Hala Kaaki
Oxford, United Kingdom
Summary
Seasoned Founder & CEO adept in leadership, innovation management, regulatory affairs, and business development. Results-driven professional experienced in advancing novel therapies and driving strategic growth. Adaptable problem-solver with a track record of achieving significant milestones.
Overview
12
12
years of professional experience
Work History
Founder & CEO
WaterBear Sciences
Bradenton
08.2023 - Current
- B2B consultancy specializing in drug discovery, business strategy, and project management.
- Created frameworks attracting clients from various industry segments.
- Delivered regulatory strategy and business development consultation to SMEs.
- Developed and launched strategic initiatives improving product offerings.
- Resolved complex client challenges by implementing tailored solutions, leading to strengthened client relationships.
- Cultivated a forward-thinking, inclusive, and performance-oriented business culture to lead the industry in innovation and push progress.
Director of Drug Discovery and Regulatory Affairs
Asha Therapeutics
Tampa
02.2020 - 06.2023
- Advanced lead assets by identifying and evaluating critical scientific targets.
- Spearheaded and directed strategy development for advancing novel therapies in Alzheimer's and Parkinson's diseases.
- Identified two high-impact targets, forming the company's neurodegenerative disease portfolio.
- Coordinated and forged partnerships among CROs, universities, and pharmaceutical enterprises.
- Developed and implemented comprehensive strategies to improve operational processes, organizational efficiency, and streamline multidisciplinary team operations.
- Forge collaborative relationships with key industry stakeholders and government agencies.
- Gained knowledge and aptitude related to regulatory affairs and quality assurance, both domestic and international.
- Created written submissions, oral presentations, and executive summaries for various stakeholders.
Head of Orphan Disease Research
Venn Therapeutics
Tampa
02.2020 - 10.2021
- Structured and developed department in Orphan Disease Research.
- Discover, evaluate, and research potential new drug targets.
- Spearheaded development of orphan drug project achieving Rare Pediatric Disease Designation (RPDD) from FDA.
- Engaged in project development for drug targets focusing on mitochondria-centric disorders including ME/CFS and KSS.
- Worked on conventional drug discovery and PROTAC therapies through comprehensive pre-clinical study designs.
- Served as a liaison to streamline communication between research teams in academia and industry.
- Ensured efficient execution of contracted experiments by overseeing CRO partnerships.
- Ensured completion of required paperwork for regulatory and grant applications.
Technician/Mac Expert
Apple Inc
Tampa
04.2013 - 05.2020
- Delivered outstanding support for Apple consumer and business sales across the US and Canada.
- Provided technical support to customers over the phone and in person for Apple products.
- Exceeded sales targets through strategic workflow.
- Built and maintained customer relationships through reliable service and support.
- Maintained up-to-date knowledge of new technologies available from Apple.
- Documented all repair processes accurately in the company's database system.
- Provided technical support for Mac users with hardware or software issues.
Education
Master of Science - Experimental and Translational Therapeutics
University of Oxford
Oxford, UK07-2025
Bachelor of Science - Cell and Molecular Biology
University of South Florida
Tampa, FL08.2019
Skills
- Entrepreneurial leadership
- Innovation management
- Strategic Planning
- Business Intelligence
- Product Development
- Project Management
- Industry partnership development
- Stakeholder Engagement
- Problem-solving aptitude
- Decision-making skills
- Critical Thinking
- Adaptability
- Molecular Biology
- Application of scientific principles
- FDA regulations
- International Regulations
- Report Writing
- Scientific Writing
- Market Analysis
- Risk Assessment
- Submission preparation
- Regulatory research
Accomplishments
Rare Pediatric Disease Designation
Treatment of Hypertrophic Cardiomyopathy in children with Noonan Syndrome - Designation request # RPD-2020-475
Provisional Patent
Co-inventor for Heterobifunctional Therapeutics for Target Protein Degradation of Mitogen-Activated Protein Kinases - Application # 63249339
Languages
English
First Language
Arabic
Advanced (C1)
C1
Timeline
Founder & CEO
WaterBear Sciences
08.2023 - Current
Director of Drug Discovery and Regulatory Affairs
Asha Therapeutics
02.2020 - 06.2023
Head of Orphan Disease Research
Venn Therapeutics
02.2020 - 10.2021
Technician/Mac Expert
Apple Inc
04.2013 - 05.2020
Master of Science - Experimental and Translational Therapeutics
University of Oxford
Bachelor of Science - Cell and Molecular Biology
University of South Florida
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