Senior Director, Clinical Development

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Department: R&D: Clinical
Reports To: Chief Medical Officer
FLSA Status: Exempt
Location: San Diego or Remote

Summary

Reporting to the Chief Medical Officer, the Senior Director, Clinical Development will develop and oversee the design, planning, and execution of clinical studies in both early and late-stage development, and provide medical monitoring across new, existing, and emerging assets in Longboard’s portfolio.  The Senior Director, Clinical Development will assist in the interpretation of study results and establish and approve scientific methods for design and implementation of clinical protocols, data collection systems and final reports.  The Senior Director, Clinical Development will also be responsible for adverse event reporting and safety responsibilities, including adherence to protocols and determining study completion.

Responsibilities

  • Responsible for the clinical and medical leadership of INDs, NDAs, BLAs and other global regulatory filings
  • Provide clinical leadership and expertise in meetings with global Health Authorities
  • Design clinical development plans and individual clinical studies for all phases.  Design, prepare, and initiate study protocols and other required documentation in compliance with project plans, federal regulations, GCP, and good medical practice
  • Work with cross-functional teams to ensure an integrated and strategic approach to execution and systematic oversight of study protocol
  • Provide clinical support and guidance in investigator selection, study initiation and conduct, patient/subject safety, or to CRO medical monitor
  • Review safety and efficacy data, lead the study team through analysis and interpretation of the study results, and make recommendations as to appropriate next steps
  • Analyze and interpret clinical trial data and prepare reports for regulatory agencies and publication
  • Lead and oversee authorship of informed consent forms, eCRFs, study manuals, clinical study reports, and investigator brochures, and provide medical input to clinical components of IND, NDA and other regulatory submission documents
  • Work closely with Clinical Operations to track study recruitment and implement action plans to address early impediments to study enrollment
  • Maintain the highest level of scientific and clinical knowledge in the neurological therapeutic area
  • Monitor timelines, objectives, and budgets
  • Ensure rapid and effective communication of high-quality data and results to project teams
  • Manage junior team members
  • Other duties as assigned

Qualifications

  • MD required
  • Board certification and/or strong experience in R&D clinical development in Neurology required
  • 12+ years industry experience with particular experience in regulated drug development of small molecules strongly preferred
  • Proven track record of designing and leading studies from early stage through regulatory submission
  • Experienced in interactions with global health authorities (FDA, EMA, PMDA)
  • Ability to engage KOLs/investigators and form Scientific Advisory Committees
  • Experience working with multiple national and international CROs
  • Ability to manage multiple work streams and projects concurrently
  • Ability to problem-solve, research issues, and propose solutions
  • Excellent interpersonal and communication skills, both written and oral, and ability to communicate complex information succinctly
  • Effective and constructive collaborator
  • Ability to function independently in fast-paced, virtual environment