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.

Open Positions:


Manager - GCP, Quality Operations

Job Summary:

Reporting to the Head of GCP Quality Assurance, this position is responsible for providing internal GCP Quality Assurance support, contributing to the establishment and maintenance of OncoMed GCP quality systems, and supporting OncoMed corporate development objectives and timelines by ensuring compliance with quality standards and applicable regulatory requirements.

In this role, the successful candidate will actively seek continuous improvement of Quality Operations by promoting the role of quality assurance (QA) in the successful execution of OncoMed clinical trials. This role requires daily interaction with OncoMed multi-disciplinary personnel, to provide quality and compliance guidance that is commensurate with the stage of development, complexity of study design and acuity of the indication under study.

The successful candidate will contribute to staff development through GCP training and mentorship, and will assist the Head of GCP Quality Assurance in the oversight and development of other GCP QA internal and external activities. The person in this role will provide data and summaries for executive management and quality review meetings, contribute to regulatory submissions and represent the company on GCP related issues.

Responsibilities:
  • Ensure the compliance of OncoMed clinical research activities with applicable domestic and international quality and regulatory requirements
  • Leads or represents QA-GCP at quality assurance and cross functional meetings
  • Supports the qualification, selection and ongoing evaluation of CROs and other Clinical Program vendors
  • Provides guidance on quality and compliance issues to support the OncoMed Clinical Team in the management of contracted CROs and Vendors
  • Contribute to the ongoing development of OncoMed’s Quality Management System through ongoing vendor qualification, change control and deviation management, CAPA management and coordination of documents to OncoMed third party contract providers and business partners, where appropriate
  • Support the development, review and approval of GCP SOPs, policies and work instructions, and ensure GCP documents are sound from a compliance perspective
  • Review and support the development of OncoMed core Clinical Trial documents such as clinical study protocols, clinical study reports, Investigational Brochures, Informed Consent Form (ICF) Templates, ancillary study plans, regulatory submissions, and other controlled documentation to support study compliance, data integrity and data traceability
  • Review, processing, and (if applicable) approval for GxP activities and documentation, using Good Documentation Practices and corporate document management policies (paper and electronic media)
  • Participate in Quality review, risk analysis, ongoing monitoring and generation of metrics to support continuous improvement and regular reporting to Quality and Executive management
  • Provide ongoing GCP training in compliance with current regulatory standards and trends
  • Participate, plan, lead and execute internal and external CRO and clinical site audits to ensure oversight of GCP compliance, data integrity, reliability and traceability in OncoMed clinical studies
  • Provide QA and compliance mentorship and support to other OncoMed personnel
  • Other activities as directed by Quality/Regulatory Management
Requirements:
  • Must possess a BA, BS, and/or MS degree in natural, applied or interdisciplinary sciences
  • 8-10 years of industry experience in clinical research, study Phases 1-3 (i.e.: Clinical Operations, Regulatory Affairs, Quality Assurance, GCP Auditor)
  • Must be proficient in Good Clinical Practices; current GCP training required (within the last two years)
  • 1-2 years of Quality Assurance / Auditing experience
  • Ability to work effectively as part of an interdisciplinary biopharmaceutical team
  • Oncology experience preferred
  • Familiar with biotechnology methods, capabilities and trends that impact oncology clinical trials
  • Proficient working knowledge of Good Documentation Practices, ICH GCP E6 and other relevant ICH GCP Guidelines, FDA regulations and related guidance documents, relevant international regulations (EU Annexes, MHRA, etc) and industry standards (WHO, ISO, etc.)
  • Must possess excellent technical writing skills with competency in the use of common MS software including Word, Excel, Power Point, Outlook and related programs/applications
  • Extensive GCP audit experience desired
  • Project management, risk and impact assessment experience and skills an asset
  • Exhibits strong initiative and independence in the performance of duties, with excellent communication, organizational and time management skills
  • CRO management experience desirable
  • Some travel may be required, including domestic and international (10-20%)

Please click here to submit CV/Resume (email to hr@oncomed.com) indicating the job title you are applying for.



Senior Scientist/Associate Director, Bioassay Development

Job Summary:

OncoMed Pharmaceuticals is developing novel biologic therapies for the treatment of cancer and currently has 7 clinical stage product candidates. Cell-based assays and plate-based binding assays are designed to establish the potency and stability of a drug substance/product. The successful applicant will have primary responsibilities for the design, conduct and oversight of new potency assays, and for enhancing existing methods. In addition, the candidate will be expected to perform routine analysis, as needed, to support process and formulations development. The job is within the Analytical Sciences group, reporting to the Director.

Responsibilities:
  • Lead the development, transfer, qualification and troubleshooting of cell-based bioassays and plate based binding assays
  • Work with members of Quality Control to define and implement strategies for critical reagent preparation and characterization to support cell-based bioassays and ELISA binding assays
  • Establish working relationships with other groups within Research and Development to support the development of the OncoMed pipeline
  • Manage, train and/or mentor others
  • Provide support to upstream, downstream and formulation development groups
Requirements:
  • PhD and 4+ years or MS and 6+ years related pharmaceutical or biotechnology industrial experience with increasing scientific responsibilities in analytical development
  • Proven record of successfully developing and transferring cell-based bioassays
  • Strong technical writing and oral presentation skills
  • Ability to work in a fast-paced team environment and prioritize work from multiple projects within a flexible work schedule
Desired but not required:
  • Knowledge of current regulatory expectations regarding potency assays
  • Knowledge of Notch/Wnt signaling pathways and/or immuno-oncology as it relates to bioassays
  • Experience applying Design of Experiments to assay optimization and qualification

Please click here to submit CV/Resume (email to hr@oncomed.com) indicating the job title you are applying for.



Senior Scientist, Protein Characterization

Job Summary:

OncoMed Pharmaceuticals is developing novel biologic therapies for the treatment of cancer and currently has 7 clinical stage product candidates. This position is for a protein characterization scientist who will help to advance the OncoMed pipeline by defining product Critical Quality Attributes, developing test method for release and stability and supporting process development.
Under limited supervision, the Scientist's primary responsibilities involve the design, conduct and oversight of protein characterization studies. In addition, the candidate will be expected to perform some testing as needed in support of process development. The job is within the Analytical Sciences group, reporting to the Director.

Responsibilities:
  • Define Critical Quality Attributes (CQA) for both early and late phase clinical programs using a combination of chromatographic, electrophoretic and biophysical approaches
  • Perform forced degradation studies to support CQA assessment, process development and specification setting
  • Perform pre-formulation studies
  • Participate in comparability assessments for later stage programs
  • Establish working relationships with other groups within Research and Development to support the development of the OncoMed pipeline
  • Manage, train and/or mentor others
  • Provide support to upstream, downstream and formulation development groups
Requirements:
  • PhD and 4+ years or MS and 6+ years related pharmaceutical or biotechnology industrial experience with increasing scientific responsibilities in analytical development
  • Proven record of successfully developing separation methods for protein therapeutic release, stability, fractionation and/or characterization
  • Strong technical writing and oral presentation skills
  • Ability to work in a fast-paced team environment and prioritize work from multiple projects within a flexible work schedule
Desired but not required:
  • Knowledge of current US and OUS regulatory expectations regarding quality, stability and comparability
  • Experience applying Design of Experiments to assay optimization and qualification

Please click here to submit CV/Resume (email to hr@oncomed.com) indicating the job title you are applying for.



Scientist, Cancer Biology

Description:

OncoMed Pharmaceuticals, Inc. is a clinical development-stage biopharmaceutical company focused on discovering and developing first-in-class protein therapeutics targeting cancer stem cells (CSCs) and immuno-oncology candidates. At OncoMed Pharmaceuticals, our employees are fundamental to our success; and we strive to create an atmosphere that inspires creativity, collaboration, and entrepreneurial innovation.

Job Summary:

The Department of Cancer Biology is seeking an outstanding motivated, innovative, and collaborative Scientist to design and conduct in vivo, molecular and cell biology studies to characterize the effects of novel anti-cancer stem cell and immune modulatory therapeutics. The successful candidate will be responsible for assisting the investigation of mechanisms of interplay between cancer cells and host immune system in murine tumor models. This highly interactive position will also work to collaborate with other members within and outside Cancer Biology.

Qualifications and Requirements:

All applicants should possess a Ph.D. in cancer biology, immunology, or a related field with at least 2+ years of postdoctoral academic lab or industry research experience. Responsibilities and desired techniques may include but are not limited to:

  • Strong in vivo tumor model experiments (subcutaneous and/or orthotopic xenografts)
  • Expertise in cancer and/or immunology signaling pathways
  • Mouse handling, dosing (oral gavage, IP, IV), blood, and tissue collection
  • Cell culture and immunologic assays
  • Isolation and analysis of immune cell populations by multi-color flow cytometry
  • Characterization of tumor and immune cell signaling (Western blot, functional assays)
  • Strong desire to learn and work in a dynamic environment
  • Solid publication record of innovative research
  • Excellent verbal, written, and analytical skills with the ability to adapt to changing project needs

Please click here to submit CV/Resume (email to hr@oncomed.com) indicating the job title you are applying for.



Senior Biostatistician

Description:

OncoMed Pharmaceuticals is a clinical-stage biotechnology company dedicated to improving cancer treatment by creating novel medicines that address the fundamental biologic pathways critical to tumor initiation, growth, metastases and recurrence. We are leveraging our understanding of cancer stem cell pathways and immuno-oncology targets to discover and develop novel therapeutics that could provide important alternatives for the treatment of cancer.

Job Summary:

We are currently looking for a Senior Biostatistician contractor to support ongoing Phase 1 and Phase 2 clinical trials. The initial contract will be for 6 months. Interested candidates should have at least 8 years of related experience and/or training and a background in SAS procedures and programming.

Responsibilities:

  • Perform statistical analysis to support Phase I dose finding and Phase 2 clinical endpoint studies performed or managed by the team.
  • Develop, write and/or review statistical analysis plans and review statistical/results sections of study protocols and reports.
  • Discuss study designs and results with the team via written and/or oral communication as required during progress of the study.
  • Maintain updated knowledge in the scientific and statistical concepts and in methods and techniques, and maintain appropriate statistical applications for company’s research interests.
  • Identify and implement good scientific and data handling practices throughout the company to ensure the highest quality of product to our clients.

Requirements:

  • Master’s Degree or equivalent in statistics or life sciences with a strong statistical component.
  • 8+ years of related experience and/or training, or an equivalent combination of education and experience.
  • Background in SAS procedures and programming, 5+ years experience with SAS is required.

Please click here to submit CV/Resume (email to hr@oncomed.com) indicating the job title you are applying for.



Manager, Regulatory Operations

Job Summary:

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.


Requirements:
  • 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 eCTD format.
  • 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.

Qualifications:
  • 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

Please click here to submit CV/Resume (email to hr@oncomed.com) indicating the job title you are applying for.