Medical Director, Senior Medical Director, Clinical Development

October 3

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BridgeBio

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Biotechnology • Pharmaceuticals • Healthcare Insurance

BridgeBio is a biotechnology company focused on designing transformative medicines for patients with genetic diseases. It employs a novel approach to drug development by integrating finance with science to deliver solutions as efficiently as possible. The company is committed to developing not only life-changing drugs but also leaders in the field, encouraging hands-on engagement and the pursuit of innovation. BridgeBio actively seeks investment to help achieve its mission of providing solutions for unique patient populations with unmet needs. Headquartered in Palo Alto, CA, BridgeBio emphasizes bridging the gap between scientific advancements and patient care.

201 - 500 employees

Founded 2015

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

📋 Description

• 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

🎯 Requirements

• 3+ years of Clinical Development experience preferred in biopharmaceutical-sponsored clinical research and/or drug development (biopharma, biotech, or other industry environments) • D. degree or equivalent, specialty or subspecialty training (e.g., cardiology) preferred • Remote – must be comfortable and efficient working from home, flexible, Eastern Standard Time zone preferred • Facility with technology • Excellent written and oral communication skills • Travel – 15%

🏖️ Benefits

• Market leading compensation • 401K with 100% employer match on first 3% & 50% on the next 2% • Employee stock purchase program • Pre-tax commuter benefits • Referral program with $2,500 award for hired referrals • Comprehensive health care with 100% premiums covered - no cost to you and dependents • Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions) • Hybrid work model - employees have the autonomy in where and how they do their work • Unlimited flexible paid time off - take the time that you need • Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents • Flex spending accounts & company-provided group term life & disability • Subsidized lunch via Forkable on days worked from our office