Julie Cramer, PhD, Joins Pittsburgh-Based Contract Research Organization, Clinical Research Strategies, LLC as Associate Director of Clinical and Regulatory Affairs
Pittsburgh, PA – November 2, 2021. Clinical Research Strategies, LLC (“CRS”), a Pittsburgh-area-based, US-owned and operated contract research organization (CRO) and executive management consultancy for the life sciences industry is pleased to announce the addition of Julie Cramer, PhD, Associate Director of Clinical and Regulatory Affairs, to the firm. Dr. Cramer earned her PhD from the University of Pittsburgh in Pathology, with a focus on intestinal stem cells and their link to intestinal cancer. When the opportunity came to join a local life sciences startup that had licensed a technology from the University of Pittsburgh, she embraced the challenge and quickly came to understand how it takes careful management of a cross-disciplinary team to navigate the often turbulent entrepreneurial waters.
Dr. Cramer then returned to her alma mater to work in commercial translation at the University of Pittsburgh’s Innovation Institute. Acting as liaison to the University’s close clinical partner, UPMC, Dr. Cramer managed diverse programs, including digital health and immunotherapy, to enable nascent technologies to mature into valuable intellectual property ready for licensing.
From academic research to commercial translation and life in a startup, Dr. Cramer has truly lived the translational science path, bringing a strong background in cancer, immunology, women’s health, digital health, diagnostics, scientific writing, technology transfer, intellectual property, funding and licensing.
Dr. Cramer is also a senior member and mentor of the Pittsburgh Chapter of Women in Bio and remains actively involved with community outreach that fosters programs in STEM.
CRS CEO and Chief Quality and Regulatory Officer, David Link, MBA, remarks, “The addition of Dr. Cramer to our team enables us to keep pace with the demands and scientific complexity of our clients’ medical products.” Alethea Wieland, President and Co-founder adds, “Julie adds an impressive set of expertise, skills and value to our firm and we are lucky to have her leadership skills as we grow both our executive management consulting and CRO business units.”
About Clinical Research Strategies, LLC: CRS is a specialty CRO and executive management consulting firm that fits-for-purpose veteran life sciences executives, attorneys, regulatory scientists and strategists, clinical operations, project management, quality assurance engineers, and sales and marketing teams to take on the biggest challenges for start-up and mid-sized life sciences companies, many of whom are developing novel, first-in-class drugs, biologics, diagnostics and medical devices, or software as a medical device (SaMD). Service areas are clinical trials, Functional Service Provider (FSP) models, selection and management of CROs, regulatory compliance strategy and submissions, QMS, EU MDR and GDPR, rescue trials, TMF, risk mitigation and remediation, training high-performing teams, staffing solutions, and decentralized trials.
Indications represented are precision medicine, immuno-oncology, central nervous system, infectious diseases, respiratory diseases, orthopedics, de novo devices, digital health and mobile apps, reproductive health, regenerative medicine, cardiology, major depressive disorder, opioid-sparing pain, cannabis, radiology, and critical care. CRS is a qualified service provider for federal grants.
CRS is an inclusive employer and does not discriminate in employment on the basis of race, color, religion, sex, gender identity, national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, education, membership in an employee organization, parental status, military service, or other non-merit factor. CRS does not tolerate censorship, surveillance, bullying, intimidation, retaliation, discrimination, or harassment of any kind.
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Alethea Wieland, President and Founder
Clinical Research Strategies, LLC