Director, Clinical Science: Trials & Translational Strategy

Bicycle Therapeutics; Lexington (MA); Hybrid; USD 195,000 - 245,000; Full time

Benefits offered by this job

401(k) plan with company match

Medical, dental, and vision insurance

Flexible spending accounts

Time off and holidays

Competitive annual bonus

Employee recognition schemes

Flexible working environment

Stock option eligibility

Job summary

Bicycle Therapeutics seeks a clinical science leader to drive our programs from early development through pivotal studies. You will design trials, interpret complex data, and partner with the physician lead to shape clinical strategy and ensure rigorous trial execution.

As the primary clinical science expert, you will contribute to Investigator's Brochures, Clinical Study Reports, and regulatory filings, collaborating across functions and with external investigators.

Qualifications

• Advanced scientific or clinical degree with extensive clinical research experience in biotech/pharmaceutical industry.
• Experience in the design and execution of clinical trials with protocol development, data analysis, and study reporting.
• Thorough knowledge of GCP/ICH guidelines and regulatory requirements.
• Ability to interpret complex data and translate into actionable strategies.

Responsibilities

• Lead scientific design of clinical studies, endpoints, and biomarker strategies.
• Author clinical trial protocols and amendments aligned with program strategy.
• Maintain current understanding of landscape to keep trial designs innovative.
• Oversee data review and interpretation of safety, efficacy, PK, and translational data.
• Partner with Biostatistics and Translational Science to develop analysis plans.
• Serve as clinical science expert for assigned programs and partners to the Clinical Lead.

Skills

Core expertise

Data / insights

Knowledge sharing

Education

Advanced scientific or clinical degree (PhD, PharmD, advanced nursing degree)

Job description

Bicycle Therapeutics seeks a clinical science leader to drive our programs from early development through pivotal studies. You will design trials, interpret complex data, and partner with the physician lead to shape clinical strategy and ensure rigorous trial execution.

As the primary clinical science expert, you will contribute to Investigator's Brochures, Clinical Study Reports, and regulatory filings, collaborating across functions and with external investigators.