Califesciences
Principal Scientist, Translational PET Imaging
Califesciences, South San Francisco, California, us, 94083
Job Description
We are seeking a motivated and experienced Translational PET Imaging Scientist to lead the transition of novel PET radiotracers from late preclinical development into first‑in‑human studies. 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.
Key Responsibilities
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.
Location Available in South San Francisco, CA; Boston, MA; West Point, PA or Rahway, NJ based on candidate preference.
Qualifications
Education : Ph.D. or equivalent doctorate degree in Biomedical/Imaging Science, Radiochemistry, Physics, Pharmacology or a related field and seven (7) years of relevant experience.
Required Experience and Skills :
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.
Compensation Salary range: $169,700.00 – $267,200.00. The range reflects several factors including relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.
Benefits We offer a comprehensive package of medical, dental, vision, and other insurance benefits for employees and families; retirement benefits including a 401(k); paid holidays, vacation, and compassionate and sick days. For more information, visit https://jobs.merck.com/us/en/compensation-and-benefits.
EEO Statement As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit EEOC Know Your Rights and EEOC GINA Supplement.
Application Apply through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
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We are seeking a motivated and experienced Translational PET Imaging Scientist to lead the transition of novel PET radiotracers from late preclinical development into first‑in‑human studies. 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.
Key Responsibilities
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.
Location Available in South San Francisco, CA; Boston, MA; West Point, PA or Rahway, NJ based on candidate preference.
Qualifications
Education : Ph.D. or equivalent doctorate degree in Biomedical/Imaging Science, Radiochemistry, Physics, Pharmacology or a related field and seven (7) years of relevant experience.
Required Experience and Skills :
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.
Compensation Salary range: $169,700.00 – $267,200.00. The range reflects several factors including relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.
Benefits We offer a comprehensive package of medical, dental, vision, and other insurance benefits for employees and families; retirement benefits including a 401(k); paid holidays, vacation, and compassionate and sick days. For more information, visit https://jobs.merck.com/us/en/compensation-and-benefits.
EEO Statement As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit EEOC Know Your Rights and EEOC GINA Supplement.
Application Apply through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
#J-18808-Ljbffr