Ronald Tashjian

Experience

1. Head of Clinical Operations

   Corium

   Jul 2021 — Present

   Provides clinical operational strategy and oversight to Corium products, indications, and programs to ensure clinical programs are conducted to meet project milestones, with detailed attention to budget and quality and in close partnership with internal and external stakeholders. Accountable for $25-30 million dollar clinical trial budgets. Leads teams directly contributing to NDA submissions and inspection readiness. Provides leadership, therapeutic expertise, and oversight for the successful management of clinical studies, including budget management, vendor oversight and risk mitigation. Responsible for vendor selection and budget negotiation for clinical service providers. Collaborates with internal stakeholders to ensure alignment of resources and budgets across clinical programs by evaluating timelines and prioritizing tasks. Provides Clinical Operations strategic direction and functional management. Leads and partners in the development and presentation of clinical operational strategy to executive leadership. Provides department financial oversight, managing spend as planned and ensuring appropriate communication with clinical and corporate finance department. Manages development of department SOPs, including a heavy emphasis on vendor oversight and participates in Quality Assurance SOP development (e.g, clinical supply management, training and compliance, CAPA, inspections, etc.). Manages the development of protocols, investigator’s brochures, informed consents, clinical study reports (CSR) and regulatory reports (e.g. DSUR, PBRER, etc.). Oversees and contributes to project team governance documents such as clinical development plans. Collaborates cross‐functionally on due‐diligence efforts and assessments for mergers and acquisitions. Collaborates with Regulatory, Medical Affairs, Legal and Commercial to assist with life cycle management of approved drug products.

Education

• University of New Hampshire

  Bachelor of Science, Nutritional Sciences

Skills

• Pharmaceutical Industry
• Fda
• Biotechnology
• Edc
• Ctms
• Ich-Gcp
• Lifesciences
• Oncology
• Drug Development
• Gcp
• 21 Cfr Part 11
• Clinical Data Management
• Management
• CRO
• Clinical Trials
• Training
• Project Management
• Clinical Development
• Medical Devices
• Clinical Research