Director, Clinical Operations

Description:

The Director is accountable for the operational execution of the Clinical Development Plan (CDP).  As a disease area thought partner, the Director is responsible for the development of the program-level operational strategy and ensuring cross-functional alignment, identifying, and resolving program-level risks that may impact timelines or budgets. The Director is also responsible for leading a team of Associate Directors, Sr. Managers, and Managers within the Global Trial Strategy & Operations (GTSO) Organization.  The position is responsible for staff development, project assignments, workload distribution, resourcing, and prioritization.  The Director directly influences departmental planning and strategy, resource allocation and management, functional communication activities, alignment of goals with organizational and trial objectives.  This position ensures common operational issues/challenges are identified proactively across trials and programs and are addressed through operational risk mitigation, including proposals for alternative solutions.

Summary of Key Responsibilities:

• Responsible for the development of the program-level operational strategy and ensuring alignment across functions, e.g., E2E connectivity across functions, share lessons learned for program-level consistency, and monitor KPIs to track program-level success).
• Accountable for the delivery of the operational strategy in alignment with the Clinical Development Plan, ensuring alignment with the business goals and trial delivery objectives (including resourcing, budget, and change control, partnering with CDST sub-teams, timeline creation).
• Accountable for representing assigned programs at cross-functional and executive governance forums, presenting operational strategy, risks, and trade-offs, and driving timely, data-informed decisions to enable successful program execution. Attend CDST and function as a strategic partner with program management for the execution across all trials in the program. Attend Leadership Team meetings as required/ requested to provide study updates or as a back-up for senior GTSO leaders.
• Lead operational scenario planning and mitigate program level risk that may Impact timelines/ budget, ensure appropriate quality oversight, and appropriately escalate Issues to CDST, Quality and functional leadership.
• Ability to effectively communicate the operational strategy and defend the operational plan and costs associated to CDST, leadership and at governance meetings as appropriate.
• Lead and ensure inspection readiness for the program
• Provide leadership during Health Authority inspections and on the identification of risks and mitigation plans at the program level for key issues.
• Provide operational leadership and support to the Associate Directors
• Build a knowledgeable and skilled team with competencies and capabilities to successfully set up and deliver clinical trials
• Oversee resource allocation
• Promote strong collaboration across cross-functional teams
• Setting objectives in alignment with company, program, and departmental objectives.
• Ensure Staff training on procedures and systems associated with their roles
• Develop a team that consistently achieves strong results through nurturing individual growth, effectively managing performance, and providing guidance

• Effectively discusses and presents study data across the Company and with development partners; collaborates with clinical development and scientists, medical writers, and investigators to write, present and/or publish data.

• Participates in, reviews, and provides direction on CRO and vendor outsourcing strategy, and key performance indicators (KPIs) ensuring vendor/ CRO partners consistently deliver high quality data to support regulatory requirements.
• High Engagement with Peer group to ensure lessons learned and best practice sharing across TAs

Key Skills:

• Must have experience leading/managing externally outsourced, cross-functional teams.
• Experience in and knowledge of the pharmaceutical development process
• Clinical Research operational knowledge and deep experience across multiple phases of studies (1-4). Must have the ability to manage all aspects of execution of a clinical trial
• Excellent decision-making, analytical and strong financial management skills are essential to this position
• Strong project planning/management, communication and presentation skills
• Must possess excellent leadership skills and proven ability to foster team productivity and cohesiveness
• Experience leading without authority and in multifunctional matrixed and global environments
• Operate and execute with limited supervision
• Willingness and proven ability to work flexibly, stepping outside of immediate role responsibilities and wearing multiple hats where needed. 
• Confident and has the professional competence to win respect and gain credibility at all levels within and outside the Company, and capable of successfully representing the Company externally.
• Strategic Thinking: General knowledge of all major aspects of drug discovery and development along with effective departmental leadership to be an effective problem solver for complex problems.   

Qualifications:

• BSc/ BA degree required - Advanced degree preferred.
• Proven previous experience gained with a CRO and/or biopharmaceutical company
• Demonstratable prior line management experience or in lieu extensive experience in a matrixed leadership environment required 
• Ability to travel 10-15%.