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.
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
2016 OncoMed Research Internship Program
OncoMed Pharmaceuticals, Inc. is a clinical development-stage biopharmaceutical company focused on discovering and developing
first-in-class protein therapeutics targeting cancer stem cells and immuno-oncology candidates. The OncoMed Summer Research
Internship Program was created to introduce undergraduate and graduate level students to careers in oncology research in the
biotechnology industry. Our internship program provides motivated students with an outstanding training environment that fosters
creativity and learning in the following areas:
- Target identification and validation
- Cancer stem cell biology
- Protein and antibody engineering
- Process and bioanalytical development
- In-vivo biology
- Translational Medicine
- Bioinformatics and Diagnostics
- Pharmacokinetics and Pharmacometrics
- Toxicology and Pathology
Summer internships at Oncomed last approximately 3 months and are open to students between May and September. Interns will work
alongside individual Scientists and attend group research meetings and seminars. In addition, interns may have the opportunity
to present their work at the conclusion of the program. A monthly stipend is provided, based on education level. However, all
housing, travel, and meals are the responsibility of the intern.
To be considered, please email a current curriculum vitae (CV), or resumé, and a cover letter that describes your interests and
desired internship length to email@example.com. Please include the following research area of interest reference code(s) when
- SI-1 Molecular Biology/Target Identification and Validation
- SI-2 In vivo Cancer Biology
- SI-3 Immunology/Immunotherapy
- SI-4 Process and Bioanalytical Development
- SI-5 Translational Medicine
- SI-6 Bioinformatics and Diagnostics
- SI-7 Pharmacokinetics and Pharmacometrics
- SI-8 Toxicology and Pathology
All applications must be received by June 1, 2016, for consideration. For more information, or to learn about OncoMed
Pharmaceuticals, please visit www.oncomed.com.
Long-term Intern, Cancer Biology
The Department of Cancer Biology is seeking a motivated and outstanding Long-term Intern (6 – 12 month appointment) to join our
efforts to execute in vivo and ex vivo studies to characterize the effects of our novel anti-CSC and immuno-oncology therapeutic
molecules and their mechanisms of action. Preferred candidates will have extensive experience working with tumor mouse models,
as well as hands on knowledge of cancer signaling pathways and some lab experience in immunology.
- Ph.D. student or Postdoctoral experience in cancer biology, immunology, or related field
- Hands-on experience conducting in vivo tumor model experiments (subcutaneous and/or orthotopic xenografts)
- Mouse handling, dosing (oral gavage, IP, IV), blood, and tissue collection
- Bioluminescence imaging
- Cell culture
- Immunfluorescence staining of cells and tissues
- Isolation and analysis of immune cell populations by multi-color flow cytometry
- Characterization of tumor and immune cell signaling (Western blot, functional assays)
- Excellent verbal, written, and analytical skills with the ability to adapt to changing project needs
- Strong desire to learn and operate as a key team player
- Significant industry drug discovery experience desired
Senior Research Associate, Target Validation
OncoMed Pharmaceuticals is discovering and developing monoclonal antibodies for the treatment of cancer. Therapeutic approaches
focus on targeting cancer stem cell pathways and harnessing anti-tumor immunity. The Target Validation group proposes, tests, and
confirms new drug candidates.
We are looking for a person with excellent experience in cellular and animal biology to contribute to the in vitro, ex vivo, and
in vivo validation of immune targets. Candidate’s primary responsibility will be to support target validation studies carried out
in mouse syngeneic and xenograft tumor models. Most studies will involve tissue culture, the use of lentiviral and adenoviral
vectors, and a vast array of immune assays. Prior experience with mouse work is required, as well as familiarity with cancer
biology and immunology. Outstanding technical skills are essential and should be reflected in excellent scientific contributions.
- B.S. or M.S. degree
- 3+ years in biological sciences
- Solid experience in tissue culture (in vitro and ex vivo) and protein detection techniques, including flow cytometry
- Prior experience with mouse work, including tumor models
- Familiar with immune functional and phenotypic assays
- Good knowledge and understanding of Health and Safety regulations
- Proficiency in database management
- Ability to multitask and thrive in a fast-paced and challenging environment
- Ability to work independently
- Excellent oral and written communications skills