Director, Clinical Development Ops — Early-Phase Trials

Flagship Pioneering; Cambridge (MA); On-site; USD 148,000 - 236,500; Full time

Benefits offered by this job

Healthcare coverage

Annual incentive program

Retirement benefits

Job summary

Flagship Pioneering in Cambridge, MA is seeking an Associate Director or Director, Clinical Operations to oversee early-phase clinical trials. The role requires strong clinical trial management experience and a collaborative approach to lead cross-functional teams.

The ideal candidate will have over ten years in drug development and experience with regulatory compliance. The position offers a salary range of $148,000 - $236,500 and attractive benefits.

Qualifications

• 10+ years of industry drug development experience, including 5 years of clinical trial management.
• Experience executing early-phase clinical trials including FIH and IND/CTA studies.
• Strong knowledge of ICH-GCP, FDA, and EMA regulations.

Responsibilities

• Lead operational execution of early-phase clinical trials.
• Collaborate closely with the Clinical Development Team.
• Manage trial budget and vendor relationships.

Skills

Clinical trial management

Cross-functional collaboration

Regulatory compliance

Vendor management

Education

Bachelor’s degree in life sciences

Tools

EDC

CTMS

eTMF

Job description

Flagship Pioneering in Cambridge, MA is seeking an Associate Director or Director, Clinical Operations to oversee early-phase clinical trials. The role requires strong clinical trial management experience and a collaborative approach to lead cross-functional teams.

The ideal candidate will have over ten years in drug development and experience with regulatory compliance. The position offers a salary range of $148,000 - $236,500 and attractive benefits.