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
This experienced Medical Writer will lead medical writing activities associated with the planning, development, and finalization of high-quality clinical and regulatory documentation. This individual is the responsible subject-matter expert in the field of medical writing and will function as an individual contributor while providing oversight of contract medical writers. The successful candidate is expected to develop strong relationships with various departments and with different levels of management, including interactions across BridgeBio subsidiaries.
The scope ranges from early clinical development through submission and maintenance of license applications.
Responsibilities
- Lead medical writing process for new protocols/synopses, protocol amendments, clinical study reports, investigator brochures, and related regulatory documents
- Align cross-functionally to set strategies and goals for the management of internal and external medical writing resources to meet corporate goals and team objectives
- Ensure company templates and medical writing deliverables conform with regulatory requirements (eg, International Conference on Harmonization (ICH) and other relevant regulatory guidelines)
- Maintain a company style guide that includes standard language for regulatory documents
- 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 information sources
- Manage the document review process ensuring conflicting and/or ambiguous comments are clarified and appropriately addressed
- Ensure documents are generated in accordance with agreed internal processes and standards, are submission ready, and are appropriately archived in 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 in order to 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
- At least a Bachelor of Science or equivalent degree, post-graduate degree preferred
- Successful experience leading medical writing activities for multiple regulatory filings at various development stages
- Excellent oral and written communication skills with an ability to summarize complex raw data in a concise, accurate and easily understandable form
- Thorough knowledge of clinical research, health authority regulations, ICH Guidelines and medical writing standards with ability to interpret and apply these to document writing
- Excellent interpersonal, active listening, and influencing skills
- Strong leadership and project management skills, ability to work independently, multi-task, and work effectively under pressure
- Prior management experience preferred
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
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.Salary$210,000—$240,000 USD
