Obsidian Therapeutics

Obsidian Therapeutics is a developer of a next-generation cell and gene therapies created to extend adoptive immunotherapy.

101-250 employees

Pharmaceutical

Private Company

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Pharmaceutical Biotechnology Health Care

Open Positions1

This is a remote roleFull-TimeBiotechnology, PharmaceuticalsPosted

Director, Medical Writing

Develop and execute medical writing strategy for clinical development, regulatory submissions, and launch readiness.
Partner with Regulatory Affairs to ensure strategic alignment, submission readiness, and compliance.
Author and finalize major regulatory documents, including BLA/NDA, CSRs, protocols, and safety/efficacy summaries.
Collaborate with Clinical Development and Biometrics to construct compelling evidence packages.
Serve as the primary medical writing representative on cross-functional program and submission teams.
Establish document planning, governance, standards, templates, and quality systems.
Build a scalable medical writing operating model and manage external partners, contract writers, and publishing vendors.

Project Management

Overview

Obsidian Therapeutics develops cell and gene therapies for cancer. The company utilizes its cytoDRiVE® platform, which regulates protein function in engineered cells using drug-responsive domains and FDA-approved small molecules. Their lead program, amsoki-cel (OBX-115), is an engineered tumor-infiltrating lymphocyte (TIL) cell therapy. OBX-115 is in Phase 2 clinical trials for advanced melanoma and Phase 1 clinical trials for non-small cell lung cancer (NSCLC). It has received Fast Track Designation from the FDA for metastatic or locally advanced melanoma resistant to PD-1/PD-L1-based immune checkpoint inhibitors. The company was founded in 2015. Obsidian Therapeutics announced a merger agreement with Galera Therapeutics in April 2026, which would result in the combined company trading on Nasdaq under the ticker "OBX". This merger includes a $350 million private placement to fund clinical operations into the second half of 2028. Obsidian Therapeutics has raised $325 million across three funding rounds, with the most recent being a $160.5 million Series C round in April 2024. Investors include Wellington Management, Foresite Capital, Janus Henderson Investors, Novo Holdings A/S, Paradigm BioCapital, RTW Investments, funds and accounts advised by T. Rowe Price Associates, Inc., and Woodline Partners LP. The company has collaborations with Bristol Myers Squibb and Vertex Pharmaceuticals.

Culture

Obsidian Therapeutics operates with a collaborative culture that emphasizes inclusion. The company indicates that it does not use silos or hierarchies and encourages the sharing of ideas and continuous learning. Its research team is based in Cambridge, MA, and its Technical Operations team is located in Bedford, MA.

Technology Story

Obsidian Therapeutics utilizes its cytoDRiVE® platform, which employs drug-responsive domains to regulate protein function in engineered cells through the use of FDA-approved small molecules. The company's website is built with technologies such as WordPress and Google Tag Manager. Its infrastructure incorporates SPF, Common Crawl, SSL by Default, Apple Mobile Web Clips Icon, HSTS, U.S. Server Location, DNSSEC, and LetsEncrypt. Obsidian Therapeutics uses products such as HTML5, DigiCert, Microsoft Outlook, Adobe Fonts, Apache Server, and GoDaddy Premium DNS.

Why Work Here

The company seeks candidates with experience in BLA/NDA submissions and a strong understanding of ICH guidelines and global regulatory requirements. Experience with cell therapy, oncology, gene therapy, or advanced therapeutics is also noted. The company mentions building a scalable medical writing operating model that leverages external partners and oversees contract medical writers, editors, and document publishing vendors. The Director, Medical Writing position is a remote role, with occasional travel potentially required. Obsidian Therapeutics states it is committed to cultivating an environment of inclusion and supports continuous learning. The anticipated base salary range for the Director, Medical Writing role is $220,500 – $269,500 USD.

Benefits and Perks

Obsidian Therapeutics provides an annual incentive bonus and long-term incentives in the form of employee stock options. The benefits package includes comprehensive medical, dental, and vision coverage. The company also offers contributions to health savings and retirement accounts, paid time off, and access to wellness programs.