Director, Clinical Research
Skills
- Experience with regulatory filings such as NDA or BLA in US/EU/other regions preferred.
- Strong interpersonal and communication skills with a proactive approach.
- Ability to work independently and in a team environment.
- Detail-oriented with strong organizational and time management skills.
- Expertise in scientific literature review, data interpretation and visualization.
- Problem solving skills and ability to handle multiple projects under pressure.
- Familiarity with biostatistics.
- Proficiency in Word, Excel, and PowerPoint.
- Willingness to travel internationally as needed.
Responsibilities
- Translate concepts and strategies into specific clinical development objectives and activities.
- Ensure scientific rigor in clinical trial design, conduct, validity, and interpretation to support regulatory submissions.
- Contribute to strategic planning and authoring/review of clinical and regulatory documents including protocols, CSRs, IBs, and regulatory filings.
- Coordinate with internal clinical operations and external partners to ensure proper study execution and data collection.
- Serve as clinical point person on cross-functional teams including CMC support and regulatory interactions.
- Contribute to development and execution of publication plans, data mining efforts, and conference planning.
- Engage with key opinion leaders and thought leaders in NASH for feedback and data dissemination.
Education
- Advanced scientific degree (MS or PhD) in life sciences.
- 8+ years of direct biotechnology or pharmaceutical industry experience in clinical research.
Benefits
Average salary estimate
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