When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

As Executive Director, Patient Safety you will oversee the management and leadership of Parexel's Patient Safety pillar, team or functions within Patient Safety organization. In this case, the Patient Safety Project Leadership Organization. The Executive Director will work with senior management, customers, business development, and project teams providing oversight of processes and functions related to the delivery of a program or portfolio of Patient Safety Services. You will lead operational level planning with significant business oversight, drive ‘positive change’ throughout Parexel through continuous process improvement programs, as well as make significant contributions to the leadership of the Business Unit (BU) and the development of the strategy and direction of the BU. The Executive Director will lead the operational contribution to proposal development and business development activities at a project level.

Key Accountabilities:

Leadership

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.

Team Management

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.

Metrics Management

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.

Client Management & New Business Generation

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.

Technical

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

Quality and Compliance

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

Skills:

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
Experience in data analysis, evaluation of safety data and the preparation of safety reports preferred
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
Experience with Pharmacovigilance related computing systems
Clinical Research or Pharmacovigilance knowledge /qualifications
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

Knowledge and Experience:

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

Education:

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. Minimum of thirteen (13) years of related experience, including seven to ten (7-10) years of progressive management experience, including direct project management or program oversight.

Executive Director, Project Management - Patient Safety

Job Description