Associate Director/Director, Clinical Pharmacology
About CytomX Therapeutics:
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, MD Anderson Cancer Center and ImmunoGen, Inc. For more information, visit www.cytomx.com or follow us on Twitter.
Location: South San Francisco, California
We are seeking a Ph.D. level, Associate Director/ Director to join the Clinical Pharmacology department in CytomX’s development organization. This individual will report to the Sr. Director of Clinical Pharmacology, and will be responsible for the development and implementation of both Clinical Pharmacology and Modeling and Simulation (M&S) strategies in support of our portfolio.
Integrate PK, PD, safety, and efficacy data with M&S methodologies, spanning population (PopPK) to quantitative systems pharmacology (QSP) approaches
Support multiple quantitative clinical pharmacology deliverables, both with hands-on contributions and via oversight of work conducted by external vendors
Provide both departmental representation and subject matter expertise on development teams
Author and/or review documents including clinical protocols, M&S analysis plans and reports (e.g. those related to PopPK, PK/PD, ER, QSP), study reports, regulatory documents, and journal articles
Attend and present at internal and external meetings
Support interactions with worldwide Health Authorities regarding clinical pharmacology issue
Supervise outsourced activities at multiple vendors
Ph.D. in Pharmacometrics, Biomedical or Chemical Engineering, Pharmaceutical Sciences, or related discipline
5+ years (10+ for director position) of industry, regulatory, and/or related post-doctoral quantitative clinical pharmacology experience
Demonstrated experience with leveraging M&S approaches (e.g. PopPK, clinical trial simulation, and/ or QSP modeling) to inform drug development
Excellent verbal and written communication skills and interpersonal skills
Strong leadership and project management skills
Hands-on experience with M&S software (e.g. NONMEM, R, MATLAB, and/or SimBiology)
Regulatory filing experience is highly desirable
CytomX is an equal opportunity employer. Employment decisions are based on merit and business needs. CytomX will not discriminate against any job applicant because of race, color, national origin, ancestry, gender, sexual orientation, age, religion, creed, physical or mental disability, gender identity, medical condition, pregnancy, marital status, veteran status, or any other characteristic protected by federal, state or local law.