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Senior Director - Clinical Biomarker Strategy Lead

Company: Jobot
Location: Cambridge
Posted on: November 22, 2021

Job Description:

Come Change the World at a Growing Leader in Therapeutics!

This Jobot Job is hosted by Conner Ferguson

Are you a fit? Easy Apply now by clicking the "Apply" button and sending us your resume.

Salary $180,000 - $220,000 per year

A Bit About Us

We are seeking a highly motivated and experienced individual with deep translational expertise to join the Oncology Translational Medicine team within Clinical Development at our company. The Clinical Biomarker Strategy Lead will work closely with the VP of Clinical Pharmacogenomics and the Clinical Operations team to achieve the company's scientific and strategic objectives focused on maximizing clinical outcomes. The Lead will bring deep scientific experience in immuno-oncology biomarkers, in-depth knowledge of oncology, and understanding of clinical development. The Lead will be responsible to design, deliver and execute biomarker and translational strategies, including clinical pharmacodynamics, proof of mechanism, target engagement, and patient selection strategies, in alignment with clinical development objectives for programs within the organization. The successful candidate will have the opportunity to build a team to support the clinical biomarker programs across the pipeline.



Why join us?

Qualifications

MD, Ph.D. or MD/Ph.D. degree with 8+ years of experience of relevant industry experience, preferably within translational biomarker roles

Deep understanding of the role of translational research and clinical biomarkers in drug development

Demonstrated scientific acumen and mechanistic understanding of cancer biology and experience in oncology and immuno-oncology clinical development

Experience with bioanalytical assays, including multi-parameter flow cytometry, multiplex IF assays, single-cell RNA sequencing

Flexibility to support multiple projects as the pipeline evolves

Ability to work in a fast-paced environment and driving towards results

Excellent written and verbal communication skills

Preferred working knowledge of data analysis and experience with reporting tools

Strong interpersonal skills and ability to work collaboratively across teams

Companion diagnostic development, including experience of IDE submission and approval, is a plus

Job Details

Lead clinical asset biomarker strategy within early clinical development programs to generate data that inform clinical mechanism of action and patient selection.

Provide input to the clinical team on biomarker-related elements of clinical protocols, IBs, INDs, CTAs, CSR, and publications.

Provide scientific expertise and technical guidance to enable timely and high-quality sample collection

Collaborate with clinical operations, the CRO, and testing labs to ensure biomarker testing and data generation

Lead data generation efforts and clinical biomarker sample analysis, data interpretation, and communication to the clinical team

Ensure output of biomarker plans meets clinical program quality standards

Align with the translational bioinformatics team and our Drug Intelligent Science to deliver novel approaches to select patients for treatment

Provide guidance and scientific input for the execution of biomarker plans for the early development programs

Proactively seek novel ways to incorporate single-cell technologies and biomarkers into clinical designs

Contribute to building a culture that embraces scientific excellence and integrity with a sense of collaboration internally and externally

Interested in hearing more? Easy Apply now by clicking the "Apply" button.

Keywords: Jobot, Cambridge , Senior Director - Clinical Biomarker Strategy Lead, Executive , Cambridge, Massachusetts

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