Mallory Lauth, Ms Email & Phone Number

• Built a community of over 3,000 women to champion other women in the pharmaceutical industry across all regions, companies and departments for mentorship and professional growth.
• Created mentorship programs, designed in-person and virtual networking events, in-person speaker panel events, and in-person workshops.
• Developed sponsorship packages for marketing to potential corporate partners.
• Built and maintained organizational website and social media accounts

Watertown, MA, US

Watertown, MA, US

• Direct operations and provide strategic direction to develop, maintain, and execute the nonclinical, clinical, CMC, regulatory, and commercial functions for clinical stage neurological programs.
• Spearhead initiatives in a growing PMO organization including developing and streamlining processes to support the program team.
• Develop and maintain standard documents for processes to create a more streamlined program management organization including the Integrated Program Plan (IPP) and program contracts.
• Collaborated with project teams to develop dashboards and execute program strategies throughout the program life cycle, from discovery through IND and all phases of clinical development.
• Coordinated preparation of high-quality program documents for corporate governance matters, the Board of Directors, and other high-level business reviews.

Novato, California, US

• Supported the program team to develop, maintain, and execute the nonclinical, development, CMC, medical affairs, and commercial strategy for rare disease programs ranging from pre-IND through commercialized products.
• Managed R&D project management processes across the portfolio, including goal setting, quarterly reviews, project prioritization, go/no-go decisions, and data reviews based on key milestones.
• Performed risk assessments and monitored project status to ensure that projects were progressing to plan, while mitigating risks and implementing measures to ensure on-time completion.
• Prioritized workloads, removed bottlenecks, directed workflow activity across resources, and drove accountability to achieve performance metrics.
• Collaborated with other departments to improve interactions and processes, capitalize on opportunities to increase productivity, reduce costs, and drive new corporate policies.
• Worked with VP of Finance to enhance the PMO budget process, including document generation to provide increased training to the organization to improve processes and team efficiency.

Morrisville, NC, US

• Designed, developed, and managed project schedules for business development, clinical, and commercial stage programs.
• Served as the primary liaison between Syneos Health and drug sponsor who ensured projects met all milestones on time and within budget; this led to additional new business opportunities.
• Assigned tasks to project support staff, directed management of clinical staff, and mentored other project managers during oversight of global clinical trial programs.
• Achieved Last Patient Randomized milestone by implementing creative strategies to turn around project which was 50% behind schedule and was in a resource-constrained environment.
• Served as liaison between company and customer to ensure project launch, execution, and closeout per the customer’s requirements and the scope of the contractual agreement.

Indianapolis, Indiana, US

• Responsible for the integration of key project management processes for the company’s largest asset while maintaining the project’s scope, timeline, budget and quality.
• Collaborated with cross-functional teams (including marketing, medical, manufacturing, clinical, and regulatory) to meet program requirements and were aligned on a single, global integrated development plan.
• Introduced new systems, processes, and workflows or proposed modifications to the organization’s existing processes and systems to improve team efficiencies.
• Optimized $180M annual budget, developed cost savings initiatives, ensured executive leadership alignment, and drove operational excellence across the project for on-time completion.
• Identified and implemented strategy and timeline for FDA submission of a new indication and collaborated with senior leadership of a diabetes late phase compound.

Indianapolis, Indiana, US

• Managed global phase 3 registration study, which included preparing for and completing interim and final database locks.
• Oversaw the overall conduct of assigned clinical trials, including all aspects of the clinical trial process from protocol concept through clinical study report completion.
• Led the submissions and workstreams and ensured early delivery on timelines and enabled on-time US and EU submissions.
• Drove process improvement initiatives to reduce the amount of time required to create patient narratives, preventing the need for a third party and saved company approximately $2M.
• Oversaw budgetary aspects of therapeutic area clinical trials, led submission meetings, and managed the completion of the Clinical Study report appendices and module 5 in preparation for FDA submissions.

Princeton, New Jersey, US

• Provide project management oversight for the internal departments to coordinate, compile, and load various aspects of the clinical database including communicating and coordinating with global teams to meet critical.
• Managed and solved technical changes related to the clinical database, issues and concerns of varied complexity.
• Assisted with trouble shooting technical and logistical issues within the project management team.
• Worked in core groups within the technical team for database updates, continuous process improvements, and quality improvements.

Princeton, New Jersey, US

• Primary departmental contact for supervisors, study leads, and lab techs when study amendments or special processes were needed and assisted in troubleshooting and investigating customer inquiries related to protocol.
• Established process to verify all team training requirements were fulfilled and supported the training of new employees and provided cross training as needed.
• Attended pre-study meetings to coordinate testing protocols and specifications with clients, study leads, scientists, and other departments including formulations, clinical pathology, and histology.

Bachelor'S Degree, Biology, General

Master'S Degree, Biotechnology Innovation And Regulatory Science