Discovery / Research

Sr. Scientist, Vector Engineering Direct Hire MA

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Job ID: 15811 Direct Hire MA

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Growing Gene Therapy company here in Cambridge is growing out their Vector Engineering team!  They are looking for a Sr. Scientist to partner with the Head of Vector Engineering and support their pre-clinical and clinical gene therapy programs!  This team strives to implement cutting-edge vector technology to improve efficacy, potency, safety and production of rAAV vectors.  Responsibilities include but not limited to:

  • Execute viral studies
  • Assist with the design and construction of rAAV vectors
  • Establish and manage relationships with external academic groups and CROs
  • Coordinate in vivo experiments internally or directly with CROs
  • Working with the cell line isolation, process development and analytical development teams, implement small-scale vector production for yield and quality assessments
  • Prepare, analyze, and present data internally and externally
  • Prepare and review technical reports and write research operating protocols (ROPs)
  • Work within cross-functional teams to drive novel programs forward towards IND studies
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Requirements:

  • PhD in Virology, Cell Biology, Molecular Biology, Biochemistry, Chemical Engineering or a related discipline  AND 3 or more years of industry experience preferred
  • Experience in mammalian cell culture, molecular biology, protein biochemistry, immunoassays, flow cytometry, and quantitative PCR methods
  • Experience in the development of complex biological assays
  • Experience with statistical analysis software (SoftMax, JMP, SAS) preferred

GLP Preclinical Study Management Direct Hire MA

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Job ID: 15778 Direct Hire MA

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100 million dollar pre-commercial gene therapy company in Cambridge is expanding their Toxicology and Non-clinical Safety team.  Come be on the forefront of rare disease and gene therapy research and development at this growing company! 

The main focus of this position is preclinical study management at their CRO network and external partners.  Low if any travel and will be based out of their headquarters in Cambridge with flexibility on schedule/WFH.    

Responsibilities include but are not limited to;
•  Preclinical study protocol design and review, study monitoring, data and report review and communication with the study director and CROs.
•  Request for quotation (RFQ) and program costs negotiation, laboratory selection.
•  Integrated nonclinical analytical and bioanalytical support.
•  Assists in the preparation of Regulatory submissions as well as assisting with quality control of documents and tracking milestone deliverables.
•  Assists in the tracking of internal metrics, including resourcing and financial information.
•  Compiling data from non-GLP studies for discussion or presentation.

Qualified candidates will have a BS or higher in a Life Science related discipline and must have experience with GLP studies and external vendor management, ideally from within small or large biotech/pharma companies or from the CRO side of the relationship.  

All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients.
 

Sr. Toxicologist for clinical-stage biotech Direct Hire Massachusetts

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Job ID: 15758 Direct Hire Massachusetts

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Our well-funded Cambridge start-up client is seeking an experienced Toxicologist to lead pipeline projects by directing GLP & non-GLP studies with CROs and participating in Regulatory filings.  You will work closely with program leaders, clinical and regulatory teams to develop an overall toxicology development plan including lead optimization, candidate selection, IND-enabling studies, etc.

Responsibilities include but are not limited to;
•  Interact with CROs for quotes, cost estimates, and monitor study activities including protocol development and report generation.  
•  Provide strategic advice to senior leadership and relevant project teams regarding potential impact of study results on program and clinical/regulatory strategy.
•  Communicating with regulatory bodies in support of global regulatory submissions.

Formal descriptions can be supplied for interested candidates. 

Qualified candidates will have a Ph.D. in Toxicology or relevant field with a minimum of 3 - 5+ years of experience in nonclinical development and conducting regulatory toxicology studies.  More experienced candidates can also be considered.  Candidates who have DABT certification are welcome but it is not required to be considered.  Candidates must have experience in various aspects of toxicology study conduct including developmental and reproductive toxicology, carcinogenicity, toxicokinetics, and safety pharmacology as well as experience in designing, conducting, monitoring, and interpreting discovery and exploratory toxicology studies to assist lead optimization and candidate selection efforts.  Must also have experience in management of external CROs and representing Toxicology function to global regulatory agencies in support of submissions.  

All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients.

Director, Biostatistics Direct Hire MA

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Job ID: 15720 Direct Hire MA

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Our Global Pharmaceutical client here in Cambridge, MA is seeking to add a Director, Biostatistics to their team!  This role will be responsible to act as the lead statistician on their Neuroscience projects.  Will be accountable for statistical aspects of clinical studies and submissions, including quality, relevance to regulatory perspective, and scientific validity.  Act as key statistical consultant within company.  Responsible for project staffing, resource planning and allocation within project team(s).  Responsibilities include:

  • Lead large or complex late phase project(s) / multiple indications of a large late phase project(s). Represent stat leadership in cross function working groups. Provide insights to innovative statistical application and operation strategies.
  • Mentor people working on the project.  Promote teamwork, quality, and innovation. Create productive work environment.  Ensure project team compliance with SOPs and departmental standards.
  • Direct statistical support and provide scientific leadership for one or more projects of clinical development.  Accountable for statistical aspects of clinical studies and submissions of the project(s).
  • Plan and track project activities, timelines, and resource use.  Provide justification for planned resource needs.  Seek to optimize resource utilization thru efficient and well-managed resource allocation and across projects or areas.  Capacity to respond to unscheduled increase in project workload.
  • Ensure productive collaborations with other functions in the aligned project team and with other statistics project leaders and in communicating with senior leadership.

Requirements: 

  • PhD/MS in statistics or related discipline with at least 8+ years of pharmaceutical experience
  • Demonstrated leadership, project management, and interpersonal/communication skill
  • Broad knowledge and superior understanding of advanced statistical concepts and techniques
  • Proven success, through previous submissions or interactions, in meeting regulatory guidelines and requirements for drug development
  • Experience in neuroscience clinical trials preferred but not required

CAR-T Scientist Direct Hire MA

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Job ID: 15301 Direct Hire MA

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Our client is a highly-regarded cell/gene therapy company in the greater Boston area and they are seeking an experienced, highly-motivated Immuno-Oncology Scientist to join their research and discovery team! You will collaborate with and help other teammates troubleshoot assays, as well as identify and develop new targets and chimeric antigen and T cell receptors (CARs & TCRs). The main function of this role is to develop cell-based assays for T cell characterization, proliferation, and function, and to coordinate new research projects to overcome obstacles within the tumor microenvironment.

Responsibilities:
•  Design/execute diverse immuno-assays to evaluate T-cell biology, including cell sorting (fluorescent and/or magnetic), multi-color flow cytometry, Luminex, cytokine profiling, etc.
•  Analyze experimental data and present internally to identify promising new CAR and/or TCR candidates for subsequent development.
•  Work collaboratively and cross-functionally for preclinical development in animal models of cancer.

Requirements:
•  PhD in Immunology, Cell/Molecular Biology, or related field.
•  1-5 years of relevant experience in immunology, I/O, or autoimmunity.
•  Experience with cell culture techniques, sorting primary human and/or animal T cells, and developing cell-based immuno-assays and T cell functional assays.
•  Applied expertise in T cell therapeutics is a plus, either in academia or industry.
 

Formal descriptions can be supplied for interested candidates.

Must be authorized to work in the U.S. indefinitely to be considered.

All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients.