Vice President Clinical Development

Halia Therapeutics, Inc.

Lehi, UTFull-timePosted Apr 22, 2026

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Qualifications

  • •(or M.D./Ph.D.) with board certification or eligibility in a relevant specialty; or Ph.D. in a life-science discipline with equivalent senior clinical development experience
  • •Minimum 12 years of progressive pharmaceutical/biotech clinical development experience, including at least 5 years in a senior leadership capacity (Director level or above)
  • •Demonstrated success leading Phase II and/or Phase III trials from design through regulatory submission, preferably in oncology, rare disease, immunology, or inflammation
  • •Proven ability to work effectively in a lean, resource-constrained environment; comfortable wearing multiple hats and driving results through influence without large internal teams
  • •Exceptional written and verbal communication skills, including experience presenting to boards, investors, and health authorities
  • •Prior experience at a small or mid-size biotech company with direct exposure to pipeline-building decisions
  • •Experience with adaptive trial designs, master protocols, patient-reported outcomes (PROs), or biomarker-driven development
  • •4 more items(s)

Responsibilities

  • •The Vice President of Clinical Development is a senior leadership role responsible for the strategic direction, design, execution, and oversight of all clinical trials across Halia's therapeutic pipeline
  • •Reporting directly to the CMO/CEO, the VP will serve as the primary clinical strategist, translating scientific hypotheses into rigorous clinical programs and guiding compounds from early-phase proof-of-concept through late-stage development and regulatory submission
  • •This individual will build and lead a high-performing clinical development organization, partner closely with Clinical Operations, Regulatory Affairs, and external collaborators, and represent the company to key stakeholders including investors, partners, and health authorities
  • •Clinical Strategy & Program Leadership
  • •Develop and own the integrated clinical development strategy for all pipeline assets, including indication selection, patient population, endpoints, and trial design
  • •Lead the creation and continuous refinement of clinical development plans (CDPs) and target product profiles (TPPs) aligned with regulatory and commercial objectives
  • •Evaluate emerging clinical data, competitive landscape, and scientific literature to adapt strategy and inform go/no-go decisions
  • •Provide clinical input into business development and in-licensing assessments, including due diligence activities
  • •Trial Design & Execution
  • •Design robust Phase I–III clinical trials and oversee protocol development, including endpoints, statistical frameworks, and operational feasibility
  • •Lead clinical review committees, data safety monitoring boards (DSMBs), and cross-functional trial teams to ensure study quality and participant safety
  • •Monitor enrollment, data integrity, and trial progress; work with the Clinical Operations team to proactively identify and resolve issues to maintain timelines and budget
  • •Ensure all studies are conducted in full compliance with GCP, ICH guidelines, FDA/EMA regulations, and applicable local requirements
  • •Regulatory Collaboration
  • •Serve as the clinical lead in interactions with the FDA, EMA, and other regulatory authorities, including pre-IND meetings, End-of-Phase meetings, and advisory committees
  • •Provide clinical sections for INDs, CTAs, NDAs/BLAs, and other regulatory submissions; review and approve clinical study reports (CSRs)
  • •Lead the publications strategy, KOL engagement, and medical education activities
  • •Serve as a key member of the executive/senior leadership team, contributing to corporate strategy, board presentations, and investor communications
  • •Partner with CMC, Translational Sciences, and Biostatistics to ensure seamless integration across the drug development continuum
  • •Represent Halia at scientific conferences, investor days, and partnership discussions
  • •17 more items(s)
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