Helen Chalk
Clinical Operations Executive Leader
- Role
- Clinical Operations Program Leader at BlueRock Therapeutics
- Location
- Franklin, MA, US
- LinkedIn followers
- 500 followers
About Helen Chalk
Clinical Development leader and change agent with over 25 years of experience in the pharmaceutical, biotechnology and CRO sectors.• Proven track record in establishment and leadership of successful results-oriented-teams working on clinical trials that have led to successful BLA, NDA and MAA filings.• Breadth of global industry experience; oversight of clinical programs incorporating Phase 1-4 global clinical trials, medical affairs and expanded access programs in indications including oncology, autoimmune disorders, rare disease, infectious diseases, cardiovascular, respiratory and other therapeutic areas.• Extensive experience in hiring, managing, training and guiding cross functional teams. • Expert knowledge of ICH/GCP and clinical trial regulations.
Experience
Clinical Operations Program Leader
Oct 2025 — Present
Education
Loughborough University
BSc Hons, Human Biology
1990 — 1994
Skills
- Edc
- Ctms
- Clinical Trials
- Clinical Development
- Ich-Gcp
- CRO Management
- Standard Operating Procedure (Sop)
- Clinical Monitoring
- Pharmaceutical Industry
- Sop
- Fda
- Regulatory Submissions
- Biotechnology
- Life Sciences
- Clinical Research
- CRO
- Drug Development
- Oncology
- Gcp
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