Head of Clinical Affairs

Actithera

Head of Clinical Affairs overseeing clinical data generation and writing for RLT portfolio. Collaborating with teams to ensure compliance and strategic decision-making.

Posted 7/30/2026full-timeRemote • Massachusetts • 🇺🇸 United StatesLead💰 $150,000 - $275,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in authoring ICH-compliant documents and statistical analysis plans, with a strong focus on clinical pharmacology and RLT sciences. Proficient in data visualization and possesses exceptional writing and analytical skills for effective communication in clinical trial settings.

Highest-signal resume keywords

PhD In Life SciencesClinical Writing ExpertiseStatistical Analysis Plans (SAPs)Data Visualization Tools (GraphPad, R)Oncology Or Radiopharmaceuticals Experience

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Investigator Brochure (IB) AuthoringClinical Study Reports (CSRs)Nonclinical Data SummarizationData AnalysisScientific Figure Design

Soft Skills

Attention To DetailInterpersonal SkillsTeam CollaborationProject Management

Tools & Technologies

GraphPadR

Industry Keywords

Clinical PharmacologyRLT SciencesBiotechPharmaOncology

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

Annual bonus
Equity participation
Comprehensive benefits program