Head of Radiopharmaceuticals

Company Overview

Two Step Therapeutics is a biotechnology company developing a pipeline built around a unique tumor-targeting polyspecific integrin-binding peptide (PIP) that can selectively bind several targets that are highly expressed on solid tumors. This multi-targeting feature enables the agent’s broad applicability to a wide range of tumor types and patient populations, overcoming the limitations of single-antigen targeting approaches. The company has leveraged this technology to create a pipeline of targeted cancer therapies for cytotoxic drug delivery and radioligand therapy.

Two Step Therapeutics was co-founded by CEO, Caitlyn Miller, in collaboration with leading academic entrepreneurs at Stanford University, including Nobel Laureate Carolyn Bertozzi, Jennifer Cochran, and Ronald Levy.

For more information, visit  or download our 2025 scientific poster (linked here).

We are seeking a Head of Radiopharmaceuticals to lead the translational and early clinical development of our radioligand program from late preclinical through first-in-human (FIH) Phase 0 imaging in cancer patients and into subsequent clinical stages for therapeutic development.

The ideal candidate has personally led tumor-targeted radioligand programs through FIH studies, possesses deep familiarity with both US and EU regulatory requirements, and can build a compelling data package that enables sound program decisions and supports continued therapeutic development.

Two Step develops targeted drug conjugates and radioligand therapies for solid tumor indications. As the company’s first radioligand-specialized hire, this role requires a highly multidisciplinary leader who can span translational strategy, nonclinical and CMC/radiochemistry oversight, clinical development and operations, regulatory interactions, and CRO/vendor management
.

• Lead and oversee all operational aspects of early-phase clinical trials of radioligand program, including CRO and site identification, contract negotiation, vendor management, study planning and execution.
• Develop comprehensive clinical development plans.
• Lead preparation and submission of key regulatory documents (protocols, IBs, IND/CTAs) for early clinical development.
• Provide technical oversight of radiochemistry/CMC strategy and execution, including management of external CMC consultants and CDMO/radio-CRO partners; ensure fit-for-stage specifications, release testing, stability, and comparability are developed to support regulatory submission and clinical operations.
• Build and manage productive relationships with Key Opinion Leaders (KOLs), CROs, trial sites, and regulatory agencies to inform clinical strategy and development pathways.
• Lead the review and interpretation of clinical data to ensure data integrity and support decision‑making.

• Advanced degree in a relevant field (PhD/MD/Pharm
  
  D) or equivalent experience in radiopharmaceutical development.
• Significant experience leading radiopharmaceutical programs (peptides and/or small molecules), including CMC/radiochemistry oversight and clinical translation.
• Demonstrated experience driving a first-in-human imaging/dosimetry study (Phase 0 / early phase), including regulatory submission and vendor management.
• Prior experience with theranostic pairs (diagnostic + therapeutic radionuclides).
• Strong understanding of US and EU clinical trial methodology, regulatory frameworks, and submission processes for radiopharmaceuticals.
• Excellent scientific judgment and communication skills; able to write and critically review clinical development plans and clinical trial protocols.

• Proven successful execution within early-stage biotech, from IND/CTA to clinical proof‑of‑concept.
• Direct experience with DOTA‑chelated radiometals (e.g., 68
  
  Ga, 111
  
  In, 177
  
  Lu) and knowledge of alpha‑emitting development considerations (e.g., 225
  
  Ac) is a plus.
• Experience in radiopharmaceutical preclinical scientific development and CMC (e.g., radiolabeling, analytical development, and formulation).
• Experience with later‑stage clinical development of radiopharmaceuticals.

At Two Step…