Barbara Norman Email & Phone Number

Boston, Massachusetts (Contracted 1 Year Via Flynn Life Sciences Group, Llc)

Oversaw planning and execution of Phase I-II neurology and respiratory clinical programs, managing the conduct of global trials across multiple indications in compliance with GCP. Coordinated cross-functional team activities for timely operational delivery of all studies within the program lifecycle, and achievement of program-level and corporate objectives. Accountable for development and management of clinical development plans and program timelines, financials, and risks.

West Point, Pennsylvania

Senior strategic lead for scientific/clinical research development and execution within Clinical Sciences & Study Management: Cross-functional organization comprised of clinical/scientific and operational resources leading complete clinical trial development and execution life cycle from Phase I-IV. Manage high-profile oncology programs in various stages of development (concept/due diligence through post-marketing life cycle management). Co-lead oncology therapeutic area, including operations planning and oversight partnering with operations senior leader. Lead a team of manager-level direct reports and senior scientific individual contributors with total indirect/matrix leadership over a team of more than 90. Oversight for program planning, protocol development, resource allocation, goal setting, compliance, audit/inspection readiness, data management, budgets, invoicing, clinical research excellence and patient safety.Directed integration of Clinical/Scientific and Operations teams into one cohesive business unit; partnered with Director of Clinical Operations to design new processes and standards to drive performance in oncology. Facilitated cultural integration of two distinct business units.Senior scientific strategic lead for high priority, high-profile immunotherapy program with constant change and aggressive timelines; delivered first compound in 2013 significantly increasing Merck’s industry recognition in oncology.Core Member, Document Review Committee: review a high volume of protocols to ensure accuracy in content, risk and compliance. Radial reviewer for all protocols.Member, Health Literacy, Diversity & Adherence Review Committee, Merck Investigator Study Program: Member of team reviewing research partner proposals and conducting due diligence to determine value, ROI and recommend funding to improve pharmaceutical & health literacy in underserved populations.

West Point, Pennsylvania

Managed oncology clinical scientific unit overseeing up to 15 core protocols in Phase I to III, as well as four life cycle management programs. Recruited, trained, supervised and developed a team of up to seven manager level reports with 40 indirect reports, including contractors and research fellow. Oversaw clinical and scientific aspects of multiple high-profile programs; directed protocol development, patient data, compliance, risk management, financial analysis, budgets, study reporting, submission and approval processes. Led strategic staff and resource reallocation/realignment initiative to prioritize key, critical compounds and meet objectives during corporate realignment; strategically realigned resources and processes to continuously meet and exceed goals with reduced headcount.Consistently met/exceeded organizational goals managing protocols and resources through adversity and change. Led process improvement initiatives to improve performance to key benchmarks and goals; developed new processes across Clinical Science Organization focused on collaboration, best practice, standardization and consolidation.

West Point, Pennsylvania

Transitioned to Oncology Therapeutic Area (Clinical Scientist Organization) in a turnaround situation to improve employee engagement, empowerment, retention and competency and meet critical goals for high-profile programs (Phase I-IV). Managed, developed and coached a team of 48 resources with nine manager level direct reports. Direct accountability for meeting aggressive program deliverables across all studies, including timelines, budgets, compliance and approval. Monitored adherence to ICH and GCP guidelines.Led successful turnaround of Oncology department focused on improving staff morale and engagement, coaching, training and empowerment. Implemented culture change to improve enterprise-wide brand of oncology to attract top talent. Improved Oncology TA performance to goals year over year, including improving study close-out performance, significantly improving employee satisfaction survey results annually, achieving above goal performance on employee engagement score across work environment, change management and morale and consistently meeting and/or exceeding Oncology goals in all programs annually. Managed team through organizational restructuring; led analysis and unit reorganization to reduce headcount by nine and reprioritized program portfolio. Effectively managed increased volume with less headcount. Team Lead, Oncology Site Facing Collaboration Model Implementation: Led a work stream to implement process improvements and business strategies to improve relationships with lead investigators. Successful initiative facilitating increased partnership with field investigators and aligning strategies and resources to optimize business and research results.

West Point, Pennsylvania

Led a team of more than 35 clinical research/scientific specialists and support staff within Clinical Research Specialist Organization managing up to 17 infectious disease/vaccine programs with majority in Phase III and IV (due diligence, licensing candidates through lifecycle management in post marketing phase). Managed strategic planning, budgeting, compliance, risk, employee engagement, talent development and resource allocation.Consistently exceeded Merck Research Laboratory’s goals for filing delivery, study start, regulatory submissions and first cycle approvals. Established and cultivated a development culture and taught leaders how to coach, retain and develop talent. Employed development model and held leaders accountable to provide recognition; established foundation for a culture of engagement and guided and taught strategic performance management.

West Point, Pennsylvania

Managed, coached, trained and developed a team of more than 30 clinical research specialists directing all aspects of Phase I-IV scientific research across more than 17 concurrent neuroscience/ophthalmology programs. Conceptualized, proposed and led neuroscience reorganization to improve performance to goals, staff development opportunities, increase efficiency and better allocate responsibilities, while reducing headcount.Member, Clinical Research Sciences Senior Management Team: developed and implemented new policies, procedures, best practices and standards for CRS organization. Created strategic plans and allocated resources to meet critical book of business and franchise objectives. Led critical, high-profile program and initiated study at 31 sites: exceeded enrollment goal by 20%+ and completed program ahead of schedule. Member of a cross-functional managerial feedback team to lead design, development and launch of year-end performance management tools.Member of high-profile, critical Global Intelligent Industrialization Detailed Design Team. Member of project team to develop and deliver Alzheimer’s data presentation to FDA.Recipient, “Merck Division/Staff Area Award”, 2004, 2007, 2008, 2009.

West Point, Pennsylvania

Managed a team of 12 clinical research specialists leading planning, startup, management and closeout of clinical studies; oversaw a CRO within Alzheimer’s disease protocol. Oversight for clinical excellence, compliance and quality assurance from Phase I-V; directed clinical site monitoring, site initiations, investigation assessments and protocol implementation. Collaborated with key internal business units across operations, US Human Health, R&D, study vendors and study sites. Trained and mentored new medical program coordinators and clinical monitors (trial physicians). Managed first Alzheimer’s disease program with a total of three protocols; authored phase IIa proof-of-concept protocol for MRL’s second Alzheimer’s program. Co-authored Alzheimer’s disease treatment protocol. Initiated and led Alzheimer’s disease treatment protocol; completed enrollment ahead of schedule. Recipient, “Merck Special Achievement Award”, 2000, 2002, 2004. Recipient, “Merck Award for Excellence”, 1996, 1997, 1999, 2002, 2005.

West Point, Pennsylvania

Promoted rapidly through all levels of research biologist. Served as supervisor as needed and trained and mentored new staff. Worked in investigational toxicology laboratory.