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 May contribute to the development of clinical operational strategy for the ...

Job Description

 

• 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
• 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
• Degree/Certification/Licensure
• BS/BA Degree required
• Advanced degree is preferred
• Experience – Responsibility and minimum number of years
• Candidate 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
• Competencies – knowledge, skills, abilities, other
• Program Management
• 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
• Operational Leadership/Decision making
• 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
• Stakeholder Management
• Addresses the concerns and needs of stakeholders while managing stakeholders’ expectations
• Uses judgement and seeks input (where appropriate) before making a decision
• Demonstrates company Core Behaviors and remains professional at all times
• 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
• Communication
• 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
• Development of team members
• 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
• Software that must be used independently and without assistance (e.g., Microsoft Suite)
• ECLIPSE, CARA, eTMF, FastTrack (or other portal), PRISM
• Enterprise Applications: SharePoint, SAP, Microsoft Suite