Director, AI Business Technology Partner (R&D)
Harmony Biosciences
August 07, 2026
On-site
Plymouth Meeting, PA
IT
Responsibilities:
- Serve as a trusted advisor to R&D leadership (Clinical, Regulatory, Safety, Medical Affairs) on technology process improvement and digital enablement.
- Lead end-to-end technology process assessments and redesign across: Clinical trial lifecycle (start-up, execution, closeout); Regulatory submission and document management; Pharmacovigilance and safety case processing; Medical information and insights generation.
- Identify inefficiencies and implement standardized, scalable, compliant technology process models.
- Establish KPIs, process metrics, and continuous improvement frameworks.
- Identify, prioritize, and deliver AI/automation use cases embedded in R&D workflows (e.g., protocol optimization, trial design analytics, patient recruitment/site selection, automated document authoring, signal detection/case processing, scientific literature mining).
- Drive adoption of GenAI copilots, NLP solutions, and predictive analytics in R&D.
- Partner with Data Science/Engineering to operationalize AI (MLOps, model lifecycle management).
- Act as primary technology business partner between R&D and IT/Data/AI teams; translate challenges into AI use cases with quantified value.
- Build/maintain multi-year R&D technology + AI roadmap; define and track value realization metrics (cycle time, cost, quality, compliance outcomes).
- Lead cross-functional delivery; manage vendors/partners; drive agile iterative deployment.
- Ensure compliance with GxP, 21 CFR Part 11, data integrity/audit trail, and applicable privacy regulations (HIPAA, GDPR).
Qualifications:
- Bachelor’s degree in Business, Information Systems, Life Sciences, Data/Analytics, or related field.
- 10+ years Pharma/Life Sciences IT-scope experience.
- 5+ years: Business technology/IT partnership; Analytics/BI/reporting; Hands-on Veeva (Vault/CRM; commercial data warehousing/reporting).
- 5+ years defining/supporting analytics, AI, automation/decision support (use case development; agentic AI).
- Proficiency in AI/ML, GenAI, NLP, automation; strong pharma process understanding (R&D and Commercial) and how AI applies.
- Proven cross-functional ability (business, IT, data, compliance, vendors).
- Familiarity with CRM analytics/customer engagement analytics; AI/ML in commercial/medical; intelligent search/summarization/copilots; data governance/master data/data quality.
- Knowledge of Responsible AI principles; CSV/CSA/validation expectations in regulated environments; change management and user adoption.
Benefits:
- Medical, Vision and Dental (first of month following start); paid time off and company holidays; disability and life insurance; 401(k); paid parental leave; ESPP; wellness programs; professional development.
Physical/work: ~5% domestic travel; quiet environment; close vision; computer/tablet/phone use; prolonged sitting.
- Serve as a trusted advisor to R&D leadership (Clinical, Regulatory, Safety, Medical Affairs) on technology process improvement and digital enablement.
- Lead end-to-end technology process assessments and redesign across: Clinical trial lifecycle (start-up, execution, closeout); Regulatory submission and document management; Pharmacovigilance and safety case processing; Medical information and insights generation.
- Identify inefficiencies and implement standardized, scalable, compliant technology process models.
- Establish KPIs, process metrics, and continuous improvement frameworks.
- Identify, prioritize, and deliver AI/automation use cases embedded in R&D workflows (e.g., protocol optimization, trial design analytics, patient recruitment/site selection, automated document authoring, signal detection/case processing, scientific literature mining).
- Drive adoption of GenAI copilots, NLP solutions, and predictive analytics in R&D.
- Partner with Data Science/Engineering to operationalize AI (MLOps, model lifecycle management).
- Act as primary technology business partner between R&D and IT/Data/AI teams; translate challenges into AI use cases with quantified value.
- Build/maintain multi-year R&D technology + AI roadmap; define and track value realization metrics (cycle time, cost, quality, compliance outcomes).
- Lead cross-functional delivery; manage vendors/partners; drive agile iterative deployment.
- Ensure compliance with GxP, 21 CFR Part 11, data integrity/audit trail, and applicable privacy regulations (HIPAA, GDPR).
Qualifications:
- Bachelor’s degree in Business, Information Systems, Life Sciences, Data/Analytics, or related field.
- 10+ years Pharma/Life Sciences IT-scope experience.
- 5+ years: Business technology/IT partnership; Analytics/BI/reporting; Hands-on Veeva (Vault/CRM; commercial data warehousing/reporting).
- 5+ years defining/supporting analytics, AI, automation/decision support (use case development; agentic AI).
- Proficiency in AI/ML, GenAI, NLP, automation; strong pharma process understanding (R&D and Commercial) and how AI applies.
- Proven cross-functional ability (business, IT, data, compliance, vendors).
- Familiarity with CRM analytics/customer engagement analytics; AI/ML in commercial/medical; intelligent search/summarization/copilots; data governance/master data/data quality.
- Knowledge of Responsible AI principles; CSV/CSA/validation expectations in regulated environments; change management and user adoption.
Benefits:
- Medical, Vision and Dental (first of month following start); paid time off and company holidays; disability and life insurance; 401(k); paid parental leave; ESPP; wellness programs; professional development.
Physical/work: ~5% domestic travel; quiet environment; close vision; computer/tablet/phone use; prolonged sitting.