Description
Headquarters Location: South San Francisco, CA
Candidate Location: Hybrid
Travel Required: 5%
Reports To: Sr. Director, Clinical Data Management
Department: Clinical Data Management
Position Type: Full-time, Exempt
About CytomX Therapeutics:
CytomX Therapeutics, Inc. is committed to changing the treatment of cancer with our novel Probody® therapeutic platform. Our commitment to transforming lives with safer, more effective therapies is driven by our curiosity and passion for innovation and our belief that by acting with integrity in an honest, respectful, ethical manner, we have the power to change lives. Our workplace embodies collaboration, open communication, celebrating our successes, and holding each other to the highest possible standards. CytomX has a broad pipeline, which comprises seven therapeutic candidates across multiple treatment modalities including antibody-drug conjugates (“ADCs”), T-cell engaging bispecific antibodies (“TCBs”), and immune modulators such as cytokines and checkpoint inhibitors (“CPIs”). Learn more at www.cytomX.com.
Who You Are and What You’ll Do:
You are passionate about life sciences and making a difference to cancer patients, their families, and healthcare providers. You will play a key role in delivering accurate, high quality clinical trial data. Overall responsibilities will include oversight of clinical data management activities from study start-up through study closure in support of trial objectives and corporate goals.
Job Responsibilities:
- Provides oversight of clinical data management activities across one or more studies
- Leads the development and maintenance of clinical data management documents, including but not limited to: Data Management Plans, Case Report Forms (CRF), CRF Completion guidelines, edit check specifications, data transfer specifications, report specifications.
- Partner with the CytomX CDM Systems & Programming team, CRO, and EDC vendors to ensure the timely design and development of clinical study databases per study requirements, including system integrations.
- Performs and organizes cross-functional User Acceptance Testing (UAT) of clinical databases and integrations.
- Reviews clinical study documents including but not limited to: Clinical Protocols, Statistical Analysis Plans (SAP), Study Plans, Project Timelines.
- Leads discussions with clinical data management partners/vendors to ensure that data management tasks and deliverables remain on target per project timelines.
- Leads and/or manages ongoing data review and data reconciliation throughout the conduct of the study to ensure timely and appropriate identification of errors, trends, and discrepancies, in collaboration with internal and external stakeholders.
- Responsible for the correction of errors and discrepancies through the query process, for documenting permanent data issues, routinely communicating issues with team members.
- Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors.
- Exercises judgments within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results.
- Other duties as assigned.
Minimum Qualifications:
- Bachelor’s degree in clinical, biological, mathematical sciences or related field is required; an advanced degree is a plus.
- Minimum 5 years of clinical data management experience in the biopharmaceutical industry; previous oncology experience required.
- Minimum 5 years of Electronic Data Capture (EDC) experience; IXRS development experience required.
- Experience with Medidata Rave required.
- Advanced knowledge of Data Management processes and systems.
- Solid understanding of clinical drug development processes.
- Excellent written and verbal communication skills.
- Experience with and understanding of ICH and GCP guidelines.
Preferred Qualifications:
- Agency filing experience a plus.
How You Will Work:
- Demonstrates collaboration and teamwork. Works well with others and understands that collaboration leads to better results.
- Possesses strong communication skills. Communicates clearly, concisely, and professionally. Listens actively to build understanding.
- Exhibits strong interpersonal skills and self-awareness. Builds and cultivates strong and enduring relationships with others. Acts with humility and understands own strengths and weaknesses.
- Shows continuous improvement and a commitment to self-management and development. Operates with a continuous improvement mindset and continuously seeks to expand own knowledge and capabilities.
- Demonstrates a patient focus. Puts the patient first in actions and decisions taken.
Compensation, Benefits, and So Much More
- The expected salary range for this role based on the primary location for this position in California is $155,000 – $175,000 per year. Offer amounts are determined by factors such as experience, qualifications, geographic location, and other job-related factors permitted by law.
- A great environment where we work collaboratively, leverage each other’s strengths, and work toward a shared vision with our common goals of doing the best thing for patients.
- A robust and enduring approach to your development and career growth fueled by a strong learning curriculum and career guidance that helps you understand how you can grow your career at CytomX.
- A robust and highly competitive total rewards program that helps you achieve your compensation goals while supporting a great work / life balance.
Conditions of Employment
- Background investigations are required for all positions at CytomX, consistent with applicable law.
CytomX’s Commitment to Diversity, Equity, Inclusion, and Belonging (DEIB)
CytomX believes that DEIB helps drive our success, and we encourage candidates from all identities, backgrounds, and abilities to apply. We are an equal opportunity employer committed to building an inclusive, innovative work environment with employees who reflect our values and ultimately, serve our patients. Therefore, in all aspects of the employment process, we provide employment opportunities to all qualified applicants without regard to race, color, religion, sex, disability, age, sexual orientation, gender identity or expression, pregnancy, medical condition related to pregnancy, creed, ancestry, national origin, marital status, genetic information, or military status, or any other protected status in accordance with applicable law.
Further, we are committed to the full inclusion of all qualified individuals. As part of this commitment, we (and the agencies we work with) will assist individuals who have a disability with any reasonable accommodation requests related to employment, including completing the application process, interviewing, completing any pre-employment testing, participating in the employee selection process, and/or to perform essential job functions where the requested accommodation does not impose an undue hardship. If you have a disability and require reasonable accommodation, or need other assistance in applying for or interviewing for this position, please direct your inquiries to Human Resources, at [email protected]
Notice to Recruiters/Staffing Agencies
Recruiters and staffing agencies should not contact CytomX Therapeutics through this page. We require that all Recruitment Vendors (e.g., search firms, recruitment agencies and staffing companies) have a fully executed, formal written agreement on file with CytomX prior to submitting candidates. Any resumes submitted through the website or directly by Recruitment Vendors will be considered unsolicited. Unsolicited vendor submissions do not constitute any actual or implied contract with CytomX, and CytomX will not be responsible for any purported fees. For more information, please contact our HR team at [email protected]
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