SVP, Clinical Development - Oncology

Location
Working from home
Posted
Oct 01, 2021
Required Education
Doctorate/PHD/MD
Position Type
Full time
About QED Therapeutics & BridgeBio Pharma

QED Therapeutics, an affiliate of BridgeBio Pharma, 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 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 aims to translate today’s discoveries into tomorrow’s medicines. We have U.S. offices in San Francisco, Palo Alto, Boston, New York, and Raleigh, with small satellites in other parts of the country. We also have international offices in Montreal, Canada, and Zug, Switzerland, and are expanding across Europe.

To learn more about our story and company culture, 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
  • 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 towards 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:
  • 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 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 – with initiatives like Women at Bridge, we are committed to fostering an inclusive environment where every person feels seen, valued, and heard


We will not accept unsolicited resumes from agencies. Please do not send agency resumes to our website or BridgeBio and affiliating employees.