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
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 firstname.lastname@example.org
Intern, Translational Medicine
The Department of Translational Medicine is seeking a motivated Intern (3 month minimum)
to perform in vivo and ex vivo studies towards understanding the biology and biomarker development
of our novel anti-cancer stem cell and immuno-oncology therapeutic target molecules. Preferred
candidates should have an understanding of cancer biology and hands-on experience working with
tumor mouse models. Additional lab experience in immunology is also highly desired.
- B.S., M.S., or Ph.D education levels with experience and knowledge of cancer biology, cell biology, biochemistry, pharmacology, or related field
- Hands-on experience with mouse tumor models
- Mouse handling, dosing, and tissue collection
- Strong desire to learn, collaborate, and operate as a team player
- Legal authorization to work in the US
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