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Head of Radiopharmaceuticals at TwoStep Therapeutics. Remote Location: SF Bay Area. Company Overview. TwoStep 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. TwoStep 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 . www.twosteptx.com. or download our 2025 scientific poster (. linked here. ).. Position Overview. 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.. TwoStep 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.. Key Responsibilities. 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.. Essential Qualifications. Advanced degree in a relevant field (PhD/MD/PharmD) 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.. Preferred Qualifications. Proven successful execution within early-stage biotech, from IND/CTA to clinical proof-of-concept.. Direct experience with DOTA-chelated radiometals (e.g., 68Ga, 111In, 177Lu) and knowledge of alpha-emitting development considerations (e.g., 225Ac) 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.. What We Offer. At TwoStep Therapeutics, we envision a future where every cancer patient has access to targeted, safe, and effective therapeutic options. We prioritize a diverse, inclusive work environment that fosters personal and professional growth. Our comprehensive benefits include:. Competitive base salary, performance bonuses, and equity compensation. Unlimited Paid Time Off (PTO). Comprehensive medical, dental, and vision benefits for individuals and families. 401(k) plan. Company-paid basic life insurance. Job title and compensation are dependent on the candidate’s experience and skillset. We will consider candidates who prefer to work in-person (San Carlos, CA), hybrid, or remote.. Equal Opportunity Employer. TwoStep Therapeutics is an equal opportunity employer. We prohibit unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law. If you require assistance in submitting an application due to incompatible assistive technology or a disability, please contact us at [email protected]. We are committed to accommodating your needs promptly.. Join Us. If you are passionate about advancing cancer therapies and want to make a meaningful impact in the field, we invite you to apply for the Head of Radiopharmaceuticals position at TwoStep Therapeutics. Together, we can shape the future of cancer treatment.