Summary
Overview
Work History
Education
Skills
Timeline
Generic

Megan Price-Schluns, MPH

Program Manager
Houston,TX

Summary

Skilled Program Manager with an MPH in Biostatistics and Epidemiology and 9+ years of experience in the biopharmaceutical and biotechnology industry. Specific experience in drug development, precision oncology, companion diagnostics, real world data, infectious disease, and vaccines.

Overview

9
9
years of professional experience

Work History

Senior Manager, Program Management, Clinical Development

Moderna Inc
10.2021 - 04.2024

Latent Virus Portfolio (Early Phase Program)

  • Co-lead the development of program strategy together with the program lead and core team on two early-phase latent virus programs to drive programs through milestones
  • Aligned internal cross-functional teams including Preclinical, CMC, Regulatory, Clinical, and Clinical Operations to lead a vaccine candidate to IND submission and Phase I Launch.
  • Support programs by working cross functionally to map out timelines and planning of governance meetings, regulatory meetings, regulatory filings, clinical development plan and launch
  • Led financial projections for long-range planning and budget reviews

Respiratory Virus Portfolio (Late Phase Program)

  • Managed the Lifecycle Strategy Workstream with Commercial and Global Supply Chain teams.
  • Initiated Observational Study Sub-team to ensure observational study stakeholders across Infectious Disease Epidemiology, HEOR, and Medical Affairs departments were aware of ongoing observational and real-world evidence and ensured they aligned with the overall program strategy.
  • Formed Initiated a Technical Review Committee that reviews all observational and real-world evidence studies across the Infectious Disease portfolio for endorsement.
  • Enhanced team performance with regular coaching sessions, focusing on individual strengths and areas for improvement

Senior Clinical Project Manager

OM1 Inc
12.2019 - 09.2021
  • Oversaw multi-site Next Generation Registry (NGR) studies that utilize real-world evidence for FDA submission including post-marketing commitment and claim expansion under the 21st Century Cures Act.
  • Aligned cross-functional teams to drive project completion, developed study plans, and ensured operational success.
  • Worked with C-suite to identify and resolve internal process issues.

Manager, Alliance Management

Foundation Medicine Inc.
07.2019 - 11.2019
  • Coordinated cross-functional teams, including biostatistics, regulatory, and platform development, to drive project completion and execute Companion Diagnostic contracts.
  • Communicated proactively on project timelines and assisted Corporate Development in formulating long-term strategies for the Biopharma team.
  • Developed and refined processes for Alliance Management in Data Products by collaborating with Cancer Genomics, Data Science, and Product Management teams.

Senior Associate, Biopharma Operations

Foundation Medicine Inc.
09.2017 - 06.2019
  • Presented webinars on study processes and timelines, fostered relationships, and managed financial tracking for genomic profiling projects.
  • Tracked operational feasibility and onboarded new associates.

Associate, Biopharma Operations

Foundation Medicine Inc.
03.2016 - 08.2017
  • Managed pharmaceutical collaboration partnerships, oversaw sample management for over 25 studies, and provided metrics on lab performance.

Clinical Data Associate

ECOG-ACRIN Cancer Research Group
12.2014 - 03.2016
  • Ensured data accuracy for phase III melanoma clinical trials, queried sites, and communicated with external institutions.

Education

Master of Public Health - Biostatistics And Epidemiology

Boston University
Boston, MA
05.2001 -

Bachelor of Science - Public Health

University of Texas At Austin
Austin, TX
05.2001 -

Skills

Microsoft Office

Smartsheet

Jira

Confluence

CRM

Project Management

Alliance Management

Program Management

Clinical Development

Observational Studies

Real World Evidence

Precision Oncology

Companion Diagnostics

Vaccines

mRNA

Biotechnology

Drug Development

Scenario Mapping

Timeline

Senior Manager, Program Management, Clinical Development

Moderna Inc
10.2021 - 04.2024

Senior Clinical Project Manager

OM1 Inc
12.2019 - 09.2021

Manager, Alliance Management

Foundation Medicine Inc.
07.2019 - 11.2019

Senior Associate, Biopharma Operations

Foundation Medicine Inc.
09.2017 - 06.2019

Associate, Biopharma Operations

Foundation Medicine Inc.
03.2016 - 08.2017

Clinical Data Associate

ECOG-ACRIN Cancer Research Group
12.2014 - 03.2016

Master of Public Health - Biostatistics And Epidemiology

Boston University
05.2001 -

Bachelor of Science - Public Health

University of Texas At Austin
05.2001 -
Megan Price-Schluns, MPHProgram Manager