Associate Director, Clinical Development - Neurology

Location: Fully onsite, remote, or hybrid; remote employees must travel to hirify.global headquarters in Carlsbad approximately once per quarter.

Salary: $168,820–$250,502 annually.

Company

hirify.global develops RNA-targeted medicines and gene-editing approaches for serious diseases, with a leading pipeline in neurology, cardiology, and other areas of high unmet patient need.

What you will do

• Lead clinical development activities for assigned neurology studies, including a high-priority Phase 3 program.
• Build relationships with investigators, clinical trial teams, site staff, key opinion leaders, advocacy organizations, regulators, and other stakeholders.
• Review clinical data and operational progress, identify emerging risks, and coordinate mitigation with cross-functional project teams.
• Write and review protocols, Investigator’s Brochures, IND submissions, Clinical Study Reports, and other regulatory documents.
• Analyze clinical trial data and prepare manuscripts, abstracts, posters, presentations, and scientific communications.
• Provide scientific leadership, training, and recommendations to project teams and senior leadership.

Requirements

• PhD, MD, or PharmD with 5+ years of pharmaceutical or biotechnology experience in clinical development.
• Significant cross-functional collaboration experience across clinical operations, regulatory, statistics, and data management.
• Experience writing protocols or protocol amendments and authoring or leading Clinical Study Report development.
• Experience leading cross-functional data reviews; familiarity with Elluminate is preferred.
• Strong interpersonal, communication, problem-solving, decision-making, and execution skills.
• Ability to work effectively as an individual contributor and flexible team player in a fast-paced, innovative environment.

Nice to have

• Experience in neurology, rare diseases, and/or pediatrics.
• Experience contributing to NDA filings.
• Experience supporting FDA Pre-Approval and BIMO inspections.
• Experience managing vendors or committees such as DSMBs.

Culture & Benefits

• Work in onsite, hybrid, or remote environments with an emphasis on collaboration and lasting professional relationships.
• Contribute to scientific innovation and treatments for patients with high unmet needs.
• Access to hirify.global’s benefits package.
• Engage with development, research, commercial, and senior leadership functions.