Clinical Scientist/Senior Clinical Scientist - 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:

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
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 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

Clinical Scientist/Senior Clinical Scientist - Oncology

Full-TimeQEDAny Office LocationClinical Development

Apply Now