Director, Clinical Scientist (Biotech)

TL;DR

Director, Clinical Scientist (Biotech): Leading clinical science for respiratory programs focusing on asthma and COPD with an accent on Phase 2 and 3 trial design, protocol development, and regulatory documentation. Focus on driving clinical execution, ensuring data quality and participant safety, and coordinating cross-functional study teams to advance protein-based medicines.

Location: Must be based in the US (Hybrid in Somerville, MA or Andover, MA, or Remote optional with travel to HQ).

Salary: $186,000 – $270,000

Company

hirify.global is a clinical-stage generative biology company pioneering the use of AI and machine learning to design proteins and accelerate drug development.

What you will do

• Lead clinical science for respiratory studies (asthma and/or COPD) as a core member of the clinical development team.
• Design and develop clinical trial protocols, study plans, CRFs, and statistical analysis plans.
• Drive the creation of regulatory documents, including IBs, CSRs, and briefing books.
• Perform medical monitoring to ensure data quality, participant safety, and protocol compliance.
• Manage relationships with CROs and vendors, tracking study progress against milestones and identifying risks.
• Collaborate with Clinical Operations, Regulatory, and Biostatistics teams to ensure trial execution.

Requirements

• Advanced degree (PhD, PharmD, MD, MS, or PMP).
• 9+ years of industry experience in clinical development.
• Direct experience in late-stage respiratory (asthma and/or COPD) studies.
• Strong knowledge of clinical research methodologies, GCP, and regulatory guidelines.
• Proven ability to lead clinical science strategy and execution in late-stage trials.
• Must be based in the United States.

Nice to have

• Experience with both small molecule and biologic modalities.
• Familiarity with AI/ML-driven drug discovery platforms.
• Previous involvement in BLA or MAA submissions.

Culture & Benefits

• Opportunity to work at the forefront of the AI revolution in drug design.
• Competitive benefits package including annual bonus and equity compensation.
• Inclusive and high-performing team culture with an emphasis on mentorship and coaching.
• Flexible work arrangements with remote options within the U.S.