Senior Director of Clinical Science

*** Senior Director of Clinical Science - Boston ***

I'm currently partnered with an Oncology biotech who are initiating a global Phase 3 trial focused on Head & Neck cancer, with other programs focused on glioblastoma & other emerging development programs. They're looking for exceptional candidates to provide clinical science leadership, lead scientific review of clinical data & medical affairs.

• Provide clinical-science leadership across Aveta's development programs, contributing to study design, protocols, Investigator's Brochures, eCRFs, data-review and statistical analysis plans, Clinical Study Reports, and regulatory submissions.
• Lead scientific review and interpretation of clinical data, integrating efficacy, safety, exposure, laboratory, imaging, pathology, ctDNA, biomarker, translational, and patient-reported outcomes. Identify meaningful trends, inconsistencies, outliers, and potential protocol deviations and
  ** escalate
  * * medically important findings appropriately.
• Translate complex clinical and translational findings into actionable insights for development strategy, internal decisions, regulatory discussions, and scientific communication, working across Clinical Operations, Data Management, Biostatistics, Translational Medicine, Pharmacovigilance, and the CRO.
• Lead medical-affairs and external scientific engagement, building trusted relationships with investigators, KOLs, academic institutions, cooperative groups, and scientific organizations and supporting advisory boards, investigator meetings, scientific workshops, congresses, and training.

• PhD, PharmD, MD, MD/PhD with 5+ years of relevant biotechnology or pharmaceutical experience in clinical development, clinical science, medical affairs, or translational medicine.
• Strong oncology experience preferred; experience in head and neck cancer, immuno-oncology, neuro-oncology.
• Hands-on experience reviewing and interpreting clinical and translational data, including EDC records, listings, tables, figures, and statistical outputs.
• Experience developing clinical, regulatory, and scientific documents, including protocols, Investigator's Brochures, Clinical Study Reports, regulatory materials, abstracts, presentations, and manuscripts.