As a consultant with Merck, I am working to transfer all clinical assets from Immune Design to Merck after Merck's acquisition of Immune Design in April of last year.

As an Associate Director within the Oncology Therapeutic Delivery Unit, I provided oversight at the program level for 5 different global oncology trials. My day to responsibilities included:• Managing the scope of work, objectives, timelines, quality of deliverables, and all other project management activities for a multi-project program.• Serve as primary project contact with internal and external customers to ensure appropriate communication channels are maintained and reporting schedules adhered to.• Develop project plans for all phases of the project or program and associated deliverables.• Review project and program budgets and scope of work, including management of multiple project budgets to meet financial and company goals and proactively ensure adherence to change control processes.• Supervise maintenance of project management information and data tracking systems.• Direct project activities for team members regarding their project-oriented tasks to ensure that project milestones are met.• Evaluate impact of risks, develop and implement quality and risk management plans for minimizing impact on program objectives and deliverables.• Continually review and ensure adequate internal and external resources are available to meet project deliverables and milestones.• Develop and implement continuous improvement processes for assigned projects.• Participate in RFP development and sales/proposal presentations; provides input on scope and budget development.• Provide technical expertise and project management experience to Project Managers and training efforts.• Serve as a project management liaison with other groups within Quintiles.

• Manage multidisciplinary study teams in the planning and execution of global oncology studies• Served as the primary interface with the study sponsor; operates as the team leader on the trial and interacts with senior management• Monitors Key Performance Indicators• Manages risk identification and mitigation• Manages the execution of the assigned clinical study per contract, from award through closeout • Ensures that all project deliverables are completed, ensuring quality deliverables on time and within budget and in accordance with SOPs and GCP• Regional Clinical Project Manager since November 2011

• Managed the execution of the clinical component of regional study protocols in accordance with the scope of work and contracted timelines• Established clinical tools and processes for the study team to support execution of the clinical deliverables• Worked collaboratively with other functional groups to support milestone achievement, track progress and develop contingency plans when necessary• Provided ongoing training and communication for the clinical team • Tracked clinical budget through regular reviews of project scope• Communicated and established a customer service relationship with the clinical client representative• Managed study CRAs, tracked resourcing and planning for database locks

• Provided site monitoring for a variety of Phase II-IV protocols requiring knowledge in multiple advanced therapeutic areas• Performed clinical monitoring in compliance with FDA regulations and all related SOPs• Administered protocol and related study training to sites and established regular lines of communication with sites to manage ongoing project expectations and issues• Evaluated the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalated quality issues to Clinical Team Lead as needed• Managed the progress of studies by tracking IRB submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution• Created and maintained appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation• Acted as a mentor for new clinical staff and provided assistance to the Project Manager and CTL as designated

• Managed prostate cancer and dermatology trials and associated study teams• Developed, implemented and managed comprehensive, cross-functional study plans, in accordance with contractual timelines and Good Clinical Practices (GCPs)• Responsibilities also included helping to write protocols, clinical site and vendor budgets, contracts and timelines

• Led CRA team on multiple phase II-IV prostate cancer and dermatology trials• Enlisted clinical sites to perform research, negotiated budgets and timelines, planned investigator meetings, wrote informed consents, interacted with IRBs• Developed source and CRF documents, developed investigator product labeling, vendor certification and contracts• Ensured compliance with protocol and overall clinical objectives using knowledge of FDA regulatory requirements