Principal Scientist
CSL
full-time
Posted on:
Location Type: Hybrid
Location: Massachusetts • Pennsylvania • United States
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Job Level
Tech Stack
About the role
- Provides scientific and clinical development input for the safe, efficient and timely execution of assigned programs, ensuring the highest quality and full compliance of all outputs
- Will contribute to the development of the scientific strategy of the clinical development plan, the design and development of trial related documents and the scientific oversight of clinical trials
- Facilitates a team to define and deliver the clinical strategy within projects and programs
- Defines scientific strategy for various program components
- Can lead development of Clinical Development Program
- Authors clinical study documents and assists with development/critical review of submission documents
- Contributes to authorship and review of manuscripts, conference abstracts, etc.
- Collaboratively develops the clinical development strategy with project teams, providing input, guidance and mentorship for project teams
- Contributes to the scientific analysis and interpretation of clinical data and the writing of clinical study reports, internal and external scientific meeting presentations and peer-reviewed publications, and all regulatory submission documents
Requirements
- Bachelor's degree or equivalent in Science, Allied Health or Engineering
- Preferred: An advanced degree (MSc, PhD) in Science, Allied Health or Engineering, PMP Certification, Masters of Business Administration (MBA) or equivalent
- 8+ years experience in the biotechnology or pharmaceutical industry (or where relevant a biomedical research organization)
- 5+ years in managing projects
- In-depth knowledge in the drug development and manufacturing processes for pharmaceuticals (CMC, non-clinical, clinical, Regulatory Affairs)
Benefits
- Health insurance
- Professional development opportunities
- Flexible work arrangements
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical developmentscientific strategyclinical trial designclinical study documentsdata analysisclinical study reportsregulatory submission documentsmanuscript authorshipproject managementdrug development processes
Soft Skills
team facilitationmentorshipcollaborationguidancecommunication
Certifications
PMP CertificationMBA