SVP, Clinical Development - Oncology

Full-TimeQEDAny Office LocationClinical Development

Apply Now

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 to treat 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 and 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:

Reporting to the CMO, this individual may be called upon to serve as the clinical lead of global filings and plan, design, execute and report on Phase l through 3 clinical trials for infigratinib in cholangiocarcinoma, urothelial carcinoma, and other disorders. This role provides medical direction and high-quality scientific and clinical knowledge to guide the strategy and execution of QED's clinical development plan. This individual will work collaboratively with multi-disciplinary teams 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. The SVP, Clinical Development will influence both internal and external audiences in a high impact, evident role as it actively contributes to the dynamic and innovative culture within QED.
Responsibilities:
  • Serve as clinical lead of regulatory submission of infigratinib, including contributing to/overseeing authoring of clinical modules and clinical review of other modules

  • Lead or assist in the synthesis of strategic clinical development plans and execute on same, including, for example, managing or assisting with
  • Regulatory briefing document preparation and review
  • Scientific literature review and summarization
  • Protocol & CRF development
  • CRO selection medical monitoring
  • Investigator meeting preparation and presentations
  • Medical data review
  • Clinical study report writing
  • Investigator brochure writing

  • Assistance with writing and preparation of abstracts, presentations, and manuscripts
  • Execute and deploy drug development strategic plans, develop contingency plans, provide technical and strategic advice, and meet milestones and budgets
  • Translate findings from research and nonclinical studies into clinical development opportunities
  • Interact with clinical investigators and thought leaders
  • Conduct clinical trials using ethical guidelines relevant to the pharmaceutical industry, and ensure compliance with these external guidelines
  • Attend key scientific congresses and meetings as requested in support of speakers and critical opinion
  • Remain current in relevant therapeutic areas and conversant with the literature as well as key emerging
  • Remain present with FDA and international regulatory guidance relevant to oncology and orphan drug development, and participate in regulatory authority meetings as required
Education, Experience & Skills Requirements:
  • MD or equivalent with at least five years of international clinical development Oncology experience is preferred
  • Demonstrated record of accomplishment in a compressed time frame; capable of prioritizing tasks and delivering on deadlines with high-performance standards and attention to
  • Demonstrated ability to collaborate successfully with multiple functions in a team environment
  • Intellectually curious with the courage to challenge and seek new ways to improve work
  • Strong written and oral communication skills, including presentation
  • Ability to analyze and interpret data and develop written reports and presentations of those data
  • Critical solid, strategic, and analytical thinking skills
  • Experience in all aspects of protocol conduct, both early and late phase, including protocol writing, start-up, study execution, analysis and
  • Experience in working closely with investigative sites, including principal investigators, sub- investigators, study coordinators, and other site personnel involved in clinical
  • Experience with pivotal studies
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.
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SVP, Clinical Development - Oncology

Full-TimeQEDAny Office LocationClinical Development

Apply Now