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Clinical Trial Manager
Alpha-9 Oncology · Boston, Massachusetts, USA
Pay
$115k–160k
Setting
On-site
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Clinical Trial Manager
Boston, Massachusetts, USA
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Your Impact
Alpha-9 Oncology is seeking a highly motivated Clinical Operations Manager with a strong background in oncology clinical trials and vendor management to support the day-to-day execution of radiopharmaceutical studies. In this role, you will ensure clinical activities are conducted in alignment with protocols, applicable regulations, and company SOPs while partnering closely with the Clinical Operations Leader, who provides overall study strategy and accountability for trial delivery.
This is a hands-on role for someone who enjoys solving problems, coordinating across teams and vendors, and driving progress in a fast-paced clinical environment. You will play a key role in translating study strategy into effective execution and helping advance therapies that impact patients. This role reports to the Clinical Operations Leader.
How You’ll Contribute
Support tracking of clinical trial timelines, budgets, key operational metrics, and study risks, including site activation, enrollment progress, and monitoring issues.
Support the CRO/vendor selection strategy and development of operational strategies including country & site selection.
Contribute to the development of site feasibility questionnaires and analysis of the feasibility results.
Manage day-to-day relationships with clinical trial vendors, including tracking vendor contracts, budgets, invoices, and payments against contracted scope of work, and escalating issues or variances to Clinical Operations leadership.
Provide operational input into the development of clinical protocols, informed consent, study manuals, study reports, eCRF and other key operational/regulatory documents.
Collaborate with cross-functional teams including Data Management, Clinical Sciences, and Clinical Development to support study execution and resolution of operational issues.
Review study site monitoring reports in alignment with the CRO oversight plan.
Responsible for maintaining internal study documents in the Trial Master File (TMF) and periodically reviewing the CRO TMF for completeness and accuracy.
Support forecasting and management of clinical trial supplies (e.g., lab kits) to ensure sites have the materials needed to conduct studies.
Assist in the preparation of Investigator and Study Coordinator Meetings.
Ensure study adherence to regulatory requirements (ICH, FDA, EMA, etc.) and ICH/GCP guidelines and SOPs.
Provide input to the drafting of governance documents, SOPs, work instructions, and other resources.
The Skills You Bring
Bachelor’s degree in Life Sciences or a related field; advanced degree preferred, with 3–5 years of experience in clinical operations within the pharmaceutical or biotechnology industry.
Working knowledge of ICH/GCP regulations.
Experience with early-stage oncology trials required; radiopharmaceutical experience preferred.
Strong organization skills and keen attention to detail.
Excellent writing and communication skills.
Proven ability to proactively identify and resolve issues and ability to work independently on operational assignments.
Willingness to roll up your sleeves and get the job done.
Strong interpersonal skills with the ability to interact effectively with all levels of associates both within and outside the organization.
What's In It For You: At Alpha-9 Oncology, we offer a competitive and comprehensive benefits package designed to support all employees. Our benefits include a competitive salary, bonus, equity, 20 vacation days, 5 sick days, a technology allowance, and commuter reimbursement. We also provide generous retirement savings plans with employer matching, extended health benefits, and paid holidays, tailored to local standards in each region. While specific offerings may vary by location, our commitment to fostering a supportive and rewarding work environment is consistent across the company.
Company Summary
Alpha-9 Oncology is a clinical-stage biotechnology company pioneering radiopharmaceutical innovation for solid tumors. Our proprietary scaffolds, composed of optimized binders, linkers, chelators, and radioisotopes, enable targeted radiation delivery to cancer cells, minimizing harm to surrounding healthy tissue. Focusing on innovative targeting moieties, we develop molecules tailored for precise tumor targeting.
Our comprehensive platform integrates imaging and therapeutic studies to ensure effective radiation delivery and improved patient outcomes. With a robust pipeline entering clinical trials and strong support from leading healthcare investors, Alpha-9 is positioned for rapid growth and advancement in cancer therapy.
More about Alpha-9 Oncology
Alpha-9 Oncology is committed to fostering a diverse and inclusive workplace and is proud to be an Equal Opportunity Employer. We provide employment opportunities to all qualified applicants without regard to race, ethnicity, religion, age, sex, gender identity or expression, sexual orientation, disability, marital status, family status, national origin, or any other characteristic protected by applicable federal, provincial, or local laws where we operate.
We are dedicated to providing reasonable accommodations to qualified applicants and employees to ensure that everyone can perform their essential job functions in an inclusive environment. For inquiries regarding accommodations in the hiring process or for current employees, please contact a member from our Talent Acquisition team.
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Listed by Alpha-9 Oncology for a position based in the United States. Employers on this board attest they are hiring domestically.
Associate Director, Analytical Development & Quality Control
Alpha-9 Oncology · Boston, Massachusetts, United States
Pay
Not listed
Setting
On-site
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Senior Manager, Analytical Development & Quality Control
Boston, Massachusetts, United States
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Your Impact
Alpha-9 Oncology is seeking a highly motivated Senior Manager, Analytical Development & Quality Control, to provide technical and operational leadership for quality control and analytical lifecycle activities across clinical-stage radiopharmaceutical programs. This role will serve as a primary analytical and QC representative supporting development programs through data trending, statistical analysis, batch release support, investigation management, CDMO oversight, analytical readiness activities, and clinical supply support.
The successful candidate will lead interactions with multiple external manufacturing and testing partners to ensure effective analytical control strategies, successful technology transfers, timely issue resolution, and reliable clinical supply support. The role will partner closely with Quality, Regulatory, Technical Operations, and Program Leadership teams to proactively identify analytical risks and support program progression. This role is based in our Boston office.
This role is based in our Boston office.
How You'll Contribute
Lead QC data review, trending, and lifecycle monitoring to support product quality and program progression.
Manage technical relationships with external CDMOs, contract laboratories, and suppliers to ensure timely execution of testing, investigations, and program deliverables.
Partner with Quality Assurance and CDMO partners to drive the resolution of deviations, non-conformances, OOS/OOT investigations, CAPAs, and other quality events.
Review and provide technical oversight for analytical development, method qualification/validation, reference standard programs, stability studies, and technology transfer activities conducted by external partners.
Collect, organize, trend, and interpret analytical, manufacturing, and stability data to identify variability, emerging risks, and opportunities for process improvement.
Utilize JMP, Excel, and other statistical tools to evaluate assay performance, process performance, and product quality trends.
Support analytical method lifecycle management, including method transfer, qualification, validation, and continuous improvement activities.
Manage the review and approval of analytical and process qualification, validation, and stability protocols and reports, collaborating with CDMOs and internal stakeholders to ensure phase-appropriate development, control strategies, and regulatory readiness.
Provide technical oversight and support for critical raw material, precursor, API, and drug product development activities conducted by external partners.
Author, review, and approve technical reports, specifications, protocols, trend reports, and other CMC documentation.
Collaborate with cross-functional teams and external partners to support clinical supply readiness, analytical control strategies, reference standard programs, and technology transfer activities.
The Skills You Bring
Ph.D. in Analytical Chemistry, Chemistry, Radiochemistry, Pharmaceutical Sciences, or a related scientific discipline with 6+ years of relevant industry experience, or M.S. with 8+ years of relevant industry experience.
Strong background in analytical development, quality control, and GMP pharmaceutical development.
Experience supporting external CDMOs, contract testing laboratories, and technology transfer activities.
Demonstrated ability to interpret analytical, manufacturing, and quality data to inform technical decision-making.
Solid understanding of analytical method qualification, validation, transfer, and lifecycle management.
Experience with statistical analysis and data trending tools (e.g., JMP, Excel).
Working knowledge of cGMP, ICH, and pharmaceutical regulatory requirements.
Strong communication, organizational, and stakeholder management skills.
Ability to manage multiple priorities in a fast-paced development environment.
Ability to travel up to 25% (domestic and international).
What's in it for you
At Alpha-9 Oncology, we offer a competitive and comprehensive benefits package designed to support all employees. Our benefits include a competitive salary, bonus, equity, 20 vacation days, 5 sick days, a technology allowance, and commuter reimbursement. We also provide generous retirement savings plans with employer matching, extended health benefits, and paid holidays, tailored to local standards in each region. While specific offerings may vary by location, our commitment to fostering a supportive and rewarding work environment is consistent across the company.
Compensation
Alpha-9 Oncology is committed to pay transparency and equitable compensation. The salary range for this position represents the Company’s good-faith estimate of base compensation at the time of posting, established using external market data and internal benchmarking. Final compensation will be determined based on experience, qualifications, education, and internal equity.
This role is eligible for an annual bonus, equity participation, and a comprehensive benefits package.
Per Year Salary Range
$175,000 - $194,000 USD
Company Summary
Alpha-9 Oncology is a clinical-stage biotechnology company pioneering radiopharmaceutical innovation for solid tumors. Our proprietary scaffolds, composed of optimized binders, linkers, chelators, and radioisotopes, enable targeted radiation delivery to cancer cells, minimizing harm to surrounding healthy tissue. Focusing on innovative targeting moieties, we develop molecules tailored for precise tumor targeting.
Our comprehensive platform integrates imaging and therapeutic studies to ensure effective radiation delivery and improved patient outcomes. With a robust pipeline entering clinical trials and strong support from leading healthcare investors, Alpha-9 is positioned for rapid growth and advancement in cancer therapy.
More about Alpha-9 Oncology
Alpha-9 Oncology is committed to fostering a diverse and inclusive workplace and is proud to be an Equal Opportunity Employer. We provide employment opportunities to all qualified applicants without regard to race, ethnicity, religion, age, sex, gender identity or expression, sexual orientation, disability, marital status, family status, national origin, or any other characteristic protected by applicable federal, provincial, or local laws where we operate.
We are dedicated to providing reasonable accommodations to qualified applicants and employees to ensure that everyone can perform their essential job functions in an inclusive environment. For inquiries regarding accommodations in the hiring process or for current employees, please contact a member from our Talent Acquisition team.
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Listed by Alpha-9 Oncology for a position based in the United States. Employers on this board attest they are hiring domestically.
Senior Director, Clinical Dosimetry & Radiation Sciences
Alpha-9 Oncology · Boston, Massachusetts, USA
Pay
Not listed
Setting
On-site
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Senior Director, Clinical Dosimetry & Radiation Sciences
Boston, Massachusetts, USA
Submit Application
Your Impact
Alpha-9 Oncology is seeking a Medical Physicist to lead clinical dosimetry and quantitative imaging across our radiopharmaceutical clinical programs. Reporting into Clinical Development, this role serves as the internal scientific lead for dosimetry methodology and imaging quantification, ensuring rigor, consistency, and interpretability across multiple active studies.
You will define and own how clinical dosimetry is performed at Alpha-9 and ensure it is fully integrated into trial design, dose escalation strategy, and regulatory decision-making. This role operates at the intersection of clinical development, clinical pharmacology, regulatory affairs, and external imaging partners, with direct influence on how quantitative radiopharmaceutical data is translated into clinical decisions.
How You’ll Contribute
Lead clinical dosimetry strategy across Alpha-9’s radiopharmaceutical programs, defining standards for absorbed dose calculation, time-activity modeling, and interpretation across early-phase clinical studies.
Establish and govern quantitative imaging standards for SPECT/CT and PET/CT, including acquisition protocols, reconstruction parameters, QC frameworks, and site qualification criteria.
Serve as the internal authority on dosimetry, translating patient- and program-level dose data into actionable insights that inform dose escalation, safety evaluation, and clinical decision-making.
Integrate dosimetry into clinical trial design and regulatory submissions, including protocols, amendments, investigator brochures, clinical study reports, and IND/CTA documentation.
Partner closely with Clinical Development, Clinical Pharmacology, Biostatistics, and Clinical Operations to ensure dosimetry is embedded in dose selection strategy and study execution.
Manage external imaging and dosimetry vendors and core laboratories, ensuring methodological consistency, data quality, and timely delivery across active programs.
Support regulatory interactions and scientific communications, including responses to agencies, investigator meetings, abstracts, manuscripts, and conference presentations.
The Skills You Bring
PhD or MS in Medical Physics, Radiation Physics, Nuclear Medicine Physics, or related discipline (Ph.D. preferred).
6–10+ years of experience in radiopharmaceutical development, molecular imaging, or medical physics within oncology drug development.
Direct experience in radiopharmaceutical or radioligand therapy clinical programs required.
Proven experience with quantitative SPECT/CT and PET/CT imaging workflows in clinical trial settings.
Strong understanding of internal dosimetry principles (e.g., MIRD methodology) and organ/tumor absorbed dose modeling.
Experience contributing to or supporting IND/CTA submissions and regulatory interactions involving imaging or dosimetry.
Demonstrated ability to translate quantitative radiopharmaceutical data into clinical development decisions.
Experience operating in cross-functional drug development teams, ideally across multiple concurrent clinical programs.
Experience influencing or contributing to dosimetry methodology, standards, or decision frameworks in clinical development preferred.
Board certification (ABR or equivalent) preferred.
Company Summary
Alpha-9 Oncology is a clinical-stage biotechnology company pioneering radiopharmaceutical innovation for solid tumors. Our proprietary scaffolds, composed of optimized binders, linkers, chelators, and radioisotopes, enable targeted radiation delivery to cancer cells, minimizing harm to surrounding healthy tissue. Focusing on innovative targeting moieties, we develop molecules tailored for precise tumor targeting.
Our comprehensive platform integrates imaging and therapeutic studies to ensure effective radiation delivery and improved patient outcomes. With a robust pipeline entering clinical trials and strong support from leading healthcare investors, Alpha-9 is positioned for rapid growth and advancement in cancer therapy.
More about Alpha-9 Oncology
Alpha-9 Oncology is committed to fostering a diverse and inclusive workplace and is proud to be an Equal Opportunity Employer. We provide employment opportunities to all qualified applicants without regard to race, ethnicity, religion, age, sex, gender identity or expression, sexual orientation, disability, marital status, family status, national origin, or any other characteristic protected by applicable federal, provincial, or local laws where we operate.
We are dedicated to providing reasonable accommodations to qualified applicants and employees to ensure that everyone can perform their essential job functions in an inclusive environment. For inquiries regarding accommodations in the hiring process or for current employees, please contact a member from our Talent Acquisition team.
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Listed by Alpha-9 Oncology for a position based in the United States. Employers on this board attest they are hiring domestically.
Join the Alpha-9 Talent Network
Alpha-9 Oncology · All Locations
Pay
Not listed
Setting
On-site
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Join the Alpha-9 Talent Network
All Locations
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Join the Alpha-9 Talent Network
At Alpha-9 Oncology, our mission is to advance next-generation radiopharmaceuticals that meaningfully improve outcomes for patients with cancer. We’re building a team of thoughtful, driven individuals who are motivated by impact and grounded in scientific excellence, collaboration, and urgency.
If you don’t see a current role that aligns with your background, we’d still love to connect. By joining our Talent Network, you’ll be considered for future opportunities as we continue to grow across Vancouver, Boston, and San Francisco.
We regularly review submissions and will reach out if there’s a strong match.
Company Summary
Alpha-9 Oncology is a clinical-stage biotechnology company pioneering radiopharmaceutical innovation for solid tumors. Our proprietary scaffolds, composed of optimized binders, linkers, chelators, and radioisotopes, enable targeted radiation delivery to cancer cells, minimizing harm to surrounding healthy tissue. Focusing on innovative targeting moieties, we develop molecules tailored for precise tumor targeting.
Our comprehensive platform integrates imaging and therapeutic studies to ensure effective radiation delivery and improved patient outcomes. With a robust pipeline entering clinical trials and strong support from leading healthcare investors, Alpha-9 is positioned for rapid growth and advancement in cancer therapy.
More about Alpha-9 Oncology
Alpha-9 Oncology is committed to fostering a diverse and inclusive workplace and is proud to be an Equal Opportunity Employer. We provide employment opportunities to all qualified applicants without regard to race, ethnicity, religion, age, sex, gender identity or expression, sexual orientation, disability, marital status, family status, national origin, or any other characteristic protected by applicable federal, provincial, or local laws where we operate.
We are dedicated to providing reasonable accommodations to qualified applicants and employees to ensure that everyone can perform their essential job functions in an inclusive environment. For inquiries regarding accommodations in the hiring process or for current employees, please contact a member from our Talent Acquisition team.
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