Senior Scientist, Personalized Medicine

LOCATION: BERKELEY, CA – USA

REPORTS TO: ASSOCIATE DIRECTOR, PERSONALIZED MEDICINE

SUMMARY & SCOPE OF POSITION:

The Translational & Predictive Medicine department contributes to the development of investigational drugs by implementing strategies to bridge preclinical research with clinical development. The Personalized Medicine team within the Translational & Predictive Medicine department partners with other functional groups within Clinical Development for clinical study design and supports clinical trials with pharmacodynamic biomarker readouts, prognostic and predictive biomarkers as well as companion diagnostics, if required.

The Senior 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.

This is an important and visible role in the product development team and requires an individual with outstanding communication and leadership skills, as well as the ability to build strong relationships with key stakeholders at Aduro. You will be viewed as a scientific and strategic leader who can work with a fast-paced clinical and product development organization to translate fundamental insights in Oncology and other disease areas into targeted therapeutic and biomarker hypotheses that can be tested in clinical trials.

PRIMARY RESPONSIBILITIES:

• 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.
• Lead Personalized Medicine activities for assigned clinical studies and provide input to clinical protocols, informed consents, sample collection manuals.
• Author study reports, biomarker components of clinical trial related documents including IB, IND, CSR and regulatory submissions.
• Design and implement clinically testable hypotheses and biomarker strategy for 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.
• Implement translational activities through direct interaction with clinical research physicians, statistician, clinical and translational operations, CRO and academic experts and internal translational medicine scientists to advance internal research and early development projects, help/guide IND enabling preclinical biomarker studies. Continually analyze progress, engage in critical thinking, and assert strong problem-solving towards delivering key data and interpretation essential for decision making.
• Implement translational activities through direct interaction with clinical research physicians, statistician, clinical and translational operation, CRO and academic experts/key investigators and internal translational medicine scientists. Lead assay development and optimization efforts for project, assess PK/PD relationship, optimal dose selection and biomarker-related label claims.
• Evaluate CRO for assay and analytical capabilities, creating contracts, interact with CRO for execution of scientific services.
• Plan and oversee large-scale testing and data analysis of clinical specimens.
• Support a matrixed team of lab scientists and bioinformatics analysts to mine genomic and proteomic data from internal and external collaborations and clinical trials to develop personalized healthcare strategies for projects.
• Mentor and supervise Scientists and Research Associates.
• Drive the publication of biomarker data in top-tier scientific, technical or medical journals.

REQUIREMENTS:

• PhD or MD/PhD in Immunology, Tumor Biology, Cell Biology, Oncology, or related
• Minimum of 8+ years of experience in developing and implementing translational medicine strategies, and a track record of success in clinical biomarker research.
• Experience in a biotech environment is required, additional experience in a global pharma company is
• Strongest consideration will be given to candidates with a scientific background in tissue microenvironments, human tumor immunology and/or immune responses to vaccination.
• Background in human immunology and immune profiling Familiarity with contemporary approaches to deconstruct immunological pathways and translate hypotheses forward experimentally.
• Track record with biomarkers in the clinical space including implementation of biomarker analyses into clinical protocols, informed consents, sample collection manuals, regulatory documents. Experience with global clinical studies
• Companion diagnostics development experience is a plus.
• Excellent interpersonal, problem-solving skills, applying scientific methods to
• 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).
• Experience in the development and utilization of biomarkers, various technologies/platforms (–omics technologies, immunohistochemistry and immunoassays, etc.).
• Ability to independently design, execute, and interpret biomarker experiments (including immune cell subset analysis), 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
• Ideally experienced in analyzing large datasets including genomic and proteomic together with a sound understanding of critical development functions, e.g. Clinical, Biomarker Development, Translational Medicine.
• Working knowledge of GCP
• Ability to work in a fast-paced environment, across multiple projects, to adapt to changing priorities and to accept responsibilities outside of initial job
• Detail-oriented and able to prioritize workload with limited
• Excellent verbal and written communication

Aduro Biotech, Inc. is at the forefront of discovery, development and commercialization of breakthrough immunotherapies. We provide a workplace where employees excel, thrive and deliver value to patients, their families and our partners. Aduro's headquarter office is located in Berkeley, California with an international office in Oss, The Netherlands.

Aduro Biotech, Inc. offers a competitive salary and benefits package. We are an Equal Opportunity Employer.