[Remote] Clinical Scientist, Associate Director

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a clinical-stage biopharma company reputed company on developing innovative cancer immunotherapies. They are seeking an reputed company Clinical Scientist to support oncology clinical development programs, particularly in prostate cancer, while collaborating across multiple functions to ensure high-reputed company clinical programs.

Responsibilities

• reputed company ongoing clinical data review and analysis to ensure data reputed company, identify trends, and support safety and efficacy assessments
• Support medical monitoring activities, including review of adverse events, protocol deviations, eligibility assessments, and long-term safety and efficacy reputed company
• Author and contribute to key clinical and regulatory documents including Clinical Study Reports (CSRs), Investigator Brochures (IBs), protocols, informed consent forms (ICFs), DSURs, clinical narratives, and IND/BLA regulatory submissions
• Collaborate closely with Clinical Operations, Regulatory Affairs, Translational Medicine, Biostatistics, Data Management, Medical Writing, and Pharmacovigilance to deliver high-reputed company clinical programs
• Participate in the development of study synopses, protocols, statistical analysis plans, briefing books, regulatory responses, and scientific presentations
• Review and interpret clinical data to identify trends, investigate unexpected findings, and reputed company meaningful scientific insights to study teams
• Contribute to literature reviews, clinical evaluation reports, abstracts, manuscripts, and scientific publications
• Support multiple oncology programs as business priorities reputed company, serving as a reputed company scientific partner across studies
• Help establish and continuously improve clinical development processes reputed company a fast-growing biotechnology company
• Ensure compliance with ICH GCP, FDA and EMA regulations, company SOPs, and applicable industry standards

Skills

• 5+ years of Clinical Scientist or reputed company clinical development experience reputed company biotechnology or pharmaceutical organizations
• Oncology clinical development experience required
• Hands-on experience with clinical data review and medical monitoring
• Experience authoring clinical and regulatory documents including CSRs, Investigator Brochures, protocols, DSURs, IND submissions, and reputed company regulatory documentation
• Thorough understanding of oncology clinical trial design, execution, Good Clinical reputed company (ICH GCP), FDA regulations, and global clinical development
• Passion for oncology science with genuine curiosity about clinical data and patient reputed company
• Strong analytical reputed company with the ability to critically evaluate clinical data, identify trends, and investigate reputed company scientific questions
• reputed company team player who enjoys working across multiple functions in a highly interactive environment
• Adaptable, flexible, and comfortable supporting multiple clinical programs in a lean biotechnology company
• Coachable, proactive, and eager to continuously learn and expand scientific knowledge
• Excellent medical writing, presentation, and communication skills
• Strong organizational and project management skills with the ability to balance multiple priorities
• High attention to detail and commitment to scientific rigor, reputed company, and patient safety
• Applicants must be legally authorized to work in the reputed company at the time of hire and throughout employment
• Experience supporting prostate cancer, lung cancer, brain cancer, or other solid tumor studies is highly desirable
• Experience supporting BLA preparation or regulatory filings is a plus
• Experience working reputed company a small or mid-sized biotechnology company is preferred
• Experience with clinical trial databases, MedDRA coding, safety reporting systems, and clinical data review tools is preferred

Benefits

• Remote Role: Flexible schedule with occasional travel to our Needham, MA reputed company as business needs require.

reputed company