Sr. Specialist/Manager, Quality Control (Scientific Data Review)

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Eidos Therapeutics, a subsidiary of BridgeBio Pharma, is a clinical-stage biopharmaceutical company focused on addressing the large and growing unmet need in diseases caused by transthyretin, or TTR, amyloidosis, or ATTR. We seek to treat this well-defined family of diseases at their collective source by stabilizing TTR. Our product candidate, AG10, is an orally-administered small molecule designed to potently stabilize TTR, a potentially best-in-class treatment aiming to halt the progression of ATTR diseases.

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 eidostx.com/www.bridgebio.com

Location

San Francisco, CA

Who You Are

The Quality Control (QC) Sr. Specialist/Manager reviews regulatory and other relevant documents focusing on non-clinical modules to ensure data integrity, data accuracy, internal consistency, adherence to company standards, and compliance with regulatory guidance (FDA, EU, ICH & country-specific, and current industry standards and practices) on ensuring GLP study data are compliant. This position requires a high degree of focus and consistent attention to detail.

Responsibilities

  • Review and revise, if appropriate, regulatory documents including, but not limited to, study reports, investigator brochures, and integrated clinical and non-clinical summaries of the NDA
  • Perform the quality control and verification of the study data, with an initial focus on non-clinical pharmacology and toxicology study data
  • Verify documents for accuracy of statements against source data
  • Perform and document gap analysis of regulatory submissions
  • Coordinate with subject matter experts to ensure consistency across study reports and other relevant documents
  • Ensure internal consistency and correct grammar, punctuation, and style
  • Verify correctness of cross-references in the documents
  • Ensure the timely and effective follow up of all identified or assigned quality/data issues OR prepare a comprehensive review of the data and submit recommendations and conclusions for consideration of the management
  • Process improvement of the review process and establish appropriate procedures and checklists

Education, Experience & Skills Requirements

  • Minimum of a Bachelor’s degree in a science-related discipline with a minimum of 3 years of relevant QC experience is required
  • Experience in non-clinical report writing is preferred
  • Proficiency in MS Word. Experience with StartingPoint Templates is helpful
  • Strong verbal and written communication skills are required
  • Previous QC review experience and familiarity with regulatory documents are required
  • A high degree of focus and consistent attention to detail is required
  • Must be able to effectively understand, interpret and apply company standards and regulatory guidance to all documents reviewed
  • Familiarity with non-clinical study reports
  • Must have experience in data auditing
  • Familiarity with GLP, GCP, and ICH clinical requirements

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

Sr. Specialist/Manager, Quality Control (Scientific Data Review)

Apply Now