Immunomedics, Inc.

  • Director, Clinical Programs

    Job Locations US-NJ-Morris Plains
    Posted Date 1 month ago(2/20/2019 1:56 PM)
    Job ID
    2018-1382
    # of Openings
    2
    Category
    Clinical
  • Overview

    The candidate for this role is an experienced leader capable of working independently while taking responsibility for the clinical operational strategy and overall delivery of clinical trial(s) delivery.  The Clinical Operations - Director of Clinical Programs is responsible for clinical operations planning, oversight and execution of the most complex global studies within one or more clinical development programs. As a clinical operations expert this role includes three primary accountabilities.  First, development and coordination of operational approaches and delivery.  Second, cross-functional team leadership for critical global studies.  And third, oversight of and interactions with CROs and other external vendors to ensure studies are conducted according to timelines, budget and quality plans. 

    Responsibilities

    • Develop, lead and manage clinical operations activities for one or more global clinical programs. 
    • Lead cross-functional teams in the delivery of clinical studies to plan, quality and cost. Provide expertise and consultation to project teams to facilitate problem resolution, successful outcomes and quality results.
    • Ensure site selection, patient recruitment, monitoring and study closeout are optimized for delivery and compliance. Develop program level country selection and site identification strategies. Ensure robust approaches are in place for all studies across one or more clinical programs that support enrollment of the right patient population and accurate end point data.
    • Manage and mentor clinical operations staff and cross-functional team members.
    • Oversee the CRO and provide timely input to ensure that the study is executed according to the agreed project plan. Specifically, track major study milestones and monitor overall operational performance metrics through the life of the study. Analyze CRO performance trends within a clinical study or across several studies and resolve or escalate accordingly.
    • Complete a study risk assessment and ensure mitigation and contingency measures are prepared and implemented. Monitor study level risk management activities and ensure risk mitigation plans are in line with program needs.
    • 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.
    • Effectively partner with cross functional program level leads to ensure operational plans for clinical studies are in line with program level goals.
    • Provide strategic input in to clinical development plans and develop operational strategies to meet program needs across multiple studies.
    • Ensure appropriate timeline tracking systems and CTMS are in place to support program execution.
    • Partner with biostatistics, medical and other functions in regular data reviews, identify and implement corrective actions or improvements.
    • May be expected to lead a program of studies involving co-development (Alliance) partners.
    • Collaborate with Clinical Digital Solutions team to ensure a state of inspection readiness for all TMFs and ensure quality expectations are met.
    • Drive creation of the budget at study start up and monitor the overall agreed budget against trial progress. Budget forecasting for studies also expected.
    • Lead and mentor direct reports and cross functional team members. Drive engagement, development, retention and resourcing. Ensure direct reports meet departmental and project productivity and quality metrics
    • Contribute to the identification, design and implementation of process improvements, in conjunction with management team(s).
    • Partner with Medical Affairs to develop program wide approaches to recruitment, advocacy, Key Opinion Leaders, Steering Committees, etc.
    • Interface and communicate with stakeholders across functions (program management, regulatory, legal, finance, commercial, etc.).
    • Maintain a positive, results orientated work environment, building partnerships and modeling teamwork as well as communicating in an open and objective manner.
    • In the absence of Clinical Study Manager, the Director will be expected to take both strategic and tactical roles to deliver the study.

     

    Qualifications

    • At least 15 years of clinical operations experience with a Biotechnology/Pharmaceutical company leading Phase I - IV multinational clinical studies. Extensive Phase 3 experience is desired.  Experience with a CRO may also be considered as part of the clinical operations experience.  Five plus years of oncology and autoimmune experience is desired.
    • Clinical development plan and protocol development experience as well as program and study level operational strategy experience are important.
    • Demonstrated experience in the successful strategic planning and execution of all clinical study activities using in-house resources and external resources.
    • Solid understanding of US and Global regulations and guidelines applicable to clinical development.
    • Strong ability to manage and motivate team across a global virtual team in a demanding and fast-paced environment.
    • Ten plus years of cross-functional team project management experience.  PMP certification desirable.
    • Extensive experience for financial oversight of a global clinical development program is desirable.
    • Extensive experience, 10 plus years, with CRO management, contracting, oversight and managing study execution through CROs, possibly including prior work experience with a CRO.
    • Proven excellence in operational strategy and demonstrated ability to execute operationally
    • Advanced ability to work in a matrix environment and develop constructive partnerships with internal and external stakeholders.
    • Three plus years of direct line leadership of clinical operations staff; 5 plus years desired
    • Demonstrated ability to deal with time demands, incomplete information or unexpected events.
    • High degree of motivation; results oriented.
    • Excellent negotiation skills, analytical and problem-solving skills

    Strong ability to manage multiple and varied tasks and prioritize workload 

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