POSITION SUMMARY

The Associate Director, Clinical Development will be responsible for supporting clinical trial related activities for Brelovitug, a key asset in Phase 3, on a cross-functional team of internal and external experts, investigators and government agencies. Activities include but are not limited to drafting key clinical trial and program-level documents, protocol development, support study startup, recruitment, ongoing clinical development management, and closeout as appropriate. Compliance with internal processes, GCP/ICH and regulatory requirements, study and data monitoring, data analysis are required. The Associate Director, Clinical Development operates in collaboration with other functions including internal Safety, Regulatory, Biometrics, and Clinical Operations teams.

JOB FUNCTIONS/RESPONSIBILITIES

• Responsible for drafting key clinical trial and program-level documents in collaboration with Clinical Operations, Biostats, Medical Writing and the CROs
• Responsible for clinical aspects of study startup, execution and close-out in close collaboration with Clinical Operations, Data Management and CRO
• Supports the monitoring of efficacy and safety data received from the clinical trials
• Supports preparation of clinical summaries for drug applications
• Supports preparation of scientific/medical questions from regulatory agencies
• Support the analysis and drafting of clinical trial and scientific publications
• Supports the planning, conduct and follow-up of external clinical development- or study-related meetings
• Responsible for clinical aspects of the TMF
• Support the running and operational aspects of the Clinical Development team including meeting support, inspection readiness and organizational support

QUALIFICATIONS

Education /Experience:

• Bachelor’s Degree and/or advanced degree in a scientific discipline.
• PhD or PharmD preferred
• 3+ years of experience in the pharmaceutical industry, including 2+ years in Clinical Development teams.
• Manage several clinical trials with multidisciplinary trial teams
• Experience in working with CROs
• Medical/scientific expertise appropriate to clinical program
• Demonstrates ability to establish strong scientific partnership with key investigators
• Thorough knowledge of Good Clinical Practice, clinical trial design, statistics, regulatory processes, and clinical development process
• Advanced knowledge of the assigned therapy area is desired, with the capability to interpret, discuss and represent trial or program level data.

Knowledge, Skills and Abilities:

• Demonstrated accountability for delivery on clinical studies.
• Demonstrates excellent scientific writing skills.
• Experience with basic statistical principles and techniques of data analysis, interpretation and clinical relevance.
• Strong experience in clinical data review and interpretation.
• Ability to execute in a fast-paced environment.
• Detail oriented with exceptional organizational skills.
• Effective communicator with strong verbal and written skills.
• Ability to identify issues, analyze situations and provide effective solutions.
• Solid understanding of the clinical development process.

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