Director, Pharmacokinetics, Early Development Vaccines

Job Description

Director – Early Development Vaccines

Description

Our company is a global healthcare leader with a diversified portfolio of prescription medicines, vaccines, and consumer health products, as well as animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.

Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity, and teamwork of people like you. To this end, we strive to create an environment of mutual respect, encouragement, and collaboration. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

The Department of Pharmacokinetics, Dynamics, Metabolism, and Bioanalytics (PDMB) Regulated Bioanalytics at Spring House Innovation Park (SHIP) is seeking a Director to join our company and lead a team of approximately 10 scientists to deliver bioanalytical solutions that enable and accelerate vaccine clinical development. The Director will report to the Executive Director of Early Development Vaccines and be part of the leadership team to design and execute a modernization effort to accelerate vaccine development. 

The primary role of the successful candidate will be to lead a team to support vaccine early development (Phase 1 and 2) and contribute to drug discovery and development teams within the Infectious Disease and Vaccines therapeutic areas via overseeing a broad portfolio of molecular and cell-mediate based serology assays and collaborating with CROs for assays that are outsourced.  The successful candidate will be a scientific leader with a passion for developing assays, delivering high-quality data, and helping teams develop a clinical assay strategy for data-driven decision-making. A record of accomplishment of successful collaboration while working in cross-functional project teams is expected.  The successful candidate will also have responsibility for mentoring, scientific supervision, and training scientists to become our future leaders.

Qualifications

Education:

• A Ph.D. or doctoral level degree in Biology, Immunology, Chemistry, Biochemistry, Pharmaceutical Sciences, or related area with 8+ years, a MS degree with 10+ years, or BS degree with 14+ years of relevant experience

Required:

• 8+ years of experience in molecular biology, immunogenicity and cell-based assay development and optimization.

• Actively working with staff to encourage and facilitate their personal and scientific development.

• A strong aptitude for and previous experience in managing inclusive scientific teams and attracting, developing, and retaining diverse talent.

• Maintaining a strong network internally and across the external academic and regulatory community is expected, as well as advancing a culture of scientific excellence and curiosity.

• Setting future strategies and bringing new technologies into the regulated labs.

• Partner with our Outsourcing team to provide scientific oversight at our Clinical Research Organizations (CROs) to ensure data quality and accuracy is aligned with our company's expectations.

• Has in-depth understanding of the drug discovery and/or development process and comprehensive knowledge of the principles and concepts of bioanalytical and/or vaccine clinical testing/regulatory filing. 

• Strong technical expertise in bioanalytical assay design, development, and execution in support of antiviral, antibacterial, cell and gene therapy, and/or vaccine discovery.   Has advanced knowledge in multiplexed immunogenicity and cell-based assays.

• Candidate must be trained in GLP and GCLP requirements and must have experience working in a regulated laboratory environment.

• Proven ability to lead the development of new, innovative bioanalytical techniques including experience in new assay technology evaluation and optimizing these technologies to garner health authority approval.

• Established external scientific reputation (e.g. publication record, leadership in consortia, external presentations).

Preferred:

• Experience with immunoassay platforms such as MesoScaleDiscovery, Luminex, ELISA, AphaLISA is a plus

• Experience in cell-based functional assays to monitor immunogenicity.

• Familiar with liquid handlers and other automation/robotic platforms for sample preparation and assay process.

• Working knowledge and proponent of developing a strategy to utilize a standardization process for Data Analysis and strong supporter of using the Design of experts to improve