Clinical Scientist/Senior Clinical Scientist - Oncology

Full-TimeQEDAny Office LocationClinical Development

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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:

The Clinical Scientist/Senior Clinical Scientist will play a supportive role in the clinical development of infigratinib for oncology and potentially non-oncology indications. Working in collaboration with Clinical Development, the position is responsible for various aspects of ongoing clinical trial program-related activities within the relevant therapeutic area. These activities include, but are not limited to, collaboration on functional area activities during program implementation, clinical study start-up/execution/closeout, data analysis/reporting, and support of NDA/MAA filings.
Responsibilities:
  • Acquires and utilizes knowledge of clinical trial design to support the development of specific study concept sheets and protocols
  • Participates in protocol review discussions concerning scientific and procedural aspects of study design
  • 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 guidance and supervision
  • In collaboration with Data Management and, with Clinical Development supervision where needed, contributes to the design and development of CRFs, Data Management Manuals, and Data Analysis Plans
  • With MD supervision, addresses questions regarding scientific and related procedural issues from Investigators
  • Contributes to the preparation and/or review of data listings, summary tables, study results, manuscripts, and scientific presentations
  • Assists in the preparation and review of regulatory documents, IND annual reports, IND safety reports, Investigator Brochures, and NDAs/MAAs
  • Supports priorities within functional areas
  • Anticipates common obstacles within a clinical study and, with guidance, implements solutions
  • May be asked to coordinate teams and provide direction
  • May lead one or more specific components of departmental strategic initiatives
  • Must be able to enter a new therapeutic area with guidance and summarize scientific information that is available in the published literature to integrate into new study development
  • Excellent verbal and written communication skills and interpersonal skills are required to maintain a working relationship with team members to ensure the scientific integrity of clinical studies
  • May be sought out for advice by others within the company to help make better decisions and resolve common problems

  • 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:
  • An advanced degree, such as PharmD or Ph.D. in clinical research or clinical pharmacology, or equivalent experience
  • 4+ years of relevant scientific and/or drug development experience with a BS degree in Biological Sciences, health care, or a related field
  • 2+ years of relevant scientific and/or drug development experience with an MS
  • Demonstrated ability to be a fast learner
  • Demonstrated ability to be flexible and adaptable to change, to move between projects quickly, and provide support/expertise where needed
  • Experienced with Microsoft Office (Excel, PowerPoint, etc.) as well as job-related programs such as SpotFire
  • Basic knowledge of FDA, EMA, and ICH regulations and guidelines a must
  • Ability to effectively collaborate cross-functionally, across all levels of the organization
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.
careers

Clinical Scientist/Senior Clinical Scientist - Oncology

Full-TimeQEDAny Office LocationClinical Development

Apply Now