Overview

The Executive Director, Programming Operations position will work with Clinical Data Management and Statistics departments to build, cultivate, manage, and grow CRO services.
In-office is preferred over working from home.

Responsibilities
• Supervises the entire department to ensure that it delivers high quality client services according to project timelines and within budget.
• Sets direction for the department and lead the department toward the goals.
• Assists in the preparation of business proposals and bid defenses.
• Assists in business development activities.
• Provides operational support for Programming Operations.
• Responsible for departmental development and managing departmental growth.
• Ensures that programming work process is in compliance with applicable Regulations, International Standards, and WuXi AppTec Policies and Standard Operating Procedures
• Develops and maintains state-of-the-art programming platform for business.
• Develops innovative programming solutions for the business.
• Identifies technology opportunities and risks for business.
• Monitors technology and social trends that could have impact on the business.
• Participates in management decisions about corporate governance.
• Communicates the company's technology strategy to partners, management, and employees.
• Maintains current information about technology standards and compliance regulations.
• Provides strategic consulting services to pharma/biotech companies on NDA submissions, ISS/ISE programming, SAS validation, programming quality control, and audit readiness.
• Develops standard operating procedures and work instructions.
• Provides mentorship to lower levels of management.
• Other duties as assigned.

Qualifications
• Master's Degree in Scientific, Programming, Information Technology or Business Management field.
• Minimum of 15 years' relevant industry experience (CRO/Pharmaceutical); or equivalent combination of education, training, and experience.

Knowledge / Skills / Abilities:
• Strategic business awareness and analytical skills.
• Excellent oral and written communication skills.
• Adaptability and flexibility to changing priorities.
• Demonstrated ability to work creatively and effectively in a fast-paced environment.
• Ability to maintain demanding timelines.
• Ability to influence others both internally and externally.
• Ability to lead, work independently and be a team player.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.
• Able to read, write and understand English, bilingual in Mandarin preferred.
• Intermediate to advance knowledge of Windows, Unix, Visual Basic, R, SAS, Microsoft Office Suite (Word, Excel, Power Point, Access, Project, and Outlook)
• Thorough understanding of FDA Guidelines, ICH, GCP, NDA, IND and other applicable regulations.
• If working remotely, must have access to high-speed internet and knowledge/ability to resolve IT and computer related challenges through remote communication channels.
• Travel is required 10-25%, primarily domestic/infrequently international, daily/overnight.
• Must have a valid driver's license and the ability to rent a car.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.