Pfizer IRT Engagement Group Lead, Global Clinical Supply (Director) in Collegeville, Pennsylvania
The IRT Global Oversight Team (IGOT) is a well-established high performing team within Pfizer's Global Clinical Supply unit striving to deliver best in class Interactive Response Technology (IRT) systems providing randomization and drug management capabilities in support of Pfizer's dynamic investigational product portfolio. The patients we serve are our number one priority and IGOT aims to employ the highest quality standards across our internal and vendor IRT solutions. As part of an innovative clinical supply chain, we routinely challenge the status quo in efforts to optimize our systems and processes.
The IRT Engagement Group Lead will manage a team of 6-8 IRT Leads within IGOT that serve as the single point of accountability to partner lines for IRT requirements elicitation, system deployments, and subsequent system amendments for Pfizer's internal and vendor IRT systems.
The IRT Engagement Group Lead will serve as a primary escalation interface for vendor partners and key business lines ensuring awareness of customer needs and priorities and maintaining a strong working relationship. This role will report to the Head of IGOT within Global Clinical Supply.
For this position you will need to have strong people management, business partnering skills, and excellent quality culture to effectively lead your team in providing optimal IRT solutions across a diverse and dynamic portfolio. Strong collaborative spirit to work with the other IGOT Group Leads to align on the IRT strategy, portfolio delivery, resource allocation and talent growth.
Provide management and oversight of IGOT's Engagement function for Pfizer's IRT systems. Provide governance and oversight for vendor IRT systems.
Point of escalation and management interface for key partner lines including Clinical Supply Strategy and Management, Clinical Research Pharmacy team, Business Technology, Quality and Global Product Development (GPD) ensuring strong alignment and partnerships maintained.
Partner closely with other IGOT's Leads for overall portfolio review, resource and workflow planning, issue escalations metrics, and process optimization.
Collaborate and align with the other IGOT Group Leads to develop talent, support the portfolio and deliver an enhanced customer experience for clinical sites and study teams.
Ensure IRT processes are compliant with GCP & GMP guidelines and principles, 21CFR Part 11, and applicable regulations.
Lead quality/compliance investigations and issue resolution and serve as SOP owner for area of responsibility.
Provide quality oversight across the team to maintain and nurture a quality culture across internal and vendor IRT systems.
Lead and/or contribute to cross-functional initiatives that drive increased compliance, quality and efficiency across GCS and GPD.
Maintain strong understanding of the nature of clinical data, with particular regard to the concepts of IRT study configuration, resupply settings, blinding, privacy protection, and data quality/integrity standards.
B.S./B.A. degree is required, with 14+ years managing scientific or clinical projects in biopharma industry
A MS or MBA in business, information systems, supply chain desired.
Advanced knowledge of IRT systems, scientific, technical or clinical disciplines, and/or people development required.
Knowledge and experience working in a GMP / GCP environment and with regulatory audit teams
Project management and/or continuous improvement experience or certification such as PMP, CBAP, AIM or Lean Six Sigma Green Belt/Black Belt a plus
Experience participating in root cause analysis using tools such as FMEA, 5-Why, Cause & Effect Matrix and/or Fish Bone diagram
Possess excellent English language written and verbal communication, interpersonal, collaboration and business partnership capabilities required
Seamlessly work with a global team, partners and customers in a change agile environment
Core Competencies include:
Dealing with ambiguity
Peer and customer relationships
Analytical capability to solve problems
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.
Other Job Details:
Eligible for Relocation Package: Yes
Eligible for Employee Referral Bonus: Yes
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.
Logistics & Supply Chain Mgmt