Mark Holst Email & Phone Number

Cambridge, Ma, Us

• Develop and oversee implementation of the study-level operational strategy and plans for the successful delivery of clinical studies.• Chair the Study Management Team to drive the development of scientifically robust and operationally feasible protocols and oversee the delivery of quality studies within timeline and budget forecasts.• Partner with the CRO SMT lead to ensure the CRO creates appropriate risk-mitigation plans and effectively identifies/resolves issues.• Champion synergies among other studies, programs and development units to enhance excellence in study planning and execution.

Lawrence Township, Nj, Us

• Leads successful and timely operational execution of global interventional clinical trials from concept to final clinical study report.• Primary operational contact for the study and leads the cross-functional global team for study execution.• Develops, manages, and maintains study deliverables through collaboration with internal and external stakeholders using data and strong interpersonal influencing skills to make robust data driven decisions.• Informs operational program lead(s) and other leadership on overall clinical trial plans and recruitment status and raises potential issues/mitigation.

Cambridge, Ma, Us

• Primary country level Biogen contact accountable for strategic development and execution of country activities related to the required sponsor oversight of CRO and clinical trial activities.• Provide global teams with detailed local operational and scientific knowledge that will substantiate the overall clinical development strategy and ensure that local opportunities and needs are integrated into operational plans. • Provide operational direction and prioritize activities for local resources to provide a single point of contact for investigators, affiliate office staff, CRO staff, and Global Clinical Operations/global teams to deliver local clinical trial quality and oversight of CRO activities, with a country level focus on performance.• Hold operational and scientific discussions and act as local GCO expert for the provision of country level therapeutic area, disease area, and program and study information to drive and support global operational strategy.

Morrisville, Nc, Us

• Responsible for the overall conduct, data quality, compliance and timelines for Phase 3 clinical trials in Type 1 and Type 2 diabetes• Provide study updates utilizing CTMS and other systems for management and other stakeholders• Ensure start-up activities, study plans and deliverables are completed per timeline and project plan• Develop and responsible for financial aspects of US clinical trial budget

North Chicago, Illinois, Us

• Create MS Project schedules and Swimlane reports for Clinical Teams and trained over 100 Clinical Operations staff members on MS Project• Identified critical path in each clinical study in MS Project to ensure key deliverables and milestones are completed per plan• Publish metric reports for management on key milestones and analyze planned vs. actual completion dates for potential process improvement

North Chicago, Illinois, Us

• Project and CRO management of Atrasentan Phase 2 and 3 domestic and global clinical studies as well as Phase 1 studies (PK, BA, DDI)• Managed global Phase 3b study in patients with secondary hyperparathyroidism• Developed study and site budgets and managed vendors per contract and project plan• Reviewed vendor proposals and managed selection of CROs and other vendors• Led Clinical Team Meetings and communicated project status reports to management and GPT• Responsible for the coordination of cross-functional activities for the timely execution and completion of clinical projects

Lake Forest, Il, Us

• Project and CRO/vendor management of Precedex Phase 3 and 4 domestic and global clinical studies• Management of CRAs including professional development and performance management• Coordinated development of systems and completion of clinical documents to ensure rapid study start-up• Communicated project status reports to management and planned/led team meetings• Developed and updated clinical SOPs and Working Instructions

Deerfield, Illinois, Us

• Program Manager for a global Phase 2 study in patients with anemia• Represented Global Clinical Affairs on corporate New Product Development initiative, resulting in reduced development timelines• Led initiative to resolve temperature excursions with a refrigerated clinical study drug• Responsible for US project and CRO management for Phase 3b study in renal failure patients and completed sNDA submission on time• Organized a panel of acute renal failure experts to assess new product ideas for unmet needs

Deerfield, Illinois, Us

• Managed CRO and project management activities for Phase 3 study in patients with thrombocytopenia, resulting in a successful NDA submission• Tracked study budget per site and CRO contracts and identified $200,000 in billing variances• Managed SAE reporting and provided updates for DSMB meetings and IND Annual Reports• Led clinical team in eCRF development using electronic data capture for two Phase 3 studies

Us

• Planned and directed the assignments of a Clinical Trials Management Team based on project plan and departmental priorities• Assisted with recruiting and staffing of CRAs for Phase 3 peri-operative pain study• Reviewed incoming Requests for Proposals (RFPs) to evaluate project feasibility and staffing• Developed timelines and reported project updates to Scirex management and the sponsor• Presented at Investigator meetings and represented Scirex at new client presentations

Abbott Park, Illinois, Us

• Maintained project timelines, reported updates to management and developed action plans• Led propofol launch team meetings with Manufacturing, Regulatory and Commercial• Responsible for protocol development, CRF design and vendor selection and management• Negotiated contracts with investigators, labs and contract statisticians and medical writers• Presented clinical program strategy to FDA with a favorable outcome advancing the program• Key clinical contributor in three clinical programs which received FDA approval• Obtained patent (U.S. #5,284,776) which significantly reduced analytical workload and costs• Developed pre-clinical protocols to evaluate LHRH antagonists and atrial natriuretic factor analogs