Director / Sr. Director, Clinical Development

ML Bio Solutions San Francisco, CA/Hybrid Clinical Development

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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. This individual will lead the upcoming pivotal trial and be responsible for the design, implementation, monitoring, analysis, and reporting of future trials, NDA, and filing activities for the LGMD2I program. The individual will contribute to and provide strategic direction to the cross-functional clinical teams and medical monitoring oversight for ongoing 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 planning, execution, and medical monitoring of global clinical trials, including serving as clinical lead for the registrational Phase 3 trial
  • 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 that form the substantive basis of the 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
  • Consistently demonstrate the capability of prioritizing tasks and delivering on deadlines with high-performance standards and attention to detail
  • Demonstrate leadership skills and ability to collaborate successfully with multiple functions and external vendors in a cross-functional team environment
  • Reliably communicate clearly and effectively in writing, oral discussion, and public presentation
  • Lead the development of written reports and representations of the scientific program data toward the development of scientific publications and presentations

Have solid critical, strategic, and analytical thinking skills

No matter your role at BridgeBio, successful team members are:

  • Patient Champions, who put patients first and uphold strict ethical standards
  • Entrepreneurial Operators, who drive toward practical solutions and have an ownership mindset
  • Truth Seekers, who are detailed, rational, and humble problem solvers
  • Individuals Who Inspire Excellence in themselves and those around them
  • High-quality executors, who execute against goals and milestones with quality, precision, and speed

Education, Experience & Skills Requirements

  • 3+ years of Clinical Development experience preferred in biopharmaceutical-sponsored clinical research and/or drug development (biopharma, CRO, or other industry environments)
  • D. degree or equivalent, specialty or subspecialty training preferred
  • Travel – 10%, remote

What We Offer

  • Patient Days, where we are fortunate to hear directly from individuals living with the conditions we are seeking to impact throughout the year and learn 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
  • An unyielding commitment to always putting patients first. Learn more about how we do this here
  • A de-centralized model that enables our program teams to focus on advancing science and helping patients. Our affiliate structure is designed to eliminate bureaucracy and put decision-making power in the hands of those closest to the science
  • A place where you own the vision – both for your program and your own career path
  • A collaborative, fast-paced, data-driven environment where we inspire ourselves and each other to always perform at the top of our game
  • Access to learning and development resources to help you get in the best professional shape of your life
  • Robust and market-competitive compensation & benefits package (Base, Performance Bonus, Equity, health, welfare & retirement programs)
  • Flexible PTO
  • Rapid career advancement for strong performers
  • Potential ability to work on multiple BridgeBio Pharma programs across multiple therapeutic areas over time 
  • Partnerships with leading institutions
  • Commitment to Diversity, Equity & Inclusion
At BridgeBio, we strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits. Below is the anticipated salary range for candidates for this role who will work in California. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, educational background, location of residence and performance during the interview process. BridgeBio is a multi-state employer, and this salary range may not reflect positions based in other states.
Salary
$220,000$350,000 USD

careers

Director / Sr. Director, Clinical Development

ML Bio Solutions San Francisco, CA/Hybrid Clinical Development

Apply Now