About Calcilytix & BridgeBio Pharma

Calcilytix Therapeutics, an affiliate of BridgeBio Pharma, is developing encaleret (CLTX-305), a negative allosteric modulator of the calcium-sensing receptor (CaSR) for the treatment of Autosomal Dominant Hypocalcemia Type 1 (ADH1), a genetic cause of hypoparathyroidism. Encaleret is currently being evaluated in a Phase 3 clinical study and has received Orphan Drug and Fast Track Designations from the US FDA.

BridgeBio is a biopharmaceutical company founded to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. We bridge the gap between remarkable advancements in genetic science in academic institutions and the delivery of meaningful medicines to patients. Founded in 2015, the company has built a portfolio of 30+ drug development programs ranging from preclinical to late-stage development in multiple therapeutic areas including genetic dermatology, precision oncology, cardiology, endocrinology, neurology, pulmonology, and renal disease, with two approved drugs.

Our focus on scientific excellence and rapid execution aims to translate today’s discoveries into tomorrow’s medicines. We have U.S. offices in San Francisco, Palo Alto, and Raleigh, with small satellites in other parts of the country. We also have international offices in Montreal, Canada, and Zurich, Switzerland, and are expanding across Europe.

To learn more about our story and company culture, visit us at https://calcilytix.com/ | https://bridgebio.com

Who You Are

The individual taking on this role will be expected to author or otherwise make substantive, individual contributions to clinical and regulatory documents. As needs grow, this individual may be required to recruit, train and otherwise manage other employees and contractors. They will be expected to lead the planning, drafting, revising, and finalization of high-quality clinical and regulatory documentation. This includes study protocols and associated documents, regulatory submission documents (INDs, Briefing Documents, NDA/MAA registration, and supplemental indication dossiers), clinical white papers, abstracts, and manuscripts for peer-reviewed publication.

In sum, this individual and (as applicable) other medical writers under their supervision will be expected to generate high-quality enduring output and project manage their production from start to finish, in collaboration with the overall owners of said documents within Clinical Development, Patient Safety, and Regulatory Affairs. The successful candidate is expected to develop strong relationships with various other affiliates and functions across BridgeBio to ensure consistently high quality of enduring output and sharing of best practices. The Cardiorenal Medical Writing department will support multiple programs across the Cardiorenal Diseases division of BridgeBio. Currently, this includes acoramidis for ATTR (Eidos affiliate) and encaleret for ADH1 (Calcilytix affiliate). This position will report to the Department Head who reports directly to the President and Chief Medical Officer.

Responsibilities

• Lead medical writing as assigned from concept to final product for clinical study protocols and associated forms, protocol amendments, clinical study reports, investigator brochures, and related clinical study documents
• Lead medical writing as assigned from concept to final product for regulatory submissions including IND applications, health agency interaction Meeting Requests, Briefing Documents, draft Meeting Minutes, and related submissions, NDA/MAA data modules and overall submission packages, and other related documentation for initial and/or supplemental applications for marketing authorization or label expansion
• Lead medical writing as assigned from concept to final product for the content and narrative of scientific communications (abstracts and manuscripts) issued from Clinical Development, in collaboration with Medical Affairs to align key messages. Medical Affairs owns the administrative management with respect to publications submissions and communications with publishers; both functions participate as collaborators within the Publications Team led by Medical Affairs
• Ensure company templates and medical writing deliverables conform with regulatory requirements (eg, International Conference on Harmonization (ICH) and other relevant regulatory guidelines)
• 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
• Suggest or identify modifications and improvements to document preparation processes and company templates to continuously improve quality, efficiency, and productivity

No matter your role at BridgeBio, successful team members are:

• Patient Champions, who put patients first and uphold strict ethical standards
• Entrepreneurial Operators, who drive toward practical solutions and have an ownership mindset
• Truth Seekers, who are detailed, rational, and humble problem solvers
• Individuals Who Inspire Excellence in themselves and those around them
• High-quality executors, who execute against goals and milestones with quality, precision, and speed

Education, Experience & Skills Requirements

• Bachelor’s or equivalent college degree required with 15 years experience; post-graduate scientific or medical degree (e.g., MS, MPH, PhD, PharmD, MD, DO) preferred with a minimum of 5 years experience
• Documented ability to write compelling, technically sophisticated, scientific narratives relevant to the audience
• Experienced in medical writing activities for multiple regulatory filings at various development stages
• Successful prior management experience preferred
• Excellent oral and written communication skills with an ability to summarize and graphically represent complex scientific and clinical data with concise, accurate, and easily understandable narrative flow and syntax
• Thorough knowledge of clinical research, health authority regulations, ICH Guidelines, and medical writing standards with the ability to interpret and apply these to document writing
• Excellent interpersonal, active listening, and influencing skills
• Strong project management skills, ability to work independently, multi-task, and work effectively under pressure

What We Offer

• Patient Days, where we are fortunate to hear directly from individuals living with the conditions we are seeking to impact throughout the year and learn how we can improve our efforts
• A culture inspired by our values: put patients first, think independently, be radically transparent, every minute counts, and let the science speak
• An unyielding commitment to always putting patients first. Learn more about how we do this here
• A de-centralized model that enables our program teams to focus on advancing science and helping patients. Our affiliate structure is designed to eliminate bureaucracy and put decision-making power in the hands of those closest to the science
• A place where you own the vision – both for your program and your own career path
• A collaborative, fast-paced, data-driven environment where we inspire ourselves and each other to always perform at the top of our game
• Access to learning and development resources to help you get in the best professional shape of your life
• Robust and market-competitive compensation & benefits package (Base, Performance Bonus, Equity, health, welfare & retirement programs)
• Flexible PTO
• Rapid career advancement for strong performers
• Potential ability to work on multiple BridgeBio Pharma programs across multiple therapeutic areas over time 
• Partnerships with leading institutions
• Commitment to Diversity, Equity & Inclusion