Lead, Early-Phase Clinical Development Operations

Pioneering Medicines; Cambridge (MA); On-site; USD 148,000 - 237,000; Full time

Benefits offered by this job

Healthcare coverage

Annual incentive program

Retirement benefits

Job summary

Pioneering Medicines, an initiative of Flagship Pioneering, seeks an Associate Director/Director, Clinical Development Operations to own one or more early-phase clinical programs. You will lead end-to-end program execution from start-up through CSR, collaborating with clinical scientists, safety, statistics, data management, and regulatory affairs.

The role requires a lean, high-ownership mindset with experience in FIH/IND/CTA trials and vendor management.

Qualifications

• Bachelor’s degree or higher in life sciences or related field.
• Minimum 10+ years of industry drug development experience.
• At least 5 years of direct clinical trial management with program ownership.
• Experience with early-phase trials (FIH/IND/CTA).
• Experience at startups or small biotech companies preferred.
• Strong knowledge of ICH-GCP, FDA, EMA and global requirements.
• Proven ability to manage multi-site global trials and vendor relationships.
• Willingness to travel up to 10% domestically and internationally.

Responsibilities

• Own end-to-end execution of one or more early-phase trials (Phase 1/2).
• Collaborate with the Clinical Development Team and cross-functional partners.
• Lead design of trials and development plans, site selection, and enrollment strategy.
• Participate in regulatory submissions and governance milestones (IND/CTA).
• Prepare program updates and materials for investigator meetings and boards.
• Oversee trial budgets, timelines, and vendor performance.
• Ensure trial data quality, TMF readiness, and risk mitigation.

Skills

Program ownership

Cross-functional collaboration

Regulatory knowledge

Project planning

Vendor management

Education

Life sciences degree

MS/PharmD/PhD preferred

Tools

EDC

CTMS

RTSM

eTMF

Job description

Pioneering Medicines, an initiative of Flagship Pioneering, seeks an Associate Director/Director, Clinical Development Operations to own one or more early-phase clinical programs. You will lead end-to-end program execution from start-up through CSR, collaborating with clinical scientists, safety, statistics, data management, and regulatory affairs.

The role requires a lean, high-ownership mindset with experience in FIH/IND/CTA trials and vendor management.