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.
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.