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Associate Director, Clinical Scientist

1 week, 5 days ago
Anywhere
Full-time
Senior
Operations Specialist
Operations
GCP
Apply Now
Celcuity

Celcuity

Celcuity is a clinical stage biotechnology company that unravels complexity and harnesses insights to develop targeted therapies for cancer patients. Their platform provides unparalleled insights into oncogenic pathways, with their lead candidate being...

Biotechnology
11-50
Founded 2012
$214M raised
View All Jobs 15

Description

  • Review clinical data and ensure quality and consistency in clinical site reporting.
  • Develop, review, and resolve cross-functional comments on clinical development documents, including abstracts, manuscripts, protocols, amendments, informed consent forms, regulatory documents, and related materials.
  • Develop and review presentations and training materials such as slide decks, posters, and other study materials.
  • Participate in Clinical Development Core Team and Clinical Sub-Team meetings as needed.
  • Collaborate with Biostatistics, Data Management, Clinical Operations, Project Management, Quality Assurance, Regulatory Affairs, and other extended project team members.
  • Represent Clinical Science in operational meetings such as Study Management Team meetings.
  • Maintain scientific and clinical knowledge in the relevant therapeutic and disease areas.

Requirements

  • Advanced science or clinical degree preferred, such as PhD, PharmD, or MD.
  • 3 or more years of clinical trial experience in a pharma or biotech industry setting.
  • Oncology research experience preferred.
  • Data listing review experience is mandatory.
  • Experience authoring experimental protocols and/or study results and conclusions.
  • Strong understanding of Phase 1 through Phase 4 drug development.
  • Sound knowledge of GCP, ICH, FDA, EMEA, NICE, and other relevant health authority guidelines and regulations.
  • Working knowledge of multidisciplinary drug development functions, including clinical operations, biostatistics, data management, regulatory, and medical affairs.
  • Excellent time and project management skills with the ability to prioritize multiple tasks and meet short- and long-term goals.
  • Strong oral and written communication skills, including interpersonal and presentation skills.
  • Good judgment and decision-making skills.

Benefits

  • Base salary range of $175,000 to $210,000.
  • Eligible for an annual performance incentive bonus.
  • New hire equity package.
  • Medical, dental, and vision insurance.
  • 401(k) match.
  • PTO and paid holidays.

Interested in this position?

Apply directly on the company website

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