Jobs at Ensem Therapeutics

We’re seeking an experienced Clinical Scientist to drive the design, execution, and interpretation of early-phase oncology trials for our precision oncology small molecule pipeline. You’ll play a critical role in the development of Ensem’s clinical portfolio, which includes ETX-636, a PI3Kα mutation selective inhibitor/degrader and ETX-929, a pan-KRAS inhibitor. In this role, you will work closely with Medical Monitor, Clinical Operations, Translational Sciences, Clinical Pharmacology, Biostatistics, Regulatory and teams representing our Contract Research Organization partners. This role suits someone who thrives in a fast-paced biotech and is comfortable wearing multiple hats. Additionally, it’s important for the candidate to be able to effectively collaborate in a virtual environment.

• Contribute to clinical and scientific strategy for Phase 1/2 oncology studies (first-in-human, dose-escalation, food effect, expansion cohorts, clinical pharmacology studies)
• Lead protocol development both as a contributor and via cross-functional engagement. Author and review protocols, amendments, ICFs, IBs, DSUR, CSR sections, and briefing documents.
• Shape dose-escalation strategy, patient selection, contribute to biomarker plans, and endpoints
• Provide primary plans for clinical data collection, procedures, data collection tools, eCRF elements and be a primary contributor to statistical analysis plans.
• Review, analyze and present emerging clinical, safety, PK/PD, and biomarker data to drive timely study decisions
• Support safety monitoring, data review meetings, and dose-escalation committee discussions
• Partner cross-functionally to align study design, operations, and study milestones/deliverables
• Represent the company with investigators, advisory boards, and at scientific conferences
• Partner with medical monitor in clinical data review of SAEs, narratives, pharmacovigilance related signal detection.

• PhD, MD, PharmD, or equivalent in oncology, cancer biology, pharmacology, or related field
• 5+ years in oncology drug development or clinical science in biotech/pharma
• Hands-on experience with Phase 1/2 oncology studies, ideally dose-escalation and expansion cohorts
• Strong grasp of GCP/ICH principles and oncology clinical development
• Proven ability to write and review clinical documents with accuracy and speed
• Excellent communication and cross-functional collaboration skills

Preferred:

• Precision oncology, targeted therapy, solid tumor or small molecule experience
• Familiarity with biomarker-driven trial design and translational data integration
• Proficiency with clinical trial systems and databases (e.g., EDC platforms such as Medidata Rave, IRT/RTSM)
• Experience in a lean, high-accountability