Clinical Scientist
Eidos Therapeutics
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Clinical Scientist

Eidos Therapeutics

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Details
Posted:
February 1, 2021
Location:
San Francisco, California
Type:
Full Time - Experienced
Discipline:
Academic / Research
Required Education:
Doctorate
Who You Are:
 
The Clinical Scientist will provide clinical and scientific support in all aspects of the clinical development program, including the design, preparation, conduct, monitoring, analyses, and reporting of the studies.  The successful candidate will be a member of a cross-functional team, ensuring that clinical and scientific issues are considered in developing and executing individual clinical studies.  The Clinical Scientist will be involved in operationalizing studies, including the adjudication process, monitoring data, medical review, and data analysis.
 
Responsibilities:
  • Participate in the development of clinical protocols and amendments, investigator brochures, and clinical study reports
  • Partner with Clinical Operations and Data Management on clinical trial conduct and data monitoring, including GCP, patient eligibility, and blinded monitoring of study data
  • Reviews clinical data listings, patient profiles, and summaries to ensure data collection proceeds consistently with the protocol and strategic objectives
  • Support the development of clinical sections for regulatory correspondence and submissions including but not limited to Information Requests, Briefing Books, and presentation materials, and IND/NDAs
  • Supports clinical studies conduct, including clinical monitoring activities, Data Safety Monitoring, or Steering Committee meetings as applicable
  • Conducts literature reviews to support clinical development programs and regulatory submissions
  • Maintain current knowledge of the external environment to ensure scientific innovations are considered and/or incorporated into the clinical trial development strategy
  • Work and partner with internal and external (CRO, investigator) stakeholders

Requirements:

  • PharmD, Ph.D., or advanced clinical degree (i.e., Nurse Practitioner) required
  • At least five to seven years of experience in clinical research and development required
  • Prior experience in biotechnology or pharmaceutical industries
  • The successful candidate must be a skilled relationship developer, employ an entrepreneurial spirit, and passionately embody the Eidos mission to develop a safe and effective disease-modifying treatment for ATTR
  • Science focused on interest in data and endpoints
  • Previous experience with clinical trials and knowledge of Good Clinical Practices,  regulatory requirements for the conduct of clinical trials
  • Good project management skills and the ability to manage multiple, diverse tasks and to prioritize tasks effectively is required
  • Ability to work collaboratively with  the internal partners of Eidos and ability to build relationships with clinical sites and outside vendors
  • The ability to work under pressure to meet deadlines, the ability to handle complex projects and to overcome delays and obstacles, and excellent team member and interpersonal skills are required
  • Previous experience with adjudication of clinical events in trials is a plus 
  • Teams in a matrix management organization with familiarity in critical clinical research tasks including protocol authorship and trial execution
  • Attention to details, able to proactively identify issues and propose solutions

Internal Number: 10213
About Eidos Therapeutics
Eidos Therapeutics, a subsidy 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 aim 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
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