Chief Medical Officer

TwoStep Therapeutics•San Carlos, CA

About The Position

We are seeking a Chief Medical Officer (CMO) to oversee and advance a differentiated pipeline of targeted drug conjugates and radioligand therapies designed to address high unmet needs across multiple solid tumor indications. The ideal candidate is a proven cross-functional development leader with experience advancing targeted oncology modalities (e.g., ADCs, peptide-drug conjugates, radioligands) from IND-enabling through late-stage clinical development.

Requirements

Education: MD with board certification in a relevant specialty (e.g., oncology, nuclear medicine, radiation oncology, or related therapeutic area).
15+ years of progressive clinical leadership experience in the biotech or pharmaceutical industry, with a demonstrated track record of successfully advancing novel therapeutics from preclinical/early clinical stages through pivotal development.
Proven expertise in global regulatory interactions, including successful submissions, negotiations, and approvals with major agencies (FDA, EMA, and others) across early and late-stage programs.
Prior experience in a CMO, senior VP of Clinical Development, or equivalent medical leadership role in a biotech or pharmaceutical organization, ideally in a fast-paced, innovative environment.
Hands-on, execution-oriented mindset with a willingness to actively contribute to pipeline advancement, including protocol design, data interpretation, and cross-functional problem-solving.
Exceptional scientific judgment, strategic thinking, and communication skills

Nice To Haves

Expertise with drug conjugates (i.e., peptide-drug conjugates, ADCs) and/or radioligand programs

Responsibilities

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.