmaceutical company, and/or Contract Research Organization (CRO). Experience in global clinical study settings and in Medical Affairs settings required. Experience in oncology desired; Experience in non-interventional studies and in medical affairs research projects in a Medical Affairs environment is highly desired and preferred.

• Demonstrated strong accomplishment in all aspects of conducting global clinical trials.
• Demonstrates extensive knowledge of design and phases of clinical studies on a global scale, global regulatory requirements, CRO operations and oversight, as well as compliance practices.
• Effectively oversee and manage CROs and builds strong relationships at the senior levels within the CRO organization.
• Sound understanding of all Medical Affairs structures and functions relevant for clinical interactions and activities on a global level.
• Supports and effectively multi-tasks different and complex global assignments and responsibilities.
• Strong management, interpersonal, prioritization, and problem-solving skills as well as excellent oral and written communication skills.
• Able to work highly structured and think strategically and anticipate broader impact of decisions on work processes.
• Understands, identifies, mitigates, and communicates risks at the study and the program level.
• Effectively leads and influences within the project management matrix at the study and program level; manages functional or direct reports.
• Sound understanding of the concepts and applications of clinical research, medical affairs terminology, and other disciplines involved in clinical research.
• Proven ability to work with minor supervision, self-responsible in a cross-functional, global matrix environment.
• Proficiency in computer applications such as Microsoft Word, Excel, PowerPoint, and Project as well as other relevant platforms related to clinical operations.
• Fluent English (oral and written)

Program / Study Planning, Budget, and Execution:
Work closely with Outsourcing and Legal on requests for proposals, scope of work documents, contracts, and any other documents necessary to ensure vendors are properly selected and contracted with, in accordance with DS policies and procedures. Oversee contracts once approved with regards to adherence to timelines, budgets, and scope of work.
Lead (Co-lead) the study teams to develop a cross-functional, integrated study implementation plan including creation of initial study budget, study kick-off and team meetings. Ensure the effective and timely delivery of the major study milestones and the that the associated budget meets the plan, approved by senior management.
Lead site selection and site qualification discussions with study team and CRO as required.

Across all programs, responsible for:

• protocol /protocol amendment development support, review and approval process, incl. integration of proper operational delivery aspects and logistics.
• development or input into other study related documents including but not limited to ICF, CRF guidelines, project management plans, monitoring plans, etc.
• input into other relevant documents related to safety, regulatory, data management, clinical supplies etc.

Oversee the CRO and other vendors to ensure that the study is executed according to the agreed project plan and in full compliance with all applicable laws and regulations. Actively conduct study risk assessments and ensure mitigation and contingency measures are prepared and implemented effectively.
Maintain highest quality and full oversight of all study deliverables from start up to delivery of the Clinical Study Report through close collaboration across functions, stakeholders, and vendors.

Represent Clinical Operations in Global Medical Affairs program team(s) and with alliance partner(s) and serve as interface for all Clinical Operation tasks and activities.

• CRO/Vendor and Quality Oversight
• Responsible for management of CRO(s)/Vendor performance to ensure adherence to scope of work within timelines and budget at an overall study level.
• Provide oversight of the CRO to ensure compliance with Daiichi Sankyo’s quality measures. Be aware of and be able to predict deviations, or potential non-compliance concerns and rapidly resolve or escalate to senior management or the appropriate Governance Committees.
• Regional Interactions
• Cooperate with all Regional MA and/or Clinical Operations Teams, as well as other relevant regional functions to ensure concepts and protocols are reviewed at the Global level with documented minutes and actions.
• People Management
• This position requires project management with the project team in a global and multi-functional matrix environment. It may require the supervision of functional and/or direct reports by providing instruction and direction of daily activities in support of goals.
• Clinical Operations Management/General
• Drive and work on GOMA ClinOps processes and systems’ related developments, implementations, and maintenance in close cooperation with other relevant GOMA and DS stakeholders and external partners.
• Participate in the development of procedures and SOP’s related to GOMA clinical operations activities, in collaboration with the Governance team.
• Collaborate with Quality Assurance, Compliance, Legal, and Regulatory to implement quality standards across all activities, systems, and processes.
• Participate in other relevant GOMA driven initiatives.