Associate Director, Clinical Assays & Biomarkers

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BridgeBio Gene Therapy, a subsidiary of BridgeBio Pharma, is focused on discovering and developing drugs for patients with grievous genetic diseases. We do this by:

Finding the right starting points to target diseases at their source.

Using a combination of a systematic assessment of the genetic disease landscape and informed diligence on the latest research, we find indications with clear mechanisms of pathogenesis that are ripe for translation into disease-modifying drugs.

Building products with world-class R&D personnel.

We employ industry-leading scientists that work closely with leading academics to prosecute a wide variety of drug programs at the highest level of scientific rigor. Our team combines biopharmaceutical veterans with up-and-coming leaders to drive entrepreneurial thinking grounded by experience.

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://bridgebio.com

Location

Remote

Who You Are

We seek a highly motivated scientist to lead and manage the development and validation of assays and biomarkers supporting gene therapy clinical trials within BBGT. The candidate will be expected to contribute strategic direction to all aspects of assay development and validation and be responsible for overseeing the clinical phase-appropriate development of assays at contract research organizations.  

The Associate Director, Clinical Assay & Biomarker will work with other scientists within BBGT (and as needed, within other BridgeBio affiliates) as well as contract research organizations to identify, design, implement, and validate candidate clinical and/or biomarker assays for multiple disorders relevant to BBGT’s pipeline of programs. The ideal candidate will have a proven track record of clinical assay development, including design, feasibility, platform assessment, tech transfer, assay validation, and oversight of external CRO validations. This position reports to the Chief Medical Officer at BBGT and partners and works closely with the Senior Director, Biomarker Development at BridgeBio Services (BBS). 

Critical skills for this role include reading and understanding published clinical assay and biomarker approaches, rapidly learning new therapeutic and disease areas, interfacing and collaborating with internal scientists, CRO partnerships, and cross-functional teams who are experts on a particular disease program. Hands-on experience with experimental science and assay development is a must. A thorough understanding of existing bioanalytical regulatory guidance, CLIA/CAP/CLSI standards, AAV biology (or other virology experience), or IVD/CDx development will be advantageous.

Responsibilities

  • Work independently and collaboratively with scientists at BBGT (and, as needed, across BridgeBio subsidiaries), consultants, and CROs in support of clinical assay development, assessment, qualification, and validation
  • Develop biomarker and clinical assays to support research and development decisions and clinical trials; may include IVD and/or CDx
  • Draft and oversight of contributory bioanalytical reports and regulatory documentation.
  • Working knowledge of assay validation
  • Knowledge of current FDA guidelines for assay qualification and validation
  • Regular cross-functional communication of updates to the broader team

Education, Experience & Skills Requirements

  • Bioanalytically focused Ph.D. or MS with equivalent experience in pharmacology, biochemistry, or related discipline
  • 2+ years biotech industry experience in assay and biomarker development
  • Diverse experience developing and implementing biomarker assays using various modalities (qPCR, ELISA, IHC, Western blot, flow cytometry)
  • Experience drafting regulatory submission documents
  • Experience evaluating novel technology approaches, including platform and instrument assessment
  • Ability to coordinately analyze diverse data sets, including bioinformatics, where appropriate
  • Ability to work in a small company with a mostly virtual environment
  • Ability to manage complexity and uncertainty
  • Solid team interaction and communication skills
  • Embraces the BridgeBio core values:  1. put patients first; 2. think independently, 3. be radically transparent; 4. every minute counts; and 5. let the science speak

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
careers

Associate Director, Clinical Assays & Biomarkers

Apply Now