Senior Clinical Safety Scientist

2 weeks ago

Cambridge, United States Apnimed Full time

Apnimed is a well-funded, clinical-stage pharmaceutical company working to transform the treatment of sleep apnea based on a simple idea – patients with obstructive sleep apnea could benefit from treatment with a safe and effective oral medication dosed once daily at bedtime. Our lead development program targets the neurologic control of upper airway muscles to maintain an open airway during sleep. Based in Cambridge, Mass., we are developing a portfolio of novel pharmacologic therapies for sleep apnea and related disorders, including through Shionogi Apnimed Sleep Sciences, a joint venture with Shionogi, Inc.


The Senior Clinical Safety Scientist plays a critical role in the Clinical Development and Safety teams, with primary responsibility of performing analytical software-driven clinical safety data analysis at both the individual participant and aggregate level. This effort supports and engages with a wide range of other core safety activities including clinical trial safety data collection, quality control, pharmacovigilance and internal and external reporting. The Senior Clinical Safety Scientist maintains up-to-date knowledge of drug development and regulatory expectations for data analysis to support new drug approval.


The Senior Clinical Safety Scientist will report to the Chief Medical Officer, and may be based in Apnimed headquarters in Cambridge, Massachusetts, or based remotely with travel to the home office as needed.


Key Job Duties include, but are not limited to:


  • Safety Data Analysis: Analyze and summarize safety data from ongoing and completed studies, providing actionable insights and recommendations at both the individual participant and aggregate levels.
  • Data Visualization and Analytics: Utilize data analytic and visualization tools to represent, explain, and document complex safety information in near real-time.
  • Signal Detection Strategy Development: Design and implement tailored signal detection strategies for assigned products to identify and evaluate safety signals effectively.
  • Regulatory Submission Support: Contribute to writing and reviewing safety and pharmacovigilance content for regulatory submissions, including NDA submission and FDA Information Request responses, collaborating with cross-functional teams as needed.
  • Conduct thorough searches and reviews of adverse event data, scientific literature, and other safety-relevant information to support safety data analysis and signal detection efforts.


Qualifications:


  • PharmD, RN, MD or equivalent healthcare-related degree.
  • Minimum 6 years of relevant pharmaceutical development experience, including at least 3 years of experience in software-driven safety data analysis.
  • Training and at least 3 years of hands-on use of data visualization software such as JMP, Power BI, Tableau, or similar
  • Experience in implementing and reviewing cumulative safety data with ability to interpret, synthesize and communicate complex safety information, including use of data analytic and visualization tools, and interpretation of statistical results.
  • Demonstrated ability to develop, execute and follow-through complex projects to completion
  • Skilled at working effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view
  • Knowledge of US drug development regulations and guidelines; knowledge of regulations in other regions is a plus.
  • Independently motivated, detail oriented and strong problem-solving ability
  • Excellent organizational skills and demonstrated ability to multi-task in a fast-paced environment with changing priorities
  • Excellent written and verbal communication skills with the ability to interact across multiple functions


What Apnimed Offers:


  • 401(k) with company match
  • Generous time off for vacation
  • Generous healthcare benefits
  • Flexible working environment
  • Motivated and experienced team


Location and Other Information:


  • Apnimed is a privately held company based in Cambridge, MA; we are generally virtual, and specific location within the US is flexible, but must be able to travel as necessary.
  • Apnimed is an EEO employer committed to an exciting, diverse, and enriching work environment.
  • Please visit us at www.apnimed.com to learn more about our work with Obstructive Sleep Apnea

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