We are seeking driven, creative, and entrepreneurial individuals to help shape our company. At Alpha-9, you’ll find a culture of collaboration, transparency, and innovation. We are passionate about developing new medicines to help people living with cancer, and we are looking to add to our growing team.

Our Core Values

We are:
Innovative
Driven
Agile
Tenacious

We are:
Supportive
Respectful
Inclusive
Knowledgeable

We are:
Open
Transparent
Thought Partners
Accountable

Open Positions

Vice President, Clinical Development

About Us

Alpha-9 Oncology is a clinical-stage biotechnology company developing radiopharmaceuticals for solid and hematologic malignancies. Alpha-9 has a portfolio of molecules entering clinical trials and a robust pipeline of additional targets for future development. With a strong cash position, raised from leading healthcare investors, Alpha-9 is poised to dramatically expand its team and accelerate its pipeline.

Radiopharmaceuticals, which enable internal delivery of radiation directly to tumor sites, are emerging as an exciting new class of cancer drugs. The field has evolved dramatically in the last few years, attributable to scientific advances and recent product launches. Radiopharmaceuticals are unique in that the same molecule can be used for imaging or therapeutic purposes, allowing doctors to visualize the molecule in patients prior to administration of therapy. The drug development cycle is also much shorter and capital efficient than traditional modalities.

Position Summary

he Vice President of Clinical Development will provide strategic direction and technical leadership in the development and execution of clinical development plans for all drug candidates and will be instrumental in building the company’s clinical development organization. The ideal candidate will have a track record of designing and executing robust clinical studies, leadership in providing expert input in scientific discussions and proactive engagement in interactions with thought leaders, health authorities, regulatory bodies and experience working with CROs. In this role, the ideal candidate’s guidance and learning throughout the planning and implementation phases will ensure clinical development timelines are met across the organization. The Vice President of Clinical Development will report to the Chief Medical Officer (CMO).

Some specific duties and tasks include, but are not limited to, the following:

  • Oversee the company’s Clinical Development activities required to design and successfully and implement of clinical programs for regulatory approval.
  • Build and support a team of professionals responsible for the development of clinical research protocols, clinical study reports, and scientific publications. Review, interpret, and communicate strategy, progress, and emerging data of ongoing research projects within and outside the organization.
  • Ensure clinical trials are conducted according to good clinical practice and all applicable regulatory requirements, standard operating procedures, and other quality standards.
  • Provide medical and drug development expertise in the design and implementation of clinical development strategies and global clinical development plans.
  • Responsible for collaborating and driving implementation of the clinical program through cross-functional teams; completing studies on time and within budget.
  • Provide clinical/scientific input during the development and execution of clinical trials.
  • Write and/or review clinical sections of clinical/statistical reports, including data presentations and other regulatory submissions.
  • Interpret clinical trial data, including participating in safety assessments.
  • Make scientific presentations at advisory boards.
  • Support in-licensing and out-licensing activities and partner relationships.
  • Support product lifecycle management for new indications as requested.
  • Provide clinical input to regulatory, safety, and medical affairs.
  • Provide medical review, analysis and medical guidance during the case handling and reporting process for Adverse Event and Adverse Reaction reports received for the Company’s investigational products.
  • Be accountable for all relevant timelines and deliverables for the clinical development department.
  • Provide medical safety expertise and training, as required.
  • Monitor and keep current on industry best practices, pharmacovigilance and changes in global safety regulations and guidelines.
  • Plan, oversee and direct risk management activities for investigational compounds.
  • Respond and resolve safety questions from regulatory authorities, as well as regulatory agency audits and inspections, and corrective action plans.
  • Responsible for keeping the management team informed of safety issues and may work with clinical programs as a medical safety advisor.
  • Recommends changes and upgrades to existing departmental policies, SOPs, and systems to ensure global regulatory compliance.

Qualifications:

  • 10+ years of proven experience in clinical development, including a minimum of 7 years in a supervisory role managing (internal/external) clinical development staff, preferably at a Head of or VP level.
  • Industry experience within pharmaceutical and/or biologics and prior experience in FDA negotiations relating to regulatory submissions, experience in radiopharmaceuticals is strongly preferred.
  • Comprehensive understanding of applicable clinical research regulations with a thorough knowledge of GCP, ICH guidelines and other US and international clinical regulatory requirements.
  • Extensive experience and superior proficiency in clinical development and clinical trial design.
  • Fluent in Good Clinical Practices (GCP), FDA and EMEA/CHMP regulations and guidelines
  • Superior proficiency in planning and project organization skills, including risk assessment and contingency planning.
  • Excellent verbal and written communication and presentation skills
  • Demonstrated scientific acumen, demonstrated analytical abilities, sound clinical judgment, scientific credibility, and strong integrity consistent with the company’s values.
  • Strong leadership experience managing direct reports, talent acquisition, team development and influencing in a matrix environment.
  • Decisiveness and the ability to perform as a respected team member and leader.
  • Ability to work independently to achieve objectives and lead more than one project simultaneously.
  • Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral form
  • Comfortable working is a small start-up resource constrained environment.
  • MD required in a relevant scientific discipline with minimum 8 years oncology clinical development experience in bio/pharma industry, accredited residency in oncology and certification a plus.
  • PhD., or significant research experience in immuno-oncology, immunology, molecular biology preferred.
  • Ability to travel as required (up to 25%).

What’s in it for you:

  • Competitive Salary, Bonus, and Equity
  • Medical, dental and vision insurance
  • Commuter Reimbursement
  • Retirement Plan with 3% employer match
  • 20 vacation days
  • 16 Holidays
  • 5 Sick Days
  • Short Term Disability
  • Long Term Disability
  • Life Insurance
  • Technology Allowance
  • Impactful rewarding work

Location: San Francisco, CA (Hybrid)

Associate Scientist II, III, Translational Biology

About Us:

Alpha-9 Oncology is a clinical-stage biotechnology company developing radiopharmaceuticals for solid and hematologic malignancies. Alpha-9 has a portfolio of molecules entering clinical trials and a robust pipeline of additional targets for future development. With a strong cash position, raised from leading healthcare investors, Alpha-9 is poised to dramatically expand its team and accelerate its pipeline.

Radiopharmaceuticals, which enable internal delivery of radiation directly to tumor sites, are emerging as an exciting new class of cancer drugs. The field has evolved dramatically in the last few years, attributable to scientific advances and recent product launches. Radiopharmaceuticals are unique in that the same molecule can be used for imaging or therapeutic purposes, allowing doctors to visualize the molecule in patients prior to administration of therapy. The drug development cycle is also much shorter and capital efficient than traditional modalities.

Position Summary

Alpha-9 Oncology is seeking an Associate Scientist, Translational Biology to join our growing team. The ideal candidate will be team oriented and have experience in providing hands-on technical support for our in vivo research programs, preferably with tumor animal models and radioactive substances. This person will be involved in, designing, conducting and analyzing in vivo research experiments with our experimental radiopharmaceuticals. The ideal candidate will have multi-tasking ability and has the willingness and flexibility to assume additional responsibilities as they come up.

Some specific duties and tasks include, but are not limited to, the following:

  • Provide consistent, high quality, compassionate care for laboratory animals
  • Perform animal monitoring and health, behavior, and welfare surveillance, along with continuous awareness of current species-specific welfare issues in accordance with Canadian Council of Animal Care guidelines. This includes animal handling, inventories and record keeping, and communications if any abnormalities are observed.
  • Perform animal handling, restraints, injections, surgery, post-operative care, blood sampling and tissue collection.
  • Contribute to experimental data generation, recording and analysis.
  • Participate in lab maintenance, order, and receipt of needed supplies.
  • Maintain clear and accurate lab records (e.g., monitoring sheets, health reports, data spreadsheets, electronic notebook)
  • Execute other tasks and provide research support as directed by the Supervisor.
  • Attend and participate in weekly meetings.

Qualifications:

  • Master’s degree or Bachelor’s degree with 2-4 years of experience in relevant discipline including experience with laboratory animals
  • 2-4 years of related industrial experience, or an equivalent combination of education and experience
  • Experience with rodent handling and in vivo experiments, with tumor models being preferred
  • Experience with lab maintenance and lab records
  • Ability to work safely in a laboratory environment.
  • Knowledge in laboratory animal standards and CCAC guidelines
  • Experience with radiopharmaceuticals preferred, but not required.
  • Observational, organizational, data management and documentation skills
  • A team-player with excellent interpersonal skills who is willing to make a real impact and accelerate the development of innovative target therapies in a fast-paced environment.

What’s in it for you:

  • Full extended health and dental benefits
  • Competitive Salary, Bonus, and Equity
  • Commuter Reimbursement
  • Group Registered Retirement Savings Plan with 5% employer match
  • 20 vacation days
  • 17 Holidays
  • 5 Sick Days
  • Long Term Disability
  • Life Insurance
  • Technology allowance
  • Impactful rewarding work

Location: Vancouver, BC

Scientist, Senior Scientist Biology

About Us:

Alpha-9 Oncology is a clinical-stage biotechnology company developing radiopharmaceuticals for solid and hematologic malignancies. Alpha-9 has a portfolio of molecules entering clinical trials and a robust pipeline of additional targets for future development. With a strong cash position, raised from leading healthcare investors, Alpha-9 is poised to dramatically expand its team and accelerate its pipeline.

Radiopharmaceuticals, which enable internal delivery of radiation directly to tumor sites, are emerging as an exciting new class of cancer drugs. The field has evolved dramatically in the last few years, attributable to scientific advances and recent product launches. Radiopharmaceuticals are unique in that the same molecule can be used for imaging or therapeutic purposes, allowing doctors to visualize the molecule in patients prior to administration of therapy. The drug development cycle is also much shorter and capital efficient than traditional modalities.

Position Summary

Alpha-9 is seeking a Scientist or Senior Scientist to join our Biology group within our growing organization. The ideal candidate will be team oriented and have excellent knowledge and skills in Cancer/Molecular/Cell Biology, Biochemistry, and or Pharmacology, with a proven experience in in vitro assay development for drug design. Industry experience is required and experience with radiopharmaceutical development is a plus.

Some specific duties and tasks include, but are not limited to, the following:

  • Lead, manage and execute experiments to validate pipeline targets.
  • Contribute to the in vitro expertise across pipeline targets
  • Design, validate and execute preclinical experiments to demonstrate in vitro activities as well as define mechanism of action of drug candidates.
  • Contribute to strategic plans and assays development.
  • Expertise in cell culture and in vitro assays to validate targets, screen drug candidates and determine MoA
  • Experience with target expression validation (e.g. flow cytometry, ELISA, western blot), andmolecular biology techniques (e.g., qPCR, cloning)
  • Interpret and analyze data, prepare, and review study reports, communicate project progress to internal team members and external collaborators.
  • Supervise and mentor junior staffs including Associate Scientists
  • Assist with lab management tasks such as lab safety advisory, lab inspections and inventories.
  • Perform other related duties within the Biology group as needed.

Qualifications:

  • A PhD in Cancer, Cell or Molecular Biology, Biochemistry, and/or Pharmacology with 2-5+ years of relevant post-doctoral training or industrial experience and a proven track record of scientific excellence and creativity
  • Expertise in the development, optimization and execution of assays to establish MoA, binding affinity, selectivity and potency.
  • Experience in radiopharmaceutical discovery preferred, but not required.
  • Excellent observational, organizational, data management, and documentation skills
  • A team player with excellent interpersonal skills and a strong passion for the discovery of targeted therapies in a fast-paced start-up environment

What’s in it for you:

  • Full extended health and dental benefits
  • Competitive Salary, Bonus, and Equity
  • Commuter Reimbursement
  • Group Registered Retirement Savings Plan with 5% employer
  • 20 vacation days
  • 17 Holidays
  • 5 Sick Days
  • Long Term Disability
  • Life Insurance
  • Technology allowance
  • Impactful rewarding work

Location: Vancouver, BC

Manager, CMC Operations

About Us

Alpha-9 Oncology is a clinical-stage biotechnology company developing radiopharmaceuticals for solid and hematologic malignancies. Alpha-9 has a portfolio of molecules entering clinical trials and a robust pipeline of additional targets for future development. With a strong cash position, raised from leading healthcare investors, Alpha-9 is poised to dramatically expand its team and accelerate its pipeline.

Radiopharmaceuticals, which enable internal delivery of radiation directly to tumor sites, are emerging as an exciting new class of cancer drugs. The field has evolved dramatically in the last few years, attributable to scientific advances and recent product launches. Radiopharmaceuticals are unique in that the same molecule can be used for imaging or therapeutic purposes, allowing doctors to visualize the molecule in patients prior to administration of therapy. The drug development cycle is also much shorter and capital efficient than traditional modalities.

Position Summary

Alpha-9 is seeking a Manager of CMC Operations to support CMC activities for our growing clinical-stage pipeline of radiopharmaceutical products. This person will be responsible for technical project management of activities associated with clinical stage manufacturing and will serve as a point of contact for our external contract development and manufacturing organization (CDMO) partners. We are seeking a candidate with a degree in a scientific discipline and a track record of operational as well as scientific/technical contributions in previous roles.

As a start-up organization, we value team members eager to make an impact and grow with us professionally. We are seeking an individual who enjoys multi-tasking and has the willingness and flexibility to assume additional responsibilities as assigned.

Some specific duties and tasks include, but are not limited to, the following:

  • Manage external CDMO partner and supplier relationships from initial project proposal through delivery of materials.
  • Drive execution of the CMC strategy for nonclinical and clinical programs by researching and designing experiments for radiopharmaceutical formulation development in preparation for CDMO technology transfer and validation activities.
  • Collaborate with cross-functional internal teams (Business Development, R&D, Pre-clinical, Clinical and Regulatory) to achieve CMC program goals and timelines.
  • Partner with internal R&D and CMC laboratory personnel for development of robust radiolabeling processes and clinical formulations that meet target product profiles for diagnostic and therapeutic applications.
  • Critically evaluate data, draw appropriate conclusions and develop follow-up plan of action. Ability to troubleshoot, identify unusual results and design experiments that establish root cause and/or enhance knowledge of the product being developed.
  • Develop and take ownership of short-term and long-range CMC project plans and budgets.
  • Drive review and approval of technical documents and reports by leveraging strong partnerships with internal and consultant subject matter experts (SMEs).
  • Ensure delivery of nonclinical and clinical supplies according to required timelines; maintain material inventories.
  • Proactively identify resource constraints, develop mitigation strategies, and establish contingency plans to avoid program delays.

Qualifications:

  • BS degree in a scientific discipline. Advanced degree in chemistry, biochemistry, radiochemistry, or related field is preferred.
  • Minimum of 5 years of relevant experience in pharmaceutical or biotechnology industry. Peptide manufacturing or radiopharmaceutical experience is ideal.
  • Strong communication skills, ability to build strong relationships at all levels of the organization.
  • Track record of successfully driving and managing CMC development and/or clinical supply programs.
  • Strong problem-solving and organizational skills.
  • Ability to independently identify external resources to bridge gaps and enhance our internal capabilities.

What’s in it for you

  • Competitive Salary, Bonus, and Equity
  • Medical, dental and vision insurance
  • Commuter Reimbursement
  • Retirement Plan with 3% employer match
  • 20 vacation days
  • 16 Holidays
  • 5 Sick Days
  • Short Term Disability
  • Long Term Disability
  • Life Insurance
  • Technology Allowance
  • Impactful rewarding work

Location: Boston, MA (Hybrid)

Senior Director, Quality Assurance

About Us

Alpha-9 Oncology is a clinical-stage biotechnology company developing radiopharmaceuticals for solid and hematologic malignancies. Alpha-9 has a portfolio of molecules entering clinical trials and a robust pipeline of additional targets for future development. With a strong cash position, raised from leading healthcare investors, Alpha-9 is poised to dramatically expand its team and accelerate its pipeline.

Radiopharmaceuticals, which enable internal delivery of radiation directly to tumor sites, are emerging as an exciting new class of cancer drugs. The field has evolved dramatically in the last few years, attributable to scientific advances and recent product launches. Radiopharmaceuticals are unique in that the same molecule can be used for imaging or therapeutic purposes, allowing doctors to visualize the molecule in patients prior to administration of therapy. The drug development cycle is also much shorter and capital efficient than traditional modalities.

Position Summary

Alpha-9 is seeking a Sr. Director, Quality Assurance, to join our growing organization.  The Sr. Director, Quality Assurance will establish our Quality Assurance team in support of early phase clinical activities.  This hands-on role will be responsible for implementing a GxP (GCP/GLP/GMP) compliant Quality Management System, performing all required functions of the Quality Unit, and building a Quality Assurance organization.

This is a pivotal role in an early-stage company, and we are seeking a candidate with the desire to build and lead a high-performing team of colleagues as the company grows and advances its pipeline.

Some specific duties and tasks include, but are not limited to, the following:

  • Conceptualize, implement and manage quality assurance and compliance systems fit for an early clinical stage biotechnology company – including a combination of authoring, reviewing, and approval of policies and SOPs in collaboration with key stakeholders.
  • Oversee continuous improvement of quality processes and procedures.
  • Recruit, lead, and mentor direct reports, to ensure execution against short- and long-term objectives.
  • Establish and manage Quality and Compliance Training program for GxP employees and contractors.
  • Qualify and manage relationships with contract research and manufacturing organizations. This includes the assurance of compliance and quality of operations performed by these organizations, as well as regulatory inspection support.
  • GMP vendor Quality oversight, including product batch records, manufacturing investigations, vendor product release, stability programs, analytical method qualifications, etc.
  • Creation and implementation of a GxP inspection readiness strategy and plan in collaboration with functional leaders.
  • Ensure effective coordination of investigations, root cause analysis, risk assessments and implementation of change control, and corrective and preventive actions to the adhered timelines as appropriate.
  • Responsible for building and maintaining a high-trust relationship between Quality and the rest of the organization, while ensuring Quality is viewed as an integral thought partner and creative problem solver across all levels and functional areas in the organization.

Qualifications:

  • BS with a minimum of 10-12 years related experience; or MS with including a minimum of 8 years within QA. Previous experience managing people, or a function required, experience leading other leaders is strongly preferred.
  • Extensive knowledge of regulatory requirements, quality systems, inspections, audits, and all applicable FDA and EMA regulations and or guidance documents.
  • Experienced in the implementation of phase-appropriate Quality Management Systems.
  • Prior experience with patient specific batch manufacturing is preferred; radiopharmaceutical experience is a plus.
  • Strong leadership experience managing direct reports, talent acquisition, team development and influencing in a matrix environment.
  • Experience partnering with CROs and CDMOs.
  • Willingness to travel to facility locations as needed.
  • Excellent interpersonal skills, clear and concise both verbal and written communications. Demonstrated ability in building relationships with both internal and external partners.

What’s in it for you:

  • Competitive Salary, Bonus, and Equity
  • Medical, dental and vision insurance
  • Commuter Reimbursement
  • Retirement Plan with 3% employer match
  • 20 vacation days
  • 16 Holidays
  • 5 Sick Days
  • Short Term Disability
  • Long Term Disability
  • Life Insurance
  • Technology Allowance
  • Impactful rewarding work

Location: Boston, MA (Hybrid)

Director, Analytical Development QC

About Us

Alpha-9 Oncology is a clinical-stage biotechnology company developing radiopharmaceuticals for solid and hematologic malignancies. Alpha-9 has a portfolio of molecules entering clinical trials and a robust pipeline of additional targets for future development. With a strong cash position, raised from leading healthcare investors, Alpha-9 is poised to dramatically expand its team and accelerate its pipeline.

Radiopharmaceuticals, which enable internal delivery of radiation directly to tumor sites, are emerging as an exciting new class of cancer drugs. The field has evolved dramatically in the last few years, attributable to scientific advances and recent product launches. Radiopharmaceuticals are unique in that the same molecule can be used for imaging or therapeutic purposes, allowing doctors to visualize the molecule in patients prior to administration of therapy. The drug development cycle is also much shorter and capital efficient than traditional modalities.

Position Summary

Alpha-9 is seeking a Director, Analytical Development & QC to join our growing organization. Our team is looking for an experienced candidate to manage and execute the development, validation and implementation of quality control procedures to support our clinical-stage programs.

We are an early-stage company, so this is a highly visible and impactful role in our growing organization. The ideal candidate will be a self-starter with the desire to collaborate cross-functionally. This position requires a high degree of collaboration, multi-tasking ability, and desire to strive in a fast-paced environment.

Some specific duties and tasks include, but are not limited to, the following:

  • Lead the CMC team’s activities as related to the testing of diagnostic and therapeutic radiopharmaceutical drug products and critical raw materials including medical isotopes and precursor materials (peptides, small molecules)
  • Support the management of relationships with external CDMO partners from initial project proposal through test method validation and clinical supply. Drive on time completion of deliverables
  • Partner with pharmaceutical development program leads to derive and communicate specifications and required phase appropriate QC testing
  • Recruit, lead, and mentor direct reports to ensure execution against short- and long-term objectives. Mentor laboratory-based scientists to ensure execution of development programs leading to efficient tech transfer, robust test methods, and successful regulatory submissions
  • Provide technical leadership on analytical method development and validation to drive program development. Review experimental data from internal teams and external CDMO partners. Summarize and interpret results, relaying findings through summary reports, technical documents, or presentations
  • Drive the authorship, review, and approval of technical documents (SOPs, specifications, protocols) and reports
  • Work with QA to ensure compliance and to support the management of quality events (non-conformances, investigations, deviations, CAPAs), as needed
  • Author CMC documents for IND and CTA regulatory submissions
  • Collaborate with cross-functional internal teams (Project Management, R&D/Discovery, Pre-clinical, Quality Assurance, Clinical, and Regulatory) to achieve program goals and timelines
  • Proactively identify resource constraints, develop mitigation strategies, and establish contingency plans to avoid program delays

Qualifications:

  • PhD/MSc in analytical chemistry, chemistry, radiochemistry, or a related field
  • Minimum of 8 years of experience in the quality control of drug substance or drug products, including 3 years in a supervisory role
  • Demonstrated experience with QC testing in a GMP environment
  • Experience with authoring CMC sections of regulatory submissions, as related to analytical method validation and QC testing
  • Knowledge or experience with QC testing of radiopharmaceuticals is preferred.
  • Prior experience with working, collaborating, and managing CDMOs is preferred.
  • Strong oral and written communication skills, and interpersonal skills
  • Ability to up travel up to 25% (domestic and international)

What’s in it for you:

  • Competitive Salary, Bonus, and Equity
  • Health, dental and vision benefits
  • Retirement Savings Plan with 3% employer match
  • 20 vacation days
  • 16 Holidays
  • 5 Sick Days
  • Commuter Reimbursement
  • Short Term Disability
  • Long Term Disability
  • Life Insurance
  • Technology allowance
  • Impactful rewarding work

Location: Boston, MA (Hybrid)

Director, Diagnostic Radiopharmaceutical Development

About Us

Alpha-9 Oncology is a clinical-stage biotechnology company developing radiopharmaceuticals for solid and hematologic malignancies. Alpha-9 has a portfolio of molecules entering clinical trials and a robust pipeline of additional targets for future development. With a strong cash position, raised from leading healthcare investors, Alpha-9 is poised to dramatically expand its team and accelerate its pipeline.

Radiopharmaceuticals, which enable internal delivery of radiation directly to tumor sites, are emerging as an exciting new class of cancer drugs. The field has evolved dramatically in the last few years, attributable to scientific advances and recent product launches. Radiopharmaceuticals are unique in that the same molecule can be used for imaging or therapeutic purposes, allowing doctors to visualize the molecule in patients prior to administration of therapy. The drug development cycle is also much shorter and capital efficient than traditional modalities.

Position Summary

Alpha-9 is seeking a Director, Diagnostic Radiopharmaceutical Development to join our growing organization. Our team is looking for an experienced candidate to lead the development and manufacturing of PET and SPECT imaging products to support our clinical-stage programs.

We are an early-stage company, so this is a highly visible and impactful role in our growing organization. The ideal candidate will be a self-starter with the desire to collaborate cross-functionally. This position requires a high degree of collaboration, multi-tasking ability, and desire to strive in a fast-paced environment.

Some specific duties and tasks include, but are not limited to, the following:

  • Lead the development and manufacture of Alpha-9’s pipeline of PET and SPECT companion imaging products, enabling clinical advancement of the company’s portfolio of radioligand therapies
  • Manage relationships with external CDMO partners from initial project proposal through process validation and clinical supply. Track project metrics and costs. Drive on time completion of deliverables
  • Recruit, lead, and mentor direct reports to ensure execution against short- and long-term objectives. Mentor laboratory-based scientists to ensure execution of development programs leading to efficient tech transfer, robust products and methods, and successful regulatory submissions
  • Provide technical leadership on radiolabeling, purification, formulation, and automation to drive program development. Review experimental data from internal teams and external CDMO partners. Summarize and interpret results, relaying findings through summary reports, technical documents, or presentations
  • Lead development of Ga-68 cold-kits to support later stage clinical programs
  • Drive the authorship, review, and approval of technical documents (SOPs, MBRs, protocols) and reports
  • Work with QA to ensure compliance in validation activities and to support the management of quality events (investigations, deviations, CAPAs), as needed
  • Author CMC documents for IND and CTA regulatory submissions
  • Collaborate with cross-functional internal teams (Project Management, R&D/Discovery, Pre-clinical, Quality Assurance, Clinical, and Regulatory) to achieve imaging program goals and timelines
  • Proactively identify resource constraints, develop mitigation strategies, and establish contingency plans to avoid program delays

Qualifications:

  • PhD/MSc in chemistry, radiochemistry, or a related field
  • Minimum of 8 years of experience in the development of PET and/or SPECT radiopharmaceuticals, including 3 years in a supervisory role
  • Demonstrated experience with GMP validation and manufacturing of radiopharmaceuticals
  • Experience with authoring CMC sections of regulatory submissions
  • Knowledge or experience with Ga-68 cold-kit development is considered an asset
  • Experience with the automation of radiopharmaceutical manufacturing preferred
  • Prior experience with working, collaborating, and managing CDMOs is preferred
  • Strong oral and written communication skills, and interpersonal skills
  • Ability to up travel up to 25% (domestic and international)

What’s in it for you:

  • Competitive Salary, Bonus, and Equity
  • Health, dental and vision benefits
  • Retirement Savings Plan with 3% employer match
  • 20 vacation days
  • 16 Holidays
  • 5 Sick Days
  • Commuter Reimbursement
  • Short Term Disability
  • Long Term Disability
  • Life Insurance
  • Technology allowance
  • Impactful rewarding work

Location: Boston, MA (Hybrid)

Manager/Sr Manager, Peptide External Manufacturing

About Us

Alpha-9 Oncology is a clinical-stage biotechnology company developing radiopharmaceuticals for solid and hematologic malignancies. Alpha-9 has a portfolio of molecules entering clinical trials and a robust pipeline of additional targets for future development. With a strong cash position, raised from leading healthcare investors, Alpha-9 is poised to dramatically expand its team and accelerate its pipeline.

Radiopharmaceuticals, which enable internal delivery of radiation directly to tumor sites, are emerging as an exciting new class of cancer drugs. The field has evolved dramatically in the last few years, attributable to scientific advances and recent product launches. Radiopharmaceuticals are unique in that the same molecule can be used for imaging or therapeutic purposes, allowing doctors to visualize the molecule in patients prior to administration of therapy. The drug development cycle is also much shorter and capital efficient than traditional modalities.

Position Summary

Alpha-9 is seeking a Manager/Senior Manager, Peptide External Manufacturing to join our growing organization. Our team is looking for an experienced candidate to lead the development, and manufacturing of peptides and small molecules to support our clinical-stage programs.

We are an early-stage company, so this is a highly visible and impactful role in our growing organization. The ideal candidate will be a self-starter with the desire to collaborate cross-functionally. This position requires a high degree of collaboration, multi-tasking ability, and desire to strive in a fast-paced environment.

Some specific duties and tasks include, but are not limited to, the following:

  • Manage external CDMO partners and supplier relationships from initial project proposal through delivery of materials. Track peptide/small molecule vendor metrics and costs.
  • Drive on time delivery of materials from CDMO vendors for preclinical development, validation, and clinical activities in line with program timelines
  • Review proposed synthetic routes from external vendors and, where necessary, collaborate with external vendors on process improvements
  • Drive and communicate specifications and required phase appropriate QC testing
  • Review experimental data from internal teams and external CDMO partners. Summarize and interpret results, relaying findings through summary reports, technical documents, or presentations. Drive the authorship, review, and approval of technical documents and reports
  • Leverage and manage external consulting subject matter experts on matters concerning peptide and small molecule precursors, including CMC regulatory experts
  • Lead and supervise the cGMP manufacture, vialing, testing, and release of materials for use in clinical trials
  • Author CMC documents for IND and CTA regulatory submissions
  • Collaborate with cross-functional internal teams (Project Management, R&D/Discovery, Pre-clinical, Quality Assurance, Clinical, and Regulatory) to achieve CMC program goals and timelines
  • Develop and take ownership of short-term and long-range CMC project plans for peptide/small molecule development and manufacturing and budgets. Communicate progress and propose changes in timeline, objectives, or direction
  • Proactively identify resource constraints, develop mitigation strategies, and establish contingency plans to avoid program delays

Qualifications:

  • PhD/MSc in Chemistry
  • Minimum of 5 years of experience in the pharmaceutical or biotechnology industry
  • Demonstrated experience in peptide or small molecule synthesis
  • Strong oral and written communication skills, and interpersonal skills
  • Ability to lead and execute complex scientific projects. Strong analytical and troubleshooting skills
  • Experience with cGMP manufacturing
  • Experience with lyophilization parameter optimization is considered an asset
  • Experience with authoring regulatory submissions and responding to regulatory questions is considered an asset
  • Experience with radiopharmaceutical precursor development is considered an asset
  • Ability to travel (domestic and international)

What’s in it for you:

  • Competitive Salary, Bonus, and Equity
  • Health, dental and vision benefits
  • Retirement Savings Plan with 3% employer match
  • 20 vacation days
  • 16 Holidays
  • 5 Sick Days
  • Commuter Reimbursement
  • Short Term Disability
  • Long Term Disability
  • Life Insurance
  • Technology allowance
  • Impactful rewarding work

Location: Boston, MA (Hybrid)

Executive Administrative Assistant

About Us

Alpha-9 Oncology is a clinical-stage biotechnology company developing radiopharmaceuticals for solid and hematologic malignancies. Alpha-9 has a portfolio of molecules entering clinical trials and a robust pipeline of additional targets for future development. With a strong cash position, raised from leading healthcare investors, Alpha-9 is poised to dramatically expand its team and accelerate its pipeline.

Radiopharmaceuticals, which enable internal delivery of radiation directly to tumor sites, are emerging as an exciting new class of cancer drugs. The field has evolved dramatically in the last few years, attributable to scientific advances and recent product launches. Radiopharmaceuticals are unique in that the same molecule can be used for imaging or therapeutic purposes, allowing doctors to visualize the molecule in patients prior to administration of therapy. The drug development cycle is also much shorter and capital efficient than traditional modalities.

Position Summary

Alpha-9 is seeking an Executive Assistant to support the Leadership Team to provide broad, cross-functional administrative support and partner with the other administrative staff to meet the administrative needs of the organization.  They will be responsible for handling day-to-day administrative activities while maintaining a solid understanding of the Company goals to ensure smooth execution of priorities. This position reports to the Chief Business Officer.

We are an early-stage company, so this is a highly visible and impactful role in our growing organization. The ideal candidate will be a self-starter with the desire to collaborate cross-functionally. This position requires a high degree of collaboration, multi-tasking ability, and desire to strive in a fast-paced environment.

Some specific duties and tasks include, but are not limited to, the following:

  • Act as the administrative support for the Leadership Team; partner with the LT on initiatives that ensure a high-functioning organization.
  • Manage calendars; schedule, reschedule, respond to invitations, prioritize and manage calendar priorities in concert with organizational priorities and timelines.
  • Plan, coordinate and schedule internal and external meetings.
  • Anticipate, identify and solve calendar and scheduling issues long-term calendar management planning
  • Assist with board management, including logistical planning for Board and Committee meetings, and respond to requests made by Board members and their administrative staff.
  • Plan, coordinate, book and manage travel arrangements.
  • Manage and submit expense reports, new vendor set up and other PO related tasks.
  • Demonstrate leadership, analytical thinking, organizational and communication skills.
  • Handle confidential material and information and exercise discretion.

Qualifications:

  • BS/BA degree coupled with 7 years of professional experience, with 5 years in administrative roles and a minimum of 3 years supporting senior-level executives and interfacing with the Board of Directors.
  • Ability to work independently, multitask, and adjust priorities as competing projects vie for attention.
  • Highly organized, detail-oriented, and able to work in a fast-paced environment.
  • Excellent analytical skills and demonstrated strategic and organizational agility.
  • Ability to influence key stakeholders and drive decisions and outcomes as needed.
  • Demonstrates impeccable interpersonal and communication skills across all levels, both within and external to the organization.
  • Ability to effectively collaborate to reach mutually agreeable outcomes and resolve potential conflicts.
  • Demonstrated track record of professionalism and discretion.
  • Ability to work strategically and collaboratively across departments.
  • Demonstrates initiative and resourcefulness as a self-starter.
  • Excellent writing, communication, and presentation skills.
  • Demonstrates proficiency with Microsoft Office (Excel, Outlook, PowerPoint, Word).

What’s in it for you:

  • Competitive Salary, Bonus, and Equity
  • Health, dental and vision benefits
  • Retirement Savings Plan with 3% employer match
  • 20 vacation days
  • 16 Holidays
  • 5 Sick Days
  • Commuter Reimbursement
  • Short Term Disability
  • Long Term Disability
  • Life Insurance
  • Technology allowance
  • Impactful rewarding work

Location: Boston, MA (Hybrid)

Director of Corporate Strategy

About Us

Alpha-9 Oncology is a clinical-stage biotechnology company developing radiopharmaceuticals for solid and hematologic malignancies. Alpha-9 has a portfolio of molecules entering clinical trials and a robust pipeline of additional targets for future development. With a strong cash position, raised from leading healthcare investors, Alpha-9 is poised to dramatically expand its team and accelerate its pipeline.

Radiopharmaceuticals, which enable internal delivery of radiation directly to tumor sites, are emerging as an exciting new class of cancer drugs. The field has evolved dramatically in the last few years, attributable to scientific advances and recent product launches. Radiopharmaceuticals are unique in that the same molecule can be used for imaging or therapeutic purposes, allowing doctors to visualize the molecule in patients prior to administration of therapy. The drug development cycle is also much shorter and capital efficient than traditional modalities.

Position Summary

Alpha-9 is seeking a Director of Corporate Strategy to act as a liaison and implementer to the CEO and CBO while partnering with the CEO and CBO on initiatives that ensure a high functioning organization. The Director of Corporate Strategy helps the Chief Executive Officer (CEO) and Chief Business Officer (CBO) work most effectively with the Leadership Team (LT) and others to deliver on our mission.  This role will scope, plan, lead and execute high priority projects; monitor progress and achievement of next steps and develop and maintain an inventory of critical projects and the corporate calendar. In addition, this role will plan, schedule and facilitate LT Meetings, track outcomes and deliverables. The role requires a highly resourceful individual with high emotional intelligence, strong analytical skills and the ability to be discrete with a commitment to confidentiality.  This position reports to the Chief Business Officer.

Some specific duties and tasks include, but are not limited to, the following:

  • Act as a liaison, sounding board, and implementer to the CEO and CBO; partner with the CEO and CBO on initiatives that ensure a high functioning organization.
  • Track high-priority initiatives for the CEO, CBO and LT and identify any obstacles; communicate initiative status, pulling in other leadership team members, as necessary.
  • Provide proactive support to the CEO and CBO through data gathering, information analyzing, and presenting considerations.
  • Maintain ongoing, regular stakeholder engagements with the leadership team to create a highly integrated organization and engage in coalition building to resolve challenges.
  • Plan, schedule and facilitate LT Meetings; prepare critical meeting agendas and send out pre-reads to attendees; capture major take-a ways, track outcomes and deliverables. and work with CBO and LT to ensure follow up and communication to a broader audience, as appropriate.
  • Ensure that LT meeting objectives are realistic, participants comprehend the level of preparation required, agenda items are prioritized, and time is appropriately allocated for discussion topics.
  • Support preparation for Board Meetings, Investor Meetings, and events.
  • Partner with program leaders, functional leaders, and administrative staff to ensure streamlined activities and the coordination and orchestration of projects or commitments directly involving the CEO and the LT.
  • Develop draft communications on behalf of the CEO and/or the LT.
  • Collaborate and partner with CEO’s Executive Assistant to remain apprised of/schedule upcoming CEO commitments.
  • Work independently and execute tasks with minimal direction, and through ambiguity.

Qualifications:

  • BS/BA degree in related discipline with 7 years or experience; MBA or advanced degree preferred coupled with 5 years professional experience in the life sciences sector strongly preferred.
  • Previous or similar experience preferred.
  • Strong ability to operate at a tactical, strategic, and operational level.
  • Excellent analytical skills and demonstrated strategic and organizational agility.
  • Proficiency in planning and project organization skills
  • Strong PowerPoint skills.

What’s in it for you:

  • Competitive Salary, Bonus, and Equity
  • Health, dental and vision benefits
  • Retirement Savings Plan with 3% employer match
  • 20 vacation days
  • 16 Holidays
  • 5 Sick Days
  • Commuter Reimbursement
  • Short Term Disability
  • Long Term Disability
  • Life Insurance
  • Technology allowance
  • Impactful rewarding work

Location: Boston, MA (Hybrid)

Clinical Trial Manager/Senior Manager, Clinical Operations

About Us

Alpha-9 Oncology is a clinical-stage biotechnology company developing radiopharmaceuticals for solid and hematologic malignancies. Alpha-9 has a portfolio of molecules entering clinical trials and a robust pipeline of additional targets for future development. With a strong cash position, raised from leading healthcare investors, Alpha-9 is poised to dramatically expand its team and accelerate its pipeline.

Radiopharmaceuticals, which enable internal delivery of radiation directly to tumor sites, are emerging as an exciting new class of cancer drugs. The field has evolved dramatically in the last few years, attributable to scientific advances and recent product launches. Radiopharmaceuticals are unique in that the same molecule can be used for imaging or therapeutic purposes, allowing doctors to visualize the molecule in patients prior to administration of therapy. The drug development cycle is also much shorter and capital efficient than traditional modalities.

Position Summary

Alpha-9 Oncology is seeking a highly motivated Clinical Trial Manager/Senior Manager, Clinical Operations with a passion for team work and a strong background in vendor management to provide operational expertise and leadership to one or more radiopharmaceutical clinical studies You will partner with the Clinical Operations Study Lead, Clinical Development, Program Management and CMC Operations to ensure timely and efficient delivery of all operational aspects of our clinical trial in accordance with the appropriate clinical trial standards including ICH/GCP and applicable regulations. This role may involve direct supervision and mentoring of team members as the Clinical Operations team grows. This role is based in our San Francisco location with flexibility for hybrid work.

Some specific duties and tasks include, but are not limited to, the following:

  • Contribute to the development of clinical trial timelines, budget and risk/mitigation strategies.
  • 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 vendor contracts and budgets, tracks vendor payments against contracted scope of work, and escalates variances to the Clinical Operations Study Lead
  • Responsible for day-to-day management and developing effective working relationships with all study vendors.
  • Provide operational input into the development of clinical protocols, informed consent, study manuals, study reports, eCRF and other key operational/regulatory documents.
  • Establish close cross-functional relationships with Data Management and Clinical Development to oversee eCRF completion and data quality issues; and CMC Operations to forecast drug product needs.
  • 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.
  • Oversee the forecasting and management of non-clinical supplies (e.g. lab kits) to ensure sites have supplies to run the clinical trial.
  • Support tracking of clinical trial metrics, including site activation, patient enrollment, site monitoring issues and risks to the Clinical Operations Lead and other relevant stakeholders.
  • 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.
  • Build collaborative relationships with key internal stakeholders to facilitate the planning and execution of clinical studies, operational strategy, risk management and mitigation strategies.
  • Provide input to the drafting of governance documents, SOPs, work instructions, and other resources.

Qualifications:

  • Bachelors in Life Sciences with an advanced degree preferred.
  • Minimum of 8 years in pharmaceutical/and or biotechnology industry with at least 5 years of experience in clinical operations
  • 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:

  • Competitive Salary, Bonus, and Equity
  • Health, dental and vision benefits
  • Retirement Savings Plan with 3% employer match
  • 20 vacation days
  • 16 Holidays
  • 5 Sick Days
  • Commuter Reimbursement
  • Short Term Disability
  • Long Term Disability
  • Life Insurance
  • Technology allowance
  • Impactful rewarding work

Location: San Francisco, CA (Hybrid)

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    Recruitment & Staffing Agencies: Alpha-9 Oncology does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Alpha-9 Oncology or its employees is strictly prohibited unless contacted directly by Alpha-9 Oncology’s internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Alpha-9 Oncology, and Alpha-9 Oncology will not owe any referral or other fees with respect thereto.