Pfizer, S.A. de C.V
Biologics & Immunogenicity Clinical Assay Lead
Pfizer, S.A. de C.V, San Diego, California, United States, 92189
Biologics & Immunogenicity Clinical Assay Lead
United States - Massachusetts - Cambridge
We’re in relentless pursuit of breakthroughs that change patients’ lives. We innovate every day to make the world a healthier place.
To fully realize Pfizer’s purpose – Breakthroughs that change patients’ lives – we have established a clear set of expectations regarding “what” we need to achieve for patients and “how” we will go about achieving those goals.
Pfizer Research & Development serves as the beating heart of Pfizer's trailblazing product pipeline, the essence of our mission to bring life‑changing medicines to the world.
Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues.
As a member of Clinical Bioanalytics within Translational Clinical Sciences, the Biologics & Immunogenicity Clinical Assay Lead will play a critical role in supporting clinical strategies in all stages of drug development and post‑marketing activities through scientific and technical leadership, oversight and management of external and internal partners involved in delivering quality, timely, and regulatory compliant PK, PD, and/or immunogenicity bioanalytical assays and data.
Organizational Relationships Reports to Biologics and Immunogenicity Group Lead or Small Molecule Clinical Assay Lead with supervisor responsibilities, Clinical Bioanalytics, within Translational Clinical Sciences.
Frequent interaction with colleagues in Translational Clinical Sciences, Clinical, Medicines or Biomedicines Design (PDM/BMD), Clinical Operations, Data Management, Statistics, Regulatory, and Finance, as appropriate.
Frequent interaction with bioanalytical Contract Research Organizations (CROs), Central Laboratories, and, as appropriate, external collaborators.
Member of Clinical sub‑teams and study teams.
Primary Responsibilities
Serve as a member of the clinical study team and bioanalytical subject‑matter expert for executing clinical study setup & conduct, contributing to protocol development & review, preparing submissions, addressing regulatory queries, implementing bioanalytical strategies & assays, and delivering regulatory compliant data and reports within program timelines.
Lead and oversee large molecule PK, PD, and immunogenicity (ADA and Nab) assay lifecycle management from early stage to registration encompassing analytical strategy, development and method design, validation, data quality review, sample analyses & reporting to meet evolving program objectives and regulatory expectations. Assist CROs with effective troubleshooting of the bioanalytical assay and issue resolution.
Function as key point of contact with external & internal laboratories and support (or lead, as appropriate) selection, qualification, performance evaluation, and periodic visits and audits of CRO laboratories conducting clinical PK, PD and immunogenicity assays.
Support the clinical trial conduct within scope of the Clinical Bioanalytics responsibilities, including development and review of documents and processes such as CRF and data setup, clinical site lab manual, sample management & reconciliation, bioanalytical study planning & reporting, budgeting & invoicing, compliance with clinical SOPs & policies, and regulatory inspection readiness & conduct.
Contribute to the development of best practices, processes, templates, and policies.
Maintain up‑to‑date knowledge of current and novel ligand binding technologies & techniques, global regulatory guidance & expectations, and industry best practices.
Lead development of novel complex methodologies, troubleshooting & resolution of complex technical & logistical issues with vendors and study teams. Identify technology/capability gaps and propose mitigation strategies, including development of novel technical capabilities with vendors. Scientifically evaluate complex data, anticipate and correct potential issues, and guide study teams through complex issue resolution.
Lead internal and cross‑functional organization initiatives, best practices and demonstrate internal and external influence.
Provide subject‑matter expertise, guidance and mentoring to colleagues. May have responsibility for dot‑direct line management of staff.
Qualifications Must Have
PhD or equivalent in biology or analytical chemistry/chemistry with 2 to 6 years of experience
M.S with 3 to 6 OR B.S. with 7 to 10 years of relevant industry experience.
Minimum of 5–8 years of industry or bioanalytical experience with PK and/or immunogenicity assay development, validation, and sample analyses involving ligand binding (ELISA and ECL) methodologies.
Working knowledge of GxP regulations governing conduct of clinical trials and regulatory guidance and expectations relevant to regulated bioanalysis.
Subject‑matter expert in regulated bioanalysis of biologics and understanding of bioanalytical techniques commonly used for biomarkers.
In depth knowledge of GxP regulations governing conduct of clinical trials and regulatory guidance and expectations relevant to regulated bioanalysis.
Demonstrated ability to think strategically, work in a highly matrixed environment, and execute multiple projects simultaneously.
Highly effective communication skills: verbal, written, and presentation.
Nice to Have
Demonstrated CRO management and outsourcing experience.
Experience with regulatory inspections.
Experience preparing regulatory submissions and addressing regulatory queries.
Understanding of clinical trial design and overall principles of clinical development and related disciplines (e.g., pharmacokinetics and clinical pharmacology, statistics, ADME, formulation and drug product).
Prior experience with training, mentoring, or managing colleagues.
Hands‑on experience with the development, validation and troubleshooting of the methods for PK and immunogenicity (including the determination of assay cut points, tolerance, and sensitivity along with experience implementing ACE, BEAD, and SPEAD methodologies) and clinical sample analysis.
Hands‑on experience with the development, validation, and troubleshooting of LC/MS quantitation of large molecules and immunocapturing hybrid assays.
Understanding of critical reagent generation & lifecycle management.
Experience with biosimilars, gene therapy, multi‑domain therapeutics, immunocapture, protein binding, cell‑based assays and technologies such as RT‑PCR, qPCR, ELISPOT, AMS and FACS.
Other Job Details Work Location Assignment: On Premise
The annual base salary for this position ranges from $135,100.00 to $225,100.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 17.5% of the base salary and eligibility to participate in our share‑based long‑term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer matching contributions, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Relocation assistance may be available based on business needs and/or eligibility.
Sunshine Act Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
EEO & Employment Eligibility Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E‑Verify employer. This position requires permanent work authorization in the United States.
Breakthroughs that change patients’ lives Research confirms what intuition tells us: that purpose‑driven companies perform better, are more innovative, attract and retain the best people, and know how to unleash the power of those people. Pfizer’s purpose—Breakthroughs that change patients' lives—fuels everything we do and reflects our passion for building on our legacy as one of the greatest contributors of good to the world.
Our Values To fully realize Pfizer’s purpose, we have established a clear set of expectations regarding “what” we need to achieve for patients and “how” we will go about achieving those goals.
The “how” is represented by four simple, powerful values—courage, excellence, equity, and joy—that define our company and our culture.
Courage:
Breakthroughs start by challenging convention, especially in the face of uncertainty or adversity. This happens when we think big, speak up, and are decisive.
Excellence:
We can only change patients’ lives when we perform at our best together. This happens when we focus on what matters, agree who does what, and measure our outcomes.
Equity:
We believe that every person deserves to be seen, heard, and cared for. This happens when we are inclusive, act with integrity, and reduce healthcare disparities.
Joy:
We give ourselves to our work, but it also gives to us. We find joy when we take pride, recognize one another, and have fun.
Benefits at Pfizer Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues. Our Pay for Performance Philosophy and Practices reward colleagues based on the contributions they make to our business.
Our Competitive Benefits Programs help our colleagues by:
Promoting Health and Wellness
to help colleagues maintain and improve their physical and mental wellbeing. Pfizer offerings include health and disability insurance, preventative health programs, medical screenings, free or reduced‑cost vaccinations, discounts on Pfizer products, mental health support, nutrition and fitness counseling and more.
Strengthening Colleagues’ Financial Security
by providing company contributions to retirement plans, life insurance and financial planning education to help colleagues achieve their financial goals.
Providing Benefits and Time off for the Moments that Matter
to ensure Pfizer colleagues have the time away from the office to recharge, recover and return to work as the best version of themselves. Vacation, Holiday time and Sick time are just the beginning, with a 12‑week parental leave policy for both parents of a newborn, 10 days of caregiver leave for those times when your family needs you, bereavement leave and additional country‑specific programs.
And so much more , depending on your country and site, Pfizer offers childcare facilities or discount programs, on‑site health and/or fitness centers, movement and mindfulness solutions, “Log in for your Day” work flexibility and so much more.
#J-18808-Ljbffr
We’re in relentless pursuit of breakthroughs that change patients’ lives. We innovate every day to make the world a healthier place.
To fully realize Pfizer’s purpose – Breakthroughs that change patients’ lives – we have established a clear set of expectations regarding “what” we need to achieve for patients and “how” we will go about achieving those goals.
Pfizer Research & Development serves as the beating heart of Pfizer's trailblazing product pipeline, the essence of our mission to bring life‑changing medicines to the world.
Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues.
As a member of Clinical Bioanalytics within Translational Clinical Sciences, the Biologics & Immunogenicity Clinical Assay Lead will play a critical role in supporting clinical strategies in all stages of drug development and post‑marketing activities through scientific and technical leadership, oversight and management of external and internal partners involved in delivering quality, timely, and regulatory compliant PK, PD, and/or immunogenicity bioanalytical assays and data.
Organizational Relationships Reports to Biologics and Immunogenicity Group Lead or Small Molecule Clinical Assay Lead with supervisor responsibilities, Clinical Bioanalytics, within Translational Clinical Sciences.
Frequent interaction with colleagues in Translational Clinical Sciences, Clinical, Medicines or Biomedicines Design (PDM/BMD), Clinical Operations, Data Management, Statistics, Regulatory, and Finance, as appropriate.
Frequent interaction with bioanalytical Contract Research Organizations (CROs), Central Laboratories, and, as appropriate, external collaborators.
Member of Clinical sub‑teams and study teams.
Primary Responsibilities
Serve as a member of the clinical study team and bioanalytical subject‑matter expert for executing clinical study setup & conduct, contributing to protocol development & review, preparing submissions, addressing regulatory queries, implementing bioanalytical strategies & assays, and delivering regulatory compliant data and reports within program timelines.
Lead and oversee large molecule PK, PD, and immunogenicity (ADA and Nab) assay lifecycle management from early stage to registration encompassing analytical strategy, development and method design, validation, data quality review, sample analyses & reporting to meet evolving program objectives and regulatory expectations. Assist CROs with effective troubleshooting of the bioanalytical assay and issue resolution.
Function as key point of contact with external & internal laboratories and support (or lead, as appropriate) selection, qualification, performance evaluation, and periodic visits and audits of CRO laboratories conducting clinical PK, PD and immunogenicity assays.
Support the clinical trial conduct within scope of the Clinical Bioanalytics responsibilities, including development and review of documents and processes such as CRF and data setup, clinical site lab manual, sample management & reconciliation, bioanalytical study planning & reporting, budgeting & invoicing, compliance with clinical SOPs & policies, and regulatory inspection readiness & conduct.
Contribute to the development of best practices, processes, templates, and policies.
Maintain up‑to‑date knowledge of current and novel ligand binding technologies & techniques, global regulatory guidance & expectations, and industry best practices.
Lead development of novel complex methodologies, troubleshooting & resolution of complex technical & logistical issues with vendors and study teams. Identify technology/capability gaps and propose mitigation strategies, including development of novel technical capabilities with vendors. Scientifically evaluate complex data, anticipate and correct potential issues, and guide study teams through complex issue resolution.
Lead internal and cross‑functional organization initiatives, best practices and demonstrate internal and external influence.
Provide subject‑matter expertise, guidance and mentoring to colleagues. May have responsibility for dot‑direct line management of staff.
Qualifications Must Have
PhD or equivalent in biology or analytical chemistry/chemistry with 2 to 6 years of experience
M.S with 3 to 6 OR B.S. with 7 to 10 years of relevant industry experience.
Minimum of 5–8 years of industry or bioanalytical experience with PK and/or immunogenicity assay development, validation, and sample analyses involving ligand binding (ELISA and ECL) methodologies.
Working knowledge of GxP regulations governing conduct of clinical trials and regulatory guidance and expectations relevant to regulated bioanalysis.
Subject‑matter expert in regulated bioanalysis of biologics and understanding of bioanalytical techniques commonly used for biomarkers.
In depth knowledge of GxP regulations governing conduct of clinical trials and regulatory guidance and expectations relevant to regulated bioanalysis.
Demonstrated ability to think strategically, work in a highly matrixed environment, and execute multiple projects simultaneously.
Highly effective communication skills: verbal, written, and presentation.
Nice to Have
Demonstrated CRO management and outsourcing experience.
Experience with regulatory inspections.
Experience preparing regulatory submissions and addressing regulatory queries.
Understanding of clinical trial design and overall principles of clinical development and related disciplines (e.g., pharmacokinetics and clinical pharmacology, statistics, ADME, formulation and drug product).
Prior experience with training, mentoring, or managing colleagues.
Hands‑on experience with the development, validation and troubleshooting of the methods for PK and immunogenicity (including the determination of assay cut points, tolerance, and sensitivity along with experience implementing ACE, BEAD, and SPEAD methodologies) and clinical sample analysis.
Hands‑on experience with the development, validation, and troubleshooting of LC/MS quantitation of large molecules and immunocapturing hybrid assays.
Understanding of critical reagent generation & lifecycle management.
Experience with biosimilars, gene therapy, multi‑domain therapeutics, immunocapture, protein binding, cell‑based assays and technologies such as RT‑PCR, qPCR, ELISPOT, AMS and FACS.
Other Job Details Work Location Assignment: On Premise
The annual base salary for this position ranges from $135,100.00 to $225,100.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 17.5% of the base salary and eligibility to participate in our share‑based long‑term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer matching contributions, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Relocation assistance may be available based on business needs and/or eligibility.
Sunshine Act Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
EEO & Employment Eligibility Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E‑Verify employer. This position requires permanent work authorization in the United States.
Breakthroughs that change patients’ lives Research confirms what intuition tells us: that purpose‑driven companies perform better, are more innovative, attract and retain the best people, and know how to unleash the power of those people. Pfizer’s purpose—Breakthroughs that change patients' lives—fuels everything we do and reflects our passion for building on our legacy as one of the greatest contributors of good to the world.
Our Values To fully realize Pfizer’s purpose, we have established a clear set of expectations regarding “what” we need to achieve for patients and “how” we will go about achieving those goals.
The “how” is represented by four simple, powerful values—courage, excellence, equity, and joy—that define our company and our culture.
Courage:
Breakthroughs start by challenging convention, especially in the face of uncertainty or adversity. This happens when we think big, speak up, and are decisive.
Excellence:
We can only change patients’ lives when we perform at our best together. This happens when we focus on what matters, agree who does what, and measure our outcomes.
Equity:
We believe that every person deserves to be seen, heard, and cared for. This happens when we are inclusive, act with integrity, and reduce healthcare disparities.
Joy:
We give ourselves to our work, but it also gives to us. We find joy when we take pride, recognize one another, and have fun.
Benefits at Pfizer Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues. Our Pay for Performance Philosophy and Practices reward colleagues based on the contributions they make to our business.
Our Competitive Benefits Programs help our colleagues by:
Promoting Health and Wellness
to help colleagues maintain and improve their physical and mental wellbeing. Pfizer offerings include health and disability insurance, preventative health programs, medical screenings, free or reduced‑cost vaccinations, discounts on Pfizer products, mental health support, nutrition and fitness counseling and more.
Strengthening Colleagues’ Financial Security
by providing company contributions to retirement plans, life insurance and financial planning education to help colleagues achieve their financial goals.
Providing Benefits and Time off for the Moments that Matter
to ensure Pfizer colleagues have the time away from the office to recharge, recover and return to work as the best version of themselves. Vacation, Holiday time and Sick time are just the beginning, with a 12‑week parental leave policy for both parents of a newborn, 10 days of caregiver leave for those times when your family needs you, bereavement leave and additional country‑specific programs.
And so much more , depending on your country and site, Pfizer offers childcare facilities or discount programs, on‑site health and/or fitness centers, movement and mindfulness solutions, “Log in for your Day” work flexibility and so much more.
#J-18808-Ljbffr