Sub-Regional Senior/Executive Director Clinical Operations

Description

Senior Executive Director, Country Clinical Operations ESP/ITA/FRA/NL/BEL

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

• Engages strategically and cross-functionally to step up country delivery and performance with, amongst others, Site Identification, Site Contracts, Site Payments, Site Activation Management, Site Relationships (Catalyst and SNP), Global Clinical Trial Management, Global Central Resourcing Management, Talent Acquisition, and Project Management.
• Oversees country Book of Work to uphold project delivery reliability and efficiency, especially for, but not limited to, the achievement of deliverables on-time and on-quality.
• Drives country clinical delivery to support and complement project financial performance, particularly as it relates to clinical operations’ services.
• Ensures country service consistency, quality, efficacy, and effectiveness by bringing about a balanced and optimal team composition. This is inclusive of managing resources effectively in consideration of workforce planning, capacity, cross-resourcing opportunities, and productivity.
• Acts as point of contact (POC) for country escalations coming from the clinical organization’s stakeholders (e.g., Project and Functional Leaders). Moreover, identifies risks and removes barriers to finding solutions to country delivery and performance challenges (e.g., at the site identification stage, for site activation progress, in setting up enrollment activities).
• Consults with relevant parties to recommend and lead the implementation of inventive solutions in startup and monitoring delivery processes and as well, for study allocation needs and resourcing challenges.
• Works in partnership with the Sites and Patients’ team, Project Delivery Leaders and, if applicable, the Regional General Management team, to identify study and patient population opportunities, strategic site relationship opportunities, and strategic country growth solutions.

LEADERSHIP

• Demonstrates visible leadership of country team and across organizational collaborations.
• Brings about commitment and accountability to country, project, and business performance in decision-making, and communicating to country team and collaborators.
• Oversees and manages country financial performance to ensure departmental targets are met for, but not limited to, utilization, cost control (e.g., resource management), and revenue realization.
• Establishes country team organization, RACI, and communication channels.
• Fosters collaboration within Sites and Patients’ country and region and as well, across project and organization stakeholders (e.g., RWLP, FSP, FSO, therapeutic business units).
• Reinforces Syneos Health’s culture of engagement and enables the implementation of country key drivers of employee engagement.
• Advances country talent optimization especially with regards to identifying and making visible growth pathways and opportunities for team members. This is also inclusive of supporting the management of employees through goal setting enhancing skill levels and knowledge, the delegation of tasks commensurate with skill level, professional development, and performance management.
• Fosters awareness and visibility of Syneos Health culture and heightens industry presence within country.

SUBJECT MATTER EXPERTISE

• Acts as country operations subject matter expert (SME) by demonstrating knowledge of country operational processes, regulatory operations, and industry clinical research environment. May use other in country SMEs for support (e.g., regulatory intelligence SMEs).
• Consults and supports the Proposal/Business Development teams to facilitate new project awards during the Pre-Award and Bid-Defense process and, where required, provides expert clinical operations guidance. May participate in marketing activities, client presentations, and proposal development.
• Serves as sponsor country affiliate POC.
• Establishes Key Opinion Leader (KOL) and Regulatory Authority relationships.
• Engages with applicable industry network (e.g., CRO consortium, regulatory).
• May serve as an office location site head and/or as office administrator for country legal entity.

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 sometime in a leadership capacity or equivalent combination of education, training, and experience are required.
• Extensive knowledge of and experience with GCP/ICH guidelines and other applicable regulations and/or regulatory requirements.
• Demonstrated excellent strategic, leadership, and tactical skills.
• Knowledge of financial concepts related to forecasting, budgeting, proposal generation, and project budgeting.
• Excellent time management, technical and organizational skills and, the ability to work independently and within a team environment.
• Demonstrated ability to self-direct tasks and set direction and priorities for others to achieve departmental goals.
• Capacity to understand, communicate, explain, and put into detailed plans project concepts.
• Demonstrated understanding of the workflow process, roles, and responsibilities of multiple functional areas.
• Ability to anticipate and address critical issues and as well, develop contingency plans in an initiative-taking manner.
• 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 excellent diligence, accuracy, and organizational, interpersonal, change management and collaborative skills. This includes excellent communication and presentation skills, both written and spoken, with an ability to inform, influence, convince, and persuade. As well, requires the ability to hold challenging conversations and to engage across, amongst others, Project Delivery, Segment Lead, Sponsor and Functional Leaders.
• 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.

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