Director, Clinical Scientist — Gene Therapy Trials

Affinia Therapeutics; Waltham (MA); On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Bonus

Equity

Competitive benefits

Job summary

Affinia Therapeutics is seeking a Clinical Scientist (Director/Senior Director) to lead the clinical development plan for its gene therapy program in BAG3-associated dilated cardiomyopathy. Join a cross-functional team to execute trials, author regulatory documents, and interact with external investigators.

The role emphasizes start-up and execution of early-phase studies, safety monitoring, and collaboration with leadership to drive regulatory strategy and scientific communication.

Qualifications

• 7+ years in pharma/biotech industry or equivalent clinical research experience.
• Experience in start-up, execution and close-out of clinical trials.
• Knowledge of cardiovascular or rare disease trials; gene therapy knowledge preferred.
• Experience authoring protocols and regulatory documents for US and major ex-US jurisdictions.

Responsibilities

• Drive deliverables for First-in-Human Phase 1b/Phase 2 trial for AFTX-201.
• Contribute to protocol development and amendments; prepare consent forms and regulatory documents.
• Support CROs, investigators and site personnel; ensure timely regulatory responses and patient safety.
• Oversee safety monitoring: AE/SAE reviews, listings, and data integrity.
• Review efficacy data; assist in data interpretation and regulatory output.
• Collaborate with Clinical Leader on regulatory interactions and advisory boards.
• Develop external medical communication strategies; support abstracts and manuscripts.

Skills

Clinical trial leadership

Regulatory writing

Biostatistics & analysis

GCP compliance

Cross-functional collaboration

Education

Advanced degree (PhD/PharmD/NP/MA/MS/MPH)

Job description

Affinia Therapeutics is seeking a Clinical Scientist (Director/Senior Director) to lead the clinical development plan for its gene therapy program in BAG3-associated dilated cardiomyopathy. Join a cross-functional team to execute trials, author regulatory documents, and interact with external investigators.

The role emphasizes start-up and execution of early-phase studies, safety monitoring, and collaboration with leadership to drive regulatory strategy and scientific communication.