Executive Director, Project Management, Patient Safety

Parexel is a leading company in the pharmaceutical and biotechnology sector, seeking an Executive Director for Project Management in Patient Safety. This role involves overseeing the Patient Safety pillar, leading operational planning, driving process improvements, and contributing to the strategic direction of the business unit.

Responsibilities:

• Leads a business function (Patient Safety Project Leadership) within the Patient Safety organization. Is accountable for setting the business function strategy and delivery against that strategy
• Provides leadership and guidance across initiatives, facilitates discussions, and contributes to strategic planning to enable and support optimal end-to-end delivery of Patient Safety projects under their remit
• Supports the achievement of Patient Safety organization financial targets. Responsible for the strategic planning of Safety Project Leadership to enhance the financial and operational performance of the wider department including plans for expanding departmental revenue, margin, and resources. Develops and implements appropriate cost reduction solutions within span to improve profitability
• Demonstrates a deep understanding of the current business offerings and stays current on all aspects of business intelligence. Continually challenges the status quo and encourages incremental improvements in strategy and efficiency of the Patient Safety organization
• Demonstrates leadership within the Patient Safety organization and wider Company, including maintaining an active external brand and thought leadership status
• Provides senior operational and strategic direction for Safety Project Leadership
• Mentor, support and direct functional team within span to develop robust patient engagement strategies and deliver programs to client specifications
• Identify knowledge gaps and develop and implement plans to build skills for self, team and operational teams across the business
• Holds team and individuals accountable for achieving financial and operational targets and corporate business goals including closure of quality issues
• Oversight of employees including goal setting and measurement, approval of timesheets, and performance reviews
• Facilitates functional team metrics collection and case study creation to support the Patient Safety organization including monthly KPI metrics
• Identifies and proposes strategies, procedures, systems, technology, or efficiencies to improve productivity of own span and Patient Safety team
• Provides support to the Parexel business operations teams in the development of proposals and the bid defense process
• Acts as an elevated point of contact for strategic partnerships and key clients
• Directs, leads and provides guidance to the teams in all aspects of Safety Project Leadership
• Provide expertise in Safety Project Leadership and project management best practices
• Strive to ensure internal and external clients receive the required deliverables within stipulated timelines and budget
• Ensure projects assigned to line reports are completed with quality, according to SOPs, and regulatory guidelines

Requirements:

• Minimum 13+ years of pharmaceutical and/or CRO experience including but not limited to areas of focus in clinical operations, sales and decentralized clinical trials/direct to patient studies
• 7-10 years of management experience, including direct project management or program oversight
• Requires BA/BS degree or equivalent combination of education and experience or equivalent related degree and/or experience, plus significant executive and/or senior management experience, preferably in worldwide clinical research, pharmaceutical, or biotechnology company
• A strong background in Safety Operations execution is desirable
• Excellent leadership and line management skills
• Excellent knowledge of drug safety and the drug development process
• Excellent knowledge of and ability to interpret and apply global safety regulations
• Excellent team / project leadership and delegation skills
• Ability to train and mentor people
• Excellent presentation skills
• Excellent interpersonal skills
• Excellent time management skills
• Client focused approach to work
• Computer proficiency, ability to work with web-based applications and familiarity with the Windows operating system and Microsoft Office apps
• Ability to comprehend various regulatory or client requests and be able to strategize a handling approach
• Flexible attitude with respect to work assignments and new learnings
• Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
• Willingness to work in a matrix environment and to value the importance of teamwork
• Experience in data analysis, evaluation of safety data and the preparation of safety reports preferred
• Experience with Pharmacovigilance related computing systems
• Clinical Research or Pharmacovigilance knowledge /qualifications