Senior Scientist, Pre-Clinical Assay Group

Why Patients Need You

Pfizer's purpose is to deliver breakthroughs that change patients' lives. Research and Development is at the heart of fulfilling Pfizer's purpose as we work to translate advanced science and technologies into the therapies. Through strategic sourcing, you will apply cutting edge capabilities to accelerate and bring the best in class medicines to patients around the world.

What You Will Achieve

As a Senior Scientist, you will be at the center of our operations and you'll find that everything we do, every day, is in line with an unwavering commitment to quality. You will be r esponsible for managing the coordination and logistics of a full range of ADME, pharmacokinetic, regulated bioanalytical and specialty outsourced studies. Core responsibilities will include managing the costing estimates, study placement, financials and oversight of outsourced ADME studies including early discovery through IND and NDA enabling BA/TK programs towards successful delivery of method acquisition, facilitation of method transfer, study coordination, study monitoring and bioanalytical troubleshooting for regulated bioanalytical studies. Duties also include technical evaluations of new CROs, onboarding CROs, SOP reviews and management/oversight of all regulatory, bioanalytical and logistical aspects of the studies towards successful completion of deliverables

How You Will Achieve It

• Vendor evaluation, relationship/contract development and management
• Finance Reporting and Metrics Maintenance
• Continuous Improvement in productivity and work process development and optimizations
• Support sourcing of studies and assays needed for internal portfolio, in-licensed assets and for external partners of choice. Support will include discovery ADME assays as well as regulated bioanalysis and toxicokinetics for GLP studies interfacing with PDM project representatives and discipline experts to understand portfolio needs
• For Regulated bioanalytical/TK sourcing: Technical assay transfer, project management, cross-site and cross-discipline coordination with internal Study Directors, PDM project representatives, CRO PIs, PDM bioanalytical members, and others as needed to ensure timely execution of studies.
• Regulatory guidance on local, regional and international regulations and guidance documents.
• Review of deliverables for compliance with procedures and regulations, adequacy of quality and achievement of acceptance criteria.
• Adhering to and managing timelines to ensure timely analysis and reporting of TK data
• Additional responsibilities and activities may also be involved commensurate with business need and incumbent's capabilities

Qualifications

Must-Have

• Bachelor's Degree
• 9+ years of experience
• Industry experience in the field of absorption, distribution metabolism and excretion
• Experience interacting and coordinating outsourced studies for regulated bioanalytical, setting-up contractual work agreements, and managing CRO priorities and timelines
• Good knowledge of ADME principles, drug development stages and the studies run to characterize ADME properties
• Knowledge of LC/MS methods for resolving pharmacokinetic parameters and a strong understanding of method development processes, acceptance criteria and incurred sample reanalysis for regulated studies/compounds.
• Demonstrates strong business acumen- Knows how businesses work; knowledgeable in current and possible future policies, practices, trends, technology, and information affecting his/her business and organization; knows the competition; is aware of how strategies and tactics work in the marketplace.
• Enjoys working hard; is action oriented and full of energy for the things he/she sees as challenging; not fearful of acting with a minimum of planning; seizes more opportunities than others.
• Strong interpersonal and communication skills, and a great team player who is well versed working in a matrix organizational system.
• Reliable and flexible to accommodate the changing regulatory and business needs.
• Good knowledge of regulatory requirement governing ADME and drug safety evaluation.
• Good understanding of modern bioanalytical chemistry.

Nice-to-Have

• Master's degree or PhD and 7+ years of relevant experience

PHYSICAL/MENTAL REQUIREMENTS

sitting, standing, walking

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

some travel (10-20%)

Other Job Details:

Eligible for Employee Referral Bonus: YES

Last Day to Apply: July 4, 2022

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

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.

Research and Development