Operations Director Medical Device jobs

Job Responsibilities

• Own pre-award strategy and commercial leadership for assigned RWLP managed accounts, including RFP/RFI strategy, service model definition, functional scope, budget structures, and vendor strategy; lead bid defense meetings and capabilities presentations.
• Lead the transition from pre-award to delivery by partnering with project delivery teams to ensure a clear handoff of strategy, assumptions, risks, scope, timelines, and budget expectations.
• Serve as the strategic account leader post-award, maintaining strategic oversight of portfolio performance and governance while partnering with delivery leadership to ensure alignment with approved strategy and commercial intent.
• Lead client-facing strategic conversations related to RWLP standards, evidence strategy, and evolving operational approaches; sustain senior-level sponsor relationships through routine governance and strategic planning discussions.
• Provide ongoing strategic guidance during study conduct, acting as a consultant to project teams to support complex problem-solving, risk assessment, and development of integrated solution options across functions, vendors, and partners.
• Maintain strategic awareness of account performance, including participation in BU or departmental reviews as needed, to proactively identify risks or opportunities, support issue resolution from a strategy perspective, and position accounts for growth.
• Align and influence matrixed teams across functions and business units to support integrated commercial and account strategies; share insights, lessons learned, and best practices to inform future pursuits and portfolio expansion.
• Set and reinforce strategic quality expectations for assigned accounts; maintain awareness of quality risks, CAPAs, and QIs to ensure issues are understood and appropriately escalated.
• Maintain awareness of vendor and partner integration, including strategic risk considerations related to third-party services and cross-BU delivery models.
• Support account growth and partnership expansion by identifying opportunities for extensions, hybrid clinical–RWLP approaches, repeat work, and preferred partnership models.
• May have line management responsibilities.
• Travel up to 25%.

QUALIFICATION REQUIREMENTS

Education

• Bachelor’s degree in life sciences or related field OR a four-year degree combined with relevant RWLP and operational experience required
• Advanced or professional degree preferred (e.g., MS, MPH, PhD, MD, MBA)

Experience

• 10–12 years of total relevant experience, which may include RWLP and/or full-service study or portfolio experience, with a minimum of 6–8 years of direct RWLP/RWE experience included within that total. RWLP/RWE experience may overlap with full-service or operational experience and is not required to be additive.
• Experience in real world late phase research within a CRO and/or pharmaceutical environment
• Strong experience with proposal development, budget development, and bid defense activities
• Demonstrated experience supporting complex client portfolios, including vendor and partner engagement
• Strong understanding of peri- and post-approval study strategy, design, and operational considerations across interventional, observational, and hybrid study types, with the ability to design and budget appropriate solutions
• Experience presenting to senior-level stakeholders, delivering training or enablement, and communicating complex concepts to diverse audiences
• Experience with hybrid, decentralized, or virtual study models preferred
• Experience partnering with stakeholders to define and evolve operational processes and procedures as RWLP/RWE requirements and delivery models change
• Experience evaluating and selecting vendors and partners that complement and enhance service offerings
• Ability to identify process gaps and emerging needs for updated procedures; familiarity with leveraging emerging technologies and digital tools (e.g., generative AI) to drive efficiency and scalability
• Demonstrated experience serving as a subject matter expert (SME) internally and externally, providing strategic guidance on RWLP/RWE approaches, evidence planning, and integrated solutions to sponsors and internal stakeholders.
• Experience representing the organization externally through participation in industry conferences, panels, webinars, podcasts, or similar forums, including delivering presentations and contributing to thought leadership discussions related to RWLP/RWE.

Knowledge & Skills

• Strong understanding of the end-to-end product lifecycle and the role of real-world evidence across peri- and post-approval phases
• Solid knowledge of RWLP operational and regulatory requirements
• Proven business, financial, and contractual acumen, including experience supporting or leading contract negotiations
• Demonstrated ability to drive strategic operational decisions in multi-stakeholder, matrixed environments
• Experience working across interventional, observational, and hybrid study designs; RWE strategy experience a plus
• Strong people leadership skills in global, diverse, matrixed organizations, including line management experience
• Excellent interpersonal, communication, and stakeholder management skills
• Ability to manage multiple priorities and deliver high-quality work in a fast-paced, evolving environment
• Proficiency with virtual collaboration tools and Microsoft Office Suite (Word, Excel, PowerPoint)
• Excellent written and spoken English

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.