• This role will primarily focus on clinical implementation of novel PET tracers in oncology studies, guide regulatory submissions, and act as the PET imaging expert within multidisciplinary project teams to ensure efficient clinical translation
• Strategy & leadership: Develop and lead the clinical imaging strategy for application of novel PET tracers in early clinical oncology trials, guiding projects from late-stage preclinical work through clinical proof-of-concept studies
• Translational study design: Design, oversee, and interpret PET imaging studies in animal models and early-phase clinical trials (Phase I), ensuring robust study design and high-quality PET data collection
• Regulatory support: Familiarity with regulatory and quality frameworks applicable to radiopharmaceuticals (GMP for radiopharmaceuticals, IND/CTA requirements, radiation safety/compliance)
• Prepare and contribute PET-specific scientific content for regulatory filings, including IND submissions
• Partner and site management: Coordinate with CROs, CDMOs, and clinical sites to support cGMP manufacturing logistics and clinical supply/distribution for radiopharmaceuticals
• Manage relationships and deliverables with external academic collaborators and CROs/CDMOs
• Cross-functional collaboration: Serve as the PET imaging subject-matter expert on project teams, working closely with biomarker scientists, clinical and medical leads, regulatory affairs, clinical operations, and CMC teams
• Reporting & dissemination: Interpret imaging data, author study reports, present findings internally and externally, and contribute to manuscripts and conference presentations
• NOTE: This role is available in South San Francisco, CA; Boston, MA; West Point, PA or Rahway, NJ based on candidate preference

This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely

• Ph.D. or equivalent doctorate degree in Biomedical/Imaging Science, Radiochemistry, Physics, Pharmacology or a related field and seven (7) years of relevant experience
• Demonstrated experience advancing novel PET tracers into clinical studies, including collaboration with academic sites and contract partners for cGMP manufacturing
• Experience as imaging lead on Phase I oncology trials and direct involvement in first-in-human novel PET tracer studies, including lead contributor to protocol design
• Strong understanding of radiopharmaceutical development, radiochemistry, and quality control; proven ability designing quantitative PET studies across species
• First-hand experience with regulatory pathways and requirements for novel PET tracers in early-phase clinical trials
• Track record of interacting with regulatory agencies or primary contributor to successful agency submissions for novel PET imaging agents

Excellent written and verbal communication skills, with a track record of effective collaboration across multidisciplinary teams

Cancer Research, Clinical Trials, Oncology, Oncology Trials, Positron Emission Tomography (PET), Project Leadership, Radiation Safety, Radiopharmaceuticals, Radiopharmacy, Regulatory Compliance, Regulatory Work, Technical Leadership, Translational Research

An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs

• The successful candidate will be eligible for annual bonus and long-term incentive, if applicable
• We offer a comprehensive package of benefits
• Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days

More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits