Kristen McCaleb

Kristen McCaleb has a diverse work experience in the pharmaceutical and healthcare industry. Kristen started their career as a Research Scientist at Roche, where they gained foundational experience in scientific research.

After their role at Roche, Kristen joined UCSF as a Program Manager in the Genomic Medicine Initiative. Their responsibilities included leveraging cutting-edge DNA sequencing techniques for the development of the clinical Precision Medicine program. Kristen successfully developed teams and collaborated with leadership to create a financial model that supported patient needs and enabled the development of new tests for clinical use.

Following UCSF, Kristen worked at Invitae as the Head of Program Management in the Chief Medical Office. In this role, they managed scientific publications and presentations, coordinated with commercial and scientific teams, and reported to the Chief Medical Officer.

Kristen then joined Exact Sciences as an Associate Director in Global Clinical Affairs. Kristen partnered with stakeholders to develop an in-vitro diagnostic version of a lab-developed test, focusing on IVDR regulations for deployment in the European Union. Kristen also collaborated with various teams to address strategic opportunities and drive market uptake.

After Exact Sciences, Kristen joined Gilead Sciences as an Associate Director of Alliance Management. Kristen spearheaded the implementation and adherence to research and development plans for a portfolio of projects. Their notable contribution includes ensuring regulatory compliance for high-profile pharmaceutical alliances by bringing key stakeholders together.

Currently, Kristen is working at Frontier Medicines as the Director of Business Operations. Their responsibilities include managing contracts and relationships with external partners and vendors to deliver IND enabling studies. Kristen collaborates with internal stakeholders and aligns internal expertise with external consultants and vendors to support IND applications.

Kristen McCaleb holds a Ph.D in Organic Chemistry from the University of Colorado Boulder. Prior to that, they obtained a B.S. degree in Chemistry, with High Distinction, from the University of Illinois Urbana-Champaign. In addition to their formal education, they have also obtained a Certificate of Achievement-Alliance Management (CA-AM) from A.S.A.P. (Association of Strategic Alliance Professionals) in October 2021.