Oncology Clinical Scientist - Protocols, Studies & Submissions

Perspective Therapeutics; United States; On-site; USD 120,000 - 170,000; Full time

Job summary

Perspective Therapeutics is seeking a Clinical Scientist to develop protocols and informed consent documents for clinical studies, and draft INDs/IBs for FDA/EMA submissions. The role drives medical monitoring and requires oncology expertise to design and deliver clinical studies independently.

You will coordinate activities to set up and monitor studies, prepare accurate status reports, and maintain study documentation. Travel up to 20% may be required.

Qualifications

• Advanced clinical degree preferred (e.g., PhD, MD, PharmD).
• 3+ years clinical research experience in biotech/pharma/CRO with oncology focus.
• Experience with trial design and regulatory submissions (IND, CTA, BLA, NDA).
• Experience in safety assessment and translational oncology research.

Responsibilities

• Serve as scientific liaison with KOLs, investigators, and external partners.
• Contribute to clinical development planning and regulatory strategy.
• Lead or support design and review of protocols, ICFs, and amendments.
• Provide updates on study progress and milestones to stakeholders.
• Review literature to support clinical strategy and regulatory submissions.
• Develop training materials for clinical sites and CRAs; present at SIVs/Investigator Meetings.
• Monitor data trends for safety and efficacy with cross-functional teams.
• Ensure CRF design aligns with protocol requirements with data management.
• Contribute to CSRs, SAPs, DMPs, publications, and regulatory documents.
• Assess patient safety data, radiology reports, and PK data with medical monitors.
• Oversee vendor performance and adherence to SLAs and quality standards.
• Assist in evaluating innovative study designs and early-phase strategies.

Skills

GCP/ICH knowledge

Regulatory knowledge

Medical writing

Clinical pharmacology

Communication skills

Leadership

Education

Advanced degree in Pharmaceutical Sciences, Oncology, or related field

Tools

Imaging modalities (PET, SPECT, CT, MRI)

Job description

Perspective Therapeutics is seeking a Clinical Scientist to develop protocols and informed consent documents for clinical studies, and draft INDs/IBs for FDA/EMA submissions. The role drives medical monitoring and requires oncology expertise to design and deliver clinical studies independently.

You will coordinate activities to set up and monitor studies, prepare accurate status reports, and maintain study documentation. Travel up to 20% may be required.