OncoMed Pharmaceuticals, Inc.  
 
 
 

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:



Senior Associate/Manager Regulatory Affairs

Description:

Job Summary The Senior Associate/Manager will plan, prepare and submit to FDA and other appropriate Health Authorities (in collaboration with internal team members/functional areas, partner companies and contract research organizations) varied regulatory filings and correspondence. They will lead and manage the process in support of regulatory objectives, advice and strategy in alignment with department and corporate goals. The candidate will keep abreast of evolving regulatory procedures and practices. This role is responsible for execution of assigned projects through the ability to work independently with guidance from direct manager, ability to multitask as well as the ability both lead and be an active team member.

Duties & Responsibilities: The Senior Associate/Manager, under limited supervision, will be responsible for managing and overseeing the coordination, compilation and submission of regulatory documentation to health agencies and will support day to day regulatory operations.
Responsibilities:

  • 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
  • Interfaces and communicates effectively with cross-functional team members and management on a regular basis to ensure projectspecific regulatory strategy, process and timelines are met
  • Supports product development teams by interpreting and strategically applying regulations, guidances and available research/information to submission and product related work
  • Interacts proactively with other departmental functions/teams, contract research organizations, and partner companies
  • Ensures that all submission documentation, record keeping and reporting remain in compliance with regulatory filings and in accordance with current regulatory requirements
  • Works effectively with regulatory and quality colleagues specializing in CMC/Manufacturing and Operations to continuously improve regulatory systems, teamwork, and efficiency
  • Contributes to improvements in department operating procedures
  • Conducts regulatory intelligence for products in research and development
  • Maintains awareness of all current, pertinent regulations, guidances, policies, procedures and practices
  • Analyzes changes and updates and advises and provides recommendations to the department and interested personnel as needed

Competencies:
  • Collaborative, team player with a positive attitude and creative problem solving abilities
  • Effective communication (written and verbal) and influencing skills
  • Ability to clearly and effectively communicate ideas, data, and concepts, while adjusting one's style based upon the audience
  • Keen attention to detail; able to detect errors and discrepancies, determine gaps in processes, and proactively mitigate them
  • Works effectively in a multi-task environment
  • Knows and uses strong planning and organization skills and practices
  • Keeps track of information and activities, monitors progress, follows up and reports outcomes as needed

Requirements:
  • BS or BA degree preferably in a scientific discipline
  • 3-7 years experience working in pharmaceutical/biotechnology organization with direct experience in regulatory affairs
  • Expert project management and interpersonal skills, as well as excellent written and verbal communication ability
  • Experience working with electronic submission platforms, eCTD and submission planning is required
  • Knowledge of applicable and evolving US regulations, guidelines, and/or specifications
  • Experience in interpretation of regulations, guidelines and precedents related to drug development
  • 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
  • The ability to manage multiple projects is required
  • Experience working with cross-functional teams and the ability to balance changing priorities is required

Submit CV/Resume



Senior Staff Accountant

Description:

Job Summary The Senior Staff Accountant assists in the preparation of General Ledger entries, monthend accrual in the R&D area, and monitoring clinical site payment. Other duties may include but are not limited to Stock Administration, GL account reconciliation/analysis and expense analysis. This position reports to the Controller.

General Responsibilities:

  • Perform certain General Ledger entries as part of the month-end close process
  • Assist Accounting Manager in monthly accrual of clinical trials and open R&D liabilities
  • Monitor processing for R&D progress payments or site payments for clinical study contracts
  • Provide financial analysis support to the clinical operations team
  • Perform bank reconciliations
  • Assist in annual financial audits and quarterly reviews
  • Assist in other closing and reporting activities including but not limited to monthly and YTD selected expense detail reports for management and assigned account reconciliation
  • Perform special projects as assigned

Stock Administration Responsibilities:
  • Administer all of the company's equity programs and maintain daily recordkeeping of equity data using Equity Edge Online
  • Ensure all participant equity plan transactions are correctly processed and settled in a timely manner; maintain Equity Edge Online database
  • Accurate and timely processing of reports to support payroll, SOX, SEC, proxy and other regulatory reporting requirements
  • Reconciling share plan activity
  • Administer the Employee Stock Purchase Plan which includes enrollments, changes and withdrawals, disposition tracking, purchase processing and reporting
  • Prepare year-end Tax Statements and Section 6039 requirements
  • Maintain trading blackout periods, pre-clearance and tracking of insider trading restrictions
  • Assist with the processing, tracking and reporting of 10bS-1 Plans and Section 16 transactions/reporting

Requirements:
  • Bachelor's Degree or equivalent experience
  • Biotech industry experience is a must. Experience in clinical trial accounting and accruals required
  • Five years minimum work experience in related field
  • Stock Administration is highly preferred, but not required
  • Equity Edge or Equity Edge Online experience is highly preferred, but not required
  • Team player and ability to work effectively in cross-functional teams
  • Must be detail oriented; good problem solving skills and be self-motivated
  • Strong verbal and written communication skills
  • Work effectively and efficiently in a fast-paced environment
  • Demonstrated ability to effectively follow-through on obtaining necessary approvals in a timely manner
  • Ability to manage many tasks with strong organization skills and prioritize tasks
  • Flexible and willing to perform other responsibilities or to assist other areas in meeting business needs
  • Efficient with MS software including but not limited to Excel and Word
  • Experience with accounting systems such as Great Plains
  • Fit with OncoMed culture and core values

Submit CV/Resume



Director of Clinical Operations

Description:

Job Summary Responsible for the planning, implementation and conduct of global clinical trials in a fast paced oncology focused company. Provide operational leadership and ensure the successful implementation of multiple global Phase 2 clinical development programs. Drive the planning of study program timelines and budgets to ensure internal and external program milestones are met. Accountable for the quality of the data and work product for all outsourced services including: clinical operations, data management, biostatistics, regulatory and pharmacovigilance.

Requirements:

  • Candidate must have a min. BS/BA degree and at least eight to ten (8 - 10) years clinical operations/development experience
  • Recent experience with outsourcing and launching global oncology studies is a requirement for this position. Responsible for all clinical operations activities for multiple early phase studies specifically focused on the execution of clinical studies based upon corporate goals and objectives. Oversee the tactical implementation of the clinical development plan for all assigned clinical programs by managing the site contracts, budget, timelines, CRO resources, enrollment, and site activities.
  • Develop and execute a proactive strategy to ensure that all assigned clinical study operations activities are conducted efficiently, meet enrollment goals, and are in compliance with all applicable regulations and corporate policies and procedures
  • Oversee the data collection activities for all assigned clinical programs. Provide input on CRF design and ensure quality data is monitored and available to support annual reports, investigator brochures, regulatory filings, and safety summaries
  • Participate in the evaluation, selection and management of CROs, contractors, and vendors. Manage overall clinical trial budget and timelines for all assigned clinical programs. Develop and maintain effective working relationships with internal team and external partners
  • Identify issues that may impact the overall project plans and initiate contingency plans, as appropriate. Provide positive, professional leadership as a Clinical Operations representative for OncoMed Pharmaceuticals
  • Proven knowledge of the drug development process, Good Clinical Practices and FDA regulatory requirements
  • Ability to lead and drive program planning and delivery in collaboration with CRO partners
  • Proven problem-solving skills to prevent and overcome complex safety and compliance related issues during clinical program implementation and execution
  • Willingness to take on a wide range of responsibilities with limited resources
  • Highly organized and able to prioritize and handle multiple tasks simultaneously
  • Experience with conducting early Phase oncology clinical trials
  • Experience with management of multiple services for multinational clinical trials
  • CRA site monitoring and CRO management experience
  • Experience with clinical database build and eCRF design
  • Ability to independently solve problems related to CRO and site management activities
  • Reports to Sr. Director, Clinical Operations

Submit CV/Resume



SRA/Scientist; Mammalian Cell Culture Protein Production/Purification

Description:

Job Summary OncoMed is seeking an experienced SRA/Scientist to work on the production and purification of candidate therapeutic molecules. The candidate will be responsible for early stage development of stable cell lines and purification of research 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.

Requirements:

  • Solid experience in cell culture, CHO cell experience a plus
  • Excellent cell culture technique
  • Must have hands on experience in performing recombinant protein expression, purification, and characterization using AKTA systems
  • Familiarity for various protein characterization techniques (IEF, SEC, etc.)
  • 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

Submit CV/Resume