
Senior Director, Strategy & Planning – Real World Late Phase, Real World Evidence
Posted 1 day ago

Posted 1 day ago
This is a fully remote position, open to applicants in Argentina.
• Take ownership of pre-award strategies and commercial leadership for designated RWLP managed accounts, which includes RFP/RFI strategy, service model definition, functional scope, budget frameworks, and vendor strategies.
• Facilitate bid defense meetings and conduct capabilities presentations.
• Ensure a smooth transition of accounts from pre-award to delivery by effectively passing 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 about RWLP standards, evidence strategy, and evolving operational methods.
• Maintain relationships with senior-level sponsors through governance and strategic planning discussions.
• Offer strategic direction during study execution and assist in complex problem-solving, risk assessment, and the development of integrated solutions.
• Monitor account performance, pinpoint risks and opportunities, facilitate issue resolution, and position accounts for growth.
• Align and influence cross-functional and business unit teams.
• Share insights, lessons learned, and best practices for future pursuits and portfolio enhancement.
• Establish and reinforce strategic quality expectations while monitoring quality risks, CAPAs, and QIs.
• Stay informed about vendor and partner integration as well as third-party service risks.
• Identify opportunities for account extensions, hybrid clinical–RWLP methodologies, repeat business, 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.
• 10–12 years of relevant experience, including at least 6–8 years of direct RWLP/RWE experience.
• Experience in late-phase real-world research within a CRO and/or pharmaceutical setting.
• Strong background in proposal development, budget creation, and bid defense activities.
• Proven experience in managing complex client portfolios, including vendor and partner collaboration.
• Deep understanding of peri- and post-approval study strategies, designs, and operational considerations across interventional, observational, and hybrid study types.
• Experience presenting to senior stakeholders, delivering training or enablement, and communicating complex concepts to varied audiences.
• Ability to collaborate with stakeholders to define and enhance operational processes and procedures.
• Proven experience in evaluating and selecting vendors and partners.
• Capability to identify process gaps and emerging needs for updated procedures.
• Familiarity with emerging technologies and digital tools, including generative AI.
• Demonstrated experience serving as a subject matter expert both internally and externally on RWLP/RWE methodologies, evidence planning, and integrated solutions.
• Proven experience representing the organization at industry conferences, panels, webinars, podcasts, or similar forums.
• Strong understanding of the complete product lifecycle and real-world evidence throughout peri- and post-approval phases.
• Solid knowledge of RWLP operational and regulatory standards.
• Proven business, financial, and contractual competence, including experience with contract negotiations.
• Ability to drive strategic operational decisions within multi-stakeholder, matrixed environments.
• Strong leadership skills in global, diverse, matrixed organizations, including experience in line management.
• Excellent interpersonal, communication, and stakeholder management abilities.
• Ability to juggle multiple priorities and produce high-quality work in a fast-paced, dynamic 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% of the time.
• An advanced or professional degree is preferred (e.g., MS, MPH, PhD, MD, MBA).
• Experience with hybrid, decentralized, or virtual study models is preferred.
• RWE strategy experience is a plus.
• Opportunities for career development and advancement.
• Supportive and engaged line management.
• Training in technical and therapeutic areas.
• Peer recognition programs.
• Comprehensive total rewards program.
• An inclusive workplace culture.
• Reasonable accommodations provided when appropriate.
Instrument
BMO U.S.
Pathward
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