Senior Director, Medical Writing – Biologics

🔥 15 minutes ago

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SAB BIO

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2014

🧬 Biotechnology

💊 Pharmaceuticals

🏥 Healthcare

Biotechnology • Pharmaceuticals • Healthcare

SAB BIO is a clinical-stage biopharmaceutical company focused on developing multi-specific, high-potency human immunoglobulin G (hIgG) therapies to treat and prevent immune and autoimmune disorders, with a stated mission to redefine diagnosis and treatment of type 1 diabetes (T1D) through disease-modifying medicines. Founded in 2014 and traded on Nasdaq (SABS) since 2021, SAB BIO uses proprietary genetic engineering and antibody technologies to generate therapeutic candidates without relying on human donors or convalescent plasma. The company has conducted seven clinical trials dosing roughly 700 individuals across multiple therapeutic areas, reporting no patients with serum sickness or neutralizing anti-drug antibodies in its safety and immunogenicity database. Its lead candidate, SAB-142, is aimed at delaying onset and potentially preventing progression of Stage 3 T1D.

📋 Description

• Provide strategic and operational leadership for the preparation, development, and delivery of high-quality regulatory and clinical documents supporting the late-stage development and anticipated commercialization of SAB’s lead biologic candidate, SAB-142, and broader pipeline programs. • Lead cross-functional development of Integrated Summaries of Safety (ISS) and Integrated Summaries of Efficacy (ISE) to support global regulatory submissions and benefit-risk assessments. • Author, review, and finalize high-quality regulatory documents including Biologics License Applications (BLA), Marketing Authorization Applications (MAA), clinical study reports (CSRs), and responses to Health Authority questions.

🎯 Requirements

• 12+ years of medical writing experience in biologics development within the biotech or pharmaceutical industry required. • Advanced degree: PhD, PharmD, MD, MS, in Immunology or related discipline • Experience with successful FDA and EMA approvals for biologic products preferred but not required. • Significant and demonstrated experience supporting biologic drug development programs through medical writing activities. • Demonstrated hands-on experience authoring and leading BLA and MAA submissions is required.

🏖️ Benefits

• Home office working environment • Occasional business related travel is expected