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Executive Director Clinical Integration Jobs (NOW HIRING)

University of Miami

NY · On-site

Executive Director, Clinical Operations The University of Miami/UHealth at Doral has an exiting opportunity for an Executive Director, Clinical Operations. The Executive Director, Clinical Operations ...

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Executive Director, Clinical Development - Neurology

Bridgewater, MA • On-site

Scorpion Therapeutics
51 - 200 employees
Learn more about Scorpion Therapeuticsexternal

$83K - $114K/yr

Other

Posted 16 days ago

Job description

Executive Director, Clinical Development – Neurology (Reports to VP, Clinical Development – Gene Therapy)Responsibilities:
  • Lead clinical programs across different diseases and supervise the clinical development team.
  • Serve as primary point person for medical monitoring and oversight of assigned clinical programs: monitor clinical studies; review and interpret clinical trial data; author clinical study and regulatory communications/documents; monitor competitor activities and data.
  • Design and implement clinical development strategy and clinical protocols; deliver high-quality clinical programs from first-in-human through full development.
  • Therapeutic area lead for Neurology Gene therapy clinical development team; partner with clinical operations, toxicology, regulatory affairs, commercial, pharmacovigilance, clinical quality, and biostatistics.
  • Provide medical leadership for clinical operational strategy (site selection, enrollment, feasibility); elevate issues affecting study quality/integrity.
  • Perform medical monitoring, coding, and data cleaning with Clinical Operations; ensure medical integrity of clinical study reports and data interpretation/communication.
  • Author or oversee clinical sections of regulatory submissions (INDs, briefing books, BLAs, NDAs, etc.) and represent the company at regulatory meetings (including Advisory Committee Meetings).
  • Prepare safety charters/DMC charters and other management plans/manuals.
  • Represent the company to external stakeholders (CROs, clinical consultants, investigational sites); organize SAB and DMC meetings.
  • Maintain clinical/scientific expertise by reviewing literature and attending medical/scientific meetings; advise gene therapy leadership on strategic direction.
Qualifications:
  • MD, DO, or foreign equivalent.
  • 10+ years global experience in neurology clinical development (pharma/biotech).
  • Experience across Phases 1–3.
  • 5+ years management experience in clinical development.
  • Prior Gene Therapy experience.
  • Neurology residency training.
  • Knowledge of ICH-GCP and FDA regulatory guidelines.
Nice to Have:
  • PhD strongly preferred.
  • Pediatric experience.
  • Prior gene therapy drug approval experience.
Travel:

~20% occasional domestic/international.

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