Medical Director / Sr. Medical Director, Clinical Development Remote - United States

Medical Director / Sr. Medical Director, Clinical Development

Remote - United States

Mavericks Wanted

When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement...read on

In 2015, we pioneered a “moneyball for biotech” approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allowsscience and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines for patients with unmet needs as fast as humanly possible.

Together we define white space, push boundaries and empower people to solve problems. If you're someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we'll ask "why not?" and help reengineer the future of biopharma.

Affiliate Overview

Eidos Therapeutics, an affiliate within BridgeBio Pharma, is a commercial-stage biopharmaceutical company focused on Transthyretin Amyloid Cardiomyopathy (ATTR-CM).

What You'll Do

BridgeBio is searching for an experienced Medical Director / Sr. Medical Director, Clinical Development, to provide high-quality scientific and clinical knowledge to guide the strategy and execution of the ACT-EARLY clinical development program. This individual will lead the upcoming pivotal ACT-EARLY trial and be responsible for the design, implementation, monitoring, analysis, and reporting of future trials, NDA, and filing activities for the ATTR prevention program. The individual will contribute to, provide strategic direction to, and eventually lead the cross-functional clinical teams in medical monitoring of ACT-EARLY. This individual will also contribute to and lead abstracts and publications related to the prevention of ATTR. This position will serve as a critical liaison between the company and clinical investigators, establishing credible relationships between BridgeBio and leaders in the field.

Responsibilities

• Serve as the primary medical monitor for the ACT-EARLY 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 relevant internal and external stakeholders 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

Where You'll Work

This is a U.S.-based remote role that will require travel as needed for visits to our San Francisco Office.

Who You Are

Rewarding Those Who Make the Mission Possible

We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return.

Skill Development & Career Paths :

$270,000 - $360,000 USD

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