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

Scientist, Chemistry, Peptides

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 to join our Chemistry group.  The ideal candidate will have hands-on experience in synthetic organic chemistry, including in the synthesis, isolation and purification of either small molecules, peptides or peptidomimetics. This person will be responsible for synthesizing peptides/peptidomimetic building blocks and precursors for radiopharmaceutical product candidates. Expertise in solid-phase peptide synthesis and the optimization of peptide ligands required.

We are an early-stage company, so you will have the opportunity to participate cross-functionally and contribute to the build-out and set-up of new laboratory facilities.  The ideal candidate will have multi-tasking ability and a desire to strive in a fast-paced environment.

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

  • Design and synthesis of peptides/peptidomimetics or small molecule-based building blocks and drug substances for radiopharmaceutical development
  • Working closely cross-functionally to achieve project goals
  • Supervision and mentoring of junior scientists
  • Compound characterization employing LC-MS/MS, GC-MS, HPLC and NMR
  • Lead project discussions and present results in team meetings
  • Key participant in the writing of patent applications
  • Maintenance of clear and accurate lab records, adherence to all safety and compliance requirements

Qualifications

  • PhD in Chemistry or related area with 5+ years of relevant industrial drug discovery experience
  • Solid understanding and practical experience in peptide drug discovery
  • Solid experience in modern synthetic and analytical techniques
  • Excellent observational, organizational, data management, and documentation skills

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
  • Impactful rewarding work

Schedule

  • Full Time Permanent

Location: Vancouver

Timing: ASAP

Scientist, 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 is seeking a Scientist to join our Translational Biology group within our growing organization. The ideal candidate should have knowledge and hands-on experience in microSPECT/PET/CT imaging in rodent models, in vivo experiments in general for drug development, preferably for applications using radiopharmaceuticals. The candidate will work collaboratively and cross-functionally with the internal research team and will be responsible for conducting the required in vivo research experiments. The ideal candidate will have multi-tasking ability and a desire to thrive in a fast-paced environment.

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

  • Design and conduct SPECT/PET/CT imaging protocols for rodent models, perform image reconstruction and analysis.
  • Maintain and calibrate microSPECT/PET/CT equipment (e.g., periodic QA/QC protocols, troubleshooting)
  • Execute other animal experiments including but not limited to ex vivo tissue harvest, biodistribution and therapy studies.
  • Perform animal handling, injections, surgery, post-operative care, monitoring, blood sampling and tissue collection.
  • Maintain clear and accurate lab records and laboratory compliances (e.g., monitoring sheets, health reports, data spreadsheets, radiation safety)
  • Write, review, and execute SOPs and animal protocols.
  • Produce high quality and well documented data with strong attention to detail.
  • Contribute to internal project teams through the setting and achievement of scientific goals, communication of results, and solving multifaceted scientific challenges.
  • Perform other research tasks, as required.

Qualifications:

  • PhD in relevant discipline with 2-5 years of industrial experience with laboratory animals or an equivalent combination of education and experience.
  • 1-3 years knowledge and experience working with SPECT/PET/CT methods and instrumentations, image analysis and handling of radioactive substances.
  • Experience with rodent handling and in vivo experiments including data analysis.
  • Experience with radiopharmaceuticals development is preferred but not mandatory.
  • Strong knowledge in laboratory animal standards and CCAC guidelines is an asset.
  • Ability to work independently in a laboratory environment.
  • Ability to communicate the results in meetings.
  • Observational, organizational, data management and documentation skills.
  • A strong 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.
  • Proven analytical, critical thinking, problem solving, decision-making and organizational skills.

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
  • Impactful rewarding work

Location: Vancouver, BC

Senior Scientist, CMC 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 is seeking a Scientist/Sr. Scientist, CMC Radiochemistry to join our growing organization. The ideal candidate will develop radiolabeling processes and analytical testing methods for targeted, peptide/small molecule-based radiopharmaceuticals will be responsible for developing and delivering novel radiolabeled diagnostic and therapeutic compounds for both pre-clinical and clinical applications with a technology transfer to our CDMO partners.

This position requires a high degree of collaboration, multi-tasking ability, and desire to strive in a fast-paced environment. You will have the opportunity to contribute to the build-out and set-up of new laboratory facilities and interface with external partners.

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

  • Conduct radiochemistry experiments leading to robust radiolabeling processes and clinical formulations that meet target product profiles for diagnostic and therapeutic applications.
  • Design and conduct experiments, critically evaluate data, draw appropriate conclusions and develop follow-up plan of action.
  • Work in multidisciplinary teams to define development project goals and timelines.
  • Develop quality control procedures, analytical methods and specifications for finished radiopharmaceutical drug products in conjunction with staff analytical chemists.
  • Develop technology transfer package for transfer of radiolabeling and analytical methods to third party CRO and CDMO partners and serve as a representative on a project team in the capacity of process chemist expert.
  • Ability to troubleshoot, identify unusual results and design experiments that establish root cause and/or enhance knowledge of the product being developed.
  • Author, revise and review technical documents including SOPs, development reports, test methods, experimental and qualification protocols, batch records, specifications and regulatory documents. Provide project data and progress status updates to internal cross-functional project team.
  • Suggest and implement continuous improvements with respect to safe handling of radioactive substances in the laboratory environment according to applicable Nuclear Safety Regulations (Canadian Nuclear Safety Commission).
  • Adhere and follow radiation safety regulations as set in the policies and conduct area radiation surveys, contamination control, radioactive waste management.
  • Ensures compliance with Health and Safety, policies, procedures and regulations applicable to the work.
  • Conduct work according to best practices and where appropriate, regulatory guidance, international pharmacopeias, ICH, established protocols and standard operating procedures.

Qualifications:

  • PhD/MSc in Radiochemistry, Chemistry, Analytical Chemistry, Nuclear Engineering or equivalent knowledge or experience
  • 2+ years’ experience (Scientist) to 5+ years’ experience (Sr. Scientist) with academic and/or commercial radiopharmaceutical process development, formulation development, production, or tech transfer.
  • Hands on experience in radiolabeling with radioisotopes used for diagnostic and therapeutic applications; experience with alpha emitters is a plus.
  • Ability to plan and execute complex scientific projects. Strong analytical and trouble shooting skills.
  • Ability to handle more than one project at a time, multitasking, effective communicator and collaborative with different teams.
  • Functional knowledge of radiopharmaceutical process/formulation chemistry, standard concepts of radiochemistry, best practices, regulatory requirements for development of radiopharmaceuticals in various jurisdictions

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
  • Impactful rewarding work

Location: Vancouver, BC

Scientist/Senior Scientist, Radiopharmaceutical Analytical 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 Oncology is seeking a Scientist/Senior Scientist, Radiopharmaceutical Analytical Development to join our growing organization. The ideal candidate will develop analytical quality control/testing processes for targeted, peptide/small molecule-based radiopharmaceuticals and will be responsible for developing finished drug product release specifications.  Responsibilities also include development of documentation to support technology transfer of analytical methods and specifications to our CDMO partners.

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 and strive in a fast-paced environment.

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:

  • Independently perform quality control (QC) testing to support internal product development activities.
  • Develop and validate analytical methods for QC testing of novel radiolabeled drug products for diagnostic and therapeutic applications. Methods to be developed include HPLC (UV detection, radio detection and/or fraction collection with subsequent gamma counting), radio-TLC, gamma spectroscopy, and osmolarity testing.
  • Prepare documentation for tech transfer of analytical methods to CDMO partners and support tech transfer activities in collaboration with process development team, representing Alpha-9 as analytical department subject matter expert.
  • Write development reports, validation and tech transfer protocols with input from other team members.
  • Contribute to development of QC specifications for drug products.
  • Review and troubleshoot methods and data from external CDMO partners.
  • Perform routine quality operations including calibration/maintenance of analytical equipment.
  • Work in multidisciplinary teams to define development project goals and timelines.
  • Adhere and follow radiation safety regulations as set in the policies and conduct area radiation surveys, contamination control, and radioactive waste management. Suggest and implement continuous improvements with respect to safe handling of radioactive substances.
  • Conduct work according to best practices and where appropriate, regulatory guidance, international pharmacopeias, ICH, established protocols and applicable standard operating procedures.
  • All other duties to support the progress of Alpha 9.

Qualifications:

  • MS/PhD in Radiochemistry, Chemistry, Analytical Chemistry, or equivalent knowledge or experience
  • 3+ years of relevant experience which should include extensive hands-on work developing and executing analytical methods for small molecules or peptides. Experience analyzing radiolabeled compounds is preferred.
  • Experience with principles of analytical method validation.
  • Hands on experience with analytical instrument operations and maintenance
  • Experience in handling radioactive material preferred (alpha, beta and positron emission).
  • Ability to plan and execute complex scientific projects. Strong analytical and trouble shooting skills.
  • Ability to handle more than one project at a time, multitasking, effective communicator and collaborative with different teams.
  • Highly organized with strong attention to detail and commitment to high quality work.

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
  • Impactful rewarding work

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

  • 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.
  • D., 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

Location: San Francisco, CA

Director, 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 Director, Clinical Operations leads and drives clinical studies in conjunction with Clinical Development. This role partners with Clinical Development, Program Management and CMC Operations to define overall strategy toward achieving/exceeding program specific corporate targets, identifying and mitigating potential issues, and ensuring budget and timeline compliance. This role may involve direct supervision and mentoring of team members as the Clinical Operations team grows.

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

  • Provides leadership in the development of clinical trial management, budget and resourcing strategy at a clinical program level as a Clinical Operations Program lead
  • Lead the CRO/vendor selection strategy to support assigned studies, oversee the documentation for contracting process (SOWs, MSAs, etc.), ensure sponsor oversight, and leverage positive working relationships to enable robust sourcing strategies for future studies.
  • Contribute to the design, preparation, and finalization of clinical protocols, study manuals, study reports, and other key operational/regulatory documents.
  • Oversees the selection of monitoring resources.
  • Ensure adherence to regulatory requirements (ICH, FDA, EMA, etc.) and GCP guidelines.
  • Provide input to the drafting of governance documents, SOPs, work instructions, and other resources.
  • Build collaborative relationships with key internal stakeholders to facilitate the planning and execution of clinical trials, operational strategy, risk management and mitigation.
  • Provides Clinical Program updates, including trial status/metrics, budget, accomplishments, and risks to CMO, Program Leaders and Managers, Senior Management, and other relevant stakeholders.

Qualifications:

  • Bachelors in Life Sciences with an advanced degree preferred.
  • Minimum of 10 years in pharmaceutical/and or biotechnology industry with experience managing clinical trials
  • Working knowledge of ICH and GCP regulations
  • Experience with selection and oversight of CROs/vendors required.
  • Experience with early-stage oncology trials required; radiopharmaceutical experience preferred.
  • Strong ability to prioritize tasks and keen attention to detail.
  • Excellent writing, communication, and presentation skills.
  • Demonstrated leadership and project management skills.
  • 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
  • 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

To apply, use the form below.

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

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