Director/Sr. Director, Clinical Development

About MLBio Solutions & BridgeBio Pharma

ML Bio Solutions (ML Bio), a BridgeBio company, is a biotechnology company founded in 2018, yet the company’s founders have been dedicated to finding a cure for Limb girdle muscular dystrophy type 2I/R9 FKRP-related (LGMD2I/LGMDR9) for close to twenty years. ML Bio is developing BBP-418, potentially the first oral treatment for patients with LGMD2I.

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 aim to translate today’s discoveries into tomorrow’s medicines. We have U.S. offices in San Francisco, Palo Alto, and Raleigh, with small satellites in other parts of the country. We also have international offices in Montreal, Canada, and Zurich, Switzerland, and are expanding across Europe. 
 
To learn more about our story and company culture, visit us at https://mlbiosolutions.com/ | https://bridgebio.com

Who You Are

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 sci