About Dr. Scott


Dr. Scott is an energetic professional with over 30 years in the pharmaceutical/biotech industry working to develop novel small molecules and biotherapeutics.  Although she has retired from full time engagements, she may be available for short term strategic consultations.  Please reach out via Linked In  https://www.linkedin.com/in/marycelinescott/

Her demonstrated capabilities include:

  • Leading teams to produce high quality dossiers (INDs and/or CTAs) for rapid and safe initiation of early trials of novel compounds, which meet or exceed the expectations of global Competent Authorities,
  • Facilitating development and implementation of streamlined investigational programs that lead to rapid test of proof of concept, and go/no go decisions,
  • Ensuring alignment and clear communication between development teams, global Health Authorities and other stakeholders,
  • Developing processes so that quality and compliance are maintained and demonstrated by project deliverables,
  • Motivating teams to rapidly advance products that will treat unmet medical needs,
  • Leading to successful marketing applications (NDA/ BLA/ MAA), resulting in approval of novel compounds with demonstrated pharmacoeconomic benefit.

Dr. Scott has worked as an independent consultant for a range of biopharmaceutical and venture capital firms, ranging from start ups and virtual companies to mid-size and large pharma, supporting global regulatory interactions from FIH to marketing authorizations, and beyond.  Engagements have included  short term support for resource-intensive projects,  serving as the sole regulatory representative for full development programs, and long-term backfill for growing and mature organizations.

Dr Scott’s last FTE position was on the Regulatory Team of  Trius Therapeutics, where she facilitated the US, EU and Canadian marketing applications for their first product, supporting Health Authority meetings (including an Advisory Committee meeting), submissions and responses to Agency queries, while building the regulatory infrastructure for a commercial organization.  Sivextro (tedizolid phosphate) was approved in the US in June 2014, following a unanimous vote for approval at the AIDAC meeting in May 2014.  Sivextro was subsequently approved in most major geographies, and all responsibilities were transferred to Cubist Pharmaceuticals, prior to their acquisition by Merck.

Prior to her work at Trius,  Mary was a Clinical Team Leader at Pfizer, where she combined her scientific and organizational skills to lead several teams working on the development of novel biotherapeutic agents in the critical space between first-in-human trials and proof of concept.  Her prior roles have been positions of increasing responsibility and scope within regulatory affairs at Pfizer, Amgen and Schering-Plough Research Institute, firms with organizational structures ranging from “virtual” small companies within the organization to fully matrixed traditional development teams.  She has worked across the scope of drug development, from pre-IND (CTA) to marketing applications, with a wide range of therapeutic modalities — traditional small molecules, traditional and novel biotherapeutics and therapeutic vaccines.  She enjoys developing talent and has been successful as a mentor for corporate colleagues, as well as university students.

Dr. Scott received a PhD from Purdue University in Pharmacology (specialization neuroscience), followed by a postdoctoral fellowship at the Mayo Clinic in the emerging field of pharmacogenetics.  She also has an MBA in Pharmaceutical/Chemical Studies from Fairleigh-Dickinson University, an MS in Biology from California State University, Long Beach and a BS in Biological Sciences from the University of California, Irvine.