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 and vaccines that matter most. Whether you are in the discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, you will apply cutting edge design and process development capabilities to accelerate and bring the best-in-class medicines to patients around the world. What You Will Achieve
As the Director, Viral Immunoassays
in the High-throughput Clinical Immunoassays & Diagnostics (HCID)
group, you will be a leader within Pfizer Vaccine R&D (VRD), reporting to the Head of HCID-Immunoassays. In this role, you will oversee clinical testing operations specifically supporting Pfizer's Viral Vaccine programs, including, but not limited to, SARS-CoV-2, RSV, and influenza. You will lead an organization of multiple senior managers who have oversight of specific types of assays and are tasked with validation of high-throughput bio-functional immunoassays and their execution to read-out the immune responses to Pfizer's vaccine candidates.
The scope will include bio-functional clinical assays such as virus neutralization assays, hemagglutination inhibition assays, and others, executed in a high-throughput testing environment following GCLP guidelines. You will work closely with cross-functional teams (eg, Assay Development, Statistics, Clinical Research) to ensure bio-functional assay methods are successfully validated and implemented to deliver high-quality clinical results for Pfizer's phase 3 clinical programs to advance Pfizer's vaccine portfolio. In addition, the position is expected to serve as an immunology and vaccine clinical assay SME for vaccine program team(s) to which they are assigned. How You Will Achieve It
- Lead team of colleagues ranging from Associate Director level to junior Associate Scientist level along with 3 direct reports to set long-term team goals and strategies for achieving those goals.
- Present experimental results, strategies, and timelines at project meetings, department meetings, and to senior VRD leadership
- Support ongoing clinical testing, including troubleshooting technical issues and managing resources
- Address assay-related queries from regulatory agencies
- Collaborate with cross-functional teams to shape overall immunoassay clinical testing strategy supporting the vaccine development pipeline
- Contribute to the selection of commercial assay partners and manage interactions with the vendors supporting clinical studies
- Stay current on clinical assay techniques and platforms by participating in scientific meetings/ seminars and through regular scientific review; advise management on new approaches and technology
- Provide training to develop assay experts in testing groups
- Prepare and review documentation supporting the life cycle of the assay, including assay test methods, reagent qualifications, and other supportive documentation
- Contribute to a culture that embraces continuous learning, development, and collaboration
- PhD with 7+ years of relevant industry experience in High throughput clinical testing.
- Expertise in virology, immunology, vaccinology, or related field
- Demonstrated leadership and management experience-of both direct reports and cross-functional projects for a minimum of 5 years.
- Pharmaceutical or CMO experience in Assays
- Working knowledge of laboratory operations in a GCLP environment, including SOPs, instrument IOQ/PQ, and good documentation practices
- Knowledge and experience with viral, cell-based bio-functional serological immunoassays
- Experience in assay validation
- Experience scaling up operations for large-scale high-throughput clinical testing campaigns
- Demonstrated ability to drive, manage, and deliver results in cross-functional projects
- Experience with automating testing workflows and use of laboratory automation systems
- Demonstration of a breadth of leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact
- Strong communication and interpersonal skills
- Scientific technical writing experience
- Experience interacting with regulatory agencies
- Ability to thrive in fast-paced, changing environment
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact. PHYSICAL/MENTAL REQUIREMENTS
Ability to perform work while standing/sitting. NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
- This position may require occasional weekend and evening work to meet critical business timelines.
- This position may require occasional travel to scientific meetings, between Pfizer sites and other business-related travel.
Relocation support available
Work Location Assignment:On Premise
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.
Research and Development