Clinical Trial Manager, Clinical Operations

CAMBRIDGE, MA

About Aura:

At Aura Biosciences, we are developing a new class of therapies based on an expressed Viral Nanoparticle-Dye conjugate to target and destroy cancer cells selectively, while leaving surrounding tissue unharmed.  By safely eliminating cancer locally, we can treat early and transform the lives of people with a wide range of cancers that are poorly managed today.

Our lead program in choroidal melanoma is designed to remove cancer cells in the back of the eye as a first-line therapy potentially long before the disease progresses and metastasizes.  Come help develop a first-in-class treatment to selectively destroy cancer cells!

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Role & Responsibilities:

This position will provide clinical trial management support for an ongoing Phase 1b/2 trial and two planned Phase 3 trials in our lead program in choroidal melanoma. Partnering closely with the cross-functional stakeholders (Clinical, Regulatory, Product Development), you will apply strong clinical and project management fundamentals for the implementation of various aspects of our clinical trials.

Essential functions:

  • Reporting to the Director, Clinical Operations, the Clinical Trial Manager will be responsible for managing various aspects of clinical trial conduct with subject matter experts including clinical development, contract vendors, and regulatory to achieve clinical trial goals on time and within budget. 
  • Develop clinical trial documents including informed consent templates, source documents, and Study Procedure Manual contents.
  • Develop and implement clinical processes and procedures including site budgets, investigator payments, protocol compliance reporting, and investigational product management. 
  • Provide oversight and management of regional Clinical Research Associates (CRAs) including review of site visit reports.
  • Oversee data entry timelines and query management, including metric reporting.
  • Oversee investigative site and CRA adherence to SOPs, Good Clinical Practice and FDA regulations.
  • Manage the Trial Master File (TMF) and ensure contents current.
  • Facilitate and manage productive team communication and collaboration, both internally and externally.

Qualifications:

  • The ideal candidate should have a minimum of a bachelor’s degree in the life sciences and 5-8 years of direct and progressive experience specific to biopharma clinical trial management. A track record of successful management of complex programs using multiple external vendors with experience in the startup environment a plus. Experience in ophthalmology and/or oncology strongly preferred.
  • Candidates should have experience with Microsoft office programs and web-based data entry platforms.
  • Candidates should have a passion for learning, creating, relating, communicating, and helping drive the success of cross functional teams.

Location:

Based in the Company’s North Cambridge office, with travel as required to support Site Qualification and Site Initiation Visits.

Interested? 

Email a cover letter and a copy of your CV to HR@aurabiosciences.com referencing the position description in the subject line.

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Associate Director/Director, CMC Program Management

LOCATION: CAMBRIDGE, MA

About Aura:

At Aura Biosciences, we are developing a new class of therapies based on an expressed Viral Nanoparticle-Dye conjugate to target and destroy cancer cells selectively, while leaving surrounding tissue unharmed. By safely eliminating cancer locally, we can treat early and transform the lives of people with a wide range of cancers that are poorly managed today.

Our lead program in ocular melanoma is designed to remove cancer cells in the back of the eye as a first-line therapy potentially long before the disease progresses and metastasizes. Come help develop a first-in-class treatment to selectively destroy cancer cells!

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Role & Responsibilities:

This position will provide technical program management of diverse CMC activities with a focus on key Intermediates (pDNA, purified protein, small molecule dye) and the final bioconjugate DS and DP. Partnering closely with the cross-functional stakeholders (Clinical, Regulatory, Product Development), you will apply strong technical and project management fundamentals to develop a CMC strategic development plan and clinical supply chain plan from phase 3 development through commercial launch.

Essential functions:

  • Reporting to the SVP Development, the Associate Director/Director, CMC Program Manager, will be responsible for developing and managing NDA deliverables for program execution with subject matter experts including process and analytical development, supply chain, and regulatory to achieve project goals on time and within budget. 
  • Develops and maintains clinical Supply Plans in close collaboration with the clinical group.
  • Facilitate strategy development and decision-making by leveraging technical and development lifecycle knowledge and seeking critical input from team leadership, SMEs, and stakeholders. 
  • Own and maintain project management tools (minutes including decisions and actions, timeline, budget, risk management, resource management) that support but do not supersede program strategy development and execution success.
  • Facilitate and manage productive team communication and collaboration, both internally and externally.
  • Communicate and publish monthly CMC dashboard to management. 

Qualifications:

  • The ideal candidate should have an advanced degree in the life sciences /engineering and 5-8 years of direct and progressive experience specific to biopharma CMC project management with a track record of successful management of complex programs using multiple external vendors. Experience with bioconjugates a plus.
  • You should have a passion for learning, creating, relating, communicating, and helping drive the success of cross functional teams.

Location:

Based in the Company’s North Cambridge office, with travel as required to oversee the virtual development and manufacturing network.

Interested? 

Email a cover letter and a copy of your CV to HR@aurabiosciences.com referencing the position description in the subject line.

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Assay Development Scientist, ELISA/Immunoassay (6-month contract)

LOCATION: CAMBRIDGE, MA

About Aura:

At Aura Biosciences, we are developing a new class of therapies to target and destroy cancer cells selectively, while leaving surrounding tissue unharmed – an approach we call molecular surgery.  By safely eliminating cancer locally, we can treat early and transform the lives of people with a wide range of cancers that are poorly managed today.

Our lead program in ocular melanoma is designed to remove cancer cells in the back of the eye as a first-line therapy potentially long before the disease progresses and metastasizes to the liver, where it almost always is fatal. Development of a first-in-class treatment option to selectively destroy cancer cells would create the possibility of a cure in this and other cancers where the disease can be detected early.

Position Summary:

Reporting to the Senior Scientist, the Assay Development Scientist, ELISA/Immunoassay will in a timely manner develop immunoassay (ELISA) methods to support DMPK study.

Responsibilities include but are not limited to:

  • Function as Analytical Development Scientist focusing on ELISA/Immunoassay development.
  • Perform method development and apply methods to monitor drug levels in biological matrices.
  • Write technical documents such as test methods, SOPs, protocols, and reports.
  • Ensure compliance with all applicable lab safety, and regulatory requirements.
  • Communicate professionally with internal and external partners.

Minimum Requirements:

  • Degree in biochemistry or related field, with 1+ years of related work experience. Knowledge and/or experience in assay qualification. Experience in GLP settings is a plus.
  • Depth of analytical knowledge and experience in immunoassay approaches to supporting DMPK, especially working experience with animal tissue samples and matrix effects.
  • Competency with common laboratory operations and troubleshooting.
  • Ability to effectively communicate in English both verbally and in writing.
  • Ability to follow lab requirements, keep detailed records, and competently peer-review analytical data and results.
  • Ability to resolve non-routine problems requiring evaluation of data and factor analysis.
  • Ability to think strategically and conceptually to properly design experiments and analyze results.

Interested? 

Email a cover letter and a copy of your CV to HR@aurabiosciences.com referencing the position description in the subject line.

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Assay Development Scientist

LOCATION: CAMBRIDGE, MA

About Aura:

At Aura Biosciences, we are developing a new class of therapies to target and destroy cancer cells selectively, while leaving surrounding tissue unharmed – an approach we call molecular surgery.  By safely eliminating cancer locally, we can treat early and transform the lives of people with a wide range of cancers that are poorly managed today.

Our lead program in ocular melanoma is designed to remove cancer cells in the back of the eye as a first-line therapy potentially long before the disease progresses and metastasizes to the liver, where it almost always is fatal. Development of a first-in-class treatment option to selectively destroy cancer cells would create the possibility of a cure in this and other cancers where the disease can be detected early.

Position Summary:

Reporting to the Senior Scientist, the Assay Development Scientist will be responsible to develop, qualify and transfer analytical methods to support biopharmaceutical product development. The incumbent will interact with in-house team and CRO/CMO to ensure timely progress in technology development, as well as documentation and smooth technology transfer.

Responsibilities include but are not limited to:

  • Function as Analytical Development Scientist for one or more projects. Design and execute laboratory experiments for development, qualification, verification, and transfer of analytical testing methods using multiple analytical techniques, to support research and development projects.
  • Write technical documents such as test methods, SOPs, protocols, and reports.
  • Ensure compliance with all applicable lab safety, and regulatory requirements.
  • Communicate professionally with internal and external partners.
  • Functions as a subject matter expert (SME) in the department.

Minimum Requirements:

  • Degree in biochemistry or related field. PhD with 2+ years, MS with 4+ years of relevant work experience.
  • Depth of analytical knowledge and experience in protein chemistry, with multiple chromatographic and spectroscopic techniques for identification, purity, and characterization of protein, nanoparticles and their chemically modified forms.
  • Competency with common laboratory operations. Competency in the operation and troubleshooting of HPLC, DLS, plate reader, and other lab equipment.
  • Experience in VLP purification and characterization techniques is a plus.
  • Ability to effectively communicate in English both verbally and in writing.
  • Basic and advanced mathematics including algebra and statistical data analysis proficiency.
  • Ability to follow lab requirements, keep detailed records, and competently peer-review analytical data and results.  
  • Ability to resolve complex non-routine problems requiring in-depth evaluation of data and factor analysis, including leading scientific investigations.
  • Ability to think strategically and conceptually to properly design experiments and analyze results.

Interested? 

Email a cover letter and a copy of your CV to HR@aurabiosciences.com referencing the position description in the subject line.

Back to Careers