- Design scientifically rigorous, operationally feasible, and cost-effective clinical study protocols that form the substantive basis of the BBP-418 Clinical Development Plan
- Contribute to the development team in the conceptual basis for clinical data collection, review, and interpretation, including oversight of CRF design elements, database design, data management plans, biostatistics, data analysis, data review, reporting with support from Clinical Operations, Data Management, and Stats & Programming
- The primary contributor to the clinical research content 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). This role would also involve participation in regulatory meetings
- Own clinical research planning, documentation, and communication
- Contribute to the cross-functional development team from the clinical and scientific perspective toward accomplishing corporate goals
- Provide clinical interpretation and integration of pre-clinical and early clinical findings into the evolving product development plan and TPP
- Provide support to Clinical Operations in relevant aspects of study execution (e.g., patient recruitment) and manage and mentor other clinical development professionals in their role(s)
- Take a leadership role in study team meetings and those with critical internal and external partners, including presenting study updates, interim results, and study progress and data to senior leadership
- Lead the Safety Review Committee for ML Bio related to BBP-418
- Develop clinical SOPs in collaboration with QA
- 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 consistently 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; may have direct reports
- 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
- 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
- 10+ years of Clinical Development experience preferred in biopharmaceutical-sponsored clinical research and/or drug development (biopharma, CRO, or other industry environments); late-stage development experience in neuromuscular disease is highly desired
- Dynamic and experienced people leadership skills
- M.D. degree or equivalent, specialty or subspecialty training preferred
- Travel approximately 10-15%
- 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
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Senior Director, Clinical Development - San Francisco, United States - BridgeBio Pharma, Inc.
Description
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.
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 |
Who You Are
ML Bio Solutions is searching for an experienced Sr.
Director of Clinical Development 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 project-level activities, including overseeing the design, implementation, medical 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, supports (primary) for regulatory documentation and engagements, and medical monitoring oversight for ongoing ML Bio-sponsored clinical trials.
Responsibilities
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