Director, Data Validation Strategy Lead, Central Services, DMM

Why Patients Need You

Pfizer Worldwide Medical and Safety colleagues play a key role in connecting evidenced based, medical decision support with colleagues and stakeholders to enable better health and treatment outcomes. Whether you are creating framework necessary to ensure our evidence is scientifically sound, providing unbiased, medically necessary expertise or investigating how to close gaps in data, our mission is simple. Empower healthcare decisions regarding the safe and appropriate use of medicines for patients.

What You Will Achieve

It is our mission to strengthen the oversight of our clinical data through stronger ownership, control, and visibility of our clinical data. You will play an important role in processing, reviewing, and receiving patient data and records. You will be organizing clinical data forms from therapeutic groups and outside investigators. You will ensure that accurate, timely, and consistent clinical data reaches the medical department and other groups. You will be relied on for data management plans including data preparation, data validation activities, etc.

You will be a subject matter expert and leverage your knowledge of industry, customer requirements and general business environment to adapt and implement strategic actions for the division. You interpret the team's strategy to establish business priorities that support and help to set a long-term direction . You managerial skills will help us manage and lead people, technological and financial resources within the division.

It is your dedication and focus that will help make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

• Set objectives for and manage multiple projects within a division.

• Ensure work is inspection ready and act as a key data management contact for regulatory inspections/audits in liaison with the appropriate Quality and Safety groups within Pfizer.

• Manage the design, development, and maintenance of key data management deliverables used to maintain the integrity of clinical data as well as ensuring quality study data set release and consistency in asset/submission data.

• Anticipate, oversee and influence change to position efficient, high-quality operational delivery.

• Develop and leverage resources to implement innovative ideas, processes or products across the Pfizer enterprise.

• Build and oversee a high performing team of Clinical Data Scientists to deliver data monitoring and management expertise with desired quality to Research/Business Units and other Global Product Development lines.

Qualifications

Must-Have

• Bachelor's Degree

• 10+ years' experience

• Demonstrated relevant experience in a pharmaceutical, biotech, CRO, or Regulatory Agency with an emphasis on building data collection and assimilation solutions

• Thorough understanding of regulatory requirements and relevant data standards

• Knowledge of vendor processes and best practices in outsourcing

• Strong communication, leadership, decision-making, influencing, negotiation, and project management skills

• Strong people management experience

• Technical skills and experience using relational databases and data visualization tools

Nice-to-Have

• Master's degree

• Relevant pharmaceutical experience

• CDISC knowledge and experience

• Oncology-related experience

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.

Work Location Assignment: Flexible

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. This position requires permanent work authorization in the United States.

Medical