Executive Director, Medical Writing

When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement...read on

In 2015, we pioneered a “moneyball for biotech” approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines for patients with unmet needs as fast as humanly possible.

Together we define white space, push boundaries and empower people to solve problems. If you re someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we ll ask "why not?" and help reengineer the future of biopharma.

Eidos Therapeutics, an affiliate within Bridge Bio Pharma, is a commercial-stage biopharmaceutical company focused on Transthyretin Amyloid Cardiomyopathy (ATTR-CM).

The primary responsibility for this role is to establish and manage the Medical Writing group for the Cardiorenal affiliates (currently includes Eidos Therapeutics and Calcilytix)  ideal candidate must have a strong understanding of health authority guidance(s) and requirements for clinical and regulatory documents, including public disclosure requirements in applicable regions.

The Senior/Executive Director will be responsible for overseeing the development and finalization of clinical and regulatory documents such as INDs, briefing documents, NDA/MAA summaries, regulatory responses, and key clinical documents (eg, protocols, clinical study reports, investigator brochures). This person will direct, plan, author, and review documents, as well as manage internal and external Medical Writers, for the preparation of high quality documents.

Other responsibilities include managing and developing staff to establish strategic, scientific, and technical expertise to support delivery of high-quality documents. Additional oversight of any vendor/contractor leveraged to complete projects. The role requires innovative problem-solving, influencing others, and change-management skills.

The Cardiorenal Medical Writing department will support multiple clinical development programs across the Cardiorenal Diseases division of Bridge Bio. Currently this includes acoramidis for ATTR (Eidos affiliate) and encaleret for ADH1 (Calcilytix affiliate).

The role reports to the VP of Regulatory Affairs.

• Oversee the Cardiorenal Medical Writing group, including leading, training, and mentoring for effective performance
• Lead medical writing (including coordination of other Medical Writers) from concept to final product for clinical study protocols and associated forms, protocol amendments, clinical study reports, investigator brochures, and related clinical study documents
• Provide strategic leadership to study teams to direct the preparation of protocols and CSRs, submissions, and other regulatory documents, and associated public disclosure documents
• Lead medical writing from concept to final product for regulatory submissions including IND applications, health agency interaction, Meeting Requests, Briefing Documents, NDA/MAA data modules and overall submission packages, and other related documentation for initial and/or supplemental applications for marketing authorization or label expansion
• Demonstrate in-depth knowledge of regulatory writing and data disclosure requirements
• Ensure company SOPs related to document development, templates, and medical writing deliverables conform with regulatory requirements (e.g., ICH and other guidelines). Take ownership of processes related to documents and guide teams through these processes
• Partner with clinical development, biostatistics, and data management in the review and development of tables, figures, and listings (TFLs), and for case narrative planning
• Work closely with study teams to ensure that results and messages in clinical documents accurately reflect the data in TFLs and other data sources
• Project manage the document…