Senior Clinical Program Lead, RNAi Therapeutics

OliX Pharmaceuticals, Inc.; Cambridge (MA); In loco; USD 180.000 - 280.000; Tempo pieno

Descrizione del lavoro

OliX Pharmaceuticals, Inc. in Cambridge, MA, seeks a Director/Senior Director, Clinical Program Lead to guide clinical development across one or two programs.

The role shapes strategy, drives execution, and leads cross-functional teams in a fast-paced RNAi setting. This leadership position requires a PhD or PharmD with 10+ years in clinical development, experience with FDA/EMA interactions, and a proven ability to manage CROs and global operations.

Competenze

• PhD or PharmD with extensive clinical and translational research experience.
• 10+ years in clinical development with direct ownership of early-phase strategy.
• Experience leading FDA or EMA meetings.
• Experience with RNAi, oligonucleotide therapeutics, or delivery platforms.
• Strong understanding of CMC dependencies and nonclinical translation.
• Excellent leadership, communication, and cross-functional collaboration skills.

Mansioni

• Develop and own the clinical development strategy for assigned programs, including indication rationale and study design.
• Define and justify FIH dose selection using NOAEL, MABEL, HED, and translational data.
• Establish clinically meaningful endpoints aligned with regulatory expectations and disease biology.
• Lead FDA and EMA interactions including pre-IND, IND, scientific advice, and milestone meetings.
• Provide strong CRO oversight and build timelines for global delivery.
• 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.
• Demonstrate strong RNAi modality knowledge including class-specific risks and biodistribution considerations.

Conoscenze

RNAi knowledge

Platform delivery

Biomarker strategy

PK/PD expertise

Team leadership

Cross-functional collaboration

Conflict resolution

Formazione

PhD or PharmD

Descrizione del lavoro

OliX Pharmaceuticals, Inc. in Cambridge, MA, seeks a Director/Senior Director, Clinical Program Lead to guide clinical development across one or two programs.

The role shapes strategy, drives execution, and leads cross-functional teams in a fast-paced RNAi setting. This leadership position requires a PhD or PharmD with 10+ years in clinical development, experience with FDA/EMA interactions, and a proven ability to manage CROs and global operations.