
Accomplished Senior Director of Project Delivery driving proven results over 20 years within the clinical research industry. Manages complex occupational issues while meeting business objectives. Strong operational skills and solid experience regulating policies and managing budget expenditures. Collaborates with management teams and stakeholders to uphold company vision and overall customer satisfaction. Strategic-thinking individual experienced in turning low-performing project management teams into top revenue producers. Offering engaging and pleasant personality with expertise improving customer relationships.
Please see job description under Senior Project Director position.
Acted as Program and Oversight Director for a rare disease gene therapy program. Participated in proposal development and bid defenses which led to three awarded studies under this program. Built a customer-CRO playbook to ensure operational consistency across each study. Supervised team performance against contract, customer expectations, and project baselines.
In addition to above, also acted as a Project Leader for a VMS trial within Women's Health that was under high escalation. Ensured customer needs were met and improved overall customer-CRO experience.
Acted as a Project Director for multiple study programs and/or large global trials (30+ countries with a NET value of $95MM) for NASH and chronic heart failure indications. Owned, drove, and delivered in Bid Defenses, Kick-Off Meetings, and overall study launch with minimal oversight. Full command and control of financial management by owning revenue projections, resource projections, and/or change order management. Directly engaged and managed Client and PRA Senior and/or Executive Management Levels including but not limited to project risks, mitigation strategies, and recovery plans with the client's Clinical Development Plan in mind. Mentored and grew Project Managers and other Functional Leads. Provided feedback on project team performance to respective line managers. Capable and able to significantly contribute to proposal development by leading operational strategy and/or supporting budget specifications. Capable and able to significantly contribute to proposal development by leading operational strategy and/or supporting budget specifications.
Acted as the client's primary liaison as Global Project Manager for a fully scoped $40MM global (21+ countries) rare disease, cardio-metabolic Phase III program. Managed global project contractual deliverables, risks, and project finances. Led and directed cross-functional team members and third party-vendors. Mentored regional Project Managers and other project team members.
Managed a small complex Gastroenterology Phase II trial within a client portfolio. Provided oversight to other Clinical Project Managers, assisted with training new project management staff, developed new working practices, and assisted with the management of clinical Standard Operating Procedures. Developed metric strategies within clinical and monitoring reporting to identify trends and areas of improvement. Developed a new protocol deviation and violation process as well as central repository to track all protocol deviations and violations to improve on identifications of major deviations/violations. Created enrollment projection reports including subject recruitment months and strategies to determine subject recruitment rates. This helped improve more visibility on project risk identification to Last Patient In.
Acted as the Regional and Lead Project Manager for 2 large, global Infectious Diseases Phase III trials under a Client-Sponsor partnership. Acted as the Lead Project Manager for 1 complex and global Rare Disease Phase III trial.
Acted as a Regional and/or Lead Project Manager for Infectious Disease, Anesthesiology, Oncology, and Immunology Phase III trials including but not limited to owning and achieving interim and final contractual deliverable according to time, quality, and cost constraints; lead and directed global cross-functional teams; managed to client expectations to achieve client satisfaction. Post award of a rescue Immunology program from another CRO, developed and implemented a successful transition project plan.