Senior Clinical Scientist Director, Gene Therapy Programs

F-Prime Capital; Waltham (MA); On-site; USD 200,000 - 300,000; Full time

Benefits offered by this job

Bonus potential

Equity

Competitive benefits

Job summary

Affinia Therapeutics in Waltham, MA is seeking a Director/Senior Director Clinical Scientist to lead the First-in-Human Phase 1b/Phase 2 trial for AFTX-201 in BAG3-associated dilated cardiomyopathy. This role requires startup, execution and close-out of trials and close collaboration with the Clinical Leader and Clinical Operations.

The successful candidate will influence protocol development, safety monitoring, data interpretation, regulatory interactions, and external partnerships with

Qualifications

• Advanced degree in clinical sciences or related field.
• 7+ years pharma/biotech trial experience or equivalent.
• Experience in protocol development and regulatory documents (U.S. and major ex-U.S.).
• Experience in start-up, execution and close-out of trials.
• Familiarity with GCP, data analysis and safety monitoring.

Responsibilities

• Lead First-in-Human Phase 1b/Phase 2 trial execution for AFTX-201.
• Develop protocols, amendments, and informed consent materials.
• Coordinate with CROs, sites, IRBs/IBC to ensure study conduct and safety.
• Monitor safety and efficacy data, contribute to data reviews.
• Support regulatory interactions and DSMB/advisory activities.

Skills

Written communication

Verbal communication

Cross-functional collaboration

Regulatory knowledge

Biostatistics knowledge

Program management

Attention to detail

Education

PhD, PharmD, NP, MA/MS/MPH (or equivalent)

Job description

Affinia Therapeutics in Waltham, MA is seeking a Director/Senior Director Clinical Scientist to lead the First-in-Human Phase 1b/Phase 2 trial for AFTX-201 in BAG3-associated dilated cardiomyopathy. This role requires startup, execution and close-out of trials and close collaboration with the Clinical Leader and Clinical Operations.

The successful candidate will influence protocol development, safety monitoring, data interpretation, regulatory interactions, and external partnerships with