ObjectiveThe Clinical Scientist will work to develop protocols and informed consent documents for clinical studies, as well as draft clinical scientific documents such as INDs, IBs, and other documents for FDA/EMA submissions. This individual will also be responsible for driving the medical monitoring process. The Clinical Scientist will have the scientific expertise necessary to design and deliver clinical studies and programs, with a comprehensive background in oncology. The role requires independent and proactive coordination of all activities needed to set up and monitor a study, including completing accurate study status reports and maintaining study documentation.Essential FunctionsServe as a key scientific liaison, collaborating with key opinion leaders (KOLs), investigators, and external partners to support clinical development initiatives.Contribute to clinical development planning and the formulation of scientific and regulatory strategies, ensuring alignment with program objectives.Lead or support the design, drafting, and review of clinical protocols, informed consent forms (ICFs), and protocol amendments.Provide timely updates on study progress, emerging data trends, and key milestones to management and relevant stakeholders.Conduct comprehensive literature reviews to support clinical strategy, protocol development, and regulatory submissions.Develop and deliver training materials for clinical sites and clinical research associates (CRAs), presenting at Site Initiation Visits (SIVs) and Investigator Meetings to ensure study alignment.Review and provide scientific input on clinical narratives, ensuring accuracy and consistency in patient-level data summaries.Monitor and analyze clinical data trends, identifying potential safety signals or efficacy patterns in collaboration with cross-functional teams.Ensure that case report form (CRF) design aligns with protocol requirements, working closely with Data Management and Programming teams.Contribute scientific expertise to clinical study reports (CSRs), statistical analysis plans (SAPs), data management plans (DMPs), publications, presentations, and regulatory documents.Assist in the assessment of patient safety, clinical pharmacology data, radiology scans, and pathology reports in collaboration with medical monitors and safety teams.Contribute to overseeing and evaluation of vendor performance, ensuring adherence to study-specific service level agreements (SLAs) and quality standards.Support the evaluation and implementation of innovative study designs, working closely with clinical directors to enhance trial efficiency.Assist in executing early-phase clinical development strategies, contributing to the advancement of novel radiopharmaceutical therapies.QualificationsTo perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.Education/ExperienceAdvanced or clinical degree preferred (e.g., RN, BSN, MSN, MS, PhD, PharmD, or MD in a relevant scientific discipline such as Pharmaceutical Sciences, Radiopharmacy, Oncology, Molecular Biology, Biomedical Sciences, or a related field). Candidates with substantial industry experience without an advanced degree may be considered with substantial industry experience.3+ years of clinical research experience in biotech, pharmaceutical, or CRO settings, with a focus on oncology, nuclear medicine, or radiopharmaceuticals preferred.Hands-on experience with clinical trial design, protocol development, and regulatory submissions (IND, CTA, BLA, 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, as well as presenting at Investigator Meetings or Site Initiation Visits (SIVs).Prior engagement with KOLs, investigators, and regulatory agencies (e.g., FDA, EMA, Health Canada) is a plus.Knowledge / Skill / AbilityStrong understanding of GCP, ICH guidelines, and regulatory requirements for drug development.Familiarity with clinical pharmacology, radiology, and imaging modalities (e.g., PET, SPECT, CT, MRI) in a clinical trial setting is a plus.Proficient in medical terminology and medical writing skills.Computer proficiency in basic database entry and graphics presentations.Exceptional verbal and written communication skills, with demonstrated ability to communicate complex scientific information to diverse audiences.Strong leadership skills with experience leading cross-functional project teams and fostering collaboration across departments.Strategic thinker with the ability to translate scientific insights into actionable clinical strategies.Highly detail-oriented with strong problem-solving skills; proactive in anticipating and resolving issues.Advanced proficiency in medical writing and technical documentation; skilled in preparing high-quality scientific and regulatory documents.Comprehensive knowledge of Good Clinical Practice (GCP), International Council for Harmonization (ICH) guidelines, and the drug development process.Must be willing to travel up to 20% of the time. Both domestic and international travel may be required.Work EnvironmentThe work environment
