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 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

The Vice President of Clinical Operations will drive the company’s development strategies by playing a lead role in the implementation of the company’s clinical studies and programs. The position will lead the strategic application and tactical execution including management, planning, and implementation of clinical studies and programs. In this role, the ideal candidate’s guidance and learning throughout the planning and implementation phases will ensure clinical operations timelines are met across the organization. The Vice President of Clinical Operations reports to the CMO and will also help set the direction for the Clinical Operations organization including hiring and mentoring of staff.

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

  • Oversee the company’s Clinical Operations activities and implementation of clinical studies and development programs.
  • Build and support a team of professionals responsible for the development of clinical operations protocols and the review, interpretation, and communication of strategy, progress, and emerging data of ongoing research projects within and outside the organization.
  • Responsible for strategically planning clinical trials, resourcing, and providing oversight and execution to achieve program objectives and high-quality deliverables within established timelines and budgets.
  • Implement processes and build a clinical operations organization to successfully plan and conduct multiple clinical trials in early to late stage to achieve pipeline objectives.
  • Own patient recruitment strategies, ensuring operational feasibility and timely implementation of study goals.
  • Ensure operational excellence in our clinical stage programs by applying high industry standards, policies, systems, and processes across all trials; ensuring all activities are completed in accordance with ICH GCP regulations, health authority regulations and SOP’s.
  • Ensure operational feasibility of clinical development plans, including timeline, budget, and resource requirements.
  • Ensure that all activities are completed in accordance with ICH GCP regulations, health authority regulations and SOPs.
  • Set the direction of the Clinical Operations organization and lead strategic discussions regarding program and study resourcing.
  • Hire, supervise and train operations personnel and assume ownership of the quality of clinical deliverables.
  • Procure CRO and vendors and provide oversight throughout the life of all assigned activities Ensure transparency for costs, deliverables, and quality expectations.
  • Effectively identify and manage external vendors to provide high-quality deliverables within established timelines and budgets.
  • Work collaboratively and communicate effectively with all functional area representatives within senior management, in the project team environment, and with external stakeholders as needed to ensure alignment across functions to support clinical programs and corporate goals.
  • Develop and implement resource management and trial metric tracking tools.
  • Develop and maintain systems for effectively managing service provider relationships. Responsible for instituting a clinical Quality program in collaboration with other functions.
  • Be accountable for all relevant timelines and deliverables for the clinical operations department.
  • Monitor and keep current on industry best practices, clinical operations practices and changes in regulations and guidelines.
  • Define patient recruitment strategies and ensure operational feasibility and timely implementation of the set study goals.
  • Work with other Medical/Clinical team members on study documents including clinical trial protocols/amendments, ICFs, CRFs, IND, IB, CRO contracts, study reports, etc.
  • Recommends changes and upgrades to existing departmental policies, SOPs, and systems to ensure clinical operations compliance.

Qualifications:

  • 10+ years of proven experience in clinical research and/or clinical trial operations, including a minimum of 7 years in a supervisory role managing (internal/external) clinical operations staff. Previous experience as a Head of or VP required.
  • Industry experience within pharmaceutical and/or biologics and prior experience in FDA negotiations relating to the conduct of regulated clinical trials, experience in radiopharmaceuticals is strongly preferred.
  • Comprehensive understanding of applicable clinical research regulations Thorough knowledge of GCP, ICH guidelines and other US and international clinical regulatory requirements
  • Extensive experience and superior proficiency in designing, managing, and interpreting clinical studies.
  • Fluent knowledge of clinical research methodologies and market research strategies.
  • Superior proficiency in planning and project organization skills, including risk assessment and contingency planning.
  • Demonstrated management, negotiation, and cross-functional collaboration skills.
  • 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
  • BS or MS in life sciences or healthcare field with additional coursework in clinical trial design and execution.
  • Comfortable working is a small start-up resource constrained environment.
  • 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
  • 18 Holidays
  • 5 Sick Days
  • Short Term Disability
  • Long Term Disability
  • Life Insurance
  • Technology Allowance
  • Impactful rewarding work

Location: San Francisco, CA – Hybrid

  • Impactful rewarding work

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
  • 18 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

Associate Scientist II/III, 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, Biology to join our growing team. The ideal candidate will have experience in providing hands on technical support for our in vitro research programs. This person will be involved designing, conducting and analyzing in vitro research experiments to screen experimental radiopharmaceutical candidates. The ideal candidate will have hands on experience with mammalian cell line culture work, biological assays, multi-tasking ability, the willingness and flexibility to assume additional responsibilities as they come up and a desire to thrive in a fast-paced environment.

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

  • Establish, cultivate, maintain and amplify as needed various mammalian cell lines following meticulous cell culture practice.
  • Design, optimize and conduct biological, microbiological, biochemical assays (e.g., ELISAs, western blot, gene cloning, flow cytometry) to evaluate radiopharmaceutical candidates.
  • Contribute to the optimization of experimental procedures and methodologies within the Biology group.
  • Contribute to experimental data generation, recording and analysis and report experimental results to project teams to ensure seamless experiments execution.
  • Participate in lab management tasks including but not limited to tracking and stocking inventories, ordering consumables, maintaining incubators and water baths.
  • Maintenance of clear and accurate lab records, adherence to all safety and compliance requirements
  • Participate in maintenance/certification schedule for equipment.
  • Perform other related duties within the Biology group as needed
  • Attend and participate in weekly meetings

Qualifications:

  • Masters degree or Bachelors degree with 2-4 years of experience in relevant discipline
  • 2-3 years industrial experience, or an equivalent combination of education and experience
  • Hands-on experience with aseptic techniques and work with mammalian cell lines
  • Experience with basic biological assays
  • Experience with lab management tasks preferred but not required
  • 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 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
  • 18 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
  • 18 Holidays
  • 5 Sick Days
  • Short Term Disability
  • Long Term Disability
  • Life Insurance
  • Technology Allowance
  • Impactful rewarding work

Location: Boston, MA (Hybrid)

Associate Scientist II/III, Radiochemistry

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 II/III, Radiochemistry to join our growing team. The ideal candidate will have hands-on experience with radiolabeling using various isotopes (e.g., 177Lu, 225Ac, 68Ga), and analytical techniques to confirm yields, (radio)purity and stability to support in vitro/vivo and formulation evaluations. The ideal candidate will have multi-tasking ability and a desire to strive in a fast-paced, highly collaborative environment.

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

  • Apply radiolabelling methods to enable preclinical evaluation of compounds with imaging and therapeutic applications
  • Assist in the design and execution of radiochemistry experiments leading to robust radiolabelling processes
  • Assist in the development of analytical methods
  • Active participation in discussions and presentation of results in team meetings
  • Diligent, clear and accurate recording of experiment procedures/outcomes
  • Support of lab maintenance and upkeep (e.g., routine instrument care, inventory management)
  • Firm adherence to all safety and compliance requirements, including radiation surveys, contamination control, and radioactive inventory/waste management.

Qualifications:

  • M.Sc. degree in Radiochemistry, Chemistry, Analytical Chemistry or related area with 0-3 years of related industrial experience.
  • Solid understanding and practical experience in radiolabeling and subsequent analysis
  • Excellent observational, organizational, data management, and documentation skills
  • Strong written and oral communication skills.
  • A team player with excellent interpersonal skills and a passion for the discovery of targeted imaging/therapy 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 match
  • 20 vacation days
  • 17 Holidays
  • 5 Sick Days
  • Long Term Disability
  • Life Insurance
  • Technology allowance
  • Impactful rewarding work

Location: Vancouver, British Columbia, Canada

Scientist, Radiochemistry

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 Scientist, Radiochemistry to join our growing team. The ideal candidate will have extensive hands-on experience with radiolabeling using various isotopes (e.g., 177Lu, 225Ac, 68Ga), and analytical techniques to confirm yields, (radio)purity and stability to support in vitro/vivo and formulation evaluations. The ideal candidate will have multi-tasking ability, be able to function independently/within a team, and a desire to strive in a fast-paced, highly collaborative environment.

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

  • Independently apply radiolabelling methods to enable preclinical evaluation for compounds with imaging and therapeutic applications.
  • Design and execution of radiochemistry experiments leading to robust radiolabelling processes.
  • Development of analytical methods, notably those involving radioactivity (e.g., radio-TLC, radio-HPLC).
  • Active participation in discussions and presentation of results in team meetings
  • Diligent, clear and accurate recording of experiment procedures/outcomes. Ability to collate results to data packages, when appropriate.
  • Supervise and mentor Associate Scientists.
  • Support of lab maintenance and upkeep (e.g., routine instrument care, inventory management)
  • Firm adherence to all safety and compliance requirements, including radiation surveys, contamination control, and radioactive inventory/waste management.

Qualifications:

  • Ph.D/M.Sc degree in Radiochemistry, Chemistry, Analytical Chemistry or related area with 1-4 years (with Ph.D) or 5 years (with M.Sc) of related industrial experience.
  • Ability to understand, plan and execute (with practical experience) radiolabeling experiments and subsequent analysis. Experience with both Alpha and PET emitters preferred.
  • Demonstrated ability to troubleshoot, identify unusual results and design experiments to establish root cause.
  • Excellent observational, organizational, data management, and documentation skills
  • Strong written and oral communication skills.
  • A team player with excellent interpersonal skills and a strong passion for the discovery of targeted imaging/therapy 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 match
  • 20 vacation days
  • 17 Holidays
  • 5 Sick Days
  • Long Term Disability
  • Life Insurance
  • Technology allowance
  • Impactful rewarding work

Location: Vancouver, British Columbia, Canada

To apply, use the form below.

Don’t see anything that matches your experience? Email us at careers@a9oncology.com

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