Pfizer Senior Manager, Diagnostics Lead in San Diego, California
A career at Pfizer offers opportunity, ownership and impact.
All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
Diagnostics Lead, Senior Manager, working under the guidance of Diagnostics Lead(s), is responsible to provide expertise and front-line help to relevant Research as well as Early Development teams in Oncology in considerations for inclusion of Diagnostics in drug programs, provision and implementation of all relevant documents to such programs, and coordination of all downstream work within the Diagnostics Group as well as relevant internal- and external-facing organizations
• Serving on relevant Early Clinical Development teams and Study teams in Oncology as a resource and authority to provide advice on inclusion of Diagnostics as appropriate
• Accountable for timely implementation of Diagnostics plans in relevant project documents for such programs in, including but not limited to, late Pre-clinical through Early Development
• Under the guidance of relevant Diagnostics Leads, accountable for timely delivery of high quality companion diagnostics required for the successful regulatory approval and commercialization, including identification of appropriate external partners and program oversight
• Accountable for the operational excellence and quality of companion diagnostics
• Accountable for sharing of key learnings in companion diagnostics across RUs and BUs as needed
• Working closely with relevant Diagnostics Lead(s) to obtain necessary guidance to make sure the above responsibilities are executed in concordance with overall strategy for all programs
• Closely working with Diagnostics Operations Leads to ensure all lab manuals, tissue requisition forms, CRFs and relevant Diagnostics SOPs are considered and oversight at testing facilities are provided in these programs
• Other duties as assigned
• Bachelor's degree in life or biomedical sciences with focus on genetics, molecular biology, oncology, clinical translational medicine, biomarker development or related field
• Detailed understanding of in vitro diagnostics landscape and technologies
• Working level understanding of diagnostics platforms for in vitro diagnostics is required
• Working knowledge of diagnostic development regulations in USA, EU and other key regions
• 3-5 years of experience in pharma and/or diagnostics companies in similar roles
• Previous industry experience relevant to Diagnostics and/or Oncology
• Hands-on experience with development of diagnostic assays / products in a lab environment
• Effective verbal and written communication as well as negotiation skills to build relationships both inside and outside the organization
• Team player who is able to articulate clear and strategic goals with measurable metrics
• Self-motivated, results oriented individual who is able to work with minimal supervision
• Working knowledge of IVD requirements including QSR compliance and class 3 medical device regulations
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.
Colleagues who are issued an Incident Final Warning (IFW) on or after January 1, 2016, are not eligible to post and compete for a position for a period of 12-months from the date an IFW is issued.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.