Agnieszka Aj J.
- Role
- Vice President, Clinical Development at BridgeBio
- Location
- Chapel Hill, NC, US
- LinkedIn followers
- 500 followers
About Agnieszka Aj J.
Clinical development physician with 20 years of both clinical and biopharmaceutical…
Experience
Vice President, Clinical Development
Aug 2020 — Present
Responsibilities: • drive development and refinement of the clinical development plans integrating clinical, pre-clinical, CMC, regulatory and corporate strategy • ensure excellence in both strategy and execution of the clinical programs by working closely with internal and external partners in clinical operations, project management, biostatistics, data management, regulatory affairs, nonclinical, CMC, medical writing, and others • advance the clinical programs by managing, performing and/or contributing to the following: o regulatory document preparation and review (e.g. briefing documents, applications for special designations, PIP, IND and BLA submissions) o scientific literature review and summarization o protocol & CRF development o medical monitoring of clinical trials including ongoing safety monitoring o as appropriate, DSMC member selection, charter development, and preparation and conduct of meetings for specified periodic data reviews, dose escalation, dose selection, study expansion and ad hoc review of serious adverse events o investigator meeting preparation and presentations o clinical trial data review including internal summary presentations as required o regulatory safety reporting (serious AEs and periodic safety updates) o clinical study report writing o investigator brochure writing • develop contingency plans for clinical development activities as needed, provide technical and strategic advice, and meet milestones and budgets • conduct clinical trials using quality (GCP) and ethical standards relevant to the pharmaceutical industry, and ensure compliance with these standards • interact with study investigators and thought leaders globally
Education
Silesian Medical University
Doctor of Medicine (M.D.)
1995 — 2001
Harvard Business School
Business Administration and Management, Continuing Education
2015 — 2016
Children's Memorial Health Institute
Doctor of Philosophy (Ph.D.)
2004 — 2009
Harvard T.H. Chan School of Public Health
MPH
2024 — 2026
University of Gdansk
Postdoctoral Research Fellow
2011 — 2013
Children's Memorial Health Institute
Postdoctoral Fellow
2009 — 2013
Postgraduate School of Molecular Medicine, Medical University of Warsaw
Doctor of Philosophy (Ph.D.)
2004 — 2007
University of Gdansk
Adjunct
2013 — 2014
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.