Positions Available

»Scientist in Target Validation/Cancer Stem Cell

»Regulatory Submissions Specialist in Regulatory Affairs

»Scientist in Antibody Engineering

»Scientist in Cell Biology

»Scientist / Sr. Scientist / Group Leader in Translational Medicine

»Informatics Scientist / Sr. Scientist in Translational Medicine

Scientist in Target Validation/Cancer Stem Cell

Job Summary:

The position's focus will be identification and functional validation of cancer stem cell-specific therapeutic targets in both in vitro and in vivo assays. Primary responsibility will be the design and hands-on realization of experiments aiming at establishing the cancer stem cell requirements (e.g. niche interactions) and the role of specific signaling pathways/molecules in maintaining cancer stem cell self renewal. Work will involve studying cancer stem cells using tumor xenograft and transgenic mouse models, gene expression profiling, knock-out and lineage tracing experiments, and ex vivo culture systems.

Requirements:

• Extensive knowledge in biology of normal or neoplastic stem cells, tumor biology, and signaling pathways implicated in tumorigenesis are required
• Experience with tumor xenograft models, mouse genetics, and generation of knockout mice are highly desirable
• Familiarity with FACS, molecular biology techniques, microarray data analysis, in vivo imaging, and immuno-histochemistry are expected
• Experience in immunology is helpful
• The candidate must have a Ph.D. and/or M.D., and at least 3 years of postdoctoral experience in a relevant discipline
• A demonstrated publication record of outstanding scientific achievement and ability to work in a team environment are pre-requisites

Regulatory Submissions Specialist in Regulatory Affairs

Job Summary:

The successful candidate will support Regulatory Affairs personnel in the coordination, preparation, and submission of all INDs/eCTDs, CTAs, BLAs, MAAs, and life cycle management of these submissions in both paper and electronic formats. He/she will be responsible for the creation and compilation of quality Regulatory submissions and lifecycle management submissions and the archiving of all related documentation.

Responsibilities:

• Planning, preparing, tracking, and archiving regulatory documents and submissions in paper and electronic formats.
• Maintaining day-to-day operations of paper and electronic archive, including Regulatory, Clinical and Quality documentation.
• Responsible for maintenance of all Regulatory, Clinical, Quality and FDA correspondence (distributing, filing into RA/QA file room and electronic document management system) within specified time frames.
• Support the development, implementation, and maintenance of document control and record maintenance systems necessary to comply with related domestic and international laws, regulations, and standards.
• Electronic Document Publishing (i.e., scanning, bookmarking/linking, and document verification) as appropriate. Primary contact for Electronic Submission Systems outsourced to Omnicia via Pacific BioDevelopment.
• Adherence to required submission timelines, publishing, and archiving of regulated documents.
• Liaise with functional source areas (clinical, nonclinical, cmc, regulatory) to ensure documents are compliant with the authoring style guide. Work with regulatory document authors to resolve issues and ensure that documents comply with regulatory and company guidance/template specifications.
• Maintain working knowledge of the regulations and processes that govern the content and maintenance of controlled documents required by the FDA and ICH.
• May represent Regulatory Operations on project teams, driving timelines and deliverables related to submission documents.
• Close interaction with authoring community to track completion of deliverables.

• BA/BS Degree, 2 years pharmaceutical industry experience, prior Regulatory Operations/Document Management experience preferred
• Knowledge of IND, BLA, MAA, eCTD requirements and guidelines, both paper and electronic
• Technical knowledge of electronic publishing systems and software
• Proficiency with MS Office suite and Adobe Acrobat applications
• Proficiency with eCTD formatting
• Knowledge of FDA procedures/guidance's regarding electronic submissions
• Knowledge of Electronic Document Management Systems
• Self-starter with superior time management skills, and ability to work both independently and on teams
• Strong attention to detail

Scientist in Antibody Engineering

Job Summary:

OncoMed Pharmaceuticals is discovering and developing monoclonal antibodies capable of destroying cancer stem cells involved in the formation and growth of solid tumors.

We are seeking an outstanding Scientist to play multiple roles within the OncoMed Pharmaceuticals antibody engineering group. Within the group, this individual will be responsible for antibody discovery using both mammalian display and hybridoma technologies, and for the development of new and innovative antibody technologies.

Requirements:

• PhD, with a record of outstanding publications
• Solid experience in antibody engineering including cloning of variable domains from B cells, antibody reformatting, affinity maturation, etc
• Experience with eukaryotic display formats or expression cloning techniques (yeast, mammalian) and flow cytometry is required
• Experience with hybridoma generation
• Broad protein biochemistry background, including protein expression, purification, and conjugation. ELISA development experience preferred
• Motivation to learn new scientific techniques and to work in a team environment is desired. Strong desire to work in a dynamic start-up environment is essential
• Ability to multitask and thrive in a fast-paced and challenging environment
• Strong organization skills and proficiency in computer skills including various databases
• Excellent oral and written communications skills a must

Scientist in Cell Biology

Job Summary:

OncoMed Pharmaceuticals is discovering and developing monoclonal antibodies capable of destroying cancer stem cells involved in the formation and growth of solid tumors.

We are looking for a person with excellent experience in molecular and cellular biology to contribute to the characterization of agents that impact important stem cell signaling pathways. Candidate will have worked on receptor-ligand signaling systems. Familiarity with cytokines, growth factors, or stem cell signaling pathways is very helpful. Excellent and hands-on research technique is essential and should be reflected in outstanding scientific contributions.

Requirements:

• 10+ years in biological sciences
• Publication record demonstrating solid and interesting scientific discovery
• Ability to multitask and thrive in a fast-paced and challenging environment
• Experience in genomic and molecular biology techniques; desire to explore novel and emerging technologies
• Excellent oral and written communications skills a must

Scientist / Sr. Scientist / Group Leader in Translational Medicine

Job Summary:

OncoMed Pharmaceuticals is discovering and developing monoclonal antibodies capable of destroying cancer stem cells involved in the formation and growth of solid tumors.

We are looking for a highly motivated leader to oversee and maintain OncoMed’s Tumor Bank within OncoMed’s Translational Medicine Group.  The tumor bank consists of minimally passaged tumors from human surgical specimens in a manner that preserves the biological characteristics of the original human tumor.  The Company believes that these xenografts closely reflect human cancer biology and their response to drugs is more predictive of clinical outcomes in cancer patients.  These xenograft models are used as the principal screen for OncoMed's monoclonal antibody therapeutics.  

Candidate will also be a key contributor to developing preclinical and clinical biomarker assays and strategies for OncoMed’s drug targets using the tumor bank and as well as innovative technologies.

Responsibilities:

• Strategic and scientific leadership of all operations of the tumor bank including propagation, quality control, and cell banking
• Spearhead strategic expansion of the tumor bank and new tumor models
• Coordinate and lead the molecular and genetic characterization of the tumor bank and cancer stem cell biomarkers
• Manage a database for cell and tumor tracking
• Work closely with cross departmental teams

• PhD in biological sciences
• Ability to multitask and thrive in a fast-paced and challenging environment
• Background in oncology, tumor biology, and/or cancer stem cells preferred
• Histology and FACs experience a must
• Experience in genomic and molecular biology techniques; desire to explore novel and emerging technologies
• Strong organization skills and proficiency in computer skills including various databases
• Excellent oral and written communications skills a must

Informatics Scientist / Sr. Scientist in Translational Medicine

OncoMed Pharmaceuticals is discovering and developing monoclonal antibodies capable of destroying cancer stem cells involved in the formation and growth of solid tumors. We are seeking a biomarker expert to work in the Translational Medicine Group.

The successful candidate will lead and conduct high level data analysis of clinical and preclinical biomarker datasets. They will also contribute significantly to developing the biomarker strategies for OncoMed’s monoclonal antibody therapeutics.

• Responsible for initiating, designing, and managing preclinical and clinical biomarker analysis.
• Identify pharmacodynamic and predictive biomarkers using primary human tumor xenograft data from OncoMed's tumor bank as well as clinical data.
• Derive meaningful biological results from data mining and meta-analysis of large data sets, including genomics, pharmacogenomics, and proteomics, as well as PK/PD analysis.
• Communicate and collaborate with clinical and therapeutic teams to effectively define and report next experimental steps from analyzed data.
• Opportunity to build up the bioinformatics function and play a pivotal role in OncoMed’s drug discovery and development.

• Ph.D. in life sciences, with 4-8 years experience handling of clinical and preclinical biologic data of various kinds including genomic and microarray data.
• Must have comprehensive training in statistics.
• Strong background in biological sciences; experience in oncology and also at the lab bench preferred.
• Experience with analysis of and reporting of clinical datasets.
• Experience with SAS, S/R, Spotfire, Linux/Unix, Matlab, and various pathway analysis tools i.e., Ingenuity, Metacore GeneGo.

Please send CV/Resume to:

Human Resources
OncoMed Pharmaceuticals
800 Chesapeake Drive
Redwood City, CA 94063
hr@oncomed.com