The Director, Clinical Operations will lead the execution of global and/or local oncology/breast cancer Phase 1-3 clinical studies, programs or franchises in adherence to Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), 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 and internal stakeholders to ensure studies are conducted according to the timeline, budget and quality measures set forth by the Study team.
The Director will take responsibility for the clinical operational strategy and overall delivery of the clinical study (i.e. Delivery Lead role) and will represent Clinical Operations on the study team. This role will ensure timely study start-up, execution and study management as well as support of database locks consistent with study/program timelines across the studies under their responsibility.
This position may require line management responsibility of Clinical Study Managers, who are primarily responsibility for the tactical execution of the study. This role will need strong functional management skills to support ongoing development of staff as well as the ability to define appropriate resource model to support new and ongoing studies. In the absence of Clinical Study Manager, the Director will be expected to take both strategic and tactical roles in order to deliver the study. At this level, the incumbent may be expected to lead a program of studies, including those involving co-development (Alliance) partners.
Responsibilities: Operational Strategy
Align with the Head of Clinical Development Operations or Senior Director, Clinical Operations on plans for successful implementation of studies. Responsible for management of compounds at the program and franchise levels. May represents Clinical Operations on the Strategy and Portfolio or Clinical Sub Teams in their therapeutic area.
Ensure operational aspects are incorporated into CDP planning and individual protocols to facilitate successful implementation of programs.
Ensure high quality delivery of all studies for which they are responsible. This includes individual studies as well as programs or franchises.
When sitting on a study team, lead the study team to develop a cross-functional, integrated study plan and create initial study budget. Review study feasibility assessments provided by the CRO(s), lead the CRO selection process and provide input into ARO selection.
Validate the study implementation plan provided by the CRO through to study close out and CSR writing. Ensure the timing of the major study milestones and the associated budget meet the needs of the overall development plan agreed to by the Global Project Team (GPT).
Lead site selection and site qualification discussions, kick-off meetings and study team meetings.
Oversee the CRO and provide timely input to ensure that the study is executed according to the agreed project plan. Complete a study risk assessment and ensure mitigation and contingency measures are prepared and implemented. Actively assess potential risks to the study and propose mitigation plans.
CRO and Quality Oversight
Responsible for oversight of all CROs utilized within their therapeutic area. May represent Clinical Operations on the DS/CRO Joint Operating Committee. Work with Process Excellence and Risk Management to ensure oversight plans are in place for all studies falling under their responsibility.
Design, update and implement appropriate innovative and best-in-class procedures and SOP's related to clinical study oversight and execution.
Work with TMF Operations to ensure a state of inspection readiness for all TMFs and ensure quality expectations are met. When sitting on a study team, responsible for management of CRO(s) performance to ensure adherence to scope of work within timelines and budget at an overall study level. Specifically, track major study milestones and monitor overall operational performance metrics through the life of the study. Identify issues early and propose solutions. Whenever possible, resolve issues that have been escalated or if warranted, take issues to the appropriate governance committee. Create the budget at study start up, and monitor the overall agreed budget against trial progress. Work closely with internal and external stakeholders to ensure team awareness of the CRO scope of work (to minimize unwarranted change orders) and budget, so both can be managed appropriately.
Provide oversight of the CRO to ensure compliance with Daiichi Sankyo's quality measures. Leads the creation of the Risk Identification and Management Log (RIM Log) and other risk related plans and ensure study team adherence and utilization. Be aware of and be able to predict deviations or potential noncompliance concerns (at a protocol level, site level, study level) and rapidly resolve or escalate to appropriate Governance Committee. Analyze CRO performance trends within a clinical study or across several studies and resolve or escalate accordingly.
People and Resource Management
Responsible for resource management within their therapeutic area. Management requires review of resources against development pipeline to identify areas of resource gaps or excess. Management includes appropriate use of DS employees and contractors to ensure adequate staffing at all times.
This position may require the supervision of functional and/or direct reports. In addition to providing instruction, direction of daily activities in support of goals, the supervisor will conduct a performance evaluation against development goals and career path requirements for their direct reports. The supervisor should coach and guide their functional and/or direct reports in support of their development needs, and facilitate conflict resolution on their behalf.
Education: - A Bachelors degree in the Sciences is acceptable. Experience: - 10 years relevant experience is required with a BS, 8 years with a MS/MPH, or 5 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.
Job Title Dir Clinical Operations
City Basking Ridge
Functional Area Clinical Development Operations
State New Jersey Associated topics: antibody, aseptic, aseptic technique, biopharmaceutical, medical, medicine, microbiological, nephrology, nutritionist, pharmacology
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.