Director, Medical Writing

Description: ABOUT BRIDGEBIO ONCOLOGY THERAPEUTICS

BBOT is a clinical-stage biopharmaceutical company advancing a next-generation pipeline of novel small molecule therapeutics targeting RAS and PI3K malignancies. BBOT has the goal of improving outcomes for patients with cancers driven by the two most prevalent oncogenes in human tumors. For more information, visit BBOTx.com.

WHO YOU ARE

The Director, Medical Writing provides strategic and operational leadership for the Medical Writing function and is responsible for the planning, development, and delivery of high-quality clinical and regulatory documents that support BBOT's development programs and global regulatory submissions.

This individual serves as a strategic partner to Clinical Development, Regulatory Affairs, Clinical Operations, and other cross-functional leaders to ensure the timely delivery of scientifically rigorous and regulatory-compliant documentation. The Director is responsible for establishing medical writing standards, building organizational capabilities, and ensuring portfolio-wide execution of medical writing activities in support of corporate objectives.

Requirements: RESPONSIBILITIES

Medical Writing

• Direct, hands-on authoring and leading complex, major regulatory document preparation (e.g., IND, NDA, BLA, and MAA, clinical protocol, IB, CSR, Agency meeting materials).
• Synthesize complex clinical and scientific data into key elements.
• Review and edit documents prepared by internal writers, contractors, or functional contributors to ensure quality and adherence to standards.
• Partner with study teams to develop key messages from clinical study data.
• Drive alignment across functions to ensure high-quality, timely, and efficient execution of clinical and regulatory documentation.

Functional Leadership and Strategy

• Develop and execute the Medical Writing functional strategy aligned with corporate and development objectives.
• Establ