Clinical Program Lead

Director/Senior Director, Clinical Program Lead

Cambridge, MA

Full-time |On-site (or Hybrid)

Position Summary

OliX US, a global RNAi therapeutics company advancing multiple clinical programs in development pipelines, is seeking an experienced and strategic Director/Senior Director, Clinical Program Lead (CPL) to join our growing drug development team in Cambridge, MA. This role provides clinical leadership across one or two programs and plays a central role in shaping clinical strategy, driving clinical execution excellence, and contributing to overall R&D direction in a fast-paced, innovation-driven environment.

Key Responsibilities

Strategic Clinical Leadership

• Develop and own the clinical development strategy for assigned programs, including indication rationale, study design, and competitive positioning.
• Define and justify FIH dose selection using NOAEL, MABEL, HED, and translational data.
• Establish clinically meaningful endpoints aligned with regulatory expectations and disease biology.
• Integrate competitive intelligence into clinical design and program differentiation.

Regulatory Strategy & Agency Engagement

• Lead FDA and EMA interactions including pre‑IND, IND, scientific advice, and milestone meetings.
• Identify and proactively mitigate clinical risks highlighted by regulators.
• Design early‑phase studies that scale globally into Phase 2/3 development.

Operational Leadership

• Provide strong CRO oversight including performance management, escalation, and quality control.
• Develop and execute site strategy to optimize recruitment, diversity, and data quality.
• Build aggressive yet achievable timelines and ensure cross‑functional alignment for delivery.

Cross‑Functional Integration

• Maintain tight CMC alignment to ensure drug supply and formulation readiness.
• Translate nonclinical findings into clinical design, safety monitoring, and dose justification.
• Partner with regulatory to anticipate agency concerns early and shape program strategy.

RNAi / Platform‑Specific Expertise

• Demonstrate strong RNAi modality knowledge including class‑specific risks such as immune activation, off‑target effects, and durability.
• Understand GalNAc vs extrahepatic delivery implications for biodistribution, safety, and monitoring.
• Build a robust biomarker strategy for PK/PD, target engagement, and translational endpoints.
• Build, motivate, and develop clinical teams under tight timelines.
• Resolve cross‑functional conflict with maturity, transparency, and accountability.

Qualifications

Education

PhD or PharmD with extensive clinical and translational research experience considered.

Experience

• 10+ years of experience in clinical development with direct ownership of early‑phase strategy.
• Proven experience leading FDA or EMA meetings.
• Demonstrated ability to manage CROs and global clinical operations.
• Experience with RNAi, oligonucleotide therapeutics, or delivery platforms strongly preferred.
• Strong understanding of CMC dependencies and nonclinical translation.
• Excellent leadership, communication, and cross‑functional collaboration skills.