Senior Director, Clinical Operations
$230,000–$281,000 year
On-site · Watertown, Massachusetts, United States
Job Summary
Senior Director, Clinical Operations to lead end-to-end operational execution of REM-422 clinical studies, overseeing timelines, budgets, enrollment, and quality in accordance with ICH GCP. Develop comprehensive program plans (protocols, risk registers, site/country strategy, risk-based monitoring, vendor approach), drive site selection/activation, and manage CRO/vendor performance while ensuring inspection readiness and TMF integrity. Represent Clinical Operations on the program team and collaborate with Regulatory Affairs and Biostatistics for submissions. Build relationships with investigators in the US and Europe. Partner with Supply Chain for clinical supply planning, contribute to protocol development and regulatory documents (IND submissions, Investigator Brochures, clinical study reports), and foster a high-performance team culture with accountability and operational excellence.
Required Qualifications
- BS/BA required
- advanced degree preferred
- 12+ years in clinical operations
- experience leading Registrational Programs
- deep oncology or rare disease trial experience
- experience running complex, multi-site studies from startup through submission readiness
- expert-level CRO oversight and vendor governance
- strong knowledge of GCP, ICH guidelines, and FDA/EMA requirements
- demonstrated experience supporting clinical programs from IND through NDA submission and regulatory approval
- demonstrated leadership and people management experience with cross-functional teams
Desired Qualifications
- 12+ years in clinical operations
- experience leading Registrational Programs
- oncology or rare disease trial experience
- expert-level CRO oversight and vendor governance
- IND through NDA submission experience
- leadership and people management in cross-functional teams
- ability to operate in ambiguity and move quickly in a small-company biotech environment
- BS/BA required, advanced degree preferred
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