Medical Director/Senior Medical Director, Clinical Development - Oncology

Full-TimeQEDAny Office LocationClinical 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 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, the individual for this role will have primary responsibility for clinical development in cholangiocarcinoma, including completing the registrational Phase 2 study, overseeing data cleaning and CSR preparation, and contributing to an NDA MAA and ROW marketing applications. In addition, this role will be responsible for the Phase 3 confirmatory trial and any additional studies in cholangiocarcinoma. This individual provides medical direction and high-quality scientific and clinical knowledge to guide the strategy and execution of QED's clinical development plan. The Medical Director/Senior Medical Director 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. 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 within QED.  
Responsibilities:
  • Serve as clinical lead of a registrational phase 2 study, including contributing to/overseeing the completion of enrollment, data cleaning, CSR writing, and authoring of clinical modules and clinical review of other modules, and leading ex-US filings
  • Lead and execute Phase 3 clinical trial, including responsibility for enrollment and integrity of the study
  • Lead internal project teams, and partner with investigators and CROs to design and implement clinical studies, respectively
  • Write protocols, investigator brochures, clinical study reports, and review clinical trial documents
  • Conduct investigator meetings and lead site initiation visits with clinical trial investigators
  • 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
  • Assistance with writing and preparation of abstracts, presentations, and manuscripts
  • Attend key scientific congresses and meetings as requested in support of speakers and key opinion leaders.
  • Remain current in relevant therapeutic areas and conversant with the literature as well as critical emerging data.
  • Remain current 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:
  • Patient-focused, with a deep commitment to understanding needs and improving the lives of patients, and a passion for developing novel therapeutics
  • Demonstrated ability to collaborate successfully with multiple functions in a team environment
  • Demonstrated record of accomplishment in a compressed time frame; capable of prioritizing tasks and delivering on deadlines with high-performance standards and attention to detail
  • Motivated to work in a fast-paced, high-accountability, small company environment; a "can-do" and collegial professional who leads through influence and interpersonal skills
  • Intellectually curious with the courage to challenge and seek new ways to improve work
  • Strong written and oral communication skills, including presentation skills
  • 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 reporting
  • Experience in working closely with investigative sites, including principal investigators, sub- investigators, study coordinators, and other site personnel involved in clinical trials
  • MD or equivalent with at least five years of international clinical development experience. Oncology experience is preferred
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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Medical Director/Senior Medical Director, Clinical Development - Oncology

Full-TimeQEDAny Office LocationClinical Development

Apply Now