Mallory Lauth, Ms Email and Phone Number
Mallory Lauth, Ms work email
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Mallory Lauth, Ms personal email
I'm a high energy project manager who has over 12 years of industry experience across a comprehensive range of laboratory, clinical, and regulatory disciplines. Throughout my career, I have worked in a program management organization (PMO), leveraging best practices and lessons learned to manage projects through all phases of development and the program lifecycle. I bring a positive an upbeat attitude and a commitment to excellence approach to any project that I work on and have a history of finding a way and delivering results. I am a collaborative and proactive leader who thrives in a fast-pace and ever-changing environment, challenges the status quo, and brings the right people together to solve complex problems. I quickly build trust with others, drive accountability across the organization, and know how to meet scheduled project timelines using limited resources. I'm passionate about serving others and in 2021 I founded an organization called Linking Pharma Women (LPW), the focus of which was to create a forum for women in the pharmaceutical industry where they could connect through community, mentorship, and professional growth. To date, LPW has become a community of over 1,500 professional women and it continues to grow. We welcome new members and you can learn more at www.linkingpharmawomen.com.Networking is something that I truly enjoy and if you would like to connect to network or to explore opportunities, send me a connection request or a DM and let's chat!
Lauth Life Sciences
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Founder & CeoLauth Life Sciences Jul 2024 - Present -
FounderLinking Pharma Women Jul 2021 - Present• 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 -
Senior Director, Head Of Program ManagementNeumora Jan 2024 - Oct 2024Watertown, Ma, Us -
Director Program And Portfolio ManagementNeumora Jun 2022 - Dec 2023Watertown, 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. -
Associate Director, Program And Portfolio ManagementUltragenyx Pharmaceutical Inc. Feb 2021 - Jun 2022Novato, 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. -
Senior Project ManagerSyneos Health Sep 2018 - Feb 2021Morrisville, 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. -
Senior Manager, Program And Portfolio ManagementEli Lilly And Company May 2018 - Sep 2018Indianapolis, 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. -
Sr. Associate, Clinical Trial Project ManagementEli Lilly And Company Jan 2016 - Apr 2018Indianapolis, 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. -
Clinical Database Designer IiCovance May 2013 - Dec 2015Princeton, 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 timelines.• 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. -
Sample Coordinator IiiCovance Dec 2011 - May 2013Princeton, 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.
Mallory Lauth, Ms Skills
Mallory Lauth, Ms Education Details
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Indiana University BloomingtonGeneral -
Purdue UniversityBiotechnology Innovation And Regulatory Science
Frequently Asked Questions about Mallory Lauth, Ms
What company does Mallory Lauth, Ms work for?
Mallory Lauth, Ms works for Lauth Life Sciences
What is Mallory Lauth, Ms's role at the current company?
Mallory Lauth, Ms's current role is Program and Portfolio Management // Clinical Excellence // Linking Pharma Women // Passionate About People & Life.
What is Mallory Lauth, Ms's email address?
Mallory Lauth, Ms's email address is ml****@****nyx.com
What schools did Mallory Lauth, Ms attend?
Mallory Lauth, Ms attended Indiana University Bloomington, Purdue University.
What skills is Mallory Lauth, Ms known for?
Mallory Lauth, Ms has skills like Six Sigma, Lean Process Improvement, Project Management, Pharmaceutical Industry, Gcp, Clinical Development, Clinical Trials, Cro, Biotechnology, Clinical Research.
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