Head of Clinical Affairs

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Draft and update the Investigator Brochure (IB), integrating data with an emphasis on RLT elements.

• Develop and supervise Statistical Analysis Plans (SAPs) for clinical trials.

• Take the lead in composing Clinical Study Reports (CSRs), merging trial outcomes and safety narratives.

• Gather and write summaries of nonclinical data for regulatory submissions.

• Create and design scientific figures and visuals for reports and presentations.

• Evaluate clinical trial data to guide decision-making and enhance team collaboration.

• Advise clinical scientists on optimal practices for document preparation and workflows.

⛳️ Requirements

• PhD in life sciences, PharmD, or MD with a specialization in clinical pharmacology or a related field.

• 8+ years of experience in clinical science or medical writing within the biotech or pharmaceutical industry, particularly in oncology or radiopharmaceuticals.

• Proficiency in creating ICH-compliant documents (IB, SAP, CSR) and skilled in data visualization tools (e.g., GraphPad, R).

• In-depth knowledge of RLT sciences, including alpha/beta emitters, ligand targeting, and the translation from nonclinical to clinical phases.

• Outstanding writing and analytical capabilities, with a keen eye for detail and the ability to manage multiple projects effectively.

• Experience working in a matrixed environment, accompanied by strong interpersonal skills for collaborative teamwork.

🏝️ Benefits

• Annual bonus

• Equity participation

• Comprehensive benefits program