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. #J-18808-Ljbffr