OUR TEAM: Mark Hronec
Mark has over 15 years of experience in the life science industry, with a primary focus on operations, project management and organizational development. Areas of expertise include: process and performance improvement, strategic sourcing and alliances, GCP compliance, senior management decision support, organizational scaling and post-merger integration. he has worked with large, mid and small-sized pharma companies and CROs, both domestically and internationally.
Before joining Scimitar, Mark served as a Director at PwC in the Pharma Life Science Group and a Principal at PRTM (acquired by PwC). He also spent several years working at Millennium Pharmaceuticals (now Millennium: the Takeda Oncology Company) in the Lead Discovery department focusing on enzyme characterization, high throughput screening and hit to lead optimization in conjunction with the oncology franchise.
Mark received his MBA from the Tepper School of Business at Carnegie Mellon University, where he focused on finance, strategy and accounting. He also graduated with Highest Honors from Brandeis University with a MS in Biochemistry and a BS in Biology, where he focused on protein crystallography and and enzyme kinetics.
- Led the strategy, design and implementation of an initiative at a biopharmaceutical company which drove efficiencies, maintained core competencies, and scaled a non-clinical organization to support 2-3x pipeline growth through process improvements, sourcing strategies, organizational alignment, and functional strategies. Initiative increased department productivity by 20-25% and captured 5-10% annual savings through sourcing strategies.
- Led an initiative in a mid-sized high growth biopharmaceutical company to first characterize their current state of their ~85 unique processes and >100 systems for their Development Operations (Clin Ops, Reg., Data Management, Drug Safety, and Project/ Program Management) and then second help them identify their 5 year future state vision as well as their roadmap to move them from the current state to the desired future state.
- Led the strategy and design for a R&D outsourcing initiative for a large biopharmaceutical company. The company moved from transactional relationships with their CRO partners to a more strategic alliance with two CRO partners to increase efficiencies in trial execution across their entire portfolio.
- Led a multi-national clinical quality improvement project at a top 5 pharmaceutical company. Overhauled and implemented a new quality management system focused primarily on standardizing GCP processes and procedures across company’s functions and regions. Reduced company’s procedural documentation by 80% while becoming globally aligned on processes, compliant with GCP and focusing the company on continuous improvement across all functions.
- Led an initiative at a mid-sized biopharmaceutical and medical device company to establish a vision, strategy and roadmap for the Phase II – IV global development organization. The strategies were tailored to fit their globally expanding development footprint and were able to support their current and future business requirements. Strategies identified included harmonizing worldwide roles and responsibilities where appropriate, introducing a more efficient and effective product governance model, developing an in-licensing and PMI model, and developing a sourcing strategy and organization.
- Led the strategy, design and implementation of an initiative at a top 5 CRO focused on increasing competitiveness, reducing cycle times, reducing costs and increasing quality in the Clinical Development Phase II – IV area. Transformational opportunities were implemented with savings of over 25% at steady state. Opportunities included process improvements, sourcing, movement to low cost countries and introduction of new technologies.