Sr Dir, Clin Operations

Description

Senior Director, Clinical Operations

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

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 accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know:
WORK HERE MATTERS EVERYWHERE

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 our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we’re able to create a place where everyone feels like they belong.

Job responsibilities

• Strategic leadership of Clinical Operations staff, responsibilities including administrative oversight, professional development, performance appraisals, and mentoring/counseling of staff, including the management and development of Clinical Operations Directors. Manages staff by establishing goals that will increase knowledge and skill levels, and by delegating tasks commensurate with skill level.
• Provide oversight of resourcing of all staff in reporting line.
• Provide expert operational oversight and guidance to support prioritization of activities, review and monitor the work performed, metrics compliance, and development of contingency plans, among others. Analyze performance and quality metrics to assure BU achievement of productivity and compliance metrics. Address improvement initiatives as identified.
• Oversees the assessment of overall Clinical Operations staff growth, ensures staff involved in the selection and hiring process are competent.
• Leads these activities for more senior level staff within reporting line. Proactively works to ensure staff retention and turnover rates remain within expected levels.
• Manage and control the financial performance regionally and/or globally within the assigned Business Unit, ensuring that departmental targets are met for utilization, gross profit, revenue realization and cost control (including contractor use and staff overheads).
• Ensures quality and adherence to Standard Operating Procedures/Work Instructions (SOP/WI) and compliance with federal and local guidelines and ICH/GCP. Ensures individual and team tasks are completed according to country specific and government regulations. Ensures all staff follow required training and completes the required documentation.
• Functions as point of escalation for clinical operations issues. Oversees progress of teams supporting clinical projects. Ensures individual and team tasks are completed according to requirements per Sponsor/Customer expectations and contract. Takes a lead role in the management of customer relationships in clinical operations.
• Leads work streams to support the development and implementation of new initiatives and strategic direction of the BU, cross-BU Clinical Operations and cross-functionally.
• Provide support to Business Development to facilitate new project awards during the Bid Defense process, providing expert Clinical Operations guidance where required. Will participate in marketing activities, customer presentations and proposal development.

Qualifications

What we’re looking for

• Bachelor’s degree in life sciences, nursing degree, or equivalent related experience, plus extensive clinical research experience in a contract research organization, pharmaceutical or Biotechnology Company, including significant time in a leadership capacity.
• 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.
• Expert knowledge of and experience with GCP/ICH guidelines and other applicable global regulations.
• 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. Knowledge of department budget development and management.
• Demonstrated ability to self-direct tasks and set direction and priorities for others to achieve departmental goals
• Strong time management, technical, and organizational skills
• Must demonstrate proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), email, and voicemail. Ability to gain working knowledge in other applicable business tools and systems
• Requires attention to detail, accuracy, and organizational, interpersonal, and team-oriented skills. This includes excellent communication and presentation skills, both written and spoken. An ability to inform, influence, convince, and persuade. Demonstrated leadership abilities.
• Ability to travel as necessary (approximately 20%)

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.

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.