
Senior Director – Strategy & Planning, Real World Late Phase, Real World Evidence
Posted Aug 21

Posted Aug 21
This is a fully remote position, open to applicants in Canada.
• Take charge of pre-award strategy and commercial leadership for designated RWLP managed accounts, encompassing RFP/RFI strategy, service model definition, functional scope, budget structures, and vendor strategy.
• Facilitate bid defense meetings and deliver capabilities presentations.
• Transition accounts from pre-award to delivery by collaborating with project delivery teams on strategy, assumptions, risks, scope, timelines, and budget expectations.
• Act as the strategic account leader post-award, overseeing portfolio performance and governance.
• Lead strategic discussions with clients regarding RWLP standards, evidence strategy, and evolving operational methods.
• Maintain senior-level sponsor relationships through governance and strategic planning dialogues.
• Provide strategic advice throughout study conduct and assist with complex problem-solving, risk assessment, and integrated solution development.
• Track account performance, pinpoint risks and opportunities, and assist in issue resolution and account growth.
• Align and influence cross-functional and business unit teams.
• Share insights, lessons learned, and best practices to inform future pursuits and portfolio expansion.
• Establish and reinforce strategic quality expectations while monitoring quality risks, CAPAs, and QIs.
• Oversee vendor and partner integration alongside related strategic risks.
• Identify opportunities for extensions, hybrid clinical–RWLP approaches, repeat work, and preferred partnership models.
• May include line management responsibilities.
• A Bachelor’s degree in life sciences or a related field OR a four-year degree combined with relevant RWLP and operational experience is required.
• An advanced or professional degree is preferred (e.g., MS, MPH, PhD, MD, MBA).
• 10–12 years of relevant experience overall, including at least 6–8 years of direct RWLP/RWE experience.
• Experience in real-world late-phase research within a CRO and/or pharmaceutical setting.
• Significant experience in proposal development, budget formulation, and bid defense activities.
• Proven track record in managing complex client portfolios, including vendor and partner engagement.
• Strong knowledge of peri- and post-approval study strategy, design, and operational factors across interventional, observational, and hybrid study types.
• Experience presenting to senior-level stakeholders, delivering training or enablement, and articulating complex concepts to diverse audiences.
• Preference for experience with hybrid, decentralized, or virtual study models.
• Experience collaborating with stakeholders to define and improve operational processes and procedures.
• Background in evaluating and selecting vendors and partners.
• Capability to identify process gaps and recognize emerging needs for updated procedures.
• Familiarity with emerging technologies and digital tools, including generative AI.
• Demonstrated expertise serving as a subject matter expert both internally and externally on RWLP/RWE methodologies, evidence planning, and integrated solutions.
• Experience representing the organization externally through industry conferences, panels, webinars, podcasts, or similar platforms.
• Solid understanding of the end-to-end product lifecycle and the significance of real-world evidence across peri- and post-approval phases.
• Comprehensive knowledge of RWLP operational and regulatory requirements.
• Proven business, financial, and contractual acumen, including contract negotiation experience.
• Ability to drive strategic operational decisions in multi-stakeholder, matrixed settings.
• Experience in interventional, observational, and hybrid study designs.
• Strong leadership skills in global, diverse, matrixed organizations, including line management experience.
• Exceptional interpersonal, communication, and stakeholder management abilities.
• Capacity to juggle multiple priorities and produce high-quality work in a fast-paced, evolving environment.
• Proficiency with virtual collaboration tools and the Microsoft Office Suite (Word, Excel, PowerPoint).
• Excellent written and spoken English skills.
• Willingness to travel up to 25%.
• Opportunities for career development and advancement.
• Supportive and engaged line management.
• Technical and therapeutic area training.
• Peer recognition.
• Comprehensive total rewards program.
• Inclusive company culture.
• Reasonable accommodations for applicants and employees, as appropriate.
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