Senior Director, Clinical Trials Strategy & Operations

Columbia University in the City of New York; New York (NY); Sur place; USD 175 000 - 225 000; Plein temps

Résumé du poste

Columbia University in the City of New York seeks a Senior Director, Clinical Trials Strategy and Operations to lead institution‑wide clinical trials strategy and services expansion. You will drive activation, optimize portfolio, and foster cross‑functional collaboration across research administration, regulatory, and contracting functions.

Reporting to the VP&S Vice Dean for Clinical Trials, you will scale shared services, establish governance, and partner with Irving Institute and Cancer

Qualifications

• Bachelor's degree or equivalent in a relevant field plus 5 years of related experience.
• Advanced degree in a relevant scientific or clinical discipline preferred.
• Experience in clinical trials within pharma/biotech/CRO or academic research environments.
• Knowledge of FDA EMA regulations, GCP, HIPAA, IRB and regulatory activities.
• Proven ability to design and implement clinical research strategies and drive cross-functional collaboration.

Responsabilités

• Develop and execute a multi-year strategy to strengthen clinical trials infrastructure and activation.
• Translate priorities into actionable operating plans, staffing models, and measurable outcomes.
• Establish governance for clinical trials with faculty, staff and stakeholders.
• Collaborate with leadership to create new multidisciplinary trial units and expand hubs.
• Lead and coordinate efforts across research offices, contracting, regulatory, and operations.

Connaissances

Clinical trials leadership

Regulatory & compliance

Cross-functional collaboration

Stakeholder management

Vendor & partner negotiations

Formation

Bachelor's degree or equivalent

Advanced degree (PhD/MD/Pharmacist/MBA)

Outils

CTMS

EHR

EDCs

REDCap

Velos

Description du poste

Columbia University in the City of New York seeks a Senior Director, Clinical Trials Strategy and Operations to lead institution‑wide clinical trials strategy and services expansion. You will drive activation, optimize portfolio, and foster cross‑functional collaboration across research administration, regulatory, and contracting functions.

Reporting to the VP&S Vice Dean for Clinical Trials, you will scale shared services, establish governance, and partner with Irving Institute and Cancer