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:


Associate Director/Director, Technical Accounting

Position Summary:

OncoMed is seeking a high-performing, business professional to join its Finance organization. The position reports to the Controller and will be a key force in driving OncoMed to the next level in SOX compliance, SEC reporting, technical accounting, equity accounting / stock administration, and tax. This individual must be a highly motivated, self-starter with strong technical accounting and analytical skills. The successful candidate will be hands-on, proactive, and driven by tackling challenging problems and delivering meaningful, yet practical, solutions.

Responsibilities:
  • Manage annual audit and quarterly reviews with external auditors, including fieldwork, audit interactions and PBC preparations.
  • Serve as subject matter expert on US GAAP and SEC regulations. Research new accounting standards and technical accounting issues. Prepare white papers and technical accounting memos summarizing technical accounting issues and application of accounting guidance to the Company.
  • Prepare and assist in management of SEC reporting requirements. Responsible for consolidated financial statements, footnotes, and MD&A for Forms 10-Q, 10-K, and proxy as well as financial information related to the quarterly press releases, including all relevant supporting schedules.
  • Manage the SOX compliance program and coordinate with finance team and external SOX service provider for phased implementation of SOX 404 requirements.
  • Thought leader and process owner of equity accounting and stock administration.
  • Interact with external tax advisors to address the Company’s tax needs, including reviewing the annual tax provision, overseeing the preparation of the annual tax filings, and addressing other tax-related requirements and issues, e.g. Section 382 study, R&D Tax Credit study, etc.
  • Own key aspects of month-end financial close and financial reporting. Assist in day-to-day technical financial accounting activities.
  • Participate in special finance and systems projects.
Requirements:
  • BS/BA in Business/Accounting (or related field), CPA required.
  • Strong technical accounting and analytical skills required.
  • 5 to 7 years of public accounting experience (Big Four experience preferred). 3 to 5 years of additional experience in life science industry desirable.
  • Problem solver, action-oriented, and process improvement-minded.
  • Self-starter, adaptable and collaborative team player.
  • Excellent written and verbal communication skills.

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



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.



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.

Sample and Data Manager

Job description:

OncoMed is currently seeking a full-time contractor with experience in Clinical sample and data management. Able to work independently in a fast-moving team-based environment, the SDM will provide Clinical Pharmacology and preclinical toxicological specimen management support and Clinical Pharmacology data management support across multiple studies in oncology. The ideal candidate is a team-player who is detail-oriented; can successfully manage several projects simultaneously; understands the broader context and impact of the support that he/she provides; knows how to identify/recognize issues and propose solutions with moderate guidance.


Job Responsibilities:
  • Provide Clinical Pharmacology data management support to clinical studies, including data transfer plans and execution, ClinPharm sample/data reconciliation, and adhere to timelines.
  • Setup appropriate internal SOPs.
  • Manage outsourcing of clinical sample management.
  • Provide in-house sample management support.
  • Maintain an accurate and concise inventory of OncoMed’s research and clinical bioanalytical samples across drug programs and third-party labs.
  • Proactively identify sample-related issues and opportunities for improvement.
  • Responsible for sample lifecycle management documenting chain of custody from sample receipt through to exhaustion/return/destruction.
  • Follow GCP/GLP/ICH guidelines, global legal and regulatory standards.

Qualifications and Background required:
  • Minimum BS or BA degree in the Life Sciences.
  • Work experience in industry lab setting.
  • Biorepository/sample management operations experience.
  • Knowledge and working experience with clinical trial database.
  • Experience with SAS programing and LIMS is highly desirable.
  • Familiarity and experience with GXP compliance.
  • Experience setting up and/or maintaining sample tracking databases is a plus.
  • Ability to work in a high paced team environment, meet deadlines, and prioritize work from multiple projects.
  • Detailed and precise record keeping skills are essential as well as the ability to track and resolve issues.
  • Excellent teamwork, communication (verbal and written), organizational, and interpersonal skills.

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