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 addi…
Skills: Population PKPD Modeling, Exposure-Response Analysis, T-cell Engagers, Immunology, Rstudio
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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 addition…
Skills: Population PKPD Modeling, Exposure-Response Analysis, T-cell Engagers, Rstudio, NonMem
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$225k–$262k/yr
Full-time
postgraduate degree
401k Match, Healthcare Coverage, Employee Stock Purchase Plan (ESPP), Annual Bonus, Equity Grant
Posted 24d ago
~40 hrs/week
Remote in United States
Responsibilities
Lead the pre-clinical and clinical investigation of PKPD, safety, and efficacy relationships for novel T-cell engagers and immune-based therapeutics. Build population models to inform dose selection, support regulatory interactions, and collaborate cross-functionally to optimize dose-escalation and RP2D decisions.
Requirements
Requires a Master's degree with 10+ years of experience or a PhD with 7+ years of experience in Pharmacokinetics or a related field. Must have prior experience with T-cell engagers and proficiency in modeling software such as NonMem, Monolix, or PUMAS.
Full job description
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 www.xencor.com. We have an excellent opportunity for aDirector, Pharmacometrics& Quantitative Medicine to join our team.
This position can be hybrid with 2 days a week onsite from either our Pasadena or San Diego office or remote with candidate available during PST working hours.
Summary:
Responsible for pre-clinical and clinical investigation of pharmacokinetic vs. pharmacodynamic, safety, efficacy and other related biomarker relationships for novel T-cell engagers and immune-based therapeutics.
Primary Responsibilities:
Builds population PKPD models with covariates to inform dose selection and support regulatory interactions
Conducts exposure-response analysis for safety and efficacy using multiple univariate and multivariate methods to inform the risk-benefit profile of XmAb drugs
Build models for characterizing tumor-growth dynamics and inform expected longer term outcomes like DoR, PFS and OS based on early clinical data
Explore novel methods like AI/ML to be able to discover hidden more complex relationships between endpoints of interest and relevant variables/covariates.
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 diseases.
Collaborates 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 decisions
Collaborate with research to inform candidate selection and implement techniques such as tumor growth inhibition models to preclinical efficacy studies.
Authors and reviews team documents including but not limited to statistical analysis plan, PKPD-ADA analysis plan, and regulatory submissions such as briefing documents, INDs, IB, clinical study reports, CTAs and NDAs
Manages functional contractors and consulting organizations to support additional workload as needed
Maintains current knowledge of the field and area(s) of scientific and technical expertise and development
Adheres to all department and company-wide policies regarding conduct, performance and procedures
Provides oversight and direction to direct and indirect reports, as applicable, in accordance with the organization’s 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 opportunities
Performs other duties as assigned.
Education/Experience/Skills:
Position requires a Master’s 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 CRO’s with timely delivery of clear, accurate and well-written study findings also required. Prior experience with T cell engagers is required.
Position also requires:
Strong immunology and T-cell engager knowledge
Proficiency with hands-on data analysis, modelling, and reporting using Rstudio, NonMem, Monolix, PUMAS or equivalent
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
Strong knowledge and user competency in additional common software and data analysis packages (e.g., Microsoft Office Suite, SoftMax Pro, GraphPad Prism, JMP)
Ability to demonstrate competencies applicable for job based on Xencor’s Leadership Competency Model. Ability to effectively manage others through coaching and supervision, in accordance with company policies and practices
Ensures employee performance meets the organization’s expectations for conduct, productivity, quality, continuous improvement, and goal accomplishment.
Occasional travel may be required, including travel between Xencor’s Pasadena and San Diego offices. Work for this position is generally performed at Xencor’s worksite and requires full-time commitment.
Expected Base Salary Range: $225,000 - $262,000
The actual salary will be based on the selected candidate’s qualifications, including skills, competencies, education and experience. Xencor offers a competitive total rewards package including 401k match, healthcare coverage, ESPP and a broad range of other benefits. In addition, this position will be eligible for an annual bonus and equity grant. For more information, please see https://xencor.com/careers/.
Americans with Disabilities Act (ADA) Statement
The 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 [email protected].
To 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 functions.
Equal Employment Opportunity (EEO) Statement
The 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 law.
Xencor 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.
Designing Proteins. Delivering Medicines.
Antibody and protein biotherapeutics are changing the way physicians treat autoimmune diseases, asthma, and cancer. At Xencor, we apply proprietary protein engineering technologies to develop better biotherapeutics – antibodies that target new biological mechanisms and are more potent, safer and longer lasting – to improve patient outcomes and quality of life.
Our XmAb antibody engineering technology dramatically augments natural antibody immune functions while maintaining over 99.5% identity to natural antibodies. This combination of new, highly potent activities while maintaining the beneficial drug features and simplicity of natural antibodies allows us to create differentiated drug candidates with potential for breakthrough performance. The XmAb® platform has resulted in a robust pipeline of antibody product candidates, including eight in human clinical trials being developed by Xencor and by pharmaceutical partners.
Xencor is also discovering biologics products that improve the performance of old antibody drugs, known as biosuperiors, to benefit patients, ease compliance and help reduce costs.
Offices: 465 N Halstead St, Suite 200, Pasadena, California 91107, US · 12770 High Bluff Drive Unit 260, San Diego, CA 92130-2077, US
Protein engineeringDrug developmentAntibody drugsBiotechnologyOncologyAutoimmune diseaseBispecific antibodiesand CytokinesHealth CareBiotechnology
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