Hillarie Plessner Windish, PhD
Senior Director, Clinical Development at Sarah Cannon Development Innovations, LLC- Claim this Profile
Click to upgrade to our gold package
for the full feature experience.
Topline Score
Bio
Tim Graham MS, MBA, PMP
It's rare to find a client so dedicated and enthusiastic about her projects and goals as Hillarie Plessner Windish. I've had the pleasure of working with her over the past 5 years, collaborating on several complex projects while at The Jackson Laboratory. What most impressed me was her attention to detail as well as her ability to adapt when hard decisions needed to be made. There's not a doubt in my mind that she will continue to be successful in her career for years to come. I wish her the very best of luck!
Tim Graham MS, MBA, PMP
It's rare to find a client so dedicated and enthusiastic about her projects and goals as Hillarie Plessner Windish. I've had the pleasure of working with her over the past 5 years, collaborating on several complex projects while at The Jackson Laboratory. What most impressed me was her attention to detail as well as her ability to adapt when hard decisions needed to be made. There's not a doubt in my mind that she will continue to be successful in her career for years to come. I wish her the very best of luck!
Tim Graham MS, MBA, PMP
It's rare to find a client so dedicated and enthusiastic about her projects and goals as Hillarie Plessner Windish. I've had the pleasure of working with her over the past 5 years, collaborating on several complex projects while at The Jackson Laboratory. What most impressed me was her attention to detail as well as her ability to adapt when hard decisions needed to be made. There's not a doubt in my mind that she will continue to be successful in her career for years to come. I wish her the very best of luck!
Tim Graham MS, MBA, PMP
It's rare to find a client so dedicated and enthusiastic about her projects and goals as Hillarie Plessner Windish. I've had the pleasure of working with her over the past 5 years, collaborating on several complex projects while at The Jackson Laboratory. What most impressed me was her attention to detail as well as her ability to adapt when hard decisions needed to be made. There's not a doubt in my mind that she will continue to be successful in her career for years to come. I wish her the very best of luck!
Experience
-
Sarah Cannon Development Innovations, LLC
-
United States
-
1 - 100 Employee
-
Senior Director, Clinical Development
-
Jan 2023 - Present
-
-
Director, Clinical Development
-
Oct 2021 - Present
-
-
-
Cancer Targeted Technology
-
United States
-
Advertising Services
-
1 - 100 Employee
-
Senior Director, Oncology Programs
-
Jun 2017 - Sep 2021
Initially hired as Director of Oncology Programs at Cancer Targeted Technology (CTT), I was promoted to Senior Director in January 2021. I interface with CMOs, CROs, academic laboratories and clinical facilities as we clinically develop targeted diagnostic and therapeutic agents for cancer therapy. I oversee the GMP manufacturing program, act as CTT's clinical interface, manage the EDC, the eCTD and non-clinical programs required to ultimately attain marketing approval. • Direct nonclinical and clinical programs to develop diagnostic and therapeutic candidates • Identify and manage expert external consultants, CROs, CMOs and collaborators • Manage eCTD (FDA) submissions, including pre-IND, IND, IND amendments and annual reports • Design nonclinical and manufacturing studies, draft and circulate relevant requests for project proposals (RFPs) • Oversee projects at CROs, CMOs, clinical studies and academic experimentation to meet program deliverables • Coordinate with CMOs for GMP manufacturing drug products • Draft successful program budgets and funding applications Show less
-
-
-
Jain Foundation Inc
-
United States
-
Research
-
1 - 100 Employee
-
Director of Preclinical Development
-
Aug 2016 - May 2017
The Jain Foundation is a privately funded non-profit organization with a mission to cure a rare autosomal recessive form of muscular dystrophy, LGMD2B/Miyoshi myopathy. Potential therapeutic avenues range from chemical drugs, biologics and mechanisms for gene therapy. Toward accomplishing this mission, the Jain Foundation team identifies roadblocks to finding a therapy and solves those problems through guided projects at academic and contract research organizations. Our model was described in Fastercures Giving Smarter Guide in November 2016 http://www.milkeninstitute.org/publications/view/834.In my role as Director of Preclinical Development, I work with academic researchers and scientists in contract research, biotechnology and pharmaceutical companies. I evaluate new potential therapeutic programs in diverse biological fields and build networks required to accomplish the organization's mission. Selected duties and accomplishments:• Contributes guidance, vision, strategy and leadership throughout complete product life cycle• Leads validation of a clinical biomarker platform in preparation for clinical trials• Delivers programs to evaluate candidate therapies in high throughput and preclinical models• Manages external scientific teams and contractors• Networks and facilitates collaborations• Scientific and technical writing projects such as drafting and editing documents and protocols and collaborates with General Council to negotiate legal agreements with collaborators Show less
-
-
Research Program Officer
-
Feb 2012 - Aug 2016
As a result of my ability to conceptualize, organize, manage and deliver programs beyond expectations, I was promoted to Director. In this role, I honed my skills in program management and in building relationships and networks needed to meet program goals.• Improved and implemented methods to increase team efficiency and organization• Introduced and spearheaded and lead contract research programs to develop a highly discriminatory biomarker panel currently in validation phase• Identify new and re-purposed drugs to take forward to clinical trials and created biopharm partnerships required to take therapeutics forward• Delivered a program to isolate iPSC from patient blood cells as a resource for the research community, including writing relevant IRB documentation and gaining safety approvals• Contributed scientific direction of all projects funded by the foundation• Contributed to scientific program programming and organization of scientific conferences Show less
-
-
-
Infectious Disease Research Institute
-
United States
-
Biotechnology Research
-
1 - 100 Employee
-
Postdoctoral Scientist
-
Sep 2008 - Jan 2012
IDRI is a not-for-profit committed to applying innovative science to the research and development of products to prevent, detect and treat infectious diseases of global importance. As a postdoctoral scientist at IDRI, not only did I perform innovative research to elucidate mechanism of action and efficacy of new vaccines, but I managed technicians and participated in improving the infrastructure. In this role, I built lasting relationships which I brought with me to my next position. • Produced mechanism of action and tested efficacy of candidate tuberculosis vaccines that have subsequently entered clinical trials • Improved on safety measures in BSL3 facilities and trained staff in BSL1, BSL2 and BSL3 facilities, experimental design and data analysis • Maximized productivity of managed scientific technicians • Trained staff in immunologic assays, necropsy and other technical laboratory skills • Completed BD Biosciences multi-color flow cytometry panel design course • Delivered high quality manuscripts, drafted and edited SOPs Show less
-
-
-
University of Pittsburgh School of Medicine
-
United States
-
Higher Education
-
700 & Above Employee
-
Immunology Graduate Student
-
Jul 2003 - Aug 2008
As a graduate student, I designed and executed scientific experiments to define how the host defends itself from the bacterium Mycobacterium tuberculosis. I published multiple high quality papers and supervised several summer research students while a student in Dr. Flynn's laboratory. As a graduate student, I designed and executed scientific experiments to define how the host defends itself from the bacterium Mycobacterium tuberculosis. I published multiple high quality papers and supervised several summer research students while a student in Dr. Flynn's laboratory.
-
-
-
Louis F. Vida, DDS
-
United States
-
Medical Practices
-
Dental Assistant
-
Jan 1998 - May 2003
As a dental assistant working with Dr. Vida, I assisted in providing excellent dental care, collected dental x-rays, sterilized instruments and procedural rooms and generally helped to make the patients visit more comfortable. I obtained this position while attending college, and maintained employment until leaving for graduate school. This position was an excellent introduction into work ethic and helped to shape my passion for bringing medical innovations to patients. As a dental assistant working with Dr. Vida, I assisted in providing excellent dental care, collected dental x-rays, sterilized instruments and procedural rooms and generally helped to make the patients visit more comfortable. I obtained this position while attending college, and maintained employment until leaving for graduate school. This position was an excellent introduction into work ethic and helped to shape my passion for bringing medical innovations to patients.
-
-
Education
-
University of Pittsburgh School of Medicine
PhD, Immunology (Infectious Disease) -
Arcadia University
BA, Biology -
NIH Office of Clinical Research
Certificate, Principles and Practice of Clinical Research