Senior Business Strategist

Summary

Join New Era Technology as a Senior Business Strategist to lead long-range planning for a portfolio of pharmaceutical innovations. This role requires a strong background in pharma and experience with IT or R&D, and involves strategic roadmapping, scenario planning, competitive and regulatory intelligence, and data-driven foresight. You will deliver high-impact visualizations, influence investment decisions, and partner with the client manager. The ideal candidate possesses exceptional communication and storytelling skills and a deep understanding of long-term IT planning, including architecture, digital health, and connected devices. This position offers the opportunity to shape the future of work in a supportive, growth-oriented environment.

Requirements

• 10+ years in strategic planning, management consulting, or pharma innovation roles
• Strong background in pharma IT, R&D, or regulatory affairs; experience with FDA validation and audit response is a plus
• Deep understanding of long-term IT planning (5–10 years), including architecture, digital health, and connected devices
• Familiarity with 21 CFR Part 11, Part 870, and global privacy regulations (e.g., GDPR, HIPAA)
• Entrepreneurial mindset with a track record of anticipating industry trends, ideally someone who speaks at conferences or has led innovation in biotech or medtech startups
• Exceptional communication, business acumen, and storytelling skills to influence senior stakeholders

Responsibilities

• Refine and evolve a multi-year product roadmap that spans over 100 drug candidates, identifying which 7 - 8 may benefit from connected or digital solutions
• Map and continuously track 8+ strategic vectors including technology, regulatory shifts, competitive moves, pipeline maturity, privacy laws, and patient delivery models (e.g., shift from injectables to orals)
• Develop predictive scenarios that anticipate how FDA guidance, political administrations, and global privacy regulations may evolve—especially in areas like AI, cybersecurity, and digital therapeutics
• Act as a “student of the industry,” continuously monitoring competitors’ strategic moves, FDA trends (e.g., 21 CFR Part 11, 870), and global privacy frameworks
• Interpret FDA behavior based on historical precedent and emerging signals to avoid surprises (e.g., security patching expectations)
• Maintain fluency in the latest guidance on medical device regulations and audit response strategies
• Lead the collection and synthesis of internal and external data, including vendor-sourced intelligence, to inform strategic decisions
• Deliver high-impact visualizations such as Gantt charts, milestone maps, and probability-weighted scenarios
• Apply a “fail-fast” mindset to predictions, validate assumptions, iterate quickly, and adjust direction based on new evidence
• Partner closely with the client manager to define workstreams and priorities, while operating independently to drive execution
• Synthesize complex data into compelling narratives that influence investment decisions and strategic direction
• Actively seek out internal and external experts, integrating their insights into cohesive strategies

Preferred Qualifications

• Strategic thinker with a bias for action
• Former IT Architect or R&D Manager in Pharma or MedTech
• Pharma Quality or Regulatory Expert with strategic planning experience
• Strong collaborator who integrates expert input into cohesive strategies
• Industry speaker or thought leader with a futurist mindset a plus
• Significant FDA Quality experience
• Adept at balancing big-picture vision with detailed execution planning
• Comfortable operating independently in ambiguous environments