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Centessa Pharmaceuticals, LLC

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Jobs at this company:

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🔥 Senior Director, Program Management, CMC
Posted 2024-11-16

🧭 Full-Time

🔍 Pharmaceutical

  • 10+ years of pharmaceutical industry experience, preferably in small molecule development.
  • 5+ years of project management leadership experience focused on CMC-related activities.
  • Strong understanding of drug development processes and cGMP requirements.
  • Organizational and analytical skills to manage multiple projects independently.
  • Decision-making and communication skills to coordinate CDMO activities effectively.
  • Excellent oral and written communication skills for scientific information.
  • Project management professional (PMP) certification preferred.
  • Expertise in MS Office including Excel, PowerPoint, and MS Project.

  • Serve as main contact for CMC project communications with internal teams and CDMOs.
  • Participate in teleconferences to maintain relationships and track progress.
  • Monitor timelines and contracts, address discrepancies.
  • Support CMC activities, track GMP and Regulatory documentation.
  • Interface with various departments to ensure timely project delivery.
  • Identify resource constraints and risks impacting timelines.
  • Coordinate shipment/logistics and manage detailed project plans.
  • Oversee project objectives and milestones while managing changes.
  • Facilitate collaboration across functional teams.
  • Communicate project updates to stakeholders.
Posted 2024-11-16
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🔥 (Sr.) Director, Program Management - Orexin Programs
Posted 2024-11-07

🧭 Full-Time

🔍 Pharmaceutical and biotechnology

  • Extensive knowledge of clinical trial processes and regulatory requirements.
  • Strong leadership and team management skills.
  • Excellent communication, collaboration, and interpersonal skills.
  • Ability to manage multiple priorities and work in a fast-paced environment.
  • Working knowledge of project management principles and current global regulatory requirements.

  • Lead and manage clinical trials within Centessa’s Orexin research programs.
  • Oversee study management from startup to completion, including enrollment and data cleaning.
  • Collaborate with various teams to ensure operational excellence.
  • Ensure compliance with regulatory guidelines and facilitate contract completion.
  • Provide updates on clinical trial progress to senior management and identify risks.
Posted 2024-11-07
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🔥 (Sr.) Clinical Trial Manager
Posted 2024-11-07

đź“Ť US

🧭 Full-Time

🔍 Pharmaceuticals

  • Bachelor’s degree (or equivalent) in a relevant scientific field preferred.
  • 8+ years’ experience in the life sciences industry.
  • 5+ years of Project Management or Clinical Trial Management experience.
  • Experience in rare disease, CNS, and/or Oncology preferred.
  • Strong communication, collaboration, and interpersonal skills.
  • Excellent analytical and organizational skills.
  • Working knowledge of project management principles; PMP certification is an advantage.
  • Knowledge of global regulatory requirements and ICH guidelines.
  • Ability to find creative solutions to timelines and budget issues.

  • Leads planning and communication with cross-functional teams for clinical trial execution.
  • Reviews and approves plans from CROs and vendors for compliance with GCP and regulations.
  • Represents the study team in the design and delivery of studies within timelines.
  • Oversees CROs and vendors to ensure protocol compliance and escalate concerns.
  • Develops and manages critical study documents and audit preparation.
  • Finalizes clinical study-related documents and prepares contingency plans.
  • Drives trial activities including site activations and database lock.
  • Maintains dashboards and reports project progress to management and governance teams.
  • Facilitates meetings with prepared materials and follow-ups.
  • Provides status reports on timelines and accruals.

LeadershipProject ManagementData AnalysisPeople ManagementProject CoordinationCross-functional Team LeadershipData analysisCommunication SkillsAnalytical SkillsCollaboration

Posted 2024-11-07
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