Project Director II Resume Example

• Served as U.S. Project lead and functional manager monitoring project goals, timelines, and deliverables for two projects on Nonalcoholic Steatohepatitis / Nonalcoholic Fatty Liver Disease (NASH/NAFLD) pharmaceutical product development
• Supervised Sr/Project Managers, five of which were leading oncology studies
• Was directly involved in pharmacy manual development, timeline development, budget negotiations, weekly safety meeting attendance/documentation for two of the five referenced oncology studies
• I was responsible for ensuring quality project implementation according to clearly delineated contract expectations and requirements as well as serving as a Sponsor interface along with the Project Manager
• Partnered with investigators and clinical staff to ensure proper training and comprehension of clinical trial processes and protocols
• Credited for project data quality and compliance by routinely monitoring Project Manager activities and providing effective coaching
• Collaborated with cross-functional teams including the Ethics Committee and regulatory staff to devise innovative solutions for clinical study and pharmaceutical trial-related issues
• Successfully co-developed site responses for third party and FDA audit findings

• Orchestrated implementation of clinical projects in indications of Chronic Insidious Constipation, Pediatric Chronic Pain, and Amyotrophic Lateral Sclerosis and the rare disease, Pompe Disease
• Established reputation for resourcefulness
• Inspired and trained cross-functional teams enabling completion of time-sensitive, compliant deliverables
• Commended for skillful management of budgeting, targeted timeline improvements, and allocation of resources for clinical projects

• Promoted through roles of increased scope and accountability for exemplary performance including Senior Director leadership for four consecutive years
• Directed global studies focused on various clinical indications, including a cardiovascular mega-trial as well as central nervous system (CNS) psychiatric diseases and Parkinson's Disease studies in the U.S
• And Europe; schizophrenia research in the U.S., Europe, and Latin America; depression in the U.S
• And a chronic spinal cord injury project in the U.S., Western Europe, India, Australia, and New Zealand

• Adeptly delegated priorities for project management team with as many as 15 direct reports (Assoc
• PM to Sr
• Director), supporting professional development regularly and consistently encouraging open communication and mentoring which resulted in team-engagement survey scores as high as those across all therapeutic areas in Project Management
• Constructed and delivered global workshop on employee engagement and participation benefits for more than 120 CNS study staff across Europe and the U.S
• Screened prospective CNS Project Management candidates for U.S
• Region partnering with internal recruiter to vet and select qualified talent for the interview process
• Executed business plans and developed [Type] tools to facilitate project initiatives, trainings and administrative activities

• Executed operational leadership support and guidance for global, multi-center schizophrenia, osteoporosis and antibiotic clinical projects, a chronic spinal cord injury study, a mega-trial for ST-elevated MI which enrolled 20,400 patients globally across approximately 650 sites in 48 countries across North America, Europe and Asia and a US-based study in Parkinson's Disease
• Interviewed and hired talented [Job title]s with expertise in [Area of expertise] to increase [Type] strengths within already gifted department

• Facilitated operations for research sites, including selecting and maintaining sites, and served as primary point-of-contact for contract research organizations and other third party vendors
• Contributed valuable solutions as participant in several task force initiatives, such as providing subject area-expertise for the Clinical Management Plan template SOP review and updates and a manual for successful collaboration with CROs
• Co-authored Clinical Study Reports and safety sections of special interest of two NDAs
• Both compounds were approved by FDA

Additional experience as Manager/Assistant Director/Senior Clinical Research Associate, Clinical Operations, HOECHST MARION ROUSSEL, Kansas City, Missouri, and Outpatient Staff Pharmacist,
UNIVERSITY OF KANSAS MEDICAL CENTER, Kansas City, Kansas.

• Served as U.S.
• Project lead and functional manager monitoring project goals, timelines, and deliverables for two projects on Nonalcoholic Steatohepatitis / Nonalcoholic Fatty Liver Disease (NASH/NAFLD) pharmaceutical product development.
• Supervised Sr/Project Managers, five of which were leading oncology studies.
• Was directly involved in pharmacy manual development, timeline development, budget negotiations, weekly safety meeting attendance/documentation for two of the five referenced oncology studies.
• I was responsible for ensuring quality project implementation according to clearly delineated contract expectations and requirements as well as serving as a Sponsor interface along with the Project Manager.
• Partnered with investigators and clinical staff to ensure proper training and comprehension of clinical trial processes and protocols.
• Credited for project data quality and compliance by routinely monitoring Project Manager activities and providing effective coaching.
• Collaborated with cross-functional teams including the Ethics Committee and regulatory staff to devise innovative solutions for clinical study and pharmaceutical trial-related issues.
• Successfully co-developed site responses for third party and FDA audit findings.

• Orchestrated implementation of clinical projects in indications of Chronic Insidious Constipation, Pediatric Chronic Pain, and Amyotrophic Lateral Sclerosis and the rare disease, Pompe Disease.
• Established reputation for resourcefulness.
• Inspired and trained cross-functional teams enabling completion of time-sensitive, compliant deliverables.
• Commended for skillful management of budgeting, targeted timeline improvements, and allocation of resources for clinical projects.

• Promoted through roles of increased scope and accountability for exemplary performance including Senior Director leadership for four consecutive years.
• Directed global studies focused on various clinical indications, including a cardiovascular mega-trial as well as central nervous system (CNS) psychiatric diseases and Parkinson's Disease studies in the U.S.
• And Europe; schizophrenia research in the U.S., Europe, and Latin America; depression in the U.S.
• And a chronic spinal cord injury project in the U.S., Western Europe, India, Australia, and New Zealand.

• Adeptly delegated priorities for project management team with as many as 15 direct reports (Assoc.
• PM to Sr.
• Director), supporting professional development regularly and consistently encouraging open communication and mentoring which resulted in team-engagement survey scores as high as those across all therapeutic areas in Project Management.
• Constructed and delivered global workshop on employee engagement and participation benefits for more than 120 CNS study staff across Europe and the U.S.
• Screened prospective CNS Project Management candidates for U.S.
• Region partnering with internal recruiter to vet and select qualified talent for the interview process.

• Executed operational leadership support and guidance for global, multi-center schizophrenia, osteoporosis and antibiotic clinical projects, a chronic spinal cord injury study, a mega-trial for ST-elevated MI which enrolled 20,400 patients globally across approximately 650 sites in 48 countries across North America, Europe and Asia and a US-based study in Parkinson's Disease.

• Facilitated operations for research sites, including selecting and maintaining sites, and served as primary point-of-contact for contract research organizations and other third party vendors.
• Contributed valuable solutions as participant in several task force initiatives, such as providing subject area-expertise for the Clinical Management Plan template SOP review and updates and a manual for successful collaboration with CROs.
• Co-authored Clinical Study Reports and safety sections of special interest of two NDAs.
• Both compounds were approved by FDA.