Replimune’s mission is to discover and deliver a new generation of cancer treatments called oncolytic immunotherapies. Oncolytic viruses combine multiple mechanisms of action, enhancing the ability of viruses to replicate in and kill cancer cells, and generating a robust patient-specific, systemic anti-tumor immune response. Oncolytic immunotherapy is expected to strengthen the effectiveness of immune checkpoint blockade and become the second cornerstone of immune-oncology approaches, moving beyond the incremental improvement in cancer treatment to help more patients overcome their disease.
Responsibilities:
Summary of job description:
Reporting into the Director of Translational Research, the Sr. Scientist / Principal Scientist Translational Research will be responsible to develop and execute translational research strategy for one or more of Replimune’s clinical programs. The candidate will contribute to the overall translational strategy of pre-clinical and clinical biomarker development. The candidate should be able to use bioinformatic platforms to analyze biomarker data in conjunction with clinical responses. The candidate will participate in team meetings and communicate on status and progress of biomarker sample collection and testing and oversee sample management from the clinical site to the central labs and to the testing lab in collaboration with Clinical Operations. The candidate will perform data analysis and generate reports from Replimune’s translational research studies including from both pre-clinical and clinical trials. The candidate will also support key activities in translational research aimed at helping to elucidate the underlying mechanisms of action of Replimune’s product candidates, and to characterize the pharmacokinetic and pharmacodynamic effects. This is a non-lab-based role and will largely manage translational studies at central labs, contract research organizations (CROs) and other specialty labs performing translational research studies.
Key responsibilities:
Develop and execute translational research strategy for one or more of Replimune’s ongoing clinical and pre-clinical programs Develop strategies to integrate different data modalities, including NGS, single-cell transcriptomes, digital pathology, with clinical observations to derive mechanistic and biomarker insights Collaborate with, and manage CROs to identify predictive biomarkers with an emphasis on the development and validation of pharmacodynamic assays to support ongoing clinical and pre-clinical studies Process images from immuno-histochemistry assays and identify feasible ways to quantify the staining of the slides. Develop and analyze data tables, graphs and reports from gene expression analyses, clinical pharmacokinetic studies and other translational research studies. Maintain project timelines for translational and clinical pharmacokinetic studies and facilitate sample testing to meet deadlines for abstract presentations and manuscript submissions. Perform correlative analysis of biomarker data with patient responses in collaboration with clinical development and biostatistics. Work closely with the clinical operations, external collaborators, and contract research organizations (CROs) to execute translational research studies. Act as a liaison to transfer translational research related assays between internal and external labs. Author the biomarker sections of Investigator Brochures, clinical study protocols and reports, program documents, regulatory submissions and responses (INDs/CTAs), and relevant pharmacology sections of regulatory documents May be asked to sit on study specific project team meetings and present translational research data as necessary.
Other responsibilities
Perform a variety of tasks, duties and responsibilities as assigned from time to time Qualifications:
Educational requirements:
Master’s degree in molecular biology or immunology with 7-8 years of relevant experience or Ph.D. with 2-3 years. Prior industry experience in immune oncology, utilizing bioinformatic tools for data analysis and managing CROs is required. Experience in solid tumor therapeutic landscape is desirable.
Experience and skill requirement:
Master’s degree in molecular biology or immunology with 7-8 years of relevant experience or Ph.D. with 2-3 years of hands-on lab experience in immunology assays. Experience with next generation sequencing platforms and data analysis using python, R and other bioinformatic platforms is a key requirement. Experience with analysis of data from Genomic sequencing, Nano String, TCR sequencing, scRNA-seq or CITE-seq is a plus Prior experience with oncology clinical trials is desirable. Solid understanding on cellular/molecular biology with prior experience with molecular biology/immunology techniques such as immune histochemistry, western blot, PCR nucleic acid isolation, flow cytometry, ELISA and next gen sequencing analysis is required. Ability to learn new scientific concepts quickly. Be a team player and work effectively in a fast-faced environment to meet deadlines with a can-do attitude and excellent organizational skills is a must. Superb attention to detail and professional demeanor Requires excellent communication and organizational skills, along with problem solving and conflict resolution, Self-motivated, with strong organizational skills Excellent proficiency in MS Office (i.e., Word, Excel, PowerPoint), Python, R and SAS or other programming platforms is required.
Note: This role is based in Woburn MA and will be required to be on site 2-3 days a week with flexibility. Visa sponsorship and work arrangements can be negotiated for candidates with highly relevant experience.