Sr/Scientist – Translational and Predictive Medicine
Location: Berkeley, CA – USA
Reports into: Head of Translational and Predictive Medicine
Summary & Scope of Position:
The Translational and Predictive Medicine department is contributing to the development of investigational drugs by implementing strategies to bridge preclinical research with clinical development and supports clinical trials with pharmacodynamic biomarker readouts, prognostic and predictive biomarkers as well as companion diagnostics, if required.
The Sr/Scientist will strengthen the quality and progress of Aduro’s clinical candidates and will provide design and implementation of Translational Medicine studies for projects ranging from late-stage Research to Phase 3 clinical studies. She/He will support clinical drug development and will develop strategies to identify potential biomarkers of response and resistance to targeted therapies as they relate to molecular subtypes of cancers (and other disease areas) and/or the investigational drugs. The scientist in this position will lead efforts in experimental design and data analysis and must possess significant experience in complex analyses of clinical samples including primary tissues and immune cells. This position requires established expertise in cell culture, immune profiling technologies and functional assays using primary human cells.
The ideal candidate will be a functional area expert with demonstrated skills, independent critical thinking, theoretical knowledge and experience to apply scientific direction and approach to projects and problems. This role requires excellent oral and written communication skills, demonstrated project management skills, the capacity to work independently and as part of a team, and the ability to contribute to multiple projects simultaneously.
- Contribute as an individual as well as a team leader to the Translational & Predictive Medicine department’s mission to understand the mechanism of action of Aduro’s therapeutics and integrate those findings into the clinical development strategy.
- Represent Translational & Predictive Medicine function in assigned projects and cross-functional teams and act as a subject matter expert for the development team.
- Provide Biomarker and Precision Medicine input to clinical protocols, informed consents, sample collection manuals and regulatory documents.
- Design and implement biomarker studies to monitor Aduro-sponsored clinical trials including implementation of pharmacodynamic biomarkers indicating target engagement/mechanism of action, biological/clinical response biomarkers and building hypotheses for patient enrichment for proof-of-concept clinical studies.
- Collaborate with colleagues in Research and Translational & Predictive Medicine to advance internal research and early development projects, help/guide IND enabling preclinical biomarker studies.
- Lead assay development and optimization efforts for project
- Plan and execute large-scale testing and data analysis of clinical specimens
- Perform immune assays using human biological samples
- Define and execute biomarker strategy for the project
- Mentor and supervise Scientists and Research Associates
- PhD in Immunology, Cell Biology, Oncology, or related field
- Minimum of 5 years (Scientist) or 8 years (Sr. Scientist) of clinical biomarker experience and a record of outstanding research
- Experience in a biotech environment is required, additional experience in a global pharma company is beneficial
- Proven track record with biomarkers in the clinical space including implementation of biomarker/CDx analyses into clinical protocols, informed consents, sample collection manuals, regulatory documents. Experience with global clinical studies desired.
- Excellent interpersonal, problem-solving skills, applying scientific methods to resolution
- Extensive background in human immunology and immune profiling technologies
- Extensive experience in the isolation and characterization of primary human immune cells and tissues utilizing a wide range of immunological techniques to support functional characterization (proliferation, cytokine secretion, phenotyping).
- Advanced multi-parameter flow cytometry skills, including panel design and validation are desired
- Ability to independently design, execute, and interpret biomarker experiments (including immune cell subsets) utilizing genetics, genomics, proteomics, molecular pathology, molecular imaging tools
- Experience in preparing for fit-for-purpose diagnostic assays (in collaboration with other stakeholders/experts) used in early phase clinical studies that may set the stage for future companion diagnostics is desired.
- Working knowledge of GCP required
- Self-motivated, ability to work in a fast-paced environment, and ability to adapt to changing priorities and to accept responsibilities outside of initial job description
- Detail-oriented and able to prioritize workload with limited supervision
- Proficiency with Microsoft Excel and data analysis software. Familiarity with GraphPad Prism a plus.
- Excellent verbal and written communication skills
Aduro Biotech, Inc. is at the forefront of discovery, development and commercialization of breakthrough immunotherapies, alone or in combination that make transformative advances in the treatment of challenging diseases. We provide a workplace where employees excel, thrive and deliver value to patients, their families and our partners. Aduro headquarter office is located in Berkeley, California and international office located in Oss, The Netherlands.
Aduro Biotech, Inc. offers a competitive salary and benefits package. Qualified candidates should forward a resume and cover letter including a statement of interest, availability, and experience in Word or PDF format to: firstname.lastname@example.org PLEASE, NO PHONE CALLS.
Aduro Biotech, Inc. is an Equal Opportunity Employer