Head of Clinical Affairs

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🔥 40 minutes ago

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $150k - $275k / year

⏰ Full Time

🔴 Lead

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Actithera

WebsiteLinkedInAll Job Openings

1 - 10 employees

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

💰 $75.5M Series A - Actithera on 2025-07

Healthcare • Biotechnology • Pharmaceuticals

Actithera is a biotechnology company developing next-generation radioligand therapies (RLTs) for cancer. The company designs molecules that link radioactive isotopes to small molecules and modified peptides to deliver targeted, sustained radiation to tumors while sparing healthy tissues. Actithera is a discovery-stage firm with assets in IND-enabling studies and aims to enable effective, better-tolerated, personalized cancer treatments with fewer therapy cycles through proprietary chemistry that matches radionuclide half-lives to tumor residence time.

📋 Description

• Author and revise the Investigator Brochure (IB), synthesizing data with a focus on RLT aspects. • Create and oversee Statistical Analysis Plans (SAPs) for clinical trials. • Lead the writing of Clinical Study Reports (CSRs), integrating trial results and safety narratives. • Compile and author summaries of nonclinical data for regulatory documents. • Design and produce scientific figures and visuals for reports and presentations. • Analyze clinical trial data to inform decisions and support team collaboration. • Guide clinical scientists on best practices for document writing and workflows.

🎯 Requirements

• 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.

🏖️ Benefits

• Annual bonus • Equity participation • Comprehensive benefits program