Immunomedics, Inc.

  • Head of Clinical Data Sciences

    Job Locations US-NJ-Morris Plains
    Posted Date 3 weeks ago(4/3/2019 12:30 PM)
    Job ID
    2019-1412
    # of Openings
    1
    Category
    Clinical
  • Overview

    Provides overall guidance to all clinical trials data collection, analysis and reporting within the organization, overseeing the Biostatistics, Data Management and Statistical Programming functions. Participates in portfolio and protocol development meetings to provide input into the development strategies and ensure that the necessary resources and processes are in place to achieve the goals of these strategies. Develops resourcing and budgetary plans to meet the demands of clinical trials within their functional areas. Ensure compliance of all data processing activities with federal regulations and industry guidelines. Advocates data quality and builds processes to insure data quality in all Clinical Data Sciences deliverables. Works collaboratively with peers and ensures collaboration within the Clinical Data Sciences organization, encourages team work and compliance with corporate policies and guidelines.

     

    Drive cross-functional team execution and perform as a subject matter expert, based on demonstrated clinical data sciences expertise, extensive leadership, and operational experience. Provide operational and strategic leadership within the clinical data sciences organization and be responsible for consistent and successful execution of all aspects of the clinical data sciences function.   Serve as a role model for leadership with both internal and external stakeholders.

    Responsibilities

    • Directs all data acquisition and analysis activities (Data Management, Biostatistics, Statistical Programming and Clinical Database Systems), as well as the related processes, training and SOP maintenance.
    • Ensures the timeliness and quality of Clinical Data Sciences deliverables throughout the clinical trial data life-cycle,and follows and effective process for estimating resources needs relative to expected deliverable to assure proper staffing within the functional areas of Biostatistics, Data Management and Statistical Programming.
    • Identifies and creates best practices to ensure the proper methods are used for data collection, analysis and reporting for all clinical trials, and that these methods are compliant with regulatory requirements/guidelines, and are in line with best industry practices, standards, and guidelines.
    • Provide guidance for the implementation of data capture, analysis, and reporting standardization to ensure consistency in the application of the methods used.
    • Provide timely technical expertise to clinical development projects across the entire Clinical portfolio.
    • Applies broad knowledge and perspective to anticipating impact of plans and changes to plans, acting quickly in identifying obstacles and implementing corrective action to assure achievement of business objectives.
    • Identifies, establishes business case for and deploys innovative technology that improves processes, reduces data processing time, increases accuracy and strengthens decision making capabilities.
    • Key contributor in the development of study protocols.
    • Reviews and provides input on critical documents submitted to regulatory agencies or any publication of clinical trials data.
    • Ensures appropriate staffing, training, adherence to SOPs including effective validation practices in a complex organizational structure that encompasses functional departments and cross-functional teams.
    • Ensures all systems are validated, SOPs are developed as needed, and all processes are in compliance with SOPs and capable of withstanding regulatory scrutiny.
    • Ensures data quality of all deliverables of the clinical data sciences group including statistical analysis plans, clinical study report Tables, Listings and Figures and Clinical Trials Database Applications,
    • Manage budget for Clinical Data Sciences assuring adequate resources and staffing
    • Contribute to the development of submissions to worldwide regulatory agencies (e.g. BLA, MAA).
    • Provides input into preparation of study reports.
    • Guides and collaborates with CRO staff to ensure alignment with established data, capture and analysis quality standards.
    • Establishes and maintains effective working relationships with management in Clinical and other departments and diplomatically resolves issues ensuring a win-win solution to all situations
    • Provide leadership to clinical data sciences team, and across the cross-functional organization, to achieve organizational objectives of an expanding matrix organization and pipeline, fostering team work, demonstrating efficient and clear decision making, embedding principles and values that place patients and quality first, and maintaining an executive presence throughout.
    • Strategically plan, resource and provide oversight/execution to achieve program objectives and high-quality deliverables.
    • As a senior leader, and in collaboration with cross functional colleagues in the Clinical organization, actively participate in the development of organizational goals and strategies design and implement processes within a matrix organization.

    Qualifications

    • MS in Business or Life Sciences, or MSc or PhD statistics, mathematics, informatics, computer science, the physical sciences or related subject.
    • 20 years directly related experience in pharmaceutical industry, or equivalent. Deep subject matter expertise in clinical data acquisition, management and analysis and associated technologies and processes. 
    • Proven ability to lead a clinical data sciences group coupled with experience partnering with vendors/strategic partners while ensuring quality deliverables in a cost-effective manner.
    • 10+ years of direct line leadership of a clinical data sciences team
    • Superior continuous improvement and change management skills, and proven ability to effectively partner with the Clinical Operations leadership team to create a best in class organization.
    • Proved track record of translating senior level clinical research/scientific business requirements into operational strategies.
    • Solid understanding of US and global regulations and guidelines (e.g., FDA, EMA, ICH) applicable to clinical development; prior success in partnering with regulatory peers to support timely and quality regulatory submissions.
    • Previous experience leading key strategic functional initiatives and change management activities
    • Strong strategic planning and decision-making skills
    • Excellent verbal, written, analytical, and presentation communication skills.  Adept at communicating a clear vision among direct reports and cross-functional teams, effectively aligning resources and motivating teams to achieve goals. Must also be able to effectively communicate with colleagues and associates outside the organization to create partnership-style relationships.
    • Demonstrated technical, organizational, project management, and negotiation skills
    • Demonstrated ability to gracefully manage through unexpected events and competing priorities
    • Highly motivated and results oriented
    • Strong knowledge of oncology and autoimmune disease

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