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Sr Director AML Early Dev in Bernards, NJ at DSI

Date Posted: 3/28/2019

Job Snapshot

Job Description

Job Summary:
The Senior Director of Clinical Operations will have extensive experience in managing global oncology Phase 1 - Phase 3 studies as well as the ability to support an outsourcing model of Phase 1 – Phase 3 studies conducted by our vendor partners. This individual will have Strong functional management skills to support ongoing development of staff as well as manage clinical operations staff to ensure the effective and efficient execution of operational aspects of clinical study planning, implementation, data delivery and reporting.

This role 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. The Sr. Director will provide business management, coaching and clinical research expertise to the regional project teams within a matrix environment to deliver high quality projects and exceed project metrics. Will represent Clinical Operations on vendor governance bodies and ensure ongoing collaboration and communication with internal stakeholders. 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.

Sr. Director will have proven ability to manage a diverse portfolio across numerous oncology indications. 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. -Ability to ensure effective site feasibility, enrollment target setting, study data currency and quality assurance are in place

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:
Education:
  • A Masters degree in the Sciences is acceptable.
  • Candidates with a Bachelors degree in the sciences with substantial experience may be considered for this position.
Experience:
  • 12 years relevant experience is required with a BS, 10 years 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.