Director, Medical Writing

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BBOT

WebsiteLinkedInAll Job Openings

51 - 200 employees

🧬 Biotechnology

💊 Pharmaceuticals

Biotechnology • Pharmaceuticals

BBOT is a biotechnology company developing targeted therapies for cancers driven by RAS signaling and PI3Kα. The company focuses on rational drug design to inhibit the active ON state of RAS and to selectively block RAS-driven PI3K activation, aiming at multiple KRAS mutants and novel approaches to maximize target inhibition. BBOT translates decades of RAS biology research into therapeutic candidates intended to improve outcomes for patients with RAS- and PI3Kα-driven tumors.

📋 Description

• Provides strategic and operational leadership for the Medical Writing function. • Responsible for planning, development, and delivery of high-quality clinical and regulatory documents. • Serves as a strategic partner to Clinical Development, Regulatory Affairs, Clinical Operations, and other cross-functional leaders. • Responsible for establishing medical writing standards, building organizational capabilities, and ensuring portfolio-wide execution of medical writing activities. • Develops and executes the Medical Writing functional strategy aligned with corporate and development objectives. • Manages Medical Writing resource plans, including internal staffing, contractor oversight, and vendor management strategies. • Establishes and maintains Medical Writing governance, standards, templates, and quality processes.

🎯 Requirements

• Bachelor's degree in Life Sciences or related discipline required; advanced degree (PhD, PharmD, MD, or Master's degree) preferred. • Minimum of 12 years of experience in the biopharmaceutical industry, including at least 10 years of progressive medical writing experience. • Minimum of 3 years of people leadership or functional management experience. • Demonstrated success leading Medical Writing activities for complex global regulatory submissions, including INDs, NDAs, BLAs, and MAAs. • Deep expertise across the clinical trial document lifecycle, including protocols, Investigator's Brochures, Clinical Study Reports, CTD summaries, and health authority briefing documents. • Extensive knowledge of global regulatory requirements and guidelines, including FDA, EMA, ICH, and GCP. • Proven experience building and managing medical writing teams, contractors, and external vendors. • Demonstrated ability to independently lead in a fast-paced, dynamic, and highly collaborative biotechnology environment. • Strong strategic thinking, organizational, and project leadership skills. • Excellent written and verbal communication skills and the ability to influence at all levels of the organization. • Proficiency with standard business applications and industry systems, including Microsoft Office, Adobe Acrobat, SharePoint, Veeva RIM, EndNote, and related document management platforms.

🏖️ Benefits

• comprehensive health benefits • annual performance bonus • company equity