Sr Director, Clinical Operations - Oncology

About Daiichi Sankyo Cancer Enterprise

The mission of Daiichi Sankyo Cancer Enterprise is to leverage our world-class, innovative science and push beyond traditional thinking to create meaningful treatments for patients with cancer. We are dedicated to transforming science into value for patients, and this sense of obligation informs everything we do. Anchored by three pillars including our investigational Antibody Drug Conjugate Franchise, Acute Myeloid Leukemia Franchise and Breakthrough Science, we aim to deliver seven distinct new molecular entities over eight years during 2018 to 2025. Our powerful research engines include two laboratories for biologic/immuno-oncology and small molecules in Japan, and Plexxikon Inc., our small molecule structure-guided R&D center in Berkeley, CA.

Job Summary:

The 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:

• 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.
• 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.
• 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/Regulatory requirements & TMF quality standards.
• Work with outsourcing procurement management to optimize the vendor governance structure, incorporate performance metrics, and contribute to outsourcing discussions.
• Provide leadership to Clinical Operations staff and to project teams for Vendor evaluation, selection , management and quality based oversight
• 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
• 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. May be asked to represent the Clinical Operations Department at senior management meetings on behalf of the Vice President.
• Responsible for the management and leadership of all staff within the Clinical Operations group including recruitment, training, mentoring, career development, work assignments, performance evaluations and discipline of staff.

Qualifications
Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education/Experience:

• Qualified candidates must have a Bachelor's degree from an accredited college or university; A Master's degree in the Sciences is acceptable.
• Candidates with a Bachelor's degree in the sciences with substantial experience may be considered for this position.
• 10 years relevant experience is required with a MS/MPH, or 7 years with PharmD/PhD
• Experience considered relevant includes 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.
• Demonstrates advanced knowledge of design and phases of Oncology clinical studies on a global scale, global regulatory issues, CRO operations, and compliance practices
• Effectively oversees, manages, and influences CROs to ensure successful execution of the studies, builds strong relationships to create strong alliances
• Effectively negotiates and influences to solve high impact/scope problems and exposure organizational problems
• Understands, identifies, mitigates, and communicates risks at the operational level
• Effectively leads and influences within the matrix at the senior leader levels within and outside the organization; manages functional or direct reports
• Develops and executes strategies to improve processes and set direction in Study Management and related areas such as compliance, CRO management, risk management, etc.

Ability to travel up to 20%

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.
Job Title
Sr Director, Clinical Operations - Oncology

City
Basking Ridge

Functional Area
Clinical Development Operations

State
New Jersey