About the role

Aplyr's Quick Take

This role is about leading the Medical Writing team for BridgeBio's Cardiorenal affiliates, focusing on creating clinical and regulatory documents. It's a senior-level position that combines strategic oversight with hands-on writing and management responsibilities.

Good fit

Ideal candidates have extensive experience in medical writing, particularly in clinical and regulatory contexts, and are comfortable managing a team. A proactive, detail-oriented approach and familiarity with health authority guidelines are essential.

Worth noting

The role emphasizes innovation and a non-traditional approach to biopharma, which may appeal to those looking for a dynamic work environment. The hybrid work model offers flexibility, but the specifics of team dynamics and expectations are not detailed.

Mavericks Wanted

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. At BridgeBio, we value curiosity and experimentation—including the ethical & thoughtful use of AI to improve clarity, speed, and quality of work.

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 responsiblites 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 (including coordination of other Medical Writers) from concept to final product for regulatory submissions including IND applic

Skills & Tags

ai ios data product marketing

Aplyr's read

BridgeBio Pharma is a dynamic biotechnology firm dedicated to tackling genetic diseases and cancers, attracting professionals passionate about impactful medical advancements.
Synthesized from recent postings & public sources

What's promising

•BridgeBio focuses on innovative treatments for genetic diseases, offering significant potential for groundbreaking medical advancements.
•The company has a robust pipeline with multiple late-stage clinical trials, indicating strong future growth prospects.
•BridgeBio's strategic partnerships enhance its research capabilities and expand its therapeutic reach.

What to watch

•The company faces high financial risk due to significant R&D expenditures without guaranteed success.
•BridgeBio operates in a highly competitive market with numerous established players.
•Regulatory hurdles for drug approvals can delay product launches and impact revenue.

Why BridgeBio Pharma

•BridgeBio's focus on genetic diseases and cancers sets it apart in the biotechnology sector.
•The company's decentralized model allows for nimble and efficient project management.
•BridgeBio's commitment to rare diseases addresses unmet medical needs, differentiating its mission.

Aplyr’s read is generated by AI from public sources. Was it useful?