Engaged with clinical-stage biotechnology companies, leading development programs ranging from early discovery through IND submissions to early phase through pivotal clinical trials.Highlighted engagements:•Centessa Pharmaceuticals: Program lead for P2 pivotal study for treatment in rare disease area (2024-present)•Sunovion Pharmaceuticals: Multiple CNS-focused programs, pre-clinical through Ph2 (2023-2024)•Roivant Sciences: Key strategic program leadership across multiple therapeutic areas, early through IND (2021)

REASON FOR DEPARTURE: COMPANY FUNDRAISING, SEEKING STRATEGIC ALTERNATIVES-Led program management activities for multiple development programs; advanced drug development through non-clinical and Ph1 and Ph2 clinical studies-Managed non-clinical studies and transition of pre-clinical programs through lead optimization and candidate selection through final formulation development-Leadership of development program from IND submission through completion of Ph1 clinical study through start-up and enrollment of a global Ph2 clinical study-Created and managed integrated project plans and timelines to drive completion of program and pipeline deliverables -Facilitated resolution of project issues by working with program team members, functional leads and executive leadership, initiating escalation plans as needed-Built and maintained relationships with all functional areas of R&D (CMC, Clinical, Regulatory, Quality, Manufacturing) as well as CROs, CMOs and external consultants-Proactively identified critical project issues and risks, communicating across all functional areas so that deliverables and interdependencies are clear-Implemented program management processes and tools, including web-based project management software, system generated timelines/dashboards, and risk management process-Supported business development activities, leading preparation of diligence materials, including corporate presentations and data room management

-Responsible for overall program management of multiple early phase development programs-Led two new program teams through candidate selection process, IND submission and initiation of Phase One clinical trials-Ensured successful submission of two new INDs by driving all preparation activities, including module and report writing, proactive review meetings and roundtables-Implemented tools such as document Tracking Matrix, ECTD templates and style guides-Supported clinical operations team in study start-up for Ph2 two clinical trial, including transition from in-patient design to decentralized study-Managed planning and execution of two virtual Clinical Advisory Boards

-Led global development teams of two rare/orphan oncology development programs-Developed program plans, timelines, and budgets for full portfolio of development programs-Served as Chair of Product Development Committee (portfolio strategy leadership team) -Supported integration activities for product/company acquisitions

Associate Director, Launch Management (2013-2015)-Developed and executed launch strategies for new generic product launches, AGx launches, and relaunches/remediation projects with a total market value of over $500m-Successfully launched products to meet company launch and revenue targets, launching over 40 products for more than $700M in net sales within three yearsAssociate Director, Project and Portfolio Management (2010 - 2013)-Established and managed project timelines for 10-15 small molecule development projects and 15-20 product relaunches within both Generic and Branded product portfolios-Managed projects through development cycle, from initiation and early-stage development through filing, post-filing, and commercial launch-Led innovative relaunch initiative while supporting quality/compliance/remediation activities

-Managed generic and proprietary drug product initiatives for $1 billion small molecule manufacturing business, including new product launches, scale-ups, alternate sources and site transfers-Led external product development projects from early stage R&D phase through submission, FDA approval process, final approval, and commercial launch

-Master Production Scheduler - Developed master production schedule for $1 billion oral contraceptive franchise (eight product lines - over 40M units per year) (1997-1999)-Strategic Sourcing Manager - Implemented new strategic partnerships with suppliers for contracts covering J&J affiliates; Created and implemented supplier consolidation plans (1995 - 1997)-MRO Buyer - Managed promotional supplier relationships for managed care business (1990-1995)