SlipstreamJobs tracks this role from the company's public career site. Apply directly on the employer's site.
Salary: USD 220,500 - 269,500 / annual
Obsidian Therapeutics is seeking a Director of Medical Writing to lead the strategic planning, development, and execution of regulatory and clinical documents supporting the advancement of the company's clinical development programs. The role combines strategic leadership with hands-on execution, positioning the individual as the company's medical writing leader and subject matter expert.
The Director will be responsible for ensuring delivery of high-quality, scientifically rigorous, regulatory-compliant documents that effectively communicate clinical evidence supporting the product. Key responsibilities include developing and executing the company's medical writing strategy in support of clinical development, regulatory submissions, and launch readiness; partnering with Regulatory Affairs to ensure strategic alignment and submission readiness; translating complex clinical, statistical, safety, translational, and manufacturing information into clear, scientifically accurate narratives; and leading the authoring, review, and finalization of major regulatory documents including BLA submission documents, Module 2 clinical summaries, Clinical Study Protocols, Investigator Brochures, Clinical Study Reports (CSRs), Statistical Analysis Plan summaries, Integrated Summaries of Safety (ISS), Integrated Summaries of Efficacy (ISE), and responses to health authority questions.
Additional responsibilities include collaborating with Clinical Development and Biometrics to construct compelling evidence packages; serving as the primary medical writing representative on cross-functional program and submission teams; establishing document planning, governance, standards, templates, and quality systems; ensuring consistency across protocols, SAPs, CSRs, safety documents, and regulatory summaries; contributing to inspection readiness and document traceability activities; establishing document development processes that support rapid execution without compromising quality; building a scalable medical writing operating model that effectively leverages external partners; overseeing contract medical writers, editors, and document publishing vendors; identifying risks, resource constraints, and submission-critical dependencies early; implementing best practices for content reuse, document standards, authoring technologies, and quality control; developing and maintaining writing templates, style guides, and document repositories; and ensuring compliance with ICH, GCP, FDA, EMA, and company quality requirements.
This is a unique opportunity to establish a phase-appropriate medical writing capability within a clinical-stage biotechnology company preparing for its first product submission. The company is working on amsoki-cel (OBX-115), a novel engineered tumor-infiltrating lymphocyte (TIL) cell therapy using the proprietary cytoDRiVE® platform for treatment of metastatic melanoma and non-small cell lung cancer. The role will partner closely with Clinical Science, Regulatory Affairs, Biometrics, Clinical Operations, Clinical Safety, CMC, and external vendors. This is a remote role; travel to support job duties may be occasionally required.
**REQUIREMENTS:**
- Advanced scientific degree preferred (PhD, PharmD, MD, or equivalent); Master's degree with significant relevant experience will be considered
- 10+ years of biotechnology or pharmaceutical medical writing experience
- Demonstrated experience authoring and leading major regulatory submission documents, including experience supporting BLA/NDA
- Cell therapy experience highly preferred
- Bonus qualifications: experience supporting a first product approval; experience with autologous cell therapy or similarly complex clinical study; participation in/leadership of at least one successful BLA approval
