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 complex RLT data like dose-response curves or imaging-based endpoints. Data Interpretation and Strategy: Analyze clinical trial data to inform go/no-go decisions, protocol amendments, and publication strategies. Collaborate with biostatisticians and data scientists for robust analyses. Cross-Functional Support: Provide scientific input to regulatory, medical affairs, and R&D teams, including responses to health authority queries. Mentorship and Process Improvement: Guide clinical scientists on best practices for document writing and implement efficiencies in scientific workflows. Qualifications PhD in life sciences, PharmD, or MD with a focus on clinical pharmacology or related field. 8+ years in clinical science or medical writing within biotech/pharma, with experience in oncology or radiopharmaceuticals. Expertise in authoring ICH-compliant documents (IB, SAP, CSR) and proficiency in data visualization tools (e.g., GraphPad, R). Strong knowledge of RLT sciences, including alpha/beta emitters, ligand targeting, and nonclinical-to-clinical translation. Exceptional writing and analytical skills, with attention to detail and ability to handle multiple projects. Experience in a matrixed environment, with strong interpersonal skills for team collaboration. Compensation Actithera offers a competitive compensation package designed to reward both performance and expertise through market-based, results-driven pay. For this role, the anticipated base salary range is $150,000 – $275,000, complemented by eligibility for an annual bonus, equity participation, and a comprehensive benefits program. Your actual salary will be determined based on the scope of the role and your unique experience and capabilities—because we know great contributions come from great people. Actithera is proud to be an Equal Opportunity Employer. Our goal is to have a diverse workforce. We do not discriminate on the basis of race, age, color, religion, national origin, gender, sexual orientation, gender identity or expression, veteran status or disability or any other status protected under federal, state or local law. All employment is decided on the basis of qualifications, merit and business need. #J-18808-Ljbffr Actithera