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Clinical Operations Lead

Job Post Index 2134BE-Sy##
Location Lawrence Township, NJ
Description: Description
  • Provide operational oversight and leadership for the execution of an operational portfolio (Late Phase, Medical Affairs Sponsored Programs) of work
  • Clinical operational leader who drives the successful execution of all operational components of a large-scale global program using solid project management, leadership, communication and organizational skills.
  • Accountable for operational execution to support a diverse portfolio of work across programs.
  • Addresses and manages risks and issue escalation.
  • May contribute to the development of clinical operational strategy for the portfolio.
  • When appropriate, develops or supports operational plan(s) with specific stakeholder’s objectives.
  • Accountable for collaboration and standards of indications in line with registrational and earlier-phase development teams.
  • May represent GCO Strategy organization as a core member within applicable matrix teams.
  • Serves as GCO operational point of contact for the programs and respective clinical trials.
  • Drives the development and/or implementation of operational program level documents.
  • Inclusive in communicating strategy and decision making across a matrix team.
  • Demonstrates financial stewardship of their clinical programs while effectively leading a large global team of individuals assigned to the clinical studies.
  • Proactive gap analysis to identify areas for training, improvement or reduce efficiencies in the operating model.
  • Provides connectivity and knowledge sharing with clinical teams.
  • Manages a disciplined approach that supports accurate, compliant documentation of the team’s work.
  • Leads cross-functional teams to ensure successful and efficient execution of studies from start up to completion.
  • Advises resource for a broad range of organizational-related issues requiring clinical knowledge and operational knowledge.
  • Works with GCO functional management and across R&D to secure necessary resources to support the program needs.
  • Provides input (as needed) to Health Authority or other regulatory submissions
  • Demonstrates an appropriate ‘sense of urgency’ to provide operational decisions in a timely manner.
  • Uses judgment to make sound decisions based on a balanced evaluation of available information within a complex environment of competing project priorities.
  • Acts decisively to address team challenges.
  • Contributes to issue identification and strategy discussions at senior level meetings.
  • Addresses the concerns and needs of stakeholders while managing stakeholders’ expectations.
  • Uses judgement and seeks input (where appropriate) before making a decision.
  • Facilitates issue resolution and communication/collaboration with stakeholders and other functional area team members.
  • Builds alliances to gain key stakeholder support, buy-in and ownership.
  • Builds and nurtures partnerships that foster an environment built upon trust.
  • Provides vision to build partnerships across functional area leadership.
  • Demonstrates positive attitude about the team’s ability to deal with challenges.
  • Drives issues to resolution; communicates to insure that issues have been worked through to completion.
  • Applies change management principles to support communication and implementation of integrated change.
  • Demonstrates diplomacy when interfacing with other functional areas, CROs and other outside vendors.
  • Communicates program status to different levels of stakeholders.
  • Provides accurate, motivating and constructive feedback and coaching to team members.
  • Authentic and genuine communicator during difficult conversations.
  • Invests time in getting to know others to understand their attitudes and views; learns others’ style to interact effectively.
  • Accommodates cultural differences.
  • Partners with functional management to set objectives for each team member to support their career development.
Skills: Qualifications
  • BS/BA Degree required; Advanced degree is preferred.
  • Must have at least 8 yrs. of experience in clinical drug development.
  • Oncology experience preferred but not required.
  • Leadership competencies and influencing skills with cross-functional leaders in a matrixed environment.
  • Effective oral and written communication skills to influence decisions; inform and guide a large global operational team.
  • Broad clinical operational experience (registration and/or post-approval) and solid project management skills.
  • Ability to foster relationships across multidisciplinary teams.
  • Software that must be used independently and without assistance (e.g., Microsoft Suite)
  • Used Systems: ECLIPSE, CARA, eTMF, FastTrack (or other portal), PRISM
  • Enterprise Applications: SharePoint, SAP, Microsoft Suite
  • Passion
  • Innovation
  • Speed
  • Accountability

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