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TA Head, Data Monitoring and Management (Senior Director)

Pfizer


Location:
Peapack and Gladstone, NJ
Date:
01/30/2018
2018-01-302018-03-02
Pfizer
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Job Details

**Role Summary:**



As part of the Data Monitoring and Management group, an integral delivery unit within the Global Biometrics and Data Management organization, the Data Monitoring and Management TA Lead is responsible for timely and high quality data management deliverables supporting the Pfizer portfolio. This role will establish asset level strategies and services across specified therapeutic areas including excellence in the application of standards, establishment of advanced, predictive data monitoring practices from database activation through database release and submission. This position drives and maintains a culture of delivering to established milestones with the highest of customer satisfaction; emphasizing communication and transparency of operations. This role will require direct leadership of functional operation teams as well as aligned, influential leadership in collaboration with Clinical Operations Group, Clinical, Regulatory and other functions as required







**Responsibilities:**



Single point of accountability for TA data management and monitoring data deliverables.



Establishes asset strategies and implements in alignment with Business Unit (BU)/Research Unit (RU) and department goals and budget for multiple, large or complex assets or indications



Establishes strong partnerships with BU/RU, department leadership and others to advance asset or indication goals. This includes connecting data strategies between research and clinical (eg. Precision Medicine)



Ensures alignment across outsourced partners as well as across CS&O for project delivery.



Anticipates, oversees and influences change to position efficient, high-quality implementation of required data flows to incorporate internal and external data sources into Pfizer informatics environment ensuring operational delivery and traceability from source. Ensures appropriate process and documentation are in place to support inspection readiness.



Promotes and oversees data integrity and Key Risk indicators in support of Risk Based Monitoring.



Identifies, evaluates and prioritizes clinical data reuse opportunities that support portfolio commitments and future horizons of scientific support.



Oversees data due diligence activities for in-licensing, co-development, and research collaborations.



Develops a strong talent base of clinical data scientists, ensuring achievement of competency standards and preparing for long-term development needs, via mentoring or matrix management



Supports and mentors data monitoring and management subject matter experts to ensure proper







**QUALIFICATIONS**







+ Bachelor or Master Degree in Biological Sciences, Statistics, IT or related field with a strong understanding of biomedical data and analytics. Advanced degree is a plus.



+ At least 10 years relevant experience in a pharmaceutical, biotech, CRO or Regulatory Agency.



+ Strong leadership capabilities including ability to drive strong following in reporting lines.



+ Experience with Clinical Trial Operations and a clear understanding of clinical data from internal as well as external sources.



+ Demonstrated knowledge of regulatory requirements supporting clinical trials and submissions.



+ Demonstrated experience to manage complex projects and cross-functional teams including delivering to project and portfolio metrics.



+ Demonstrated strong communication, interpersonal and negotiating skills in relating to colleagues and associates internal/external to the organization and leveraging of those competencies to ensure continuous progress.



+ Strong track record of building successful relations with supervisors, peers, direct reports, suppliers, customers, partners and stakeholders is essential.



+ Strong strategic experience and business analytics ability to distill research needs and define business, technical, and operational requirements.







Expertise in globalizing functions to operate in a standardized fashion. Sound knowledge and experience working across international boundaries and cultures.







**ORGANIZATIONAL RELATIONSHIPS**







+ Reporting to VP and Global Head, DMM



+ Supports Study and Asset Teams across the Global Product Development, Worldwide Research and Development and other internal organizations. Accountable for establishing and managing operations in the United States, India, China and external vendor / partners.







**RESOURCES MANAGED**



**Financial Accountability**



Shared accountability along with peer LT members for overall DMM budget and planning and specific accountability for DMM deliverables. Align delivery strategy to ensure responsible, efficient use of resources to deliver analyses required within budget. Accountable for accurate forecasting for future budget estimates and direct reports expenses.







**Supervision**



A global team of approximately 8-10 direct reports inclusive of both people managers and individual contributors of Associate Directors and Directors. Indirect management of 80 plus individuals.







**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.







**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.







**Other Job Details:**







+ Additional Location Information: Collegeville PAEligible for Relocation Package - YesEligible for Employee Referral Bonus - Yes







Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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