Sr Director of Operations, Real World Late Phase ** Open to several locations **

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

Providing overall leadership and strategic direction to Project teams. Subject matter expert for operations strategies

• Serve as SME, translates and executes strategies as defined by clients and leadership. Works with leadership to develop strategy for area of responsibility.  Develops operations strategies from deep understanding of broad client strategic needs representing RWLP within large accounts 
• Ensuring cost-effective integrated solutions are presented consultatively to our clients to successfully address their peri- and post-approval evidentiary needs
• In partnership with other matrixed roles and functions at Syneos Health, this position is accountable for the growth and support of multiple RWLP-aligned client accounts, to be achieved through ensuring excellence in operational delivery, alongside proactive, consultative development of repeat RWLP and/or cross-divisional business opportunities.
• This client-facing role assumes oversight in RWLP for all aspects of the client relationship, including proposal development through delivery of awarded projects until completion.
• The Director of Operations RWLP maintains a strategic focus towards their assigned accounts regardless of the immediate scope of services and works across service lines to provide optimal solution(s) and delivery of portfolio to their clients.

• Accountable for ensuring delivery of one or more books of work from RWLP-managed account (s) according to the contracted scope, timeline, and budget, in accordance with Company's SOPs, GPP. GCP, and ICH guidelines and all applicable regulations.
• Works with assigned clients to identify their RWE needs and ensure that these are understood and acted upon directly through the RWLP BU or through collaboration with other BUs, including identifying the necessary SME to provide optimal consultation and/or support for operational delivery.
• Leads discussion with clients, to articulate and position RWLP business unit operational processes, peri- and post-approval research standards.
• Maintains senior management-level relationships with clients via routine meetings (e.g., 1:1’s with counterparts), governance meetings and other forums to create an environment of trust and continuous dialogue about potential risks and/or limitations associated with conducting real world research and offering workable solutions.
• Independently provide strategic leadership and oversight for the development of a variety of formal communications with clients, including, but not limited to general capabilities presentations, BDM presentations, key client meetings. Participates in governance meetings with clients (Steering Committees). Ensures relevant strategic input and fit for purpose operational approach, inclusive of appropriate project budget for scoped services
• Accountable for RFP and RFIs for assigned accounts, including vendor selection, strategy, services, and leading the functioning leads to providing a fit for purpose model. Includes building the budget and overall proposal framework and lead slide deck development
• With an objective, global view works in a matrix to align and motivate RWLP teams working on a variety of research studies/programs under their accounts towards excellence in delivery.
• Shares lessons learned and best practices across programs, building relationships with key stakeholder’s cross-functionally, across all levels
• Provide technical and operational leadership for the client RW portfolio inclusive of:
  • Ensuring achievement of operational and financial targets through active participation in the Risk Review Process and routine review of metrics and KPIs via the available suite of dashboards and reports.
  • Participates in strategic resourcing/stakeholder and prioritization of projects across the portfolio.
  • Ensures quality standards are set and maintained over all areas of responsibility. Ensures adherence to CAPA and QI timelines and outcomes for assigned book of work.
• Identify and oversee the delivery of RWLP vendor/partner services, including the development and integration of service offerings that best meet operational needs. May interact with senior management of sponsor companies, vendors, and other groups to address operational risks and issues.
• Effective financial management of the total RWLP book of work within the assigned accounts.
• Participates in Business Unit and department level financial reviews
• Provides oversight to project management teams in driving management of financial aspects of assigned projects to ensure adherence to the whole financial process flow—i.e., executed contracts, CNFs, change orders, forecasting, invoicing, etc.
• Serve as an escalation point within the RWLP BU, the larger Syneos Health organization and clients for the assigned accounts.
• Rapidly identifies key issues in complex situations. Includes and leads appropriate participation in informal problem-solving teams when appropriate and brings alternatives integrated possible solutions for business
•  Acts as a liaison and facilitator between other functional areas for overall operational issues.
• Enables a culture of proactive risk identification and mitigation, rapid issue resolution, a sense of urgency, customer satisfaction and stakeholder collaboration
• Provides senior level steer and direction to teams in regularly and comprehensively assessing and mitigating risks within the projects or portfolio.
• Contribute account-level insights to surface and mitigate operational risks and areas for process improvement within the RWLP BU.
• May have direct reports
• May travel up to 25% of time.

QUALIFICATION REQUIREMENTS

• Bachelor’s degree in life sciences or equivalent (e.g., BSc, BS)
• Advanced / Professional degree in life sciences or business management preferred (e.g., MSc, MPH, PhD, MD, MBA)
• At least six (6) years - Eight (8) years managing studies. At least six (6) - eight (8) years RWLP experience
• Previous Real World Late Phase CRO/pharma experience in peri- and post-approval research, with increasing levels of positional responsibility and portfolio/client/account complexity
• Proven ability to work independently across multiple accounts, navigates complex Stakeholder structures (internal and external) , proactive problem solving for portfolio delivery and financial impact mitigation plans. 
• Virtual/decentralized study experience preferred
• Prior cross-functional project management experience within the CRO/Pharma industry is require
• A track record for successful management and delivery of client portfolios
• Direct experience with account / client (vendor) management, including RFP/proposal development, Bid Defenses, Capabilities presentations
• Strong knowledge of the end-to-end life product cycle development process and how real-world research fits into it
• Solid business and financial acumen, including experience with contractual negotiations.
• Demonstrated ability to drive strategic operations decisions where multiple stakeholders involved
• Global and diversity-oriented people management experience including line management and matrix management.
• Flexibility, with the ability to handle multiple tasks to meet deadlines delivering high quality work in a dynamic, rapidly changing environment.
• Strong interpersonal and communications skills as well as a proven team-oriented approach.
• Strong working knowledge of real world operational and regulatory requirements
• Proficiency in virtual communications and Microsoft Office Suite (Word, Excel, and PowerPoint)
• Excellent written and spoken English
• 6-8 years of experience managing RWLP studies required.

Disclaimer:

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.

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.

http://www.syneoshealth.com

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.