Senior Director, Regulated Vaccine Assay Outsourcing

Job Description

Description:

The Translational Sciences & Outsourcing group in the department of Pharmacokinetics, Dynamics, Metabolism and Bioanalytics (PDMB) is seeking a Senior Director to lead the regulated vaccine assay outsourcing (OS) team. The OS function within PDMB is responsible for the oversight of contract research organization (CRO) regulated preclinical/clinical assay method development, qualification/validation, and testing in support of Our Company’s vaccine programs.  The Senior Director is a leadership position responsible for the strategic vision, oversight and operational excellence for vaccine bioanalytical outsourcing, ensuring alignment with corporate objectives and regulatory requirements. The Senior Director will oversee a multidisciplinary team of scientists in the development, validation, and execution of bioanalytical methods that support vaccine development programs at external lab partners, while ensuring the highest standards of quality and compliance and fostering a culture of scientific rigor, collaboration, and continuous improvement. The Senior Director’s responsibilities will include establishing departmental goals, managing budgets, and overseeing resource allocation to enhance outsourcing execution and efficiency. The Senior Director will collaborate closely with cross-functional teams, including research and development, regulated bioanalytical, clinical research, regulatory affairs, and quality assurance, to provide scientific leadership and strategic and operational guidance throughout the project lifecycle. Additionally, the Senior Director will play a critical role in mentoring and developing talent within the organization, fostering a culture of professional growth, diversity, innovation, and scientific excellence. This position offers a unique opportunity to influence the development of life-saving vaccines, improving public health and driving advancements in the biopharmaceutical industry.

PLEASE NOTE THAT THIS IS NOT A LABORATORY-BASED POSITION.

Main Responsibilities include, but are not limited to:

• Providing scientific and operational leadership to direct reports within the regulated vaccines assay outsourcing group.  Leading and managing change initiatives within the group, fostering a culture of innovation and adaptability.

• Defining and implementing a strategic vision for the vaccines outsourcing group that aligns with organizational goals.  Strong understanding of market trends and regulatory changes that impact bioanalytical practices and drug development. 

• Driving optimization of internal and external processes aimed at improving operating efficiencies, quality, and compliance. Identifying and integrating innovative bioanalytical techniques and technologies to enhance CRO capabilities and efficiency. 

• Cross-functional collaboration and engagement with internal and external stakeholders, including regulatory agencies, to facilitate successful project outcomes and build strategic partnerships. Effectively engage and build internal relationships with diverse teams across the organization, including Regulated Bioanalytical, Clinical Research, Regulatory, Procurement, Biostatistics, etc. to ensure Our Company scientific and quality expectations are achieved.

• Leading and decision-making in consultation with senior management where necessary and through participation in governance meetings, as relates to vaccine assay strategy and team management.

• Managing and overseeing multiple bioanalytical projects simultaneously from initiation to completion, ensuring alignment with development timelines and regulatory requirements. 

• Mentoring and developing future leaders within the organization, promoting professional growth and scientific excellence.  Serve on the OS leadership team to collaborate with other OS leaders on maintaining a strong OS organization with a focus on ensuring scientific excellence and employee development opportunities. 

• Contract Research Organization (CRO)/vendor relationship management, setting clear expectations and standards for CRO performance and quality to ensure compliance, data quality and integrity, and on-time completion of testing.

• Maintaining the highest standards of quality and compliance in all bioanalytical activities, ensuring data integrity and reliability. Establishing performance metrics and driving continuous improvement initiatives to enhance CRO laboratory outcomes.  Raising performance or resource concerns to vendor and escalating within Our Company, if performance issue remains unresolved. 

• Representing Our Company leadership in Site Visits to external lab partners, including data review and compliance assessment against Our Company and regulatory agency expectations.

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