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About the Role

This cross-functional role includes working directly with the study team and vendors to ensure execution on the clinical strategy, as well as assembling, evaluating, and presenting operational data. The Clinical Trial Manager will report to the Vice President, Clinical Operations and collaborate closely with Clinical Development, Clinical Pharmacology, Biostatistics, Data Management, Sample Management and Program Management.

Responsibilities

Develops and manages the execution of clinical trial operational activities to ensure completion according to timelines while anticipating potential study problems and preparing contingency plans as needed.
Works directly with study team and/or vendors on development of study documents, plans and manuals including but not limited to: protocol and amendments, investigator brochure, informed consent form, annual reports, clinical study report, pharmacy manual, laboratory manual and internal data review plan.
Develops and ensures compliance with clinical monitoring plan and associated key performance indicators (KPIs).
Reviews monitoring trip reports and ensures accurate identification, tracking and resolution of all protocol deviations and action items.
Collaborates with the clinical development team to ensure appropriate data review and accurate data reporting.
Procures and manages contracts with CROs, study vendors and investigative sites.
Provides vendor oversight of assigned clinical trial vendors.
Reviews and approves vendor and investigative site invoices.
Manage, either directly or through supervised delegation, other study-wide activities such as sample handling, drug re-supply and investigator payments.
Provides frequent study updates to management upon request.
Partners with study team to ensure trial activities are documented in the trial master file in accordance with regulatory requirements and SOPs.
Collaborates cross functionally in the preparation of scientific publications including posters, abstracts, and manuscripts.
Supports the implementation of new clinical SOPs, systems and processes.
May mentor, manage and develop other team members.

Requirements

A minimum of a Bachelor's degree in clinical, biological, mathematical sciences or related field is required, an advanced degree is preferred.
A minimum of 5 years pharmaceutical development experience is strongly preferred with 3+ years of CTM or study lead experience.
Oncology experience is required, gastrointestinal cancer experience is strongly preferred.
Prior experience managing or leading Phase I oncology trials is required.
Veeva Vault or similar system experience is strongly preferred.
Demonstrated experience operating in a small or early-stage biotech environment with direct hands-on ownership of study execution (not soley CRO oversight), is required.
Must have demonstrated problem solving abilities and strong organizational skills.
Excellent written and verbal communication skills are required.
Experience and understanding of ICH and GCP is preferred.
Must be a demonstrated self-starter and team player with strong interpersonal skills.
Demonstrates collaboration and teamwork.
Possesses strong communication skills.
Exhibits strong interpersonal skills and self-awareness.
Shows continuous improvement and a commitment to self-management and development.
Demonstrates a patient focus.

Skills

Clinical trial management
Clinical operations
Data review
Data reporting
Vendor management
Contract management
Invoice approval
Sample handling
Drug re-supply
Investigator payments
Trial master file documentation
Scientific publication preparation
SOP implementation
Problem solving
Organizational skills
Written communication
Verbal communication
ICH
GCP
Teamwork
Interpersonal skills
Self-management
Development

Location

Emeryville, CA

Work Type

Hybrid
Full-time

Experience Level

3+ years of CTM or study lead experience
5 years pharmaceutical development experience

Education Level

Bachelor's degree in clinical, biological, mathematical sciences or related field
Advanced degree preferred

Salary/Compensations

$135,000 - $165,000 per year

Benefits

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.

About the Company

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.

Equal Opportunity

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 hr@cytomx.com