Director, Clinical Development Operations
Syneos Health
Director, Clinical Development Operations
Syneos Health
Global provider of integrated clinical-to-commercial services
Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.
Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need.
Discover what your 25,000 future colleagues already know:
Why Syneos Health
• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.
Job Responsibilities
Lead Technical Strategy for FSP Enablement Team, provides 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. Drive ‘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.
• 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, responsibilities including professional development, performance appraisals, and employee counseling for junior and management staff. Manages staff by establishing goals that will increase knowledge and skill levels, and by delegating tasks commensurate with skill level. Manage senior level professional staff.
• Supports the development of the regional staff plan, identifying needs to hire new staff in a timely fashion and oversee 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 any area concerning project management to support new or existing project management processes. Supports enterprise-wide project management systems and tools. Evaluates project progress, while producing and distributing resource status reports as well as functional area plans, to appropriate members of senior management.
• 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.
• Within the department, manages courses of action on all management / human resources’ matters, including salary administration; employment hires, transfers, terminations; performance appraisals and professional development; job description preparation, and employee counseling. Works with and advises staff on administrative policies and procedures, technical problems, priorities, and methods.
• Interview candidates for positions in department. Supports the Department at professional meetings or seminars. Establishes and maintains training materials for established roles. Provide input and requirements for long range IT/enterprise plans.
• Performs other work-related duties as assigned. Some travel may be required (up to 25%).
• 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.
Get to know Syneos Health
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.
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.
Global provider of integrated clinical-to-commercial services
Syneos Health provides end-to-end biopharmaceutical solutions across the clinical-to-commercial spectrum. It helps biopharma companies, healthcare organizations, and investors by offering specialized expertise, insights, and technology-enabled services to move therapies faster to patients. Its offerings include Kinetic, a modern omnichannel customer engagement platform that uses targeting and analytics to coordinate nationwide healthcare communications, and Syneos One, an asset development approach that aligns strategy and execution from early concept through commercialization. The company uses AI and advanced tech to improve performance and reduce risk in drug development and market delivery. Its goal is to be a trusted partner that accelerates therapy development and delivery by combining scientific know-how with integrated, data-driven services.
Explore more opportunities at Syneos Health