Associate Director/Director, Clinical Science

Location
Brisbane, California
Posted
Jul 20, 2021
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Contract
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 for the treatment of 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 as well as for 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 Associate/Director of Clinical Science will play a supportive role in the clinical development of infigratinib for oncology, initially focusing on supporting Phase 2 and Phase trials of infigratinib for treatment of FGFR2 fusion+ cholangiocarcinoma. In addition, working in collaboration with the Executive Medical Director, 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 develop 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 appropriate guidance and supervision
  • 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/review of regulatory documents, IND annual reports, IND safety reports, Investigator Brochures, and sNDAs/MAAs
  • Supports priorities within functional area
  • Anticipates moderately complex obstacles within a clinical study and, with guidance, implements solutions
  • May be asked to coordinate teams and provide direction
  • May lead two or more specific components of departmental strategic initiatives
  • Must be able to enter a new therapeutic area and summarize scientific information 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 moderately complex problems
  • Manage, train, and mentor junior clinical science staff to support department and company goals


Education, Experience & Skills Requirements:
  • Typically requires a higher degree such as PharmD or Ph.D.in clinical research or clinical pharmacology and 2+ years of work experience in oncology in a pharmaceutical company, or a contract research organization
  • 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
  • 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.