Senior Clinical Scientist, Trials & Data Quality

Regulatory Jobs; United States; Remote; USD 171,000 - 236,000; Full time

Benefits offered by this job

Annual bonus

401(k) with company match

Medical, dental, vision insurance

Parental leave

Job summary

Deciphera, a biopharmaceutical company, is advancing clinical programs with a focus on hematology-oncology. The Associate Director Clinical Scientist contributes to executing development plans, operationalizes studies, and ensures data integrity for regulatory documents and publications.

The role involves coordinating with clinical operations, data management, biostatistics, regulatory, and medical affairs in a multidisciplinary environment, with travel up to 20% as needed.

Qualifications

• PhD or equivalent plus 5+ years of pharmaceutical industry experience in clinical drug/biologics development and regulatory processes.
• Bachelor’s or Master’s with 10+ years in pharmaceutical development and regulatory exposure.
• Experience with clinical data analysis and regulatory documentation is essential.
• Excellent communication and presentation skills are required.
• Ability to travel up to 20% for site and advisory interactions.

Responsibilities

• Monitor clinical data quality and patient safety; escalate issues to the medical director as appropriate.
• Collaborate with data management, clinical operations, and monitors to ensure efficient data review.
• Author and review clinical documents including protocols, investigator brochures, and regulatory submissions.
• Prepare for and participate in study team meetings, advisory boards, and investigator meetings; present data and study designs.

Skills

Clinical data analysis

Communication skills

Presentation skills

Cross-functional collaboration

Business travel

Education

PhD or equivalent + 5+ years pharma experience

Bachelor’s or Master’s + 10+ years pharma experience

Job description

Deciphera, a biopharmaceutical company, is advancing clinical programs with a focus on hematology-oncology. The Associate Director Clinical Scientist contributes to executing development plans, operationalizes studies, and ensures data integrity for regulatory documents and publications.

The role involves coordinating with clinical operations, data management, biostatistics, regulatory, and medical affairs in a multidisciplinary environment, with travel up to 20% as needed.