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.

Affiliate Overview

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

What You\'ll Do

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) at BridgeBio. The 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 BridgeBio. Currently this includes acoramidis for ATTR (Eidos affiliate) and encaleret for ADH1 (Calcilytix affiliate).

The role reports to the VP of Regulatory Affairs.

Responsibilities

• 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 review process, ensuring conflicting and / or ambiguous comments are clarified and appropriately addressed in a timely and efficient manner
• Ensure documents are generated in accordance with agreed internal processes and standards, are submission-ready, and are appropriately archived in the agreed document management system
• Ensure that appropriate documented quality control (QC) checks are performed on medical writing deliverables, respond to findings, and recommend quality process improvements
• Establish Medical Writing support models and implement strategies to improve operational efficiencies. Suggest or identify modifications and improvements to document preparation processes and company templates to continuously improve quality, efficiency, and productivity. Apply relevant experience in process initiative and / or vendor management

Where You\'ll Work

This is a hybrid role and requires in-office collaboration 2-3x per week, or as needed, in our San Francisco, CA & Palo Alto, CA offices.

Who You Are

Rewarding Those Who Make the Mission Possible

We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return.

Skill Development & Career Paths :

At BridgeBio, we strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits. Below is the anticipated salary range for candidates for this role who will work in California. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, educational background, location of residence and performance during the interview process. BridgeBio is a multi-state employer, and this salary range may not reflect positions based in other states.

$260,000 - $300,000 USD

Are you legally authorized to work in the United States?

If hired by BridgeBio or one of its affiliates, will you now or in the future require sponsorship for employment visa status (e.g. H-1B, TN, OPT, etc)?

How did you hear about us?

Are you open to relocating to the San Francisco Bay Area?

U.S. Standard Demographic Questions

We invite applicants to share their demographic background. If you choose to complete this survey, your responses may be used to identify areas of improvement in our hiring process.

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