Sr. Director/Executive Director, Analytical Development

About Eidos Therapeutics & BridgeBio Pharma

Eidos Therapeutics, an affiliate of BridgeBio Pharma, is a commercial stage biopharmaceutical company focused on addressing the large and growing unmet need in diseases caused by transthyretin, or TTR, amyloidosis, or ATTR. We seek to treat this well-defined family of diseases at their collective source by stabilizing TTR. Attruby (acoramdis) is an orally administered small molecule designed to stabilize TTR, a best-in-class treatment aiming to halt the progression of ATTR diseases.

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 eidostx.com/ | https://bridgebio.com

Who You Are

BridgeBio seeks a Sr. Director/Executive Director, Analytical Development to lead our analytical development (AD) and commercial quality control (QC) groups supporting our late-stage novel small molecule development programs. While this position is responsible for authoring and revising analytical development (AD) sections of regulatory submissions (e.g., IND, IMPD, NDA, MAA, etc.), input on CMC regulatory strategy for both drug substance (DS) and drug product (DP) across the BridgeBio cardiorenal small molecule portfolio is also expected. Therefore, a comprehensive understanding of relevant ICH guidelines and health authority expectations for small molecule new chemical entities (NCEs) is required.   

As BridgeBio is a virtual organization, external CDMO management experience is a plus. Additional responsibilities include oversight of late development/launch preparation activities, including analytical method transfers, method development, phase-appropriate validation for both DS and DP and the review of analytical packages for the release of clinical/commercial supplies. The position requires close collaboration with drug substance and formulation scientists and Quality Assurance. Working knowledge of GMPs, various small molecule analytical techniques, including HPLC, GC, GC/MS, LC/MS, ICP, dissolution (discriminating and USP), UV, IR, NMR, XRPD, Karl Fischer titration, DSC, and TGA is required—excellent communication skills (both verbal and written) a must.

Responsibilities

• Proven leadership experience in managing analytical chemists at various levels, externally (CRO/CMO management) and internally (direct report management)
• Experience writing, reviewing, and responding to queries on all Module 3 analytical sections of BridgeBio Cardiorenal CTDs.  Expected to contribute to the overall control strategy for all regulatory filings (incl. DS and DP)
• Candidates with prior NDA/MAA authoring experience will be preferred. Prior NCE filing experience is a plus
• Management of direct reports
• Sophisticated understanding of how and when to appropriately apply the cGMP requirements; ability to distinguish regulated and non-regulated activities and expectations
• Travel, when necessary, to third-party manufacturing and/or testing sites
• Oversight of third-party development of analytical methods, method validation, and investigations for out-of-specification, out-of-trend, and/or anomalous results
• Collaboratively plan and execute cross-functional studies for chemical development and formulation development
• Proficiency in various analytical techniques and regulatory areas, including HPLC, LC/MS, GC, GC/MS, USP dissolution testing apparatus, pH meters, UV/Vis spectroscopy, KF, and phase-appropriate analytical method validation
• Experience with various solid-state characterization techniques, including XRPD, PSD measurement, DSC, and TGA, as well as familiarity with drug product (disintegration, hardness, and friability) testing, is also desired
• Responsible for developing phase-appropriate qualifications and/or validating requisite analytical methods.  The ideal candidate will be familiar with current statistical techniques used in method development and validation
• Able to communicate results internally and externally through verbal and written updates and formal reports as necessary

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

• Ph.D./M.S. in life sciences, ideally Chemistry or Analytical Chemistry, with 10+ years of experience in analytical development in a pharmaceutical setting.  B.S. will be considered with/an additional 5 years of industrial experience
• Proven abilities in leadership and personnel management
• Knowledge and direct experience with CMC analytical requirements for IND and NDA/MAA filing
• Ability to communicate effectively with vendors regarding project scope, scientific results, and project updates
• Strong oral and written communication skills

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