Job Description
Are you ready to pioneer the next generation of life-saving therapeutics? Avenis BioPharma is seeking an exceptional, high-caliber Senior Clinical Research Scientist to join our clinical development team in Boston, MA. In this role, you will be at the absolute forefront of oncology and immunology drug development, translating groundbreaking scientific discoveries into transformative clinical treatments.
We offer a collaborative, cutting-edge research environment equipped with industry-leading resources. If you are a driven scientific professional with a passion for clinical trial design, strategic data analysis, and cross-functional leadership, this is your opportunity to make a lasting impact on global patient health.
Responsibilities
- Lead the strategic design, authoring, and execution of complex Phase II and III clinical trial protocols, investigator brochures, and clinical study reports.
- Serve as the primary scientific expert and point of contact for clinical trial sites, key opinion leaders (KOLs), and global medical monitors.
- Analyze, interpret, and synthesize highly complex clinical trial data to ensure robust scientific integrity and identify emerging safety or efficacy trends.
- Collaborate closely with Regulatory Affairs to draft, review, and submit IND/NDA filings to the FDA, EMA, and other international health authorities.
- Present scientific findings, clinical development plans, and trial progress to executive leadership, advisory boards, and international medical congresses.
- Mentor junior clinical scientists and associate clinical trial managers, fostering a culture of high performance and scientific excellence.
Qualifications
- Ph.D., Pharm.D., or M.D. in a relevant scientific or life sciences discipline (e.g., Pharmacology, Oncology, Immunology, or Molecular Biology).
- Minimum of 5 years of direct clinical research and development experience within a pharmaceutical or biotechnology company.
- Proven track record of designing, initiating, and managing Phase II or Phase III global clinical trials.
- Deep understanding of FDA, ICH, and GCP guidelines, with direct experience in regulatory submission processes.
- Exceptional analytical capabilities, with demonstrated expertise in parsing and interpreting complex clinical data sets.
- Superb written and verbal communication skills, with a proven ability to engage and influence multidisciplinary teams.