Sr Director of Operations, Real World Late Phase ** Open to several locations ** jobs in United States
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Syneos Health · 1 month ago

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. The Sr Director of Operations, Real World Late Phase will provide overall leadership and strategic direction to project teams, ensuring the delivery of integrated solutions to clients while maintaining operational excellence and fostering client relationships.

BiotechnologyHealth CarePharmaceuticalTherapeutics
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H1B Sponsor Likelynote

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

Real World Late Phase experienceClient management experienceLife sciences degreeProject management experienceFinancial acumenVirtual study experienceRegulatory knowledgeInterpersonal skillsCommunication skillsTeam-oriented approachFlexibilityProblem-solving skills

Required

Bachelor's degree in life sciences or equivalent (e.g., BSc, BS)
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
Prior cross-functional project management experience within the CRO/Pharma industry is required
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

Preferred

Advanced / Professional degree in life sciences or business management preferred (e.g., MSc, MPH, PhD, MD, MBA)
Virtual/decentralized study experience preferred

Benefits

Career development and progression
Supportive and engaged line management
Technical and therapeutic area training
Peer recognition
Total rewards program
Total Self culture

Company

Syneos Health

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Syneos Health, the only fully integrated end-to-end clinical and commercial solution organization.

H1B Sponsorship

Syneos Health has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (35)
2024 (26)
2023 (49)
2022 (63)
2021 (84)
2020 (63)

Funding

Current Stage
Public Company
Total Funding
$524.65M
2023-09-28Private Equity
2023-05-10Acquired
2021-03-01Post Ipo Secondary· $524.65M

Leadership Team

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Costa Panagos
Chief Executive Officer
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Michael Bonello
Executive Vice President and Chief Financial Officer
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Company data provided by crunchbase