Company Description

Halia Therapeutics is an innovative, clinical-stage biopharmaceutical company dedicated to discovering and developing novel therapeutics for patients with serious unmet medical needs. Operating with the agility of a small team and the ambition of a larger organization, Halia fosters a science-driven, collaborative culture where every team member has meaningful impact. As we advance our pipeline toward pivotal milestones, we are seeking an exceptional clinical leader to join our team and drive our programs forward.

Position Summary

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.

Key Responsibilites

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.

Cross-Functional & Executive Leadership

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.

Qualifications and Experience

Required

M.D. (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.

Deep knowledge of FDA regulations, ICH guidelines, GCP, and the IND/NDA/BLA submission process; international regulatory experience (EMA) strongly preferred.

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.

Preferred

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.

Track record of building clinical development teams from an early stage.

This position is an onsite position in Lehi, Utah.