Pharmaceutical Sciences, Technology & Innovation Lead (Sr. Director)
BioSpace · Boston, MA · 1 wk ago
Analyst$212k–$333k/yrFull-time
About the role
This is a senior scientific, strategic, and technology leadership role within Pharmaceutical Sciences (PharmSci), R&D, accountable for shaping and advancing an integrated PharmSci technology and innovation strategy with particular emphasis on AI/ML, computational, and in silico-first approaches for CMC applications.
Responsibilities
- Define and maintain the integrated PharmSci technology and innovation strategy, with specific focus on AI/ML, data-driven, and in silico-first capabilities that enable CMC advancement across development, industrialization, manufacturing readiness, and lifecycle management.
- Identify and prioritize high-value use cases where AI/ML, predictive modeling, simulation, and computational approaches can improve CMC outcomes, including speed, robustness, control strategy, process understanding, risk reduction, and right-first-time execution.
- Serve as a senior scientific and strategic leader connecting CMC domain needs with digital, data science, and computational capabilities to ensure that innovation investments are grounded in practical business value and lifecycle applicability.
- Act as a primary PharmSci representative and ambassador in external collaborations, alliances, and partnership governance, including participation in joint steering committee (JSC) and related forums focused on data/digital, AI/ML, and in silico innovation.
- Build, manage, and grow a strong external ecosystem across biotech partners, technology companies, academia, consortia, and other collaborators to expand PharmSci access to emerging computational, AI/ML, and digital capabilities relevant to CMC.
- Translate external partnership opportunities into actionable internal strategies, pilots, and capabilities by connecting external innovation with PharmSci priorities, scientific needs, governance requirements, and implementation pathways.
- Partner across PharmSci technical functions, DD&T, data science, and other enterprise enabling teams to ensure AI/ML and digital solutions are scalable, compliant, sustainable, and aligned to enterprise architecture and operating models.
- Provide leadership for the evaluation, piloting, adoption, and scaling of digital and computational capabilities, ensuring they are supported by appropriate governance, data foundations, change management, and measurable value realization.
- Ensure that AI/ML and in silico-first approaches are applied with appropriate scientific rigor, CMC context, and regulatory/compliance awareness, supporting inspection readiness, lifecycle robustness, and operational feasibility.
- Drive performance management across the technology and innovation portfolio by defining success metrics, monitoring value realization, and communicating progress, risks, and opportunities to senior stakeholders.
Qualifications
- Strong end-to-end understanding of the CMC lifecycle, spanning development, scale-up, tech transfer, manufacturing, quality, and regulatory implications.
- Deep expertise in the application of AI/ML, advanced analytics, modelling, simulation, and/or in silico approaches to scientific or CMC-related problems.
- Strong understanding of how digital, data, and computational capabilities can be translated into practical CMC use cases and scalable business value in a regulated environment.
- Strong computational fluency, including familiarity with modern AI/ML methods, model development and deployment considerations, and the data requirements needed to enable successful use in practice.
- Ability to evaluate emerging AI/ML and computational technologies critically, including their scientific fit, maturity, scalability, and potential value for PharmSci.
- Strong understanding of CMC technology strategy and the interplay between scientific innovation, data foundations, digital platforms, implementation pathways, and lifecycle readiness.
Skills
- Strong CMC background with deep understanding of end-to-end lifecycle considerations from development through manufacturing, quality, and regulatory.
- Demonstrated expertise in applying AI/ML, computational, modeling, simulation, and/or in silico approaches to scientific, technical, or CMC-relevant problems.
- Demonstrated ability to identify, shape, and translate data/digital or AI/ML opportunities into practical solutions with measurable business and scientific value.
- Proven ability to represent an organization effectively in external collaborations, alliance governance, and/or joint steering committee environments.
- Strong ability to bridge technical and scientific communities, including CMC experts, data scientists, digital teams, and external collaborators.
- Strong computational literacy and fluency with current AI/ML concepts, methods, and emerging technology trends, including ability to assess applicability and limitations in regulated environments.
- Strategic thinking and ability to drive change through vision, prioritization, communication, and adoption support.
Pay
$212,000.00 - $333,190.00
Schedule
Hybrid