Senior Business Strategist

Summary

We are seeking a visionary and analytically rigorous Senior Business Strategist to lead long-range planning across a portfolio of pharmaceutical innovations. This role is ideal for a seasoned strategist with a strong background in pharma and experience with IT or R&D, someone who thrives at the intersection of business foresight, regulatory intelligence, and emerging technology.

Key Responsibilities

• Strategic Roadmapping & Scenario Planning
  • 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.
• Competitive & Regulatory Intelligence
  • 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.
• Data-Driven Foresight & Deliverables
  • 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.
• Stakeholder Engagement & Influence
  • 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.

Qualifications:

• 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.

Attributes for Success:

• 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.