Head of Clinical Affairs

Head of Clinical Affairs Position Summary The Head of Clinical Affairs is a critical scientific leadership role dedicated to generating and interpreting clinical data for the company's RLT portfolio. This position ensures the scientific integrity of all clinical documents and visuals, supporting evidence-based decision-making and regulatory submissions. Reporting to the Head of Clinical Development or CMO, the role demands expertise in clinical pharmacology, biostatistics, and RLT-specific sciences to translate complex data into actionable insights. The focus is on writing key documents like investigator brochures, statistical analysis plans, clinical study reports, nonclinical summaries, and scientific figures, while emphasizing the unique pharmacodynamics of radiopharmaceuticals. Key Responsibilities Investigator Brochure (IB) Writing: Author and revise the IB, synthesizing preclinical, clinical, and safety data with a focus on RLT aspects such as radionuclide decay, biodistribution, and therapeutic efficacy. Ensure compliance with ICH guidelines and timely updates based on emerging data. Statistical Analysis Plan (SAP) Development: Create and oversee SAPs for clinical trials, defining endpoints, statistical methods, and subgroup analyses tailored to RLT outcomes (e.g., response rates via PET imaging or dosimetry metrics). Clinical Study Report (CSR) Preparation: Lead the writing of CSRs, integrating trial results, safety narratives, and interpretations to support regulatory filings and publications. Highlight RLT-specific findings, such as radiation dosimetry correlations with efficacy. Nonclinical Summaries: Compile and author summaries of nonclinical data (e.g., toxicology, pharmacokinetics) for inclusion in regulatory documents, emphasizing translation to clinical RLT applications. Scientific Figures and Visuals: Design and produce all scientific figures, tables, and graphics for reports, presentations, and manuscripts, ensuring they effectively communicate co