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

Posted Aug 21

This is a fully remote position, open to applicants in Canada.

📋 Description

• 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.


⛳️ Requirements

• 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%.


🏝️ Benefits

• 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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