TwoStep Therapeutics

Medical Director

• Lead the overarching clinical development strategy and execution for the pipeline, ensuring seamless alignment with corporate goals, scientific innovation, and long-term patient impact.
• Serve as the primary medical expert for novel therapeutics to deliver rigorous, high-quality clinical, scientific, and regulatory outcomes.
• Collaborate closely with R&D, and external partners to align clinical strategies with corporate priorities, manufacturing capabilities, and development plans.
• Lead the preparation, review, and submission of critical regulatory documents (e.g., protocols, Investigator's Brochures) to enable efficient early-phase clinical development.
• Cultivate and maintain relationships with Key Opinion Leaders (KOLs), academic investigators, advisory boards, CROs, and trial sites.
• Engage effectively with investors, board members, and external stakeholders to communicate program progress, scientific rationale, and strategic value.

Chief Medical Officer

Director

• Own and execute phase-appropriate CMC development plans from discovery handoff through clinical development
• Lead all drug substance (DS) and drug product (DP) activities, including process development and optimization, cGMP manufacturing, analytical development (including method validation and stability programs), and formulation development (fill/finish, lyophilization optimization, etc.)
• Oversee CMC execution for radioligand programs, including management of radioisotope suppliers, radiochemistry development partners, and clinical radio-CMC operations
• Drive selection, contracting, and management of CDMOs to ensure high-quality and on-time phase-appropriate batch delivery to external vendors/clinical sites
• Manage timelines and budgets, monitor performance metrics, and proactively mitigate technical and supply chain risks
• Ensure compliance with cGMP, ICH guidelines, and global regulatory standards across all CMC activities
• Lead preparation, authoring, and review of CMC sections for regulatory submissions (INDs, IMPDs, NDAs, and future BLAs/MAAs). Serve as CMC technical lead in regulatory interactions with FDA, EMA, and other health authorities
• Serve as the CMC subject matter expert on cross-functional program discussions across Research, Nonclinical Development, Clinical Development, and Quality Assurance

Chief Medical Officer

CMC Director – Head