Medical Director

Full-TimeQEDBrisbane, CAClinical Development

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QED Therapeutics, a subsidiary of BridgeBio Services, focuses on precision medicine for FGFR-driven cancers and diseases. The company’s first therapy, TRUSELTIQTM (infigratinib), is an orally administered FGFR1-3 tyrosine kinase inhibitor that the US FDA recently approved for the treatment of patients with previously treated locally advanced or metastatic cholangiocarcinoma (CCA) harboring an FGFR2 fusion or rearrangement. We are also evaluating infigratinib for the treatment of other FGFR-driven cancers as well as for the treatment of achondroplasia and other skeletal dysplasias.
 
QED is derived from the Latin “Quod Erat Demonstrandum” —Thus; It Has Been Proven. Our business is inspired by our values:
 
PUT PATIENTS FIRST
LET SCIENCE SPEAK
EVERY MINUTE COUNTS
THINK INDEPENDENTLY
BE RADICALLY TRANSPARENT
 
FGFR=fibroblast growth factor receptor.
 
BridgeBio finds, develops, and delivers breakthrough medicines for genetic diseases. The company bridges remarkable advancements in genetic science with the entrepreneurial engine required to rapidly create lifesaving medicines for patients with unmet needs. Founded in 2015 by a team of industry veterans, the company has built a portfolio of 20 transformative drugs ranging from pre-clinical to late-stage development in multiple therapeutic areas, including genetic dermatology, oncology, cardiology, neurology, endocrinology, renal disease, and ophthalmology. The company’s focus on scientific excellence and rapid execution aims to translate today’s discoveries into tomorrow’s medicines. We have offices in San Francisco, Palo Alto, Boston, New York, and Raleigh, with small satellites in other parts of the country.
 
To learn more, visit us at  https://www.qedtx.com/ | https://bridgebio.com

Who You Are:

QED is searching for an experienced Medical Director to own the planning, implementation, and daily operation of late-stage global study development. This clinical leader will provide high-quality scientific and clinical knowledge to guide the strategy and execution of QED’s clinical development plan. Working collaboratively with multi-disciplinary teams, this role is responsible for the design, implementation monitoring, analysis, and reporting of studies conducted within QED’s portfolio to ensure the program meets the needs of patients and QED’s business. In addition, this role will influence both internal and external audiences in a high-impact, prominent part as it actively contributes to the dynamic and innovative culture with QED and BridgeBio.
Responsibilities:
  • Act as the clinical science lead for late-stage, global studies
  • Support the clinical/medical monitoring for assigned clinical trials, including assessment of emerging clinical data trends, interim analyses planning, and Data Safety Monitoring Board or Steering Committee meetings
  • Provide clinical input on CRF design, statistical analysis plan, and analysis of study results
  • Participate in the synthesis and execution of strategic clinical development plans
  • Liaise with clinical investigators and thought leaders
  • In collaboration with Medical Writing and Clinical Operations, prepares study protocols, amendments, specific sections of study manuals and Investigator meeting materials, and other documents as needed with appropriate guidance
  • With MD supervision, prepare regulatory responses and briefing documents regarding questions about complex clinical development issues (e.g., safety or efficacy)
  • Deploy drug development strategic plans, provide technical and strategic advice, and meet milestones and budgets
  • Participate in ongoing enhancements/development of team systems, tools, and other resources; as appropriate, mentors less experienced Clinical Scientist
Education, Experience & Skills Requirements:
  • MD or equivalent and 3+ years of international clinical oncology development experience; title will be commensurate with experience
  • Board Eligible/Certified
  • Oncology experience is preferred
  • Knowledge of FDA, EMA, and ICH regulations and guidelines
  • Experience in all aspects of protocol conduct, both early and late phase, including protocol writing, start-up, study execution, analysis, and reporting
  • Experience in working with investigative sites, including principal investigators, sub- investigators, study coordinators, and other site personnel involved in clinical trials
  • Excellent oral and written communication skills and experience working with cross-functional teams
  • Ability to work in a small company with a largely virtual environment; start-up experience preferred
  • Ability to manage complexity and uncertainty
  • Embraces the company core values:  1. put patients first; 2. think independently, 3. be radically transparent; 4. every minute counts; and 5. let the science speak
What We Offer:
  • Patient Days, where we are fortunate enough to learn more about the lives we are looking to impact and a real exchange of ideas as to 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
  • Learning and development training to help employees be the best version of themselves
  • Collaborative business environment
  • Excellent compensation package (Base, Performance Bonus, Stock, RSU programs)
  • Excellent benefits package
  • Flexible PTO
  • With office locations in San Francisco, Boston, New York, and Raleigh, there are ample cross-collaboration opportunities with other BridgeBio Pharma programs
  • A fast-paced, data-driven, work environment with world-class R&D minds and capabilities
  • Work with the most productive groups of R&D operators in the industry
  • Partnerships with leading institutions
  • A platform for meaningful scientific contributions to shine
  • Commitment to Diversity & Inclusion – with initiatives like Women at Bridge, we are committed to fostering an inclusive environment where every person feels respected for who they are, empowered to contribute, inspired to lead, and supported in their efforts to do so
We will not accept unsolicited resumes from agencies. Please do not send agency resumes to our website or BridgeBio and affiliating employees.
careers

Medical Director

Full-TimeQEDBrisbane, CAClinical Development

Apply Now