Director, Clinical Pharmacology & Pharmacometrics
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Job Location:
Pasadena, TX - USA
Monthly Salary:
Not Disclosed
Posted on:
3 days ago
Vacancies:
1 Vacancy
Job Summary
Introduction:Xencor is a public clinical-stage biopharmaceutical company located in the Los Angeles area (Pasadena) and in San Diego. Our focus is developing high-potential XmAb bispecific T-cell engagers and additional engineered drug candidates that leverage our differentiated technology platforms and we are advancing our pipeline toward clinical proof-of-concept decisions. Our goal is to create high-impact therapeutics for patients with cancer and other serious diseases. More than 20 XmAb drug candidates engineered with our technology are in clinical development and three XmAb medicines have been marketed by partners. For more information please visit . We have an excellent opportunity for a Director Clinical Pharmacology & Pharmacometrics to join our position is hybrid with 2 days a week onsite from either our Pasadena or San Diego office. This position has the potentially to be fully : Responsible forpre-clinical and clinical investigation of pharmacokinetic and pharmacodynamic (PK/PD) relationships for novel T-cell engagers and immune-based Responsibilities:Integrates pharmacokinetic and pharmacology expertise to support preclinical and clinical activities for programs including T-cell engaging bispecifics for oncology or auto-immune and other immunology-based therapeutics for autoimmune compartmental or non-compartmental models for PK including population PK models with covariatesConduct exposure response analyses for safety as well as efficacy to help support dose decisions within a trial and from one trial to the next Supports candidate selection and pre-IND activities including FIH dose selectionCollaborates cross-functionally with Research/Biometric/Bioinformatics/Clinical/ Translational team to analyze and integrate PKPD and activity readouts to inform dose optimization dose-escalation/expansion and RP2D/RP3D decisionsLeads the execution of clinical pharmacology studiesAuthors and reviews documents including clinical protocols and regulatory submissions such as briefing documents INDs IB clinical study reports CTAs and NDAsManages functional contractors to support additional workload as neededMaintains current knowledge of the field and area(s) of scientific and technical expertise and developmentAdheres to all department and company-wide policies regarding conduct performance and proceduresProvides oversight and direction to direct and indirect reports as applicable in accordance with the organizations policies and procedures. The responsibilities may include but are not limited to recruiting training communicating job expectations appraising and managing job performance delivering feedback and coaching and providing career development planning and opportunitiesPerforms other duties as assigned. Education/Experience/Skills:Position requires aMasters degree in Pharmacokinetics Pharmaceutical Sciences Pharmacology Applied Mathematics or a related discipline plus a minimum of 10 years of related experience; a PhD with 7 years of related experience is preferred. Experience managing external service providers and CROs with timely delivery of clear accurate and well-written study findings also required. Strong immunology experience and prior experience with T cell engagers is also requires:Strong immunology knowledgeProficiency with hands-on data analysis modelling and reporting using Phoenix WinNonLin MATLAB Rstudio NonMem Monolix PUMAS or equivalent Strong knowledge and user competency in additional common software and data analysis packages (e.g. Microsoft Office Suite SoftMax Pro GraphPad Prism JMP) Strong knowledge of drug development and FDA and ICH guidance documents Excellent communication skills including technical writing and verbal communications for productive cross-functional team interactions Ability to demonstrate competencies applicable for job based on Xencors Leadership Competency Model. Ability to effectively manage others through coaching and supervision in accordance with company policies and practices Ensures employee performance meets the organizations expectations for conduct productivity quality continuous improvement and goal travel may be required including travel between Xencors Pasadena and San Diego offices. Work for this position is generally performed at Xencors worksite and requires full-time commitment. Expected Base Salary Range: $225000 - $262000 The actual salary will be based on the selected candidates qualifications including skills competencies education and offers a competitive total rewards package including 401k match healthcare coverage ESPP and a broad range of other addition this position will be eligible for an annual bonus and equity grant. For more information please see with Disabilities Act (ADA) StatementThe Company will provide reasonable accommodations (such as a qualified sign language interpreter or other personal assistance) with the application process upon your request as required to comply with applicable laws. If you have a disability and require assistance in this application process please contact perform this job successfully an individual must be able to perform each essential duty satisfactorily. Reasonable Accommodations may be made to enable qualified individuals with disabilities to perform the essential Employment Opportunity (EEO) StatementThe Company is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to age race color religion sex sexual orientation gender or gender identity national origin disability status protected veteran status or any other characteristic protected by state or federal does not accept profiles or resumes from recruiting vendors without a binding written agreement. Any unsolicited submission of services and or resumes in no way creates an obligation or duty by Xencor implied or otherwise.
Required Experience:
Director
