Head of Program Management

• Feb 2021 - Present

Founder

• Jun 2017 - Feb 2021

• Founder of Ascentix Consulting, a Project Management and Team Leadership consulting firm serving the Life Sciences industry www.ascentixconsulting.com • Project Manager and Team Leader managing teams responsible for driving complex NCE and 505(b)(2) global development programs from POC through approval and commercialization • Oversight of Phase I, II, and III clinical trials and regulatory submissions • Development of detailed project plans, direct client team meetings, manage program budgets, align development strategy with executive management, risk mitigation, and drive issue resolution to deliver approvable US and EU submissions Show less

Head of PMO, Portfolio Management

• Jan 2016 - Jun 2017

• Established the consulting PMO to oversee client relationships and manage staffing of over 70 FTE and 1099 resources from Project Management, Regulatory Affairs and Operations, and Quality Assurance • Developed new processes and governance structures for cross-functional project lifecycle management and established reliable portfolio resource planning and analysis practices enabling data-based strategic resourcing decisions • Prepared project plans and Gantt charts for multiple complex multi-indication integrated client drug development projects, and managed cross-functional team meetings • Managed mid- and high-level PMO colleagues Show less

Associate Director, Global Program Management

• Mar 2013 - Dec 2015

• Lead Project Manager for late-stage oncology drug candidate teams with cross-functional, cross- geographical and cross-company membership. Oversaw the strategic development and operational execution of over 15 clinical studies in Phase I, II, and III, over 20 investigator- sponsored trials, and multiple nonclinical studies • Competitive Intelligence Team Lead responsible strategic lifecycle management decisions • Developed integrated NDA and MAA submission strategy for multiple indications • Oversaw annual cross-functional operating budgets exceeding $50M and 50 FTEs Show less

Associate Director, Global Portfolio Management,

• Aug 2010 - Mar 2013

• Project Manager and Operation Team Lead for multiple cross-functional, cross-geographical teams charged with the research, medical and clinical development, commercialization, and marketing of global pharmaceutical and medical device products• Leadership of global cross-functional project teams consisting of R&D, medical, clinical, commercial, marketing, market access, outcomes research, and regulatory colleagues. Facilitation of live and virtual team meetings, driving team endorsements and decisions• Drive team execution of strategy, timelines, and deliverables to achieve stakeholder goals• Develop project performance and valuation metrics to enable prioritization decisions• Development and maintenance of project plans, timelines, deliverables, budgets, and resource allocations using MS Project, Excel, PowerPoint, Word, Enterprise Project Management, and other project management, financial, and business software and systems• Translate team’s strategic objectives into operational plans; provide insight into operational feasibility of proposed strategies and activities; drive creation and maintenance of discreet deliverables that are well characterized with associated timing, resources, quality parameters, and interdependencies across lines • Model cross-functional development options and develop project proposals, challenging timelines and resource constraints to ensure project progression against portfolio resource constraints• Drive project risk management processes, identifying risks to scope, timelines, budget, and resource allocations; development of mitigation and contingency plans • Analyze organizational processes and workflows to determine opportunities for business efficiency, developing new models to improve effectiveness and implementing new processes within matrix organizations Show less

Senior Professional Healthcare Representative

• May 2006 - Aug 2010

• Exceeded sales quotas for territory, district and 4-state region for 4 consecutive years• Successfully launched the first inhaled insulin product and the first FDA-approved fibromyalgia product, with highest sales attainment in 4-state region• Recognized as regional technical expert and appointed as District Product Lead, leading regional training for sales representatives to hone technical, scientific, and selling skills

Global Lead, Pharmaceutical Sciences Training

• Oct 2005 - May 2006

• Oversaw global educational initiatives in the development and implementation of the global strategic plan to promote overall team leadership and effectiveness • Oversaw the design, implementation, facilitation, and review of team leader training and development programs• Developed training in general drug development, regulatory and compliance, World Wide Pharmaceutical Sciences and Pfizer Global Manufacturing best practices, emerging development paradigms, technical and business concepts• Provided strategic direction and assemble communication forums, fostering employee engagement and disseminating knowledge and understanding Show less

Senior Project and Portfolio Manager

• Nov 2001 - Oct 2005

• Directed multi-functional project teams in the research and development of drug candidates, guiding project strategy and influencing team decisions to ensure timely project progression against portfolio resource constraints• Created detailed process maps and project plans, oversaw project activities and deliverables, prepared budget and resource estimates and track to ensure effective allocation, and managed plan execution and quality standards• Presented project and portfolio performance and product reviews to executive leadership teams for strategic portfolio management and endorsement decisions• Modeled development options and develop project proposals, including project scope, strategy, timelines, and resources• Analyzed organizational processes and workflows to determine opportunities for business efficiency, develop new models to improve effectiveness, and implement new processes within matrix organizations Show less

Business Strategy and Communications Lead – Special Assignment

• Sep 2004 - Mar 2005

• Guided strategic planning activities, and ensure consistency with site strategies and departmental business objectives.• Developed and managed the departmental Business Plan. Oversaw annual goal setting processes and plans ensuring alignment with business strategies. Led ongoing progress reviews and status reporting.• Facilitated Leadership Development forums. Set agendas and summarize outcomes, including timely communications to colleagues and stakeholders.• Developed a Communications Strategy, translating business strategies into action to ensure colleague understanding, alignment and commitment to goals and objectives. Show less

Senior Regulatory Scientist

• Apr 1999 - Nov 2001

• Provide regulatory guidance to project teams, interpreting regulations and guidelines and coordinating all regulatory project activities• Conduct manufacturing plant investigations and data audits• Compile U.S. and international regulatory submissions, such as INDs and NDAs

Product Research Scientist

• Jan 1993 - Apr 1999

• Develop methods for qualitative and quantitative analytical testing of drug supplies for toxicology and clinical studies • Manage 5 student interns, providing laboratory training and mentorship • Develop Standard Operating Procedures for laboratory techniques and use of scientific equipment • Prepare and present project scientific technical overviews to senior level management • Develop methods for qualitative and quantitative analytical testing of drug supplies for toxicology and clinical studies • Manage 5 student interns, providing laboratory training and mentorship • Develop Standard Operating Procedures for laboratory techniques and use of scientific equipment • Prepare and present project scientific technical overviews to senior level management