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BridgeBio Pharma

Related companies:

🏢 Praxis Precision Medicines, Inc.
🏢 Precision AQ
🏢 Nuvalent, Inc.

Jobs at this company:

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🔥 SVP, Quality Assurance
Posted 2024-10-21

📍 United States

💸 330000 - 425000 USD per year

🔍 Biopharmaceutical

  • Bachelor's degree in pharmacy, chemistry, biology, or related field; advanced degree preferred.
  • Minimum of 15 years of progressive experience in quality assurance roles within the pharmaceutical industry.
  • At least 5 years in a senior leadership position.
  • In-depth knowledge of GXP, ICH guidelines, and regulatory requirements.
  • Proven track record of leading quality assurance teams.
  • Strong understanding of quality risk management principles.
  • Excellent leadership and communication skills.
  • Demonstrated experience in leading regulatory inspections.
  • Strategic thinker with strong analytical skills.
  • Ability to travel regularly.

  • Overall responsibility for the development and implementation of the vision and strategy for the quality function.
  • Manage and mentor a high-performing Quality organization.
  • Develop comprehensive GXP quality assurance strategies.
  • Ensure readiness for PAI and BIMO inspections.
  • Oversee quality management systems including document control and CAPA.
  • Collaborate with cross-functional teams to integrate quality processes.
  • Drive quality risk management initiatives.
  • Promote a culture of quality throughout the organization.

LeadershipGCPQAStrategyComplianceCoaching

Posted 2024-10-21
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🔥 Director, Biostatistics
Posted 2024-10-21

📍 United States

💸 230000 - 275000 USD per year

🔍 Biotechnology

  • PhD in statistics or biostatistics and 8+ years relevant experience in the pharmaceutical/biotechnology industry or MS in Biostatistics or Statistics with 11+ years of relevant experience.
  • Experience with NDA submissions.
  • Strong knowledge of statistical methodologies and current drug development trends.
  • Proficient programming skills in SAS and/or R.
  • Excellent oral and written communication skills.
  • Strong analytical and problem-solving skills.

  • Leads statistical and statistical programming team at the product level.
  • Provides statistical input for study designs, including sample size calculations and protocol development.
  • Collaborates with various teams to ensure data quality and meet project timelines.
  • Oversees CRO biostatisticians and statistical programmers to ensure deliverables are accurate and timely.
  • Contributes to documents for global Health Authority submissions and interacts as needed.

LeadershipProject ManagementData AnalysisPeople ManagementCross-functional Team LeadershipData analysisCommunication SkillsAnalytical SkillsCollaborationProblem Solving

Posted 2024-10-21
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🔥 Associate Statistical Geneticist/Statistical Geneticist
Posted 2024-10-21

📍 United States

🧭 Full-Time

💸 130000 - 200000 USD per year

🔍 Biopharmaceutical

  • PhD in Statistical Genetics, Human Genetics, Computational Biology, or related fields.
  • 0-2 years of industry or postdoctoral experience.
  • Experience with QC, analysis, and interpretation of human genetics data.
  • Basic understanding of EHR data architecture and analytics, preferably with hands-on experience.
  • Familiarity with genomics data databases and relevant programming skills.

  • Design, execute, and interpret genetics studies using large-scale cohorts.
  • Perform integrative analysis of genetic and EHR data for clinical target discovery.
  • Communicate findings to internal teams and the broader scientific community.
  • Stay updated on state-of-the-art algorithms, methods, and tools in human genetics.

AWSPythonSQLBusiness DevelopmentCloud ComputingGitMachine LearningAlgorithmsBusiness developmentPostgresCommunication Skills

Posted 2024-10-21
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🔥 Director, Medical Writing
Posted 2024-10-18

📍 United States

🧭 Full-Time

💸 210000 - 235000 USD per year

🔍 Biotechnology

  • Excellent oral and written communication skills.
  • Strong understanding of clinical development and regulatory requirements.
  • Interpersonal and influencing skills for team collaboration.
  • Ability to set realistic timeline expectations and deliver on time.
  • Ability to work independently and manage multiple competing priorities.
  • 8-12 years of medical writing experience in the pharmaceutical industry.
  • Experience managing medical writing responsibilities across multiple studies.
  • Bachelor of Science or equivalent degree.
  • Critical strategic thinking with a solution-oriented approach.
  • Experience with eCTD submission requirements.

  • Participate in scientific communication planning, including development of strategic medical communication plans.
  • Provide medical & regulatory writing support and supervise medical writing activities.
  • Facilitate the development of project timelines, document content, and comment resolution discussions.
  • Develop and maintain a company style guide for regulatory documents.
  • Perform literature searches/reviews as necessary for document development.
  • Manage external and future internal medical writing resources.
  • Foster clear communication and collaboration across teams.

LeadershipProject ManagementData AnalysisPeople ManagementJiraCross-functional Team LeadershipData analysisCommunication SkillsAnalytical SkillsCollaboration

Posted 2024-10-18
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