Senior Mrg/Associate Dir, Clinical Science
$182,000–$189,000 year
On-siteSan Diego, California, United States
Job Summary
Serve as the Clinical Science representative on cross-functional study teams, providing scientific and clinical input to support study planning, execution, data review, and study-related decision-making. Contribute to the design and development of clinical studies, including protocol development, feasibility assessments, and clinical sections of regulatory submissions. Partner with Clinical Operations, Data Management, Biostatistics, Pharmacovigilance, Regulatory Affairs, and external vendors to support study execution, protocol compliance, and overall trial oversight. Conduct ongoing clinical review of safety and efficacy data, including data trend analysis, signal identification, and assessment of data quality. Develop and review study training materials, support investigator meetings, and author clinical narratives for study closeout activities. Interact with investigators and key opinion leaders to ensure alignment with scientific and regulatory requirements while reviewing scientific literature to support clinical development. This role requires periodic travel up to 25% of the time, including overnight trips, and involves handling multiple projects in a fast-paced environment.
Required Qualifications
- Bachelor's degree
- 6+ years of experience in the life sciences industry or an equivalent combination of academic and industry experience
- Experience conducting clinical data listing reviews
- Familiarity with standard clinical and regulatory references (e.g., CTCAE, MedDRA)
- Working knowledge of principles and techniques of clinical data analysis and interpretation
- Experience reviewing and contributing to clinical study protocols and related documents
- Knowledge of GCP (Good Clinical Practice), ICH, FDA, EMA, and other relevant guidelines and regulations
- Proven ability to collaborate within cross-functional teams
- Ability to understand and assimilate complex scientific and clinical information
- Demonstrates initiative, strong organizational skills, and attention to detail
- Proficiency in Microsoft Word, Excel, PowerPoint, and Electronic Data Capture systems (e.g., RAVE), J-Review, or similar data review tools
- Excellent communication and interpersonal skills, with the ability to collaborate effectively with internal and external stakeholders
- Strong analytical and problem-solving abilities, with a strategic mindset
- Periodic/regular travel, including up to 25% of work, time which may include overnight travel
- On-site requirement (Monday through Thursday) for San Diego-based candidates
Desired Qualifications
- Advanced medical or life sciences or a related area degree (e.g., MS, Ph.D., MPH, PharmD)
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