AskBio Inc.

Senior Director, Clinical Trial Management

AskBio Inc.

full-time

Posted on:

Location Type: Hybrid

Location: Durham • North Carolina • Ohio • United States

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Job Level

Senior

Tech Stack

Google Cloud Platform

About the role

  • Manage overall execution of assigned clinical programs
  • Develop operational strategies and decisions to achieve clinical objectives
  • Oversee multiple clinical programs and Director-level employees
  • Ensure meeting all operational deliverables in timeline, cost, and quality
  • Maintain overview of status, issues, and communicate progress proactively
  • Co-lead a Clinical Sub Team and manage strategic topics
  • Interface with key internal and external stakeholders
  • Provide program leadership and expertise to trial teams
  • Mentor and coach Clinical Operations program team
  • Manage performance, talent, and resource for Trial Management staff
  • Ensure compliance with company and regulatory standards
  • Create a positive work environment

Requirements

  • B.S./B.A. degree in a related field
  • 12+ years of relevant industry experience
  • At least 10 years focused on clinical trial management
  • Significant experience developing and implementing program-level plans
  • 4+ years of experience leading clinical teams
  • Proven experience directing clinical program strategy
  • Previous experience in Neurology clinical trials
  • Extensive knowledge of FDA Regulations, GCP, and ICH guidelines
  • Strong computer skills including knowledge of Excel, Word, PowerPoint, and Outlook
  • Proficient written and verbal communication skills
  • Approx. 25% domestic and/or international travel may be required
Benefits
  • Secondment opportunity for unique experience
  • Encouragement of developmental discussions with managers
  • Collaboration across Bayer-AskBio partnership
  • Commitment to advancing gene therapy
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
clinical trial managementprogram-level planningclinical program strategyFDA RegulationsGCPICH guidelines
Soft Skills
leadershipmentoringcoachingcommunicationproblem-solving