Senior Director, Medical Writing

Parabilis Medicines • Cambridge, MA

6d • $250,000 - $300,000

About The Position

Parabilis Medicines is a clinical-stage biopharmaceutical company dedicated to creating extraordinary medicines that unlock high-impact protein targets long-considered undruggable. The company has developed a new class of stabilized, cell-penetrant alpha-helical peptides – Helicons™ – capable of modulating intracellular proteins that are inaccessible to traditional drug modalities. Headquartered in Cambridge, Mass., Parabilis is advancing a focused pipeline of multiple first-in-class therapies across both rare and common cancers. Its lead candidate, FOG-001, is the first direct inhibitor of the interaction between β-catenin and the T-cell factor (TCF) family of transcription factors, implicated in colorectal cancer, desmoid tumors, and a range of other Wnt/β-catenin-driven tumors. Parabilis is also advancing investigational degraders of ERG and ARON for the treatment of prostate cancer, as well as other preclinical programs. What’s the opportunity? The Senior Director, Medical Writing will join the growing Clinical Operations organization and serve as the strategic and operational leader for all medical writing activities across clinical development programs. This role will own the authorship, quality, and delivery of critical clinical and regulatory documentation and will ensure that Parabilis’ scientific and clinical narratives are communicated with clarity, accuracy, and regulatory excellence. This is a high-impact position that will partner cross-functionally with Clinical Development, Regulatory Affairs, Program Management, Biometrics, Nonclinical, and CMC teams. The Senior Director will shape documentation strategy for a rapidly advancing first-in-class therapeutic modality and will directly influence clinical execution, regulatory interactions, and the company’s ability to translate groundbreaking science to patient benefit.

Requirements

• Advanced degree in a scientific discipline (MS, PharmD, PhD, MD) or equivalent experience.
• 15+ years of relevant medical writing experience in the biotechnology or pharmaceutical industry, including leading writing strategy for clinical-stage programs.
• Proven expertise with clinical and regulatory documents (protocols, CSRs, IBs, regulatory submissions).
• Proven track record of delivery and utilization of new techniques & approaches such as AI/ML to ensure efficiency and accurate production of documents.
• Strong understanding of GCP, ICH guidelines, and global regulatory expectations.
• Experience working in cross-functional, fast-paced development environments.
• Demonstrated ability to manage vendors and complex documentation workflows.
• Experience supporting early-phase oncology programs.
• Experience preparing documentation for Health Authority interactions (FDA, EMA).
• Familiarity with novel modalities, platform technologies, or mechanisms requiring clear scientific translation.
• Ability to influence without authority and build trusted relationships across functions.

Responsibilities

• Lead medical writing strategy and execution across clinical development programs, ensuring timely delivery of high-quality documents aligned to corporate and regulatory objectives.
• Collaborating with the Clinical Leader, serve as the chief author or lead reviewer for key documents including: Clinical Protocols and Amendments Investigator Brochures Clinical Study Reports (CSRs) Informed Consent Forms Regulatory submission components (e.g., IND/IMPD documents, briefing books, safety updates, module content) Clinical-scientific narratives and safety summaries
• Partner with Regulatory and Clinical leaders to develop documentation plans and timelines for major milestones (Phase transitions, Health Authority meetings, submissions).
• Oversee and manage external writing vendors, freelancers, and CRO deliverables; ensure consistent standards, templates, style guides, and quality control processes.
• Develop and maintain medical writing templates, SOPs, and best practices to support high-quality, efficient document generation across the organization.
• Ensure all documents meet ICH, GCP, and global regulatory requirements.
• Contribute to story development, message alignment, and scientific accuracy across Parabilis’ clinical and regulatory communications.
• Mentor cross-functional authors and reviewers on writing best practices and effective documentation strategies.
• Play a leadership role within Clinical Operations, helping drive operational excellence, cross-functional alignment, and a patient-focused mindset.

Benefits

• The base salary range for this position is $250,000–$300,000 per year, depending on experience, qualifications, and internal practices.
• Parabilis’s total compensation package also includes an annual target bonus, equity, and a comprehensive suite of competitive benefits designed to support our employees’ overall well-being.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree