Associate Director, Clinical Scientist
$190,000–$240,000 year
On-siteSouth San Francisco, California, United States
Job Summary
Partner with the VP, Clinical Development Lead and cross-functional governance teams to plan and execute clinical research studies for cardiovascular disease assets. Drive the development of clinical study documents, including protocols, amendments, statistical analysis plans, and site materials, while ensuring scientific integrity in data monitoring and interpretation. Author medical monitoring plans, data monitoring plans, and clinical study reports, and support Data Monitoring Committees with charter development, data reviews, and synthesized reports. Collaborate with data management, statistics, and safety teams to integrate pharmacokinetic, efficacy, and safety data into study designs, maintaining compliance with FDA, EMEA, ICH, and GCP guidelines.
Required Qualifications
- Advanced degree or equivalent education/degree in life science/healthcare (PhD, MD, PharmD)
- 5+ years of pharmaceutical drug development experience in the biopharmaceutical/biotechnology industry
- Familiarity with clinical trial design principles, clinical trial operational execution, and regulatory requirements (e.g., FDA, EMA)
- Strong understanding of biostatistics and experience in interpreting clinical trial data
- Proficiency in medical writing and developing high-quality scientific documents
- Familiarity with Good Clinical Practices (GCP) and experience in ensuring compliance with GCP guidelines in scientific writing and publication
- Proven ability to create and generate scientific presentations for consumption by diverse audiences
- Excellent organizational, interpersonal, and communication skills
- Must be willing and possess the expertise to work effectively in a fast-paced, team-based matrix environment as well as the ability to function independently as appropriate
- Flexible to accommodate changes in team and project needs
- Ability to handle multiple projects at a time and have a strong attention to detail while understanding the higher-level strategy
Desired Qualifications
- Advanced degree or equivalent education/degree in life science/healthcare (PhD, MD, PharmD) preferred
- Experience in the cardiovascular therapeutic area preferred
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