Generate Biomedicines
Senior Director, Clinical Operations Business & Excellence
$219K–$329K
Remote +1 · Remote · Director · Full-time · Posted Oct 28, 2026
- Location
- Remote
Somerville, Massachusetts, United States - Experience
- 12 or more years; demonstrated scope, leadership impact, and results will be considered alongside years of experience.
- Education
- BSc in a scientific, business, healthcare, or related discipline. An advanced degree, such as an MBA, MS, PhD, or PharmD, is preferred.
About the job
Sets strategy and leads a centralized Clinical Operations Business Office to improve portfolio-wide operational performance, quality, and continuous inspection readiness.
What you'll do
- Establish and oversee the Business Office operating model, governance, roadmap, resources, and performance measures.
- Lead clinical vendor governance, sourcing and contracting, site budgeting, eTMF operations, and audit and inspection readiness.
- Set portfolio-wide standards for risk-based quality management, monitoring oversight, process improvement, and digital enablement; lead cross-functional teams and develop staff.
What they ask for
- 12 or more years of progressively responsible experience in clinical operations, clinical business operations, or related functions within biotechnology or pharmaceutical organizations; demonstrated scope, leadership impact, and results are considered alongside years.
- Experience preparing pivotal programs for inspection and developing teams to maintain inspection readiness.
- Expertise in clinical sourcing, CRO and vendor governance, contract negotiation, and investigator site budgeting.
- Experience with eTMF governance, inspection readiness, clinical quality processes, ICH-GCP, and risk-based quality management.
Pay
$219,000 — $329,000 USD (base salary per year)
Tools
eTMF, ICH-GCP, E6(R3), CRO
AI focus
No AI work is specified for this role; the company description mentions AI-driven drug design and development.
Model-written summary · the original posting is authoritative