Director, Clinical Scientist
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Job Description
Clinical Scientist directing oncology clinical trials and regulatory documentation at Perspective Therapeutics. Advancing novel radiopharmaceutical therapies through medical monitoring and cross-functional study leadership.
Responsibilities:
- Develop protocols and informed consent documents for clinical studies
- Draft clinical scientific documents such as INDs, IBs, and other FDA/EMA submission documents
- Drive the medical monitoring process
- Design and deliver clinical studies and programs
- Coordinate activities required to set up and monitor studies
- Complete accurate study status reports and maintain study documentation
- Serve as a scientific liaison with KOLs, investigators, and external partners
- Contribute to clinical development planning and scientific and regulatory strategies
- Lead or support design, drafting, and review of clinical protocols, ICFs, and protocol amendments
- Provide study progress, emerging data, and milestone updates to management and stakeholders
- Conduct literature reviews supporting clinical strategy, protocol development, and regulatory submissions
- Develop and deliver training materials for clinical sites and CRAs; present at SIVs and Investigator Meetings
- Review and provide scientific input on clinical narratives and patient-level data summaries
- Monitor and analyze clinical data trends, identifying safety signals and efficacy patterns
- Ensure CRF design aligns with protocol requirements with Data Management and Programming teams
- Contribute to CSRs, SAPs, DMPs, publications, presentations, and regulatory documents
- Assist with assessment of patient safety, clinical pharmacology data, radiology scans, and pathology reports
- Contribute to vendor performance evaluation and adherence to SLAs and quality standards
- Support innovative study design evaluation and implementation
- Assist in early-phase clinical development strategies for novel radiopharmaceutical therapies
Requirements:
- Advanced or clinical degree preferred, such as RN, BSN, MSN, MS, PhD, PharmD, or MD in a relevant scientific discipline
- Candidates with substantial industry experience without an advanced degree may be considered
- 3+ years of clinical research experience in biotech, pharmaceutical, or CRO settings, preferably focused on oncology, nuclear medicine, or radiopharmaceuticals
- Hands-on experience with clinical trial design, protocol development, and regulatory submissions including IND, CTA, BLA, and NDA
- Experience with clinical data review, safety assessments, and translational research in oncology or targeted radiotherapy is highly desirable
- Experience developing training materials for clinical sites and CRAs and presenting at Investigator Meetings or Site Initiation Visits
- Prior engagement with KOLs, investigators, and regulatory agencies such as FDA, EMA, and Health Canada is a plus
- Strong understanding of GCP, ICH guidelines, and regulatory requirements for drug development
- Familiarity with clinical pharmacology, radiology, and imaging modalities including PET, SPECT, CT, and MRI is a plus
- Proficiency in medical terminology and medical writing
- Computer proficiency in basic database entry and graphics presentations
- Exceptional verbal and written communication skills, including communicating complex scientific information to diverse audiences
- Strong leadership skills and experience leading cross-functional project teams
- Strategic thinking and ability to translate scientific insights into actionable clinical strategies
- Strong attention to detail and problem-solving skills
- Advanced proficiency in medical writing and technical documentation
- Comprehensive knowledge of GCP, ICH guidelines, and the drug development process
- Willingness to travel up to 20% of the time, domestically and internationally
- Ability to work outside regular hours, including off-shift, weekend, and holiday work, as business needs require
- Ability to sit or stand for long periods of 8+ hours per day
- Willingness to wear required personal protective equipment
- Willingness to complete safety training within allotted timeframes
Benefits:
- Equal employment opportunities and protection from discrimination and harassment
- Reasonable accommodation for individuals with disabilities
- Opportunity to work in a team-based environment
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