Associate Director Clinical Science

EPM Scientific; Boston (MA); On-site; USD 90,000 - 130,000; Full time

Job summary

EPM Scientific in Boston is seeking a hands-on Clinical Scientist to support oncology development programs, starting with prostate cancer and expanding to solid tumors. You will lead clinical data review, monitor patient safety, and contribute to key regulatory deliverables such as protocols and submissions.

The role requires a strong background in oncology, cross-functional teamwork, and the ability to operate in a lean, fast-paced biotech environment.

Qualifications

• 5+ years in Clinical Science or Clinical Development in biotech/pharma.
• Strong oncology experience, especially solid tumors.
• Experience contributing to study oversight and safety reviews.
• Track record in developing regulatory documents and submissions.

Responsibilities

• Lead clinical data review, analysis, and medical monitoring to support study execution and patient safety.
• Interpret data, identify trends, and generate insights to inform development decisions.
• Contribute to protocols, CSRs, IBs, and regulatory submissions.
• Collaborate with Clinical Operations, Regulatory, Biostatistics, Data Management, and cross-functional teams.
• Support junior staff and act as hands-on clinical subject matter expert in a lean biotech setting.

Skills

Clinical Science

Clinical Development

Oncology

Cross-functional collaboration

Data interpretation

Regulatory submissions

Job description

• Support oncology clinical development programs, initially focused on prostate cancer with exposure to additional solid tumor studies
• Lead clinical data review, analysis, and medical monitoring activities to support study execution and patient safety
• Contribute to key clinical and regulatory deliverables, including protocols, CSRs, IBs, and regulatory submissions
• Partner closely with Clinical Operations, Regulatory, Biostatistics, Data Management, and other cross-functional teams
• Interpret clinical data, identify trends, and generate scientific insights to inform development decisions
• Ideal for a hands-on Clinical Scientist who enjoys wearing multiple hats in a lean, fast-paced biotech environment
• Strong preference for candidates with oncology experience, particularly in solid tumors, and a passion for advancing innovative cancer therapies
  

• Support oncology clinical development programs, initially focused on prostate cancer with exposure to additional solid tumor studies
• Lead clinical data review, analysis, and medical monitoring activities to support study execution and patient safety
• Contribute to key clinical and regulatory deliverables, including protocols, CSRs, IBs, and regulatory submissions
• Partner closely with Clinical Operations, Regulatory, Biostatistics, Data Management, and other cross-functional teams
• Interpret clinical data, identify trends, and generate scientific insights to inform development decisions
• Ideal for a hands-on Clinical Scientist who enjoys wearing multiple hats in a lean, fast-paced biotech environment
• Strong preference for candidates with oncology experience, particularly in solid tumors, and a passion for advancing innovative cancer therapies
  

Desired Skills and Experience

• - Seeking candidates with 5+ years of experience in Clinical Science, Clinical Development, or a closely related function within biotech or pharma.
  
• - Strong background supporting oncology programs, particularly in solid tumors
  
• - Experience contributing to study oversight through clinical data evaluation, safety review, and cross-functional collaboration.
  Track record of supporting key clinical development deliverables and health authority submissions throughout the drug development lifecycle.
  
• - Familiarity with developing study-level and regulatory documentation, including protocols, study reports, and other submission-related materials.
  
• - Experience supporting BLA preparation or regulatory filings is a plus.
  
• - Experience working within a small to mid-sized biotechnology company is preferred.