Job description
Vantage Specialized Medicine is seeking a highly skilled Clinical Scientist to join our focused medicine division in Boston. This role blends clinical insight with rigorous research to advance therapies in rare and complex diseases.
As a member of our interdisciplinary team, you will design and execute studies, collaborate with investigators, CROs, and regulatory bodies, and contribute to peer‑reviewed publications.
We offer a competitive compensation package, comprehensive benefits, and a commitment to professional development in a collaborative, patient‑centered environment.
Responsibility
- Lead the design, execution, and oversight of clinical trials in specialized medicine, ensuring protocol compliance and high data quality.
- Collaborate with clinicians, biostatisticians, and regulatory teams to optimize study design and endpoints.
- Coordinate with CROs and vendors to manage timelines, budgets, and deliverables.
- Analyze and interpret complex datasets; prepare statistical reports and contribute to publications.
- Ensure adherence to regulatory standards (FDA/EMA), GCP, and ethical guidelines.
- Prepare and review medical writing, informed consent forms, and study materials.
- Mentor junior scientists and support professional development within the team.
- Represent the organization at scientific meetings and stakeholder engagements.
Qualification
- MD or PhD in Medicine, Biomedical Sciences, or a related field; board certification preferred.
- 5+ years of clinical research experience in specialized medicine (e.g., rare diseases, oncology, immunology).
- Strong understanding of trial design, endpoints, statistics, and biostatistics.
- Proficiency in data analysis software (SAS, R, Python) and electronic data capture systems.
- Excellent scientific writing and communication skills; proven track record of publications.
- Experience with regulatory submissions and quality systems (GCP, ICH, FDA/EMA guidance).
- Ability to manage cross-functional teams and external vendors.
- Detail-oriented, strategic thinker with strong problem-solving skills.