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Form of workDaiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.
SummaryThe Senior Director of Clinical Operations will manage Clinical Operations staff to ensure the effective and efficient execution of operational aspects of clinical study planning, implementation, data delivery and reporting. Will represent DSPD Clinical Operations in a range of cross-functional groups, global functional committee(s) and initiatives intended to enhance function and company efficiency and productivity, regionally and globally. Will represent Clinical Operations on vendor governance bodies and ensure ongoing collaboration and communication with internal stakeholders. Detailing The Senior Director will ensure a robust communication plan including status and timing of operational deliverables are in place for all studies and programs. Will support the development of policies, procedures and training relevant to the Clinical Operations function. Will ensure that global and local clinical studies are executed, in adherence to Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs) and relevant regulations Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. A key focus will be the oversight of and interactions with CROs and other external vendors to ensure studies are conducted according to the timeline, budget and quality measures set forth by the Study teams. This leader will also ensure a robust escalation and communication plan is in place for each CRO to best support each program. This position will require line management responsibility of Directors, Associate Directors, Clinical Study Managers, who are primarily responsibility for the clinical operational and overall delivery and tactical execution of the clinical studies. The senior director will ensure a strong focus on competencies supportive of project management; vendor management and stakeholder management. At this level, the incumbent may be expected to serve as Program level Delivery Lead on large and/or complex programs, including those involving co-development (Alliance) partners.
Responsibilities
- Provide outstanding leadership skills based on a sound knowledge of clinical research standards and GCP.
- Develop operational strategies for implementation of clinical studies regionally/globally in conjunction with project teams and other cross functional departments.
- Ensure consistent and successful execution of all operational aspects of regional and global studies as appropriate, data delivery and reporting.
- Accountable for the effective support of clinical activities within the Development organization.
- Ensure a “Quality Mindset” is in place across the organization by focusing on detailed plans to monitor the conduct of our studies, the management of our vendors and working closely with our QA organization to implement ongoing learnings from regulatory inspections.
- Engage and motivate Clinical Operations employees to execute the strategy through collaboration and transparent communication.
- Member of the Clinical Operational leadership team and global Clinical Operations committee enabling cross functional and regional collaboration, delivery of regional and global objectives and implementation of process improvements.
- Contribute to the development and review of regional / global policies and procedures. Ensure compliance with all Company and Regulatory requirements.
- Work with outsourcing procurement management to optimize the vendor governance structure, incorporate performance metrics, and contribute to outsourcing discussions.
- May be asked to represent the Clinical Operations Department at senior management meetings on behalf of the Vice President, Clinical Development Operations.
- Provide leadership to Clinical Operations staff and to project teams for Vendor evaluation, selection , management and quality based oversight
- Provide guidance and training to Clinical Operational members of clinical study teams
- Develop best practices and lessons learned mechanisms within Clinical Operations
- Develop risk assessment & risk management and clinical project management competencies within Clinical Operations
- Work in collaboration with Quality Management and Quality Assurance to develop and implement quality activities within Clinical Operations
- Design, update and implement appropriate innovative and best-in-class procedures and SOP’s related to clinical study planning and execution, in collaboration with relevant functions
- Assist in implementing TMF quality standards
- Assist in developing and overseeing the implementation of CAPA in relation to sponsor’s audit or regulatory inspections and ensure lessons learned are developed and shared.
- Support the Vice President of Clinical Operations and above in establishing and maintaining an organizational structure and staffing to effectively accomplish the Clinical Operations goals and objectives.
- Responsible for the management and leadership of all staff within the Clinical Operations group including recruitment, training, mentoring, work assignments, performance evaluations and discipline of staff.
- Accountable for performance management, coaching and development of staff ensuring effective talent management.
- Plan career development and assess training requirements of Clinical Operations employees and contractors. Responsible for the development of adequate training programs to maximize employee potential.
- Anticipate resource issues and plan remedial action. Assist with staff training and orientation for new employees.
- Develop staff by assigning them with their responsibilities, establishing goals that will increase knowledge / skill levels and delegate tasks commensurate with skill level.
Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Education Qualifications (from an accredited college or university)
- Bachelor's Degree in Life Sciences and a minimum of 12 years’ experience in pharmaceutical or biotechnology drug development required or
- Master's Degree and a minimum of 10 years’ relevant experience in pharmaceutical or biotechnology drug development with a MS/MPH preferred
- PharmD 7 years with PharmD/PhD
- Experience in clinical or basic research in a Pharmaceutical company, a Medical device/Diagnostic company, Academic Research Organization (ARO) or Contract Research Organization (CRO). CRA experience is preferred. Time spent directly in a medical environment (e.g. as a Study Site Coordinator) is also considered relevant preferred
- Experience developing, implementing and building Clinical Operations infrastructure including SOPs and managing vendors preferred
- Records Management experience in a GCP environment preferred
- Technology enablement in a global business preferred
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
