- 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.
- Perform a variety of tasks, duties and responsibilities as assigned from time to time.
- 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 Requirements:
- 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.
Replimune is an equal opportunity employer.
EEO & Employment Eligibility
Replimune is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, ancestry origin, disability or veteran status. Replimune also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.
Replimune, Inc. does not accept agency resumes unless contacted directly by internal Replimune Talent Acquisition. Please do not forward resumes to our careers site, employees or any other company location of Replimune. Replimune will not be responsible for any fees related to unsolicited resumes.
Replimune now requires Covid vaccination disclosure for all US employees.