Director / Senior Director, Clinical Scientist (Part-time, Temp)

The Role

Superluminal Medicines is seeking a detail-oriented and collaborative Clinical Scientist to join our team 15-20 hours per week. Reporting directly to the Executive Director of Clinical Development, you will play a critical role in the scientific design, execution, and data-driven evaluation of our clinical trial programs.

You will serve as a core scientific engine within the clinical team, bridging the gap between non-clinical findings and clinical execution. Your work will directly shape protocol design, safety monitoring, data analysis, and the synthesis of scientific evidence to advance our pipeline through Phase I–IV trials safely and effectively.

Key Responsibilities

• Protocol & Document Authoring: Author and review key clinical trial documents, including but not limited to Clinical Study Protocols (CSPs), Investigator’s Brochures (IBs), Clinical Study Reports (CSRs), and Informed Consent Forms (ICFs).
• Clinical Data Review & Signal Evaluation: Lead ongoing scientific and medical data review, analyzing emerging safety signals, evaluating lab trends, assessing protocol compliance, and drafting data summaries for medical oversight.
• Trial Design & Endpoint Strategy: Conduct literature reviews and evaluate clinical data to support scientific rationales, select robust primary/secondary/exploratory study endpoints, and refine study design strategies.
• Cross-Functional Partnership: Serve as the primary scientific liaison for clinical trial site/s, CROs, and external investigators while collaborating closely with Medical Directors, Clinical Operations, Clinical Pharmacology, Biostatistics, and Regulatory Affairs.
• Regulatory & Scientific Dissemination: Author and review clinical components of regulatory submissions (INDs, CTAs, NDAs/BLAs) and contribute to scientific abstracts, manuscripts, and conference presentations.
• Governance & Oversight: Prepare for and present scientific data during Data Safety Monitoring Board (DSMB) meetings, Advisory Board meetings, and Investigator Meetings.

Qualifications

• Education: Scientific degree (BS), Advanced degree preferred (MS, PharmD or equivalent) in Biology, Immunology, Biochemistry, Pharmacology, Pharmaceutical Sciences, or a related scientific/healthcare field.
• Experience: 8+ years of clinical research experience within the biopharmaceutical industry, CROs, or academic clinical trial centers, with a track record of supporting trial execution.
• Expertise: Deep understanding of clinical trial methodology, biostatistical concepts, GCP/ICH guidelines, and medical data review tools (e.g., Spotfire, JReview, Medidata Rave).
• Communication: Exceptional oral and written communication skills, with a proven ability to translate complex clinical data into clear scientific documents and stakeholder presentations.
• Mindset: A collaborative and adaptable team player who thrives in a fast-paced environment and excels at managing cross-functional dependencies.