Key Accountabilities:

Business/ Operational Leadership

• Drive business and projects growth; increasing revenues and profits.

• Help to implement a lean management approach and process improvements, in line with corporate, quality, client and team feedback, and quality audits.

• Strong customer focus.

• Contribute to projects, committees and task force groups as needed.

• Ensure direct reports meet departmental and project productivity and quality metrics.

• Review TIME entries and TIME reports and provide accurate input into monthly reports.

• Provide team consultation, facilitate appropriate metrics collection and develop action plans.

• Promote new business by participating in internal PAREXEL meetings and work streams, project/program bids and client presentations as appropriate.

Team Leadership

• Recruit, retain and develop a team of skilled, experienced and motivated staff.

• Ensure direct reports meet and aim to exceed their personal goals and objectives by developing appropriate orientation/induction, performance review and development plans for all direct reports.

• Support and improve levels of productivity/billability through effective task-allocation, staff assignment and defining roles & responsibilities.

• Enable- a high-performance culture through a positive, results-oriented work environment, building partnerships and modeling teamwork, communicating to the staff in an open, balanced and respectful manner.

• Complete the formal performance and salary review processes to corporate standards.

Trade Compliance

• Evaluate requirements, proposals, project objectives, products and countries involved and support and/or develop import/export strategies for projects/clients that meet local and international trade regulations.

• Ensure that ongoing/revised project documentation and correspondence is accurate, complete and meets customs regulations of applicable countries.

• Create, review and update customs and regulatory policy, documentation and processes, including monitoring compliance with SOPs.

Risk management

• Verify the project contracts and ensure tasks and strategies meet contractual obligations with minimum risk to clients and the company, following escalation process as required.

• Participate in review of contracts to define trade compliance language.

Knowledge and Experience:

Knowledge:

• In-depth knowledge of clinical trial supply, drug development, ancillary and/or clinical laboratory market.

• Good understanding of cGXP and how it impacts import and export processes.

• Financial knowledge and profitability mind-set (e.g. KPI measurement, Budgeting & Forecasting).

• System knowledge in supply chain enterprise solutions.

• Good understanding of customs, the regulatory drug development and logistics framework and ability to apply technical knowledge to complex global business transactions.

Experience:

Expert experience with regulatory framework in all regions of the globe, and the ability to understand and work within a multitude of government regulatory schemes and agencies.
Profound experience in working with global virtual teams and collaborative environment, developing, coaching staff and managing performance review.
Extensive experience in risk assessment and process improvement methods to drive continuous improvement, including participating in regulatory and/or client audits.
Extensive experience with development of project plans/strategy, actionable deliverables and change management.
Relevant direct pharmaceutical industry experience in trade compliance management and Clinical Trial Supply.
Leadership experience in a high growth global service environment.
Building and retaining client relationships in the biopharmaceutical industry.

Education:

Educated to B.A./B.S. degree (logistics, pharmacy, biological science or other health related discipline or M.B.A. preferred) or equivalent.