Kristen Nickens, Phd Email & Phone Number

Washington, DC, US

CDER/OPQ/Office Of Biotechnology Products

• Coordinates a team of at least three full-time primary product quality assessors and provides guidance, leadership, and training focused on both individual and collaborative team success
• Involved in a variety CDER-mission focused teams and activities, such as working groups, trainings, and presentations

CDER/OPQ/Office Of Biotechnology Products

• Performed secondary-level oversight of product quality assessments and facilitated the review work of 3-4 primary assessors
• Strategically collaborated with Senior Management to plan and execute work-flow management tools and approaches, as well as participated in work-force hiring and engagement
• Performed risk-based product quality assessments for a range of biotechnology products

CDER/OPQ/Office Of Biotechnology Products

• Performed risk-based assessments of CMC information submitted in pre-INDs, INDs, BLAs, post-approval
• Communicated product quality recommendations with pharmaceutical company representatives, scientists, internal and external customers, supervisors, senior-level management, and inter-disciplinary teams
• Conducted international and domestic pre-approval and biosimilar-associated comparative analytical assessment inspections

CBER/Office Of Tissues And Advanced Therapies

• Successfully and simultaneously conducted CBER mission-driven biological research and biological product quality review of regulatory submissions
• Product quality review and examination of CBER-regulated products submitted as original INDs
• Reviewed protocol amendments (i.e. media formulation changes), examined Humanitarian Device Exemption submissions, examined Master Files (monoclonal antibodies, devices, and drugs), examined product labels, and.
• Evaluated methods used in obtaining scientific results, and assisted in determining the safety, effectiveness, validity, and completeness of cell therapy, associated medical devices, and tissue-engineered products.

• Lead on novel assay development for the clinical detection of prostate cancer in bio-specimens and benefit of the overall public health
• Experience in Institutional Review Board material preparation and submission
• Experience in biological specimen collection, storage and quality assurance
• Conduct systematic literature reviews on basic research and translational public health studies
• Develop, evaluate, and compose laboratory standard operating procedures
• Exposure to SAS: public health data analysis and reporting

Rockville, MD

• Worked with a multidisciplinary team to coordinate career fair
• Recruited company sponsorship
• Participant recruitment

• Co-fellow/translational medicine consultant for the personalized medicine virtual intern group
• Interviewed, evaluated and selected interns
• Led discussions on science advocacy with a focus on evidence-based scientific research that effects public health issues and science policies
• Developed health disparities curriculum
• Conducted weekly virtual communication-based discussions with interns and other policy fellows

• Gained expertise in project development, execution and evaluation
• Established and met project metrics: analyzed, evaluated and presented progress to senior committee members
• Experienced grant writer and manuscript peer-reviewer
• Received National Institutes of Health Research Supplement to Promote Diversity in Health Related Research. Supplement to NIH R01CA107972 to Susan Ceryak
• Conducted, analyzed, and published original basic science research results in peer-reviewed journal (Nickens et al., 2012)
• Conducted and published results of a systematic literature review on a public health carcinogen (Nickens et al., 2010)

• Post-baccalaureate research training focused on understanding the regulation of TGF-beta signaling in carcinogenesis
• Gained exposure to the federal government and programs developed for the protection and promotion of public health
• Trained in cutting edge molecular biology and immunological experimental techniques

• Post-baccalaureate research training on the role of TGF-beta isoform compensatory mechanisms in autoimmunity and inflammation in in vivo murine models
• Gained exposure to the federal government and programs developed for the protection and promotion of public health
• Trained in cutting edge molecular biology techniques

• Science outreach
• Provided advisement, mentorship, and educational instruction and development to student participants
• Program coordination and communications liaison
• Conducted program evaluations and provided written and oral assessments of progress to program managers

Conducted research on the physical mechanisms of T-cell activation.

Conducted research on early-onset periodontitis and its effects on a vitamin D receptor polymorphism.

Investing Now is an enrichment program focused on academic success through advising, tutoring, and mentoring underrepresented students in math and science throughout their high-school years. I began as a participant and progressed to a tutor and volunteer for the program.

Phd, Molecular Medicine/Oncology

Received the National Institutes of Health Research Supplement to Promote Diversity in Health-Related Research to support graduate thesis.

Bs, Biology

Activities and Societies: Beta Kappa ChiAwarded a Team Approach to Research Excellence (TARE) fellowship to study the effects of inorganic.

Certificate, Chief Science Officer: Pathways To Leadership, Careers In Life Science

36-hour certificate program in Leadership, Negotiation, Project Management, First-line Supervision and Finance focusing on relevance for.

Certificate, Understanding Patents And The Patent Applications Process For Engineers And Scientists

Review the context of Patents within the various IP Regimes; An overview of the patent application process (from filing strategy, to.

High School Diploma