Job Description:
• Responsible for coordinating and carrying out the full spectrum of activities related to the development and validation of bioanalytical methods according to client requests and within the required timeframes
• Develops a solid understanding of clinical trial design and applies this knowledge to support the creation of study concept documents and clinical protocols
• Participates in protocol review meetings, contributing to discussions on scientific rationale and operational study design considerations
• Assists in the preparation of study protocols, protocol amendments, investigator meeting materials, study manuals, and other clinical trial documentation under appropriate guidance
• Contributes to the development of Case Report Forms (CRFs), Data Management Plans, and Statistical Analysis Plans with supervision
• Supports responses to investigator inquiries related to scientific, clinical, and procedural aspects of studies
• Assists in the preparation and review of data outputs, summary reports, study findings, manuscripts, and scientific presentations
• Provides support in the development and review of regulatory submission documents
• Identifies and helps address moderately complex study-related challenges, implementing solutions with guidance from experienced team members
• May coordinate project teams and provide direction on assigned activities when required
• May perform clinical monitoring responsibilities for individual studies or specific components of larger clinical programs
• Demonstrates the ability to quickly learn new therapeutic areas and synthesize relevant scientific literature to support study development activities
• Ensures compliance with applicable regulatory requirements, Good Clinical Practice (GCP) guidelines, and company Standard Operating Procedures (SOPs).
Requirements:
• PharmD or PhD with 3+ years in clinical research or clinical pharmacology with scientific and/or drug development experience in the biopharma industry, healthcare, consulting, academia or a related environment
• MS with 6+ years’ relevant scientific and/or drug development experience
• BS or RN with 8+ years’ relevant scientific and/or drug development experience
• Relevant experience in Multiple Myeloma and/or CAR-T Therapy is preferred
• Experienced with Microsoft Office and other job-related programs
• Must demonstrate good computer skills especially in the utilization of Microsoft Word and Excel and analytical software (E.g. Analyst)
• Demonstrates skills in scientific problem solving
• English level: Required bilingualism includes communicating verbally and in writing on topics that are often technical, and writing procedures or technical reports.
Benefits:
• Health benefits to include Medical, Dental and Vision
• Company match 401k
• Eligibility to participate in Employee Stock Purchase Plan
• Eligibility to earn commissions/bonus based on company and individual performance
• Flexible paid time off (PTO) and sick time