Director/Senior Director of Clinical Development

San Francisco, CA /
Eidos – Clinical Operations /
Full-time
Eidos Therapeutics, a BridgeBio Pharma company, 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 finds, develops, and delivers breakthrough medicines for genetic diseases. The company bridges remarkable advancements in genetic science with the entrepreneurial engine required to rapidly create lifesaving medicines for patients with unmet needs. Founded in 2015 by a team of industry veterans, the company has built a portfolio of 20 transformative drugs ranging from pre-clinical to late-stage development in multiple therapeutic areas, including genetic dermatology, oncology, cardiology, neurology, endocrinology, renal disease, and ophthalmology. The company’s focus on scientific excellence and rapid execution aims to translate today’s discoveries into tomorrow’s medicines. We have offices in San Francisco, Palo Alto, Boston, New York, and Raleigh with small satellites in other parts of the country.
 
To learn more, visit us at eidostx.com / https://bridgebio.com
 
Who You Are:

The individual in this role will be responsible for executing the ATTR polyneuropathy (ATTR-PN) Phase 3 clinical development program for Eidos Therapeutics. This individual will lead the study team and serve as the primary medical monitor for the currently initiating Phase 3 pivotal trial (“ATTRibute-PN”;NCT04418024). This individual will also serve as a medical monitor for the longer-term Part B (primary readout: a hierarchical analysis of all-cause mortality, frequency of CV hospitalization, and change in 6-minute walk distance, after 30 months of study drug treatment) of the ATTRibute-CM trial in ATTR cardiomyopathy (NCT03860935). A separate team will, in parallel, be engaged in preparing and filing an initial NDA for Part A of that study (primary readout: change in 6MWD and KCCQ QoL at 12 months). In addition to leading the cross-functional ATTRibute-PN team, the individual will serve as a critical liaison between Eidos and clinical investigators, clinical advisors, the independent Data Monitoring Committee, Data Reporting Center, primary clinical CRO (PRA Health Sciences), core labs, and will be responsible for establishing and maintaining credible relationships between Eidos and leading clinicians and scientists in the field.

Responsibilities:

    • Lead the ATTRibute-PN Study Team and serve as the primary medical monitor for the study
    • Own the medical input and clinical development sections of regulatory documents such as Briefing Documents, NDAs/MAAs and supplemental registration filings, the annual DSUR, and any inquiries from national health authorities, ethics committees, or other stakeholders
    • Partner with Patient Safety on pharmacovigilance activities
    • Own and/or partner with ClinOps, Regulatory, and Medical Affairs on relationships with investigators in a very “hands-on” manner, establishing and maintaining a proactive rapport with crucial individuals worldwide
    • Ensure cross-functional alignment on an ongoing basis throughout the execution of the program with functional area experts in Development Operations, Regulatory Affairs, Quality and Compliance, Program Management, Medical Affairs, Commercial, CMC/Drug Supply, DMPK, Legal, Finance, Human Resources, and Administration
    • Monitor study progress, ensure proper study conduct and adherence to the protocol, lead data review, evaluation, and analyses with support from Data Management and the Biostatistics & Programming teams
    • Monitor Study Quality metrics in collaboration with Clinical Operations and Data Management
    • Participate in the study team and vendor oversight meetings
    • Provide support to Clinical Operations in relevant aspects of study execution (e.g., patient recruitment)
    • Present study updates, interim results, and final headline data to senior management and the Board of Directors as required
    • Implement and assist in ensuring compliance with all clinical R&D policies, SOPs, and related directives
    • Maintain a strong and consistent patient-focused approach, with a deep commitment to understanding the medical needs and improving the lives of patients driven by a passion for developing novel therapeutics
    • Motivated to work in a fast-paced, highly accountable, small company environment, the individual will be a “can-do” and collegial professional who leads through influence and interpersonal skills
    • Be capable of prioritizing tasks, demonstrating excellent time management skills, and delivering on deadlines with high-performance standards and attention to detail
    • Demonstrate leadership skills and collaborate successfully with multiple functions and external vendors in a cross-functional team environment
    • Possess strong written and oral communication and presentation skills
    • Analyze and interpret data and develop written reports and presentations of those data, including contributing to the development of scientific publications and presentations
    • Possess strong critical, strategic, and analytical thinking skills
    • Continue to develop subject-matter medical knowledge in ATTR

Education, Experience & Skills Requirements:

    • 8+ years of clinical development experience
    • Experience with clinical research in industry (3+ years in clinical research and/or drug development in a biopharmaceutical company or related CRO
    • MD/DO degree or equivalent; specialty (e.g., internal medicine) or subspecialty (e.g., neurology) training preferred

What We Offer:

    • Patient Days, where we are fortunate enough to learn more about the lives we are looking to impact and a real exchange of ideas as to 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
    • Learning and development training to help employees be the best version of themselves
    • Collaborative business environment
    • Excellent compensation package (Base, Performance Bonus, Stock, RSU programs)
    • Excellent benefits package
    • Flexible PTO
    • With office locations in San Francisco, Boston, New York, and Raleigh, there are ample cross-collaboration opportunities with other BridgeBio Pharma programs
    • A fast-paced, data-driven, work environment with world-class R&D minds and capabilities
    • Work with the most productive groups of R&D operators in the industry
    • Partnerships with leading institutions
    • A platform for meaningful scientific contributions to shine
    • Commitment to Diversity & Inclusion – with initiatives like Women at Bridge, we are committed to fostering an inclusive environment where every person feels respected for who they are, empowered to contribute, inspired to lead, and supported in their efforts to do so