- Experienced leader in global Biopharma specializing in enterprise drug development project and portfolio planning solutions, innovative clinical data insight generation, knowledge management, managing complex PMOs, change management for large strategic initiatives, governance models to share data and resources to drive investment decisions and deliver results in an agile environment.
Sr. Director Product Engineering & Marketing
- Product engineering head for concocting new product ideas to serve Biopharma needs using clinical and commercial data.
- Designed seamless data architecture, systems and processes encompassing data democratization to leverage the full potential of data in R&D and product commercialization.
- Created cCatalyst - an innovative insight engine combining data from multiple data sources including Clinical and CMS open data platforms to assess clinical trial efficiency & optimization, and to aid in site selection, patient recruitment, patient sentiment analysis, patient compliance, targeting and segmentation.
Principal Business Capability Owner
- Business owner for Clinical Data Search enterprise solution, sourcing data from 14+ GxP and non-GxP systems to enable cross country and cross departmental search of clinical data across geographies and regulated platforms. It was rated the #1 for most favorable on meeting business needs, user friendliness and performance, across all R&D solutions.
- Core member of organizational transformation programs and initiatives for drug development Project and Portfolio Management (PPM) aimed at long-term strategy, committee decision making principles and R&D productivity.
- R&D Planning transformation lead, focusing on new mindset and culture around planning across Roche enterprise. Lead for global cross-functional team using agile/scrum methodologies.
- Led global teams of 40+ members and broad array of stakeholders across Roche Pharma in delivering annual strategic roadmap for enterprise PPM business and system landscape via building prioritization frameworks, simplifying business processes, leveraging technology and pursuing transparency working with cross-functional leaders and teams.
- Key contributor in the business process/system integration between Confidential and Roche for medication kit labeling and subject treatment randomization for blinded clinical trials.
- Interfaced with senior leaders and stakeholders to define business needs and develop business rules for clinical regulatory reports, hosted with Cognos 8.0 on Oracle platform.
- Directed end-to-end analysis for remediation of all functionalities received from eClinical CTMS to Operational Data Store.
- Key contributor in validated safety distribution work stream for migration of project from legacy ARISg to Argus 5.0. Planned and managed validated system migrations, pertaining to Global Safety noti cation portal for notifying authorities of safety adverse events.
- Implemented multiple systems including - IRIMS, Dispatch Log, Pro-Watch, Professional Flight Management system, Passage Point etc. Managed a global team of 15+ for development and operations support.
- Enabled monitoring of trends/issues associated with subject/site visit and widespread availability of data on Site Contacts, Investigators, Clinical Research Associates, Institutional Review Board, and Informed Consent Forms.
- Held chief oversight on global, cross-functional team of 15+ contributors.