Director/Sr. Director, Clinical Development
CytomX Therapeutics is a clinical-stage biopharmaceutical company with a deep and differentiated oncology pipeline of investigational Probody™ therapeutics. Probody therapeutics are designed to exploit unique conditions of the tumor microenvironment to more effectively localize antibody binding and activity while limiting activity in healthy tissues. The Company’s pipeline includes proprietary cancer immunotherapies against clinically-validated targets, such as PD-L1, and first-in-class Probody drug conjugates against highly attractive targets, such as CD166 and CD71, which are considered to be inaccessible to conventional antibody drug conjugates due to their presence on healthy tissue. In addition to its wholly owned programs, CytomX has strategic collaborations with AbbVie, Amgen, Bristol-Myers Squibb Company, Pfizer Inc., MD Anderson Cancer Center and ImmunoGen, Inc. For more information, visit www.cytomx.com or follow us on Twitter.
The Director/Senior Director of Clinical Development will provide clinical oversight for one or more projects and will work with a cross functional team to plan, develop, design, implement and complete clinical development (Phase 1 to 3) trials. This position will have accountability for medical monitoring, analysis, and reporting of studies. These programs will involve interactions and developing strategic relationships with research and clinical experts as well as regulatory agencies. Duties may include interaction with regulatory and other partners/stakeholders in completion and submission of investigational new drug (IND) applications.
This position may be the project leader of one or more clinical staged project and may also provide oversight for drug safety and pharmacovigilance.
As a member of the clinical leadership team, this position is responsible for establishing and maintaining a work environment focused on quality and that fosters learning, respect, open communication, collaboration, integration, and teamwork.
This position works on abstract problems across clinical programs of the business. Identifies and evaluates fundamental clinical issues across clinical programs through assessment of intangible variables.
Depending on the performance of the incumbent, this position may also have supervisory responsibility for other physicians over time and have accountability for building the clinical team.
This position will report to the Vice President of Clinical Development
• Provide medical monitoring for clinical stage programs and function as the clinical representative on the cross-functional project teams.
• Provide support for the preparation of clinical protocols, integrated clinical and statistical summary reports, journal articles, and other documents.
• Review individual adverse experience reports for accuracy and clinical importance, and summarize their relationship to the study drug. Provide reports to FDA or other regulatory agencies summarizing adverse experiences in compliance with regulatory guidelines.
• Attend and present material, as requested, at meetings within the Company as well as external meetings, such as investigator meetings.
• Play a key role in growing the company’s relationship with Investigator sites and Key Opinion Leaders.
• At the senior director level position, may function as a project team leader on one or more clinical stage project team.
• Provide cross-functional leadership to ensure project deliverables are met.
• Business travel is required.
• Other duties as assigned.
• MD board certified Internist or Pediatrician with 5+ years of experience (10+ for senior director position) in the biotechnology/pharmaceutical industry. Immunolo-oncology expertise and/or experience as well as familiarity with antibody-drug-conjugates is preferred as is board-certification in medical or pediatric oncology. Development experience with anti-cancer agents would also be a plus.
• Biotechnology/pharmaceutical experience in all phases of clinical trial, including late stage development experience and management of phase 3 clinical trials is required.
• Must be willing and possess the expertise to work within multi-disciplinary team of peers and outside experts.
• Experience with early clinical trials, data analysis and interpretation as an understanding of safety and pharmacovigilance principles is required.
• Expertise to interpret pre-clinical and translational data to inform a scientific driven clinical development plan
• Must be versed in clinical aspects of FDA and global regulatory guidance and regulations.
• Successful track record of establishing relationships with important external constituents such as clinical and/or research experts, government agencies, regulatory bodies, and advocacy groups.
• Must be highly motivated and have outstanding attention to detail, particularly in terms of medical monitoring.
• Highly effective in prioritizing tasks and goals to ensure activities are on time, on target, and within budget.
• Excellent interpersonal, verbal and written communication and influencing skills.
• Excellent clinical and scientific presentation skills.
• Excellent negotiation, judgment and decision-making skills.
• Effective working within a cross-functional team and highly collaborative.
• Committed to developing drugs that will make a difference in the life of patients.