Senior/Executive Director, Clinical Development

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Job description

About Eidos Therapeutics & BridgeBio Pharma

Eidos Therapeutics, an affiliate of BridgeBio Pharma, is a clinical-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. Our product candidate, AG10, is an orally administered small molecule designed to potently stabilize TTR, a potentially 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, Boston, New York, and Raleigh, with small satellites in other parts of the country. We also have international offices in Montreal, Canada, and Zug, Switzerland, and are expanding across Europe.

To learn more about our story and company culture, visit us at eidostx.com/ |

Who You Are:

This individual will be responsible for developing and executing the clinical development program for Eidos, including the clinical leadership of the trials, input in regulatory interactions, and providing medical monitoring and scientific support into study execution. The individual will lead and provide strategic direction to the cross-functional clinical teams.

Responsibilities:

• Contribute to design scientifically rigorous, operationally feasible, and cost-effective clinical protocols that reflect clinical development strategy
• Provide medical input and contribute to the clinical development sections of regulatory documents such as Dossiers, INDs, Safety, and Annual reports, handling of responses to regulatory agencies and Ethics Committees regarding questions about clinical development issues (e.g., safety or efficacy) as well as respond to protocol related questions
• Contribute to clinical development plans that integrate pre-clinical and early clinical findings while working to ensure cross-functional alignment on an ongoing basis throughout the phases of clinical development
• Serve as the Medical Monitor, responsible for oversight of and collaboration with the CRO Medical Monitors, review of clinical study data, and as serve as a medical expert for Phase III studies, supporting the process from protocol development (protocol amendment) through study execution to completion of study reports and integrated regulatory documentations
• Monitor study progress, ensure proper study conduct and adherence to the protocol, lead data review, evaluation, and analyses with support from Data Management and Statistics & Programming team
• In collaboration with Clinical Operations and data management, monitor study quality metrics; Participate in study team meetings and meeting with the vendors/partners; Provide support to Clinical Operations in relevant aspects of study execution, Facilitate productive cross-functional collaboration for study management
• Present study updates, interim results, and final topline data to senior management as required
• Implement clinical R&D policies, SOPs, and related directives
• Capable of prioritizing tasks and delivering on deadlines with high-performance standards and attention to detail
• Demonstrated leadership skills and ability to collaborate successfully with multiple functions and external vendors in a cross-functional team environment
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 towards 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:

• 5+ years of clinical development experience
• Experience in clinical research and/or drug development in CRO or pharmaceutical environment.
• MD degree, specialty, or subspecialty training is 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 - with initiatives like Women at Bridge, we are committed to fostering an inclusive environment where every person feels seen, valued, and heard

We will not accept unsolicited resumes from agencies. Please do not send agency resumes to our website or BridgeBio and affiliating employees.