Careers at OncoMed
OncoMed, a pioneer and leader in the development of novel cancer therapies directed toward tumor initiating cells, also known as “cancer stem cells”, fosters a culture of innovation as the company strives to provide significant alternatives for the treatment of cancer.
Headquartered in Redwood City, California, our employees bring a passionate dedication to the advancement of novel treatments for patients with cancer.
OncoMed is seeking an experienced Scientist/Senior Scientist to work on building new biologic agents that impact receptors/ligands
within the immune system. The candidate will work on novel strategies to modulate anti-tumor immune response and will contribute
to early stage discovery and characterization of therapeutic antibodies and fusion proteins. Successful candidate will collaborate
with other scientists throughout the company on the discovery and development of therapeutic antibodies to novel cancer targets.
- Solid familiarity with isolation of immune cell types and common in vitro assays with primary immune cells
- Experience with both human and murine immunology
- Experience testing agents (e.g. antibodies) in murine tumor models
- Excellent cell culture technique
- Cell-based assay development
- Motivation to learn new scientific techniques and to work in a team environment
- Ability to multitask and thrive in a fast-paced and challenging environment
- Excellent oral/written communication and interpersonal skills
Manager, Regulatory Operations
The Manager of Regulatory Operations will be responsible for the planning, scheduling and coordination of eCTD submissions in
collaboration with internal team members/functional areas, partner companies and contract research organizations. He/she will
actively participate to plan, prepare and submit electronic dossiers to FDA and/or other Health Authorities, in alignment with
department and corporate goals. He/she will ensure that communications to and from North America/Global Health Authorities are
archived to the appropriate databases, systems, and/or repositories.
This position will play a key role in the strategic development and implementation of Regulatory infrastructure utilizing Omnicia
software, Regulatory Document Management Systems (Sharepoint), and in-house databases/ tracking tools in support of the Regulatory
Affairs Department activities. This role will be integral in the continued development of processes and tools to support eCTD
submissions on an ongoing basis.
- Manages Microsoft Word document formatting, editing, proofing, creating and manipulating complex tables, converting text and
graphics, scanning, bookmarking, hyperlinking, and Adobe Acrobat PDF rendition according to Regulatory Operations standards
and/or Style Guide.
- Supports ongoing submission activities, including (but not limited to) the assembly of regulatory submissions to US FDA in
- Supports submission activities to global Health Authorities, including (but not limited to) the preparation, formatting,
and QC of documents being submitted globally through CROs and Partner companies.
- Archives all Health Authority communications received either directly or from affiliates.
- Independently plans, prepares, reviews and submits to FDA and other appropriate Health Authorities varied regulatory filings
and correspondence including annual reports and other routine submissions. Maintain and/or meet timelines and ensure content,
quality, accuracy and the format of submissions comply with applicable laws, regulations and corporate standards
- Interacts proactively with other departmental functions/teams, contract research organizations, and partner companies
- Works effectively with regulatory and quality colleagues specializing in CMC/Manufacturing, Operations and Project Management
to continuously improve regulatory systems, teamwork, and efficiency.
- Provides accurate regulatory operations guidance and information to project management teams. Provides advice on regulatory
acceptability of submission plans. Assists in establishing submission timelines and ensures timelines are met.
- Provides strategic writing, development, and implementation of department-wide SOPs, policies and/or work processes to
streamline all submission activities and standardize interactions with other departments
- Maintains awareness and continually expands knowledge of all current, pertinent laws, regulations, guidances, policies,
procedures and practices.
- BS or BA degree preferably in a scientific discipline.
- 5-7 years experience working in pharmaceutical/biotechnology organization. 5+ years with direct experience in regulatory submissions and project coordination with demonstrated ability to interact successfully with team members and health authorities where appropriate
- Demonstrated experience working with eCTD publishing systems and related publishing/ PDF processing tools, submission planning and document management
- Advanced working knowledge in MS Word, MS Excel, MS PowerPoint, and Adobe Acrobat are required
- Knowledgeable in global CTD/eCTD structure and requirements as well as industry trends for dossier preparation (INDs, CTAs, etc.).
- Experienced with records and/or document management standards
- Experienced with developing compatible Word templates to publishing software
- A person who is self-motivated, well organized, detail oriented, able to prioritize, works effectively under pressure and has excellent written and verbal communication skills.
- Experienced working with cross-functional teams and the ability to balance changing priorities and manage multiple projects
- Familiarity with MS Project, MS Visio applications, and XML and SQL specifications is preferred
- Demonstrated understanding of the drug development process is highly preferred
- project management experience is highly preferred
- Outstanding interpersonal, planning and organizational skills
- Keen attention to detail and accuracy; able to detect errors and discrepancies, determine gaps in processes, and proactively mitigate them
- Ability to work independently and under pressure with rapidly shifting priorities, and to prioritize workload, manage multiple projects and meet deadlines
Postdoctoral Fellowship, Cancer Biology
OncoMed Pharmaceuticals, Inc. is a clinical development-stage biopharmaceutical company focused on discovering
and developing first-in-class protein therapeutics targeting key pathways involved in cancer stem cells (CSCs)
and immuno-oncology. At OncoMed Pharmaceuticals, our employees are fundamental to our success; and we strive to
create an atmosphere that inspires creativity, collaboration, and entrepreneurial innovation.
To this end, the Department of Cancer Biology is seeking a motivated and outstanding Postdoctoral Fellow to join
our efforts to discover, explore, and characterize the effects of our novel anti-CSC and immuno-oncology therapeutic
molecules, and their mechanisms of action, using a variety of in vivo and ex vivo techniques. Preferred candidates
will have a strong understanding of cancer signaling pathways, experience working with tumor mouse models and some
lab experience in immunology.
- Applicants must have recently completed a doctoral degree.
- Preference will be given to those candidates who have demonstrated scientific creativity and scientific
accomplishment by publishing in top peer-reviewed journals.
To apply, please send a cover letter, current CV, and a list of 3 references to email@example.com
Intern, Bioanalytical Sciences
Bioanalytical Sciences Group is seeking motivated undergraduate/graduate level long-term intern
(6-12 months). The successful candidate will work in a team responsible for assay development and sample
analysis to support preclinical and clinical development of novel biotherapeutics. Ligand-binding assays
and cell-based assays, including ELISA, HTRF, Luminex, and Flow Cytometry, are utilized for the assessment
of pharmacokinetics, pharmacodynamics, immunogenicity, and biomarkers. The intern will be involved in all
stages of assay development including reagent generation, experimental design, assay optimization/qualification,
and sample analysis. Other responsibilities include laboratory notebook/binder documentation and data presentations.
- Previous wet laboratory experience is a requirement
- Experience working with biological matrices/products such as serum and/or plasma is a plus
- Basic laboratory and computer skills
- Demonstrated ability to work in a team and fast paced environment
- Excellent written and verbal communication skills
- Legal authorization to work in the US