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 allows science 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

ML Bio Solutions (ML Bio), an affiliate within BridgeBio Pharma, was founded in 2018, dedicated to finding a cure for limb-girdle muscular dystrophy type 2I/R9 FKRP-related (LGMD2I/LGMDR9). ML Bio is developing BBP-418, potentially the first oral treatment for patients with LGMD2I.

What You’ll Do

ML Bio Solutions is searching for an experienced Medical Director to provide high-quality scientific and clinical knowledge to guide the strategy and execution of the BBP-418 clinical development plan, including the ongoing pivotal trial as well as future (including pediatric) trials. We are seeking an individual with solid critical, strategic, and analytical thinking skills who can communicate clearly and effectively in writing, oral discussion, and public presentation. Importantly, the individual should consistently demonstrate the capability of working collaboratively, prioritizing tasks and delivering on deadlines with high-performance standards and attention to detail. The individual will contribute to and provide strategic direction to the cross-functional clinical teams and medical monitoring oversight for several ML Bio-sponsored clinical trials. This position will serve as a critical liaison between the company and clinical investigators and establish credible relationships between ML Bio Solutions and leaders in the field. 

Responsibilities

• Act as a key contributor to BBP-418 clinical development, including execution, and medical monitoring of global clinical trials, including the ongoing pivotal program and launching future planned studies (including pediatric trials) 
• Serve as the primary medical point of contact/medical monitor in responding to protocol-related inquiries, eligibility questions, safety issues, and other inquiries from investigative sites, CROs, CRAs, CRMs, and other matrix study team members 
• Perform ongoing medical review of clinical trial safety data – adverse events, serious adverse events, vitals, labs, protocol deviations, listings, and efficacy data – and respond as needed or in real-time as medical monitor and liaison 
• Collaborate with other members of the clinical team in the development and implementation of eCRFs, edit checks, coding, report development, and database lock processes 
• Develop and contribute to SOPs and guidelines to ensure proper study conduct and adherence to clinical study protocols 
• Monitor Study Performance and Quality Metrics in collaboration with Clinical Operations and Data Management 
• Contribute to the clinical research contributions sections of regulatory submission documents, including amendments to INDs, Briefing Documents, the medical and scientific content of regulatory correspondence, NDA/MAA submissions, safety reports and updates, and annual reports (DSUR/PSUR) 
• Provide clinical interpretation and integration of pre-clinical and early clinical findings into the evolving product development plan and TPP  
• Design scientifically rigorous, operationally feasible, and cost-effective clinical study protocols as part of the broader BBP-418 Clinical Development Plan 
• Provide support to Clinical Operations in relevant aspects of study execution (e.g., patient recruitment) 
• Take a leadership role in study team meetings and those with key internal and external partners, including presenting study updates, interim results, and final headline data to senior management 
• Be consistently patient-focused with a deep commitment to understanding the needs and improving the lives of patients through a passion for developing novel therapeutics 
• Be always motivated to work in a fast-paced, highly accountable, small company environment through a “can do” attitude as a collaborative, collegial professional who leads through influence and interpersonal skills 
• Demonstrate leadership skills and ability to collaborate successfully with multiple functions and external vendors in a cross-functional team environment 
• Lead the development of written reports and representations of the scientific program data toward the development of scientific publications and presentations

Where You’ll Work

• This a U.S-based remote role that will require quarterly, or as needed visits to our San Francisco Office; also, travel to study sites and medical conferences will be required, as needed.

Who You Are

• M.D. degree or equivalent 
• 3+ years of Clinical Development experience preferred in biopharmaceutical-sponsored clinical research and/or drug development (biopharma, CRO, or other industry environments) 
• Subspecialty training and prior experience with pediatric trials preferred 
• Travel – ~10-20% (including office visits to San Francisco, CA) 

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. 

Financial 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

Health & Wellbeing:

• 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

Skill Development & Career Paths:

• People are part of our growth and success story – from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility
• We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp Coaching
• We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities