Jacquelyn Ritchie Email and Phone Number

Lead an integrated development operations group that is accountable for the execution and compliance of clinical trials. Provide strategy and leadership to functions including clinical operations, clinical data management, quality management, investigator budgets, medical writing and clinical technology innovations. Member of Product Development and Medical Affairs Leadership Team; contributing to leadership/governance ensuring scientific and operational excellence.Collaborate with other area heads to establish clear objectives for clinical trial programs, across the drug development & lifecycle management continuum. Define & evolve the operating model to support execution of clinical trials including multi faceted partnerships.

The VP of Product Team Leadership oversees Product Team Leaders (PTLs) who are responsible for integrating efforts of a cross-functional team accountable for the successful development and life-cycle management of drug candidates in the Exelixis product development pipeline.Build, implement and manage new governance and team structure for the development organization. Serve as Product Team leader for development assets.

Accountable for a cross functional and multi-therapeutic delivery unit for a strategic client: including the development and implementation of the unit. Lead team of ~120 project managers, clinical leads and regulatory specialist in all aspects of clinical research programs. Accountable for overall delivery, growth of portfolio and customer satisfaction. Provide executive leadership for the team including strategic direction, clinical trial innovation, ensuring successful program delivery, fiscal management ($550MM P&L) as well as determining the strategic planning, risk mitigation and direction of the group.

Provide Executive Oversight for large-mid size pharma clients within Oncology. Accountable for operational delivery, client growth, building alliances and P&L of my portfolio (~$500MM). Provide executive oversight, strategic direction and leadership to my team and clients.

Responsible for designing and implementing an alliance management organization. This includes ensuring exceptional partner experience, collaboration performance, organizational logistics and tracking of collaborations. Oversee all aspects of alliances, including joint governance, alliance vision and plans, communication and alignment, and issue resolution. Building trust, credibility and solution-orientation at all levels (C-Suite to Program team) while ensuring to maintain and foster a collaborative working relationship with our partners. Deeply understand all aspects of partner, collaboration and contracts, educate stakeholders on relevant maters and track performance and obligations. Key knowledge owner for internal and external developments, trends and dynamics. Continually evaluate current and future opportunities within strategic alliances and recommend collaboration expansion opportunities as appropriate. Work closely with Business Development team to establish new collaborations to ensure seamless implementation upon collaboration execution. Developed vision and strategy for enhanced alliance management function within NanoString as well as lead change management efforts for the organization.

Responsible for strategic and operational portfolio management for Metabolic Pathways and Cardiovascular Therapeutic Area. Contribute to the broader portfolio assessments that are taken to key leadership/ governance teams (R&D leadership, annual investment boards). Serve on leadership teams for the therapeutic area leveraging experience and insight and strategy generation. Additionally manage a new portfolio management process in a dynamic manner. The process uses differential development to move our midphase pipeline forward, faster and in a transformative manner for the R&D organization.

Chair, Blinding Program October 2014 – March 2016Appointed to manage the R&D Blinding Panel Review Board, a governance committee responsible for ensure the blinding integrity of clinical trials within GSK. Led the launch of the new Board and change management efforts to successfully embed it into the structure of GSK clinical development. Leading a cross functional matrix team within R&D to Identify business activities and system features which could present a blinding risk, from trial design through to data lockInterim Director, IxRT Program March 2015 – March 2016Lead the internal Interactive Response Technology (IxRT) team. This is a 25 person global team that is accountable for the set up and maintenance and helpdesk that supports the IRT for clinical trials within GSK. The group is a liaison between the clinical and supply chain organizations and well as an interface to our sites that conduct GSK clinical trials and ensuring we have a secure supply chain to meet the needs of our patients. Simplifying Clinical Development (SCD) April 2013 – October 2014SCD was a strategic, long term and transformational change program at GSK to simplify the IT solutions for R&D. I was the lead for the final phase of the accountable for 10 separate work streams and their accompanying project teams. I was accountable to the head of the program as well as the Executive steering team (Sr. R&D leaders). The program analyzed and implemented strategic changes within our clinical IT systems. I was accountable for successful delivery of the multiple solutions and for ensuring mechanisms are established for initial implementation, longer term embedding and sustainability of IT clinical systems. IT systems areas of focus were in statistics (randomization tools), Supply chain (medication dispensing), data repository, internal business intelligence tool, study portal and risk based monitoring tools.

Project Team Leader: I provided project leadership for development teams in the Oncology Business Unit. Lead the project team in planning and execution for global regulatory submissions including sNDAs and MAAs. I was responsible for leading the team through the internal governance process as well as the planning for submission, responses and advisory committees or oral hearings globally. I orchestrated with the matrix team through planning, implementation, and close-out phases within budget and against agreed timeline, leading efforts across multiple workstreams/subteams. Provide leadership to the program – including scope; business objectives; outcomes; internal governance; key inter-dependencies; risks; and constraints; key deliverable; and milestones. Direct interface to key stakeholders, including senior management, throughout the program, maintaining positive relationships; and communicating plans, status, issues and risks. Plan and drove activities of the project team– from SVP-level to subject matter experts – to ensure project plan delivery. Lead cross-functional Global Product Team to develop and drive an global product strategy. Provide strategic leadership to the program – including scope; business objectives; outcomes; internal governance; key interdependencies; risks; and constraints; key deliverables; and milestones. Worked closely to influence, advise and coordinate strategic and operational efforts across all key product development functions, including the development teams, Regulatory, Safety, CMC, Medical Affairs and Commercial functions

Responsible for the global oversight of 3 oncology assets during their clinical life cycle. This included oversight of the clinical trials programs and the management of the staff running the day to day operations of the programs and the strategy and management of asset. Worked strategically with global colleagues to ensure an effective strategy for the use of strategic partners. Drove key organizational process improvement initiatives to include recruitment, training and resource management. This included all operational aspects and implementation of multiple clinical trials within the asset (budget, process, timelines). I lead the global operational planning aspects for Global regulatory submission and was key operational point of contact for regulatory inspections. I served as the main point of contact globally for senior management and senior level matrix teams and was accountable for end-to-end study leadership across all functional lines of the study team: including management CROs and key strategic partnerships.

Lead the Clinical Research Unit for the Abramson Cancer Center. Under my direction I had a team of 26 Clinical Research Staff ( Nurses, Data coordinators, Research assistants and Regulatory Specialists). Our team had over 200 ongoing clinical trials ranging from large pharmaceutical sponsored trials, Cooperative group trials from the NCI to programs that were designed and managed by UPENN staff. Key accountabilities: Develop Strategy and direction of the Unit, Lead and Develop team, Create processes and establish rigor within the department. Accountable for the unit's operating budget.