[Hiring] Director, Clinical Development Operations @Syneos Health

Role Description

Lead Technical Strategy for FSP Enablement Team, providing direction and management associated with the Company’s business operations, ensuring the Company’s Trusted Process™ methodology, project management standards, and Standard Operating Procedures (SOPs) are optimized and implemented consistently. Works to ensure internal and Customer quality standards, Good Clinical Practice (GCP), International Conference on Harmonization (ICH) guidelines are fulfilled. Provides strategic and operational level planning. Drives ‘positive change’ throughout the company through effective participation in continuous process improvement program. Manages and provides leadership to Syneos Health, including the supervision of more senior level management positions in the assigned Business Unit and region.

Job Responsibilities

• Participates in both short and long-term planning for all aspects of the Department’s operations and growth.
• Contributes operational input to other departments as appropriate, including developing and distributing appropriate reports to executive management.
• Leads the forecasting, planning and logistics for clinical operations activities, ensuring performance and quality standards are met.
• Reviews performance of the Company’s activities and makes recommendations for improvement in quality/efficiency.
• Leads or oversees assigned business and assigned strategic improvement initiatives to achieve the desired outcomes.
• Line management of Syneos Health staff, including professional development, performance appraisals, and employee counseling for junior and management staff.
• Supports the development of the regional staff plan, identifying needs to hire new staff in a timely fashion.
• Oversees the talent acquisition process in the assigned country.
• Proactively works to ensure staff retention and turnover rates remain within expected levels.
• Liaison and facilitator between the Company’s operation’s departments and clinical business units supporting consistent implementation of project management standards, process optimization and quality delivery.
• Contributes to efforts and refines project management processes within the Company, using established process modeling techniques.
• Leads teams of subject matter experts to develop and review SOPs and WIs related to project management.
• Supports enterprise-wide project management systems and tools.
• Evaluates project progress, producing and distributing resource status reports as well as functional area plans.
• Develops, collects, and analyzes project metrics.
• Oversees conduct of project reviews with operational staff focusing on budget, schedule and risk analysis.
• Leads global project management systems and processes to increase efficiency.
• Plans for the efficient allocation of resources within operations.
• Manages courses of action on all management / human resources’ matters.
• Works with and advises staff on administrative policies and procedures, technical problems, priorities, and methods.
• Interviews candidates for positions in department.
• Supports the Department at professional meetings or seminars.
• Establishes and maintains training materials for established roles.
• Provides input and requirements for long range IT/enterprise plans.
• Performs other work-related duties as assigned. Some travel may be required (up to 25%).

Qualifications

• BA/BS degree or equivalent combination of education and experience; and management experience preferably in worldwide clinical research pharmaceutical, or biotechnology company.
• Management skills and experience, including but not limited to short and long-term planning, evaluation, directing and motivating staff, marketing and financial management.
• Desired technology experience with PowerApps, PowerBI, Sharepoint, Oracle, Agents building Co-pilot, financial review, Dashboards, and Enterprise level technology exposure, etc.
• Highly required Clinical Research background.
• Thorough knowledge of ICH GCP and general regulatory authority requirements, drug development, and clinical project management procedures is necessary.
• Must have a record of engaging diverse interests for the common good; adept at marketing and able to communicate and work with a diverse group of individuals to accomplish common goals.
• Membership and/or affiliations with applicable professional organizations related to the Company’s business are highly preferred.
• Demonstrated strong leadership, tactical and strategic thinking skills.
• Ability to anticipate and address critical issues; and develop contingency plans in a proactive manner.
• Knowledge of financial concepts as related to forecasting, budgeting, and proposal generation.
• Demonstrated ability to self-direct tasks and set direction and priorities for others to achieve departmental goals.
• Advanced proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), is required.
• Experience working in a matrix team environment is preferred.

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.