Head of Radiopharmaceuticals
About The Position
We are seeking a Head of Radiopharmaceuticals to lead the translational and early clinical development of our lead 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.
Requirements
- 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.
Nice To Haves
- 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.
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.
Benefits
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Executive
Education Level
Ph.D. or professional degree
